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An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01772823
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : December 21, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infection
Interventions Behavioral: 3MV
Behavioral: PCC
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Enrollment 200
Recruitment Details This research was conducted at 12 clinical sites. Accrual was open between July 2012 and September 2013.
Pre-assignment Details  
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Period Title: Behavioral Intervention (BL -3MV or PCC)
Started 128 72
Completed 116 70
Not Completed 12 2
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             1             1
Inadvertent enrollment             1             0
Inelligible at rescreen             2             1
Wk 0 not completed, 30 days of baseline             6             0
Moved out of area             1             0
Period Title: Treatment Phase (Week 0- Week 48)
Started 116 70
Completed 88 52
Not Completed 28 18
Reason Not Completed
Lost to Follow-up             15             13
Withdrawal by Subject             6             1
Moved out of area             4             3
Incarcerated             1             0
Suicide gesture/disruptive behavior             1             0
Wk 0 not completed, 30 days of baseline             1             1
Period Title: Extension Phase (Visits 24,48wks Post tx
Started 63 [1] 42 [2]
Completed 53 33
Not Completed 10 9
Reason Not Completed
Lost to Follow-up             6             5
Withdrawal by Subject             1             2
Moved out of area             2             2
Became unavailable for study visits             1             0
[1]
25 of the 88 subjects that completed the Treatment Phase were not eligible for the Extension Phase
[2]
10 of the 52 subjects that completed the Treatment Phase were not eligible for the Extension Phase
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group Total
Hide Arm/Group Description 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 128 72 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 72 participants 200 participants
20.14  (1.40) 20.25  (1.23) 20.18  (1.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 72 participants 200 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
128
 100.0%
72
 100.0%
200
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/ethnicity Number Analyzed 128 participants 72 participants 200 participants
Asian/Pacific Islander
2
   1.6%
0
   0.0%
2
   1.0%
Black/African American
55
  43.0%
38
  52.8%
93
  46.5%
White
26
  20.3%
16
  22.2%
42
  21.0%
White/Hispanic
15
  11.7%
6
   8.3%
21
  10.5%
Other/Mixed Race
30
  23.4%
12
  16.7%
42
  21.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic Ethnicity Number Analyzed 128 participants 72 participants 200 participants
Hispanic
39
  30.5%
14
  19.4%
53
  26.5%
Non-Hispanic
89
  69.5%
56
  77.8%
145
  72.5%
Refused
0
   0.0%
2
   2.8%
2
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 128 participants 72 participants 200 participants
128
 100.0%
72
 100.0%
200
 100.0%
BMI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 72 participants 200 participants
Underweight (<18.5 kg/m^2)
3
   2.3%
6
   8.3%
9
   4.5%
Normal (18.5-<25 kg/m^2)
71
  55.5%
38
  52.8%
109
  54.5%
Overweight (25.0-<30 kg/m^2)
25
  19.5%
18
  25.0%
43
  21.5%
Obese (=>30 kg/m^2)
29
  22.7%
10
  13.9%
39
  19.5%
1.Primary Outcome
Title Number of Participants With Serum Creatinine Event of Grade 1 or Higher
Hide Description

This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM

Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 – 1.3 x ULN, where ULN is the Upper limit of normal.

Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with visit data through 48 weeks. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 137
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
2.Primary Outcome
Title Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
Hide Description

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM."

The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48.

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects with DXA results for Baseline and Week 48 The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease in absolute BMD >=1%
97
  71.9%
Decrease in absolute BMD >=5%
16
  11.9%
Decrease in absolute BMD >10%
1
   0.7%
3.Primary Outcome
Title Lumbar Spine Bone Mineral Density at Baseline and at Week 48
Hide Description

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for lumbar spine.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: g/cm2
Lumbar spine BMD at baseline Number Analyzed 197 participants
1.09  (0.15)
Lumbar spine BMD Week 48 Number Analyzed 135 participants
1.08  (0.14)
4.Primary Outcome
Title Femoral Neck Bone Mineral Density at Baseline and at Week 48
Hide Description

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for femoral neck.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: g/cm2
Femoral neck BMD at baseline Number Analyzed 197 participants
1.04  (0.18)
Femoral neck Week 48 Number Analyzed 135 participants
1.03  (0.20)
5.Primary Outcome
Title Total Body Bone Mineral Density at Baseline and at Week 48
Hide Description

