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An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)

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: NCT01769456
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : November 13, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Gilead Sciences
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infection
Interventions Behavioral: PCC
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Enrollment 78

Recruitment Details This research was conducted at 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.
Pre-assignment Details  
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description 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: Overall Study
Started 78 [1]
Completed 41
Not Completed 37
Reason Not Completed
Lost to Follow-up             19
Withdrawal by Subject             3
Did not receive PCC intervention             6
Moved out of the area             3
No wk 0 visit w/in 30 days of screening             5
Parental request to youth to withdraw             1
[1]
1 subject inadvertently enrolled, discontin'd after baseline, re-enrolled later and completed study
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description 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 Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
16.52  (0.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
0
   0.0%
Male
78
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Hispanic or Latino
35
  44.9%
Not Hispanic or Latino
42
  53.8%
Unknown or Not Reported
1
   1.3%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Black/African-American Number Analyzed 78 participants
Black/African-American
33
  42.3%
Non-Black/African-American
45
  57.7%
[1]
Measure Description: Modified binary variable for race, distinguishing only those who identified as Black/African-American from those who did not.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race/ethnicity Number Analyzed 78 participants
Asian/Pacific Islander
2
   2.6%
Black/African American
23
  29.5%
White
11
  14.1%
White/Hispanic
16
  20.5%
Other/Mixed Race
26
  33.3%
[1]
Measure Description: Derived variable combining information on race and ethnicity.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 78 participants
78
 100.0%
Lumbar spine bone mineral density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 75 participants
1.03  (0.15)
[1]
Measure Analysis Population Description: Subjects with DXA data at baseline.
Femoral neck bone mineral density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 75 participants
0.99  (0.16)
[1]
Measure Analysis Population Description: Subjects with DXA data at baseline.
Total body bone mineral density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 75 participants
1.15  (0.11)
[1]
Measure Analysis Population Description: Subjects with DXA data at baseline.
Total hip bone mineral density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 75 participants
1.06  (0.15)
[1]
Measure Analysis Population Description: Subjects with DXA data at baseline.
Number of participants reporting unprotected sex with a male partner in the past month   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
52
  86.7%
[1]
Measure Description:

From the participant ACASI question referring to male partners in the past month:

“Of these males, how many did you have unprotected oral or anal sex with in the past month?”

An event is defined as an answer of greater than 0.

[2]
Measure Analysis Population Description: Participants who provided a response to this question on the ACASI survey.
Number of male sexual partners in the last month   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Male sexual partners
Number Analyzed 73 participants
1.95  (2.15)
[1]
Measure Description:

From the participant ACASI question:

"During the past month, how many male partners have you had sexual contact with (oral or anal)?"

[2]
Measure Analysis Population Description: Participants who provided a response to this question on the ACASI survey.
1.Primary Outcome
Title Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
Hide Description

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
Hide Description

The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:

Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percent change
2.59  (3.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Reported p-value is the calculated value provided by SAS output.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
3.Primary Outcome
Title Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
Hide Description

The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:

Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects with DXA data at both baseline and Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percent change
1.16  (3.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
4.Primary Outcome
Title Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
Hide Description

The percent change in total body BMD from baseline measurement to Week 48 is calculated as:

Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects with DXA data at both baseline and Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percent change
1.29  (2.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
5.Primary Outcome
Title Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
Hide Description

The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:

Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects with DXA data at both baseline and Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percent change
1.27  (3.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCC Behavioral Intervention Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
6.Primary Outcome
Title Number of Participants With Decrease in Bone Mineral Density
Hide Description

The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

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
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease in absolute BMD >=1% baseline to Wk48
16
  37.2%
Decrease in absolute BMD >=5% baseline to Wk48
2
   4.7%
Decrease in absolute BMD >10% baseline to Wk48
0
   0.0%
7.Primary Outcome
Title Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
Hide Description

Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:

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

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing data for this question at Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
25
  80.6%
8.Primary Outcome
Title Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
Hide Description

Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:

“Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?”

