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Pre-Exposure Prophylaxis in YMSM

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ClinicalTrials.gov Identifier: NCT01033942
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : March 29, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition HIV
Interventions Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Drug: Placebo
Behavioral: Many Men, Many Voices (3MV)
Enrollment 68

Recruitment Details This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.
Pre-assignment Details Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description

Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Period Title: Overall Study
Started 20 19 19
Completed 18 15 18
Not Completed 2 4 1
Reason Not Completed
Withdrawal by Subject             1             1             1
Lost to Follow-up             1             0             0
Enrolled in Extension Study             0             3             0
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control Total
Hide Arm/Group Description

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 20 19 19 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 19 participants 58 participants
19.8  (1.44) 20.26  (1.45) 19.84  (0.96) 19.97  (1.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
19
 100.0%
19
 100.0%
58
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Hispanic or Latino
7
  35.0%
6
  31.6%
10
  52.6%
23
  39.7%
Not Hispanic or Latino
13
  65.0%
13
  68.4%
9
  47.4%
35
  60.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
American Indian or Alaska Native
1
   5.0%
0
   0.0%
0
   0.0%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  50.0%
12
  63.2%
9
  47.4%
31
  53.4%
White
1
   5.0%
1
   5.3%
2
  10.5%
4
   6.9%
More than one race
8
  40.0%
6
  31.6%
8
  42.1%
22
  37.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 19 participants 58 participants
20 19 19 58
Education   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Eighth Grade of Less 0 0 1 1
GED 0 1 1 2
Highschool Diploma 10 3 5 18
Some College 8 14 8 30
[1]
Measure Description: Not all participants answered every question.
Current Employment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Unemployed 12 11 9 32
Full Time 2 2 2 6
Part Time 6 6 8 20
Housing Experience (Responded YES)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Kicked out of House Due to Sexual Orientation 4 2 3 9
Spent at least 1 Night in Shelter S 5 6 8 19
Have Exchanged Sex for Money or Place to Stay 2 3 5 10
[1]
Measure Description: Not all participants answered every question
Unprotected Anal Sex with Man in Past 30 Days  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Yes 9 7 8 24
No 11 12 11 34
Unprotected Anal or Vaginal Sex with Woman  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Yes 0 2 1 3
No 20 17 18 55
1.Primary Outcome
Title Actual Number of Study Visits Completed by 24 Weeks
Hide Description This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Least Squares Mean (Standard Error)
Unit of Measure: Visits
3.5927  (0.7387) 4.6263  (0.9783) 4.6374  (0.9784)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6983
Comments The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Acceptability of Size of Pill
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: Participants
Did not like it at all 3 3
Did not like 3 3
Liked 3 6
Liked a lot 1 0
Missing response 10 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6921
Comments Not all subjects answered every question.