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for total body.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: g/cm2
Total body BMD at baseline Number Analyzed 197 participants
1.20  (.011)
Total body BMD Week 48 Number Analyzed 135 participants
1.18  (0.11)
6.Primary Outcome
Title Total Hip Bone Mineral Density at Baseline and at Week 48
Hide Description

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for total hip.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: g/cm2
Total hip BMD at baseline Number Analyzed 197 participants
1.10  (0.16)
Total hip BMD Week 48 Number Analyzed 135 participants
1.08  (0.17)
7.Primary Outcome
Title Number of Participants With Unprotected Sex Acts
Hide Description

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

Responses to the participant ACASI question referring to male partners in the past month/since the last survey:

"Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month?" (Baseline), or "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?" (Week 48) An event is defined as an answer of greater than 0.

Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
Had unprotected oral/anal w/male (BL) Number Analyzed 177 participants
143
  80.8%
Had unprotected oral/anal w/ male (Wk48) Number Analyzed 119 participants
103
  86.6%
8.Primary Outcome
Title Number of Sex Partners
Hide Description

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:

"During the past month, how many male partners have you had sexual contact with (oral or anal)?" (Baseline), or "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?” (Week 48)

And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:

"Of those you had unprotected sex with, how many did you know were HIV positive?”

Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: sexual partners
Male sexual partners last month (baseline) Number Analyzed 200 participants
5.41  (26.03)
Male sexual partners since last survey (Wk 48) Number Analyzed 137 participants
2.46  (2.92)
Number HIV+ male partners last month (baseline) Number Analyzed 200 participants
1.65  (16.77)
Number HIV+ male partners since last survey(Wk48) Number Analyzed 137 participants
0.15  (0.38)
9.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill
Hide Description

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 101 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
13
  12.9%
5
   8.2%
Did not like
26
  25.7%
18
  29.5%
Liked
60
  59.4%
36
  59.0%
Liked a lot
2
   2.0%
2
   3.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7513
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the "Size of the Pill") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
10.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill
Hide Description

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about the taste of the pill.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 100 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
11
  11.0%
8
  13.1%
Did not like
33
  33.0%
23
  37.7%
Liked
53
  53.0%
29
  47.5%
Liked a lot
3
   3.0%
1
   1.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8281
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the "Taste of the Pill") differ between intervention arms.
Method Chi-squared
Comments Pearson Chi-Square
11.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill
Hide Description

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about the color of the pill.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 101 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
3
   3.0%
2
   3.3%
Did not like
7
   6.9%
6
   9.8%
Liked
73
  72.3%
48
  78.7%
Liked a lot
18
  17.8%
5
   8.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3761
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the "Color of the Pill") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
12.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day
Hide Description

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about taking the pill every day.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 100 60
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
6
   6.0%
4
   6.7%
Did not like
24
  24.0%
17
  28.3%
Liked
63
  63.0%
31
  51.7%
Liked a lot
7
   7.0%
8
  13.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4359
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on "Taking the pill every day") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
13.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study
Hide Description

This outcome addresses the objective "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about taking part in the study.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 102 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
1
   1.0%
1
   1.6%
Did not like
2
   2.0%
1
   1.6%
Liked
35
  34.3%
29
  47.5%
Liked a lot
64
  62.7%
30
  49.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3801
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on "Taking part in the study") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
14.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit
Hide Description

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 102 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
1
   1.0%
0
   0.0%
Did not like
1
   1.0%
4
   6.6%
Liked
29
  28.4%
15
  24.6%
Liked a lot
71
  69.6%
42
  68.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1968
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on "HIV test at every visit") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
15.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit
Hide Description

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 102 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
2
   2.0%
1
   1.6%
Did not like
1
   1.0%
5
   8.2%
Liked
38
  37.3%
23
  37.7%
Liked a lot
61
  59.8%
32
  52.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1226
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on "Risk Reduction counseling at every visit") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
16.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior
Hide Description

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 101 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
1
   1.0%
1
   1.6%
Did not like
8
   7.9%
13
  21.3%
Liked
61
  60.4%
31
  50.8%
Liked a lot
31
  30.7%
16
  26.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0994
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on "Questions about sexual behavior") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
17.Primary Outcome
Title Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam
Hide Description

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 12 who provided a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 101 61
Measure Type: Count of Participants
Unit of Measure: Participants
Did not like it at all
1
   1.0%
1
   1.6%
Did not like
13
  12.9%
4
   6.6%
Liked
54
  53.5%
38
  62.3%
Liked a lot
33
  32.7%
18
  29.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5285
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the "Physician exam") differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
18.Primary Outcome
Title Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
Hide Description

This outcome addresses the objective: "Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350– 699 fmol per punch (2–3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily).