This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.

Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants providing data for this question at Week 48.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: male sexual partners
1.64  (1.88)
9.Primary Outcome
Title Acceptability of PrEP Regimen and Study Visits
Hide Description

This represents one of the indicators associated with 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.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question)
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 62
Measure Type: Count of Participants
Unit of Measure: Participants
Size of the pill Number Analyzed 59 participants
Did not like it at all
3
   5.1%
Did not like
14
  23.7%
Liked
36
  61.0%
Liked a lot
6
  10.2%
Taste of the pill Number Analyzed 60 participants
Did not like it at all
8
  13.3%
Did not like
27
  45.0%
Liked
22
  36.7%
Liked a lot
3
   5.0%
Color of the pill Number Analyzed 61 participants
Did not like it at all
2
   3.3%
Did not like
8
  13.1%
Liked
42
  68.9%
Liked a lot
9
  14.8%
Taking the pill every day Number Analyzed 59 participants
Did not like it at all
1
   1.7%
Did not like
17
  28.8%
Liked
34
  57.6%
Liked a lot
7
  11.9%
Taking part in the study Number Analyzed 62 participants
Did not like it at all
1
   1.6%
Did not like
0
   0.0%
Liked
26
  41.9%
Liked a lot
35
  56.5%
HIV test at every visit Number Analyzed 62 participants
Did not like it at all
1
   1.6%
Did not like
4
   6.5%
Liked
25
  40.3%
Liked a lot
32
  51.6%
Risk Reduction Counseling at every visit Number Analyzed 61 participants
Did not like it at all
2
   3.3%
Did not like
3
   4.9%
Liked
26
  42.6%
Liked a lot
30
  49.2%
Questions about sexual behavior at every visit Number Analyzed 62 participants
Did not like it at all
2
   3.2%
Did not like
10
  16.1%
Liked
36
  58.1%
Liked a lot
14
  22.6%
Physician exam by a doctor Number Analyzed 60 participants
Did not like it at all
1
   1.7%
Did not like
9
  15.0%
Liked
35
  58.3%
Liked a lot
15
  25.0%
Health clinic for study visits Number Analyzed 62 participants
Did not like it at all
1
   1.6%
Did not like
3
   4.8%
Liked
41
  66.1%
Liked a lot
17
  27.4%
10.Primary Outcome
Title Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
Hide Description

This outcome addresses the objective: 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.

Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.

The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).

The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)

Time Frame Week 4, Week 12, Week 24, Week 36, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
DBS RBC TFV-DP (fmol/punch), Week 4 Number Analyzed 65 participants
Below level of quantification
3
   4.6%
<2 days
12
  18.5%
2 days
11
  16.9%
4 days
24
  36.9%
Daily
15
  23.1%
DBS RBC TFV-DP (fmol/punch), Week 8 Number Analyzed 63 participants
Below level of quantification
3
   4.8%
<2 days
13
  20.6%
2 days
14
  22.2%
4 days
21
  33.3%
Daily
12
  19.0%
DBS RBC TFV-DP (fmol/punch), Week 12 Number Analyzed 60 participants
Below level of quantification
3
   5.0%
<2 days
17
  28.3%
2 days
7
  11.7%
4 days
22
  36.7%
Daily
11
  18.3%
DBS RBC TFV-DP (fmol/punch), Week 24 Number Analyzed 55 participants
Below level of quantification
15
  27.3%
<2 days
18
  32.7%
2 days
5
   9.1%
4 days
12
  21.8%
Daily
5
   9.1%
DBS RBC TFV-DP (fmol/punch), Week 36 Number Analyzed 44 participants
Below level of quantification
17
  38.6%
<2 days
11
  25.0%
2 days
6
  13.6%
4 days
7
  15.9%
Daily
3
   6.8%
DBS RBC TFV-DP (fmol/punch), Week 48 Number Analyzed 40 participants
Below level of quantification
19
  47.5%
<2 days
8
  20.0%
2 days
2
   5.0%
4 days
7
  17.5%
Daily
4
  10.0%
11.Secondary Outcome
Title Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation
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 session interesting, was it relevant to their life, and did they learn from the session)
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected; only one type of risk reduction intervention was ultimately implemented.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants Using Text Messaging Reminders
Hide Description This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.
Time Frame Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Signed up for text message reminders Number Analyzed 78 participants
22
  28.2%
Discontinued reminders while on study agent Number Analyzed 22 participants
2
   9.1%
Discontinued reminders while still on study Number Analyzed 22 participants
1
   4.5%
13.Secondary Outcome
Title Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Hide Description