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Acceptability of the Taste of the Pill
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 4 3
Did not like 1 4
Liked 4 5
Liked a lot 1 0
Missing response 10 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4655
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
4.Primary Outcome
Title Acceptability of the Color of the Pill
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 1 1
Did not like 2 3
Liked 4 5
Liked a lot 3 3
Missing response 10 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
5.Primary Outcome
Title Acceptability of Taking the Pill Everyday
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 3 1
Did not like 3 7
Liked 2 4
Liked a lot 2 0
Missing response 10 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2297
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
6.Primary Outcome
Title Acceptability of Taking Part in the Study
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 2 0 0
Did not like 0 1 0
Liked 0 2 1
Liked a lot 8 9 12
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1886
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
7.Primary Outcome
Title Acceptability of Participating in Group Sessions
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 0 1 0
Did not like 1 2 0
Liked 0 2 4
Liked a lot 9 7 9
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1908
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Primary Outcome
Title Acceptability of Being Randomly Assigned to a Group
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 1 4 0
Did not like 3 2 2
Liked 4 4 5
Liked a lot 1 2 6
Missing response 11 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2240
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
9.Primary Outcome
Title Acceptability of Having an HIV Test at Every Visit
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like 0 1 0
Liked 0 3 1
Liked a lot 10 8 12
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1538
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
10.Primary Outcome
Title Acceptability of Risk Reduction Counseling at Every Visit
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 0 1 0
Liked 1 5 4
Liked a lot 9 6 9
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2151
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
11.Primary Outcome
Title Acceptability of Questions About Sexual Behavior at Every Visit
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 0 1 0
Did not like 0 1 0
Liked 1 4 4
Liked a lot 9 6 9
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2809
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
12.Primary Outcome
Title Acceptability of Being Contacted by the Research Team in Between Visits
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like 0 2 0
Liked 4 5 3
Liked a lot 6 4 10
Missing response 10 8 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1850
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
13.Primary Outcome
Title Acceptability of Physical Examination by a Doctor
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like it at all 0 3 0
Did not like 1 0 0
Liked 2 3 3
Liked a lot 7 6 10
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2366
Comments Not all participants answered every question
Method Fisher Exact
Comments [Not Specified]
14.Primary Outcome
Title Acceptability of Health Clinic for Study Visits
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: participants
Did not like 0 2 0
Liked 4 4 3
Liked a lot 6 6 10
Missing response 10 7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4089
Comments Not all subjects answered every question.
Method Fisher Exact
Comments [Not Specified]
15.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 4
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
10
(0 to 32)
10
(0 to 27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 8
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
14
(0 to 28)
8
(0 to 29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 12
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
10
(0 to 29)
6.5
(0 to 28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 16
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
5
(0 to 27)
19
(0 to 28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 20
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
5
(0 to 35)
10
(0 to 27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
20.Primary Outcome
Title Number of Missed Doses Based on Self-Report Calendar Data-Week 24
Hide Description Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed Doses
17
(0 to 35)
5.5
(0 to 11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Primary Outcome
Title Number of Missed Doses Over Time Based on Self-Report Calendar Data
Hide Description The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Least Squares Mean (Standard Error)
Unit of Measure: Doses
0.4752  (0.3965) 0.4021  (0.3596)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8934
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
22.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Week 4
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 7)
0
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
23.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Week 8
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 1)
0
(0 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
24.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Week 12
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 7)
0
(0 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
25.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Week 16
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 8)
0
(0 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
26.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Week 20
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 3)
0
(0 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6462
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
27.Primary Outcome
Title Number of Missed Doses Based on Medication Refill Dates-Overall
Hide Description Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time Frame 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: Missed doses
0
(0 to 8)
0
(0 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8505
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
28.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 2 0
Measure Type: Number
Unit of Measure: percentage of participants
0 0
29.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 19 2 0
Measure Type: Number
Unit of Measure: percentage of participants
63.2 0
30.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 17 18 17
Measure Type: Number
Unit of Measure: percentage of participants
47.1 0 0
31.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 15 1 1
Measure Type: Number
Unit of Measure: percentage of participants
60 0 0
32.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 13 13 14
Measure Type: Number
Unit of Measure: percentage of participants
53.8 0 0
33.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 12 1 0
Measure Type: Number
Unit of Measure: percentage of participants
41.7 0
34.Primary Outcome
Title Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
Hide Description Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 10 0 0
Measure Type: Number
Unit of Measure: percentage of participants
20
35.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Was Away From Home
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 31.76 48.39
Rarely 34.12 20.43
Sometimes 16.47 26.88
Often 17.65 4.30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7434
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
36.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 47.06 58.06
Rarely 30.59 16.13
Sometimes 15.29 21.51
Often 7.06 4.30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6153
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
37.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Simply Forgot
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 38.82 60.22
Rarely 40.00 16.13
Sometimes 9.41 15.05
Often 11.76 8.60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
38.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 92.94 95.70
Rarely 7.06 2.15
Sometimes 0.00 1.08
Often 0.00 1.08
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5265
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
39.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 82.35 91.40
Rarely 9.41 3.23
Sometimes 0.00 2.15
Often 8.24 3.23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2559
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
40.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 88.24 92.47
Rarely 5.88 4.30
Sometimes 2.35 0.00
Often 3.53 3.23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3846
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
41.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 62.35 70.97
Rarely 25.53 15.05
Sometimes 7.06 10.75
Often 7.06 3.23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5133
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
42.Primary Outcome
Title Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 87.06 95.70
Rarely 5.88 2.15
Sometimes 3.53 0.00
Often 3.53 2.15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1661
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
43.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 68.24 86.02
Rarely 24.71 6.45
Sometimes 4.71 4.30
Often 2.35 3.23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0729
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
44.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 81.18 89.25
Rarely 11.76 5.38
Sometimes 4.71 3.23
Often 2.35 2.15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1912
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
45.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 83.53 92.47
Rarely 12.94 2.15
Sometimes 0.00 3.23
Often 3.53 2.15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2829
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
46.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 94.12 97.85
Rarely 4.71 1.08
Sometimes 0.00 1.08
Often 1.18 0.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2685
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
47.Primary Outcome
Title Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.