Time Frame Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 173 participants
Below level of quantification
13
   7.5%
<2 days
35
  20.2%
2 days
58
  33.5%
4 days
59
  34.1%
Daily
8
   4.6%
Week 8 Number Analyzed 164 participants
Below level of quantification
7
   4.3%
<2 days
32
  19.5%
2 days
30
  18.3%
4 days
69
  42.1%
Daily
26
  15.9%
Week 12 Number Analyzed 159 participants
Below level of quantification
12
   7.5%
<2 days
32
  20.1%
2 days
26
  16.4%
4 days
55
  34.6%
Daily
34
  21.4%
Week 24 Number Analyzed 148 participants
Below level of quantification
28
  18.9%
<2 days
36
  24.3%
2 days
14
   9.5%
4 days
42
  28.4%
Daily
28
  18.9%
Week 36 Number Analyzed 134 participants
Below level of quantification
30
  22.4%
<2 days
27
  20.1%
2 days
23
  17.2%
4 days
26
  19.4%
Daily
28
  20.9%
Week 48 Number Analyzed 120 participants
Below level of quantification
37
  30.8%
<2 days
24
  20.0%
2 days
18
  15.0%
4 days
26
  21.7%
Daily
15
  12.5%
19.Primary Outcome
Title Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
Hide Description PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.
Time Frame Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: pmol/punch
DBS RBC FTC-TP at Week 4 Number Analyzed 173 participants
0.20  (0.11)
DBS RBC FTC-TP at Week 8 Number Analyzed 164 participants
0.19  (0.12)
DBS RBC FTC-TP at Week 12 Number Analyzed 159 participants
0.18  (0.12)
DBS RBC FTC-TP at Week 24 Number Analyzed 148 participants
0.16  (0.12)
DBS RBC FTC-TP at Week 36 Number Analyzed 134 participants
0.17  (0.13)
DBS RBC FTC-TP at Week 48 Number Analyzed 120 participants
0.15  (0.13)
20.Primary Outcome
Title Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
Hide Description

This outcome addresses the objective: "Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations.

Time Frame Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: fmol/punch
DBS RBC TFV-DP at Week 4 Number Analyzed 173 participants
584.56  (365.37)
DBS RBC TFV-DP at Week 8 Number Analyzed 164 participants
783.18  (505.67)
DBS RBC TFV-DP at Week 12 Number Analyzed 159 participants
793.37  (548.87)
DBS RBC TFV-DP at Week 24 Number Analyzed 148 participants
657.66  (619.06)
DBS RBC TFV-DP at Week 36 Number Analyzed 134 participants
671.72  (678.37)
DBS RBC TFV-DP at Week 48 Number Analyzed 120 participants
528.24  (570.80)
21.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 1 of 10: "I learned a lot from this workshop/session"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 83
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
47
  69.1%
32
  38.6%
Agree
16
  23.5%
47
  56.6%
Disagree
2
   2.9%
4
   4.8%
Strongly Disagree
3
   4.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
22.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 2 of 10: "I will be able to apply what I learned from this workshop/session in my life"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 83
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
50
  73.5%
48
  57.8%
Agree
13
  19.1%
34
  41.0%
Disagree
2
   2.9%
1
   1.2%
Strongly Disagree
3
   4.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
23.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 3 of 10: "I was given an opportunity to participate and discuss information with others"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
55
  80.9%
55
  67.1%
Agree
10
  14.7%
21
  25.6%
Disagree
0
   0.0%
4
   4.9%
Strongly Disagree
3
   4.4%
2
   2.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0766
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
24.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 4 of 10: "The workshop/session was well organized"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
49
  72.1%
66
  80.5%
Agree
13
  19.1%
15
  18.3%
Disagree
4
   5.9%
1
   1.2%
Strongly Disagree
2
   2.9%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1581
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
25.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 5 of 10: "The topic of this workshop/session was interesting"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 67 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
47
  70.1%
56
  68.3%
Agree
16
  23.9%
23
  28.0%
Disagree
2
   3.0%
3
   3.7%
Strongly Disagree
2
   3.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4300
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
26.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 6 of 10: "The presenter(s) stimulated my interest in the material"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
50
  73.5%
54
  65.9%
Agree
14
  20.6%
26
  31.7%
Disagree
1
   1.5%
2
   2.4%
Strongly Disagree
3
   4.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1201
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
27.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 7 of 10: "The topic of this workshop/session was relevant to my life"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 83
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
50
  73.5%
65
  78.3%
Agree
13
  19.1%
17
  20.5%
Disagree
1
   1.5%
1
   1.2%
Strongly Disagree
4
   5.9%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1682
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
28.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 8 of 10: "The workshop/session was enjoyable."