This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.

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:

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Were away from home Number Analyzed 40 participants
Never
15
  37.5%
Rarely
8
  20.0%
Sometimes
12
  30.0%
Often
5
  12.5%
Were too busy with other things Number Analyzed 40 participants
Never
15
  37.5%
Rarely
10
  25.0%
Sometimes
7
  17.5%
Often
8
  20.0%
Simply forgot Number Analyzed 40 participants
Never
21
  52.5%
Rarely
4
  10.0%
Sometimes
7
  17.5%
Often
8
  20.0%
Had too many study pills to take Number Analyzed 40 participants
Never
36
  90.0%
Rarely
4
  10.0%
Sometimes
0
   0.0%
Often
0
   0.0%
Wanted to avoid side effects Number Analyzed 40 participants
Never
37
  92.5%
Rarely
2
   5.0%
Sometimes
1
   2.5%
Often
0
   0.0%
Did not want others to notice you taking meds Number Analyzed 40 participants
Never
36
  90.0%
Rarely
3
   7.5%
Sometimes
0
   0.0%
Often
1
   2.5%
Had a change in daily routine Number Analyzed 40 participants
Never
27
  67.5%
Rarely
4
  10.0%
Sometimes
5
  12.5%
Often
4
  10.0%
14.Secondary Outcome
Title Demographic and/or Behavioral Difference Between Study Groups. 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 were not collected.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Evaluation of the Process of Protocol Implementation
Hide Description

Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.

NOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:

Gilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9.

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Quantitative data were not collected for this outcome.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.
Hide Description Behavioral disinhibition/risk compensation endpoints will be compared.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title PCC Behavioral Intervention Group
Hide Arm/Group Description:

PCC Behavioral Intervention Group 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 (PrEP).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
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 PCC Behavioral Intervention Group
Hide Arm/Group Description

PCC Behavioral Intervention Group 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 (PrEP

All-Cause Mortality
PCC Behavioral Intervention Group
Affected / at Risk (%)
Total   0/78 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PCC Behavioral Intervention Group
Affected / at Risk (%) # Events
Total   3/78 (3.85%)    
Infections and infestations   
Appendicitis  1  1/78 (1.28%)  1
Cellulitis  1  1/78 (1.28%)  1
Nervous system disorders   
Convulsion  1  1/78 (1.28%)  1
Psychiatric disorders   
Suicidal Ideation  1  1/78 (1.28%)  1
Depression  1  1/78 (1.28%)  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%
PCC Behavioral Intervention Group
Affected / at Risk (%) # Events
Total   6/78 (7.69%)    
Investigations   
Weight Decreased  1  1/78 (1.28%)  1
Metabolism and nutrition disorders   
Abnormal loss of weight  1  2/78 (2.56%)  4
Hypokalaemia  1  1/78 (1.28%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/78 (1.28%)  1
Psychiatric disorders   
Suicidal Ideation  1  1/78 (1.28%)  1
1
Term from vocabulary, MedDRA SOC
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications, and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
Results Point of Contact
Name/Title: Dr. Bob Harris
Organization: Westat
Phone: 301-251-1500
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01769456     History of Changes
Other Study ID Numbers: ATN 113 Version 2.0
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: October 6, 2017
Results First Posted: November 13, 2017
Last Update Posted: January 17, 2018