Overall Number of Participants Analyzed 20 19 0
Measure Type: Number
Unit of Measure: % of participants in each category
Never 90.59 96.77
Rarely 4.71 0.00
Sometimes 1.18 2.15
Often 3.53 1.08
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2342
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
48.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 9 10
PrEP 4 1
Don't Know 5 6
Don't Understand Question 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7314
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
49.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 8 9
PrEP 5 2
Don't Know 4 7
Don't Understand Question 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3770
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
50.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 6 6
PrEP 3 2
Don't Know 5 8
Don't Understand Question 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
51.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Hide Description [Not Specified]
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 6 5
PrEP 2 1
Don't Know 4 9
Don't Understand Question 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4668
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
52.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Hide Description [Not Specified]
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 4 6
PrEP 3 2
Don't Know 4 6
Don't Understand Question 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7573
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
53.Primary Outcome
Title Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: participants
Placebo 2 8
PrEP 3 0
Don't Know 4 4
Don't Understand Question 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
54.Primary Outcome
Title Perceived Risk of Becoming HIV Positive at Week 4
Hide Description Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Strongly Disagree 52.63 38.89 33.33
Disagree 21.05 33.33 22.22
Neutral 10.53 11.11 27.78
Agree 15.79 11.11 0.00
Strongly Agree 0.00 5.56 16.67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3176
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
55.Primary Outcome
Title Perceived Risk of Becoming HIV Positive at Week 8
Hide Description Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Strongly Disagree 29.41 66.67 58.82
Disagree 17.65 27.78 11.76
Neutral 23.53 0.00 11.76
Agree 23.53 5.56 11.76
Strongly Agree 5.88 0.00 5.88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1348
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
56.Primary Outcome
Title Perceived Risk of Becoming HIV Positive at Week 12
Hide Description Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Strongly Disagree 40.00 75.00 31.25
Disagree 40.00 6.25 37.50
Neutral 20.00 6.25 12.50
Agree 0.00 12.50 6.25
Strongly Agree 0.00 0.00 12.50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0420
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
57.Primary Outcome
Title Perceived Risk of Becoming HIV Positive at Week 16
Hide Description Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19
Measure Type: Number
Unit of Measure: percentage of partcipants
Strongly Disagree 58.33 80.00 42.86
Disagree 16.67 13.33 21.43
Neutral 8.33 6.67 21.43
Agree 8.33 0.00 0.00
Strongly Agree 8.33 0.00 14.29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FTC/TDF as PrEP, Placebo Pill Control, No Pill Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4906
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
58.Primary Outcome
Title Perceived Risk of Becoming HIV Positive at Week 20
Hide Description Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants answered every question
Arm/Group Title FTC/TDF as PrEP Placebo Pill Control No Pill Control
Hide Arm/Group Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Overall Number of Participants Analyzed 20 19 19