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
47
  69.1%
49
  59.8%
Agree
14
  20.6%
28
  34.1%
Disagree
5
   7.4%
4
   4.9%
Strongly Disagree
2
   2.9%
1
   1.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2747
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
29.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 9 of 10: "I would recommend this workshop/session to others."

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 82
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
49
  72.1%
47
  57.3%
Agree
10
  14.7%
31
  37.8%
Disagree
6
   8.8%
4
   4.9%
Strongly Disagree
3
   4.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
30.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session."
Hide Description

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 10 of 10: "I felt comfortable participating in this workshop/session."

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing a response to this question on the Session Evaluation Form
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:
3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Overall Number of Participants Analyzed 68 83
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
54
  79.4%
55
  66.3%
Agree
9
  13.2%
23
  27.7%
Disagree
2
   2.9%
5
   6.0%
Strongly Disagree
3
   4.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0290
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
31.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's age at enrollment.

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Mean (Standard Deviation)
Unit of Measure: years
20.28  (1.32) 19.93  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1070
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
32.Secondary Outcome
Title Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's race (5 categories)

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Measure Type: Count of Participants
Unit of Measure: Participants
Asian/Pacific Islander
2
   1.4%
0
   0.0%
Black/African American
71
  50.4%
22
  37.3%
White
25
  17.7%
17
  28.8%
White/Hispanic
15
  10.6%
6
  10.2%
Other/Mixed Race
28
  19.9%
14
  23.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2991
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).
Method Fisher Exact
Comments [Not Specified]
34.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's race (2 categories)

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Measure Type: Count of Participants
Unit of Measure: Participants
Black/African-American
84
  59.6%
25
  42.4%
Non-Black/African-American
57
  40.4%
34
  57.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0298
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).
Method Fisher Exact
Comments [Not Specified]
35.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Measure Type: Count of Participants
Unit of Measure: Participants
Hispanic or Latino
36
  25.5%
17
  28.8%
Non-Hispanic
103
  73.0%
42
  71.2%
Refused to answer
2
   1.4%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8643
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).
Method Fisher Exact
Comments [Not Specified]
36.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's BMI (kg/m2), assessed categorically.

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Measure Type: Count of Participants
Unit of Measure: Participants
Underweight (<18.5)
6
   4.3%
3
   5.1%
Normal (18.5- <25)
78
  55.3%
31
  52.5%
Overweight (25.0 - <30)
31
  22.0%
12
  20.3%
Obese (>=30)
26
  18.4%
13
  22.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9037
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).
Method Fisher Exact
Comments [Not Specified]
37.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 141 59
Mean (Standard Deviation)
Unit of Measure: copies/ml
1.22  (0.60) 1.14  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5279
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
38.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)
Hide Description

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing ACASI data for these questions
Arm/Group Title On Prep Off Prep
Hide Arm/Group Description:
Remained on study agent
Prematurely discontinued from the study agent
Overall Number of Participants Analyzed 123 54
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (Had high risk sex acts w/ male partner)
101
  82.1%
42
  77.8%
No (no high risk sex acts w/ male partner)
22
  17.9%
12
  22.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On Prep, Off Prep
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5369
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).
Method Fisher Exact
Comments [Not Specified]
39.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
Hide Description Total number of subjects who signed up for text message reminders
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
76
  38.0%
40.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
Hide Description Number of subjects who discontinued receiving text message reminders while they were still on the study agent
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.
Overall Number of Participants Analyzed 76
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.9%
41.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Were away from home?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
31
  41.9%
22
  44.9%
Rarely
17
  23.0%
11
  22.4%
Sometimes
19
  25.7%
10
  20.4%
Often
7
   9.5%
6
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2193
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
42.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Were too busy with other things?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
33
  44.6%
24
  49.0%
Rarely
17
  23.0%
10
  20.4%
Sometimes
14
  18.9%
11
  22.4%
Often
10
  13.5%
4
   8.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1255
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
43.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Simply forgot?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
28
  37.8%
21
  42.9%
Rarely
18
  24.3%
14
  28.6%
Sometimes
18
  24.3%
9
  18.4%
Often
10
  13.5%
5
  10.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0706
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
44.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Had too many study pills to take?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 73 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
62
  84.9%
46
  93.9%
Rarely
7
   9.6%
1
   2.0%
Sometimes
2
   2.7%
1
   2.0%
Often
2
   2.7%
1
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
45.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Wanted to avoid side effects?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 73 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
64
  87.7%
42
  85.7%
Rarely
7
   9.6%
4
   8.2%
Sometimes
2
   2.7%
1
   2.0%
Often
0
   0.0%
2
   4.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2482
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
46.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Did not want others to notice you taking meds?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
65
  87.8%
43
  87.8%
Rarely
7
   9.5%
3
   6.1%
Sometimes
1
   1.4%
1
   2.0%
Often
1
   1.4%
2
   4.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1647
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
47.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Had a change in daily routine?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
51
  68.9%
31
  63.3%
Rarely
9
  12.2%
5
  10.2%
Sometimes
10
  13.5%
7
  14.3%
Often
4
   5.4%
6
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6880
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
48.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt like the study pill was toxic/harmful?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
71
  95.9%
45
  91.8%
Rarely
3
   4.1%
1
   2.0%
Sometimes
0
   0.0%
1
   2.0%
Often
0
   0.0%
2
   4.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2881
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
49.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Fell asleep/slept through dose time?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
52
  70.3%
35
  71.4%
Rarely
13
  17.6%
6
  12.2%
Sometimes
5
   6.8%
7
  14.3%
Often
4
   5.4%
1
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2223
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
50.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt sick or ill?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
61
  82.4%
43
  87.8%
Rarely
9
  12.2%
1
   2.0%
Sometimes
3
   4.1%
4
   8.2%
Often
1
   1.4%
1
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0617
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
51.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt depressed/overwhelmed?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
62
  83.8%
43
  87.8%
Rarely
10
  13.5%
1
   2.0%
Sometimes
1
   1.4%
4
   8.2%
Often
1
   1.4%
1
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0868
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
52.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Ran out of study pills?"

Time Frame 48 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
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3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
67
  90.5%
44
  89.8%
Rarely
7
   9.5%
1
   2.0%
Sometimes
0
   0.0%
1
   2.0%
Often
0
   0.0%
3
   6.1%
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Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1847
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
53.Secondary Outcome
Title Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)
Hide Description

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Didn't think you needed it because you weren't having risk sex?"

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled at Week 48 providing a response to this question.
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description:

3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis

Overall Number of Participants Analyzed 73 49
Measure Type: Count of Participants
Unit of Measure: Participants
Never
58
  79.5%
43
  87.8%
Rarely
12
  16.4%
4
   8.2%
Sometimes
1
   1.4%
1
   2.0%
Often
2
   2.7%
1
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3MV Behavioral Intervention Group, PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks.
Adverse Event Reporting Description Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
 
Arm/Group Title 3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Hide Arm/Group Description 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
All-Cause Mortality
3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)      0/72 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/128 (5.47%)      1/72 (1.39%)    
Gastrointestinal disorders     
Colitis  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Injury, poisoning and procedural complications     
Road traffic accident  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Psychiatric disorders     
Suicide attempt  1  2/128 (1.56%)  3 0/72 (0.00%)  0
Post-traumatic stress disorder  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Suicidal ideation  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Psychotic disorder  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/128 (0.00%)  0 1/72 (1.39%)  1
1
Term from vocabulary, MedDRA SOC
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3MV Behavioral Intervention Group PCC Behavioral Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/128 (7.81%)      4/72 (5.56%)    
Gastrointestinal disorders     
Diarrhoea  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Nausea  1  0/128 (0.00%)  0 1/72 (1.39%)  1
Immune system disorders     
Hypersensitivity  1  2/128 (1.56%)  2 1/72 (1.39%)  1
Infections and infestations     
Cytomegalovirus Hepatitis  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Gastroenteritis Shigella  1  1/128 (0.78%)  1 0/72 (0.00%)  0
Inj