Pre-Exposure Prophylaxis in YMSM

Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)

This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Behavioral: Many Men, Many Voices (3MV); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Childrens Memorial Hospital
    • Chicago, Illinois, United States, 60612
      • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Willing and able to independently provide written informed consent;
• Of male gender at birth;
• Between the ages of 18 years and 0 days through 22 years and 364 days at the time of signed informed consent;
• Self-reporting at least one episode of unprotected anal intercourse with a male within the last 12 months at the time of Personal Digital Assistant (PDA) Screening Interview;
• Tests HIV negative at time of screening (using any FDA-approved HIV diagnostic test);
• Willing to provide locator information to study staff;
• Willing to be assigned to any of the three biomedical intervention conditions;
• Does not report intention to relocate out of the study area during the course of the study; and
• Does not have job/other obligations that would require long absences from the area (> 4 weeks at a time).

Exclusion Criteria:

• Transgender (behavioral intervention not targeted toward this population);
• Presence of serious psychiatric symptoms (e.g., active hallucinations);
• Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior);
• Intoxicated or under the influence of alcohol or other drugs at the time of consent;
• Acute or chronic hepatitis B infection (exclude if hepatitis B surface antigen positive);
• Renal dysfunction (Creatinine Clearance < 75 ml/min); Use Cockcroft-Gault equation: Glomerular Filtration Rate (GFR) = (140-Age in years) x (Weight in kg) / (72 x serum creatinine) for males
• Any history of bone fractures not explained by trauma;
• Confirmed proteinuria (repeated positive [> 2+] urine dipstick), unless explained by orthostatic proteinuria;
• Confirmed glucosuria (repeated positive [> 1+] urine dipstick) in the presence of normal blood glucose (<120 mg/dL);
• Any Grade 3 toxicity on screening tests/assessments;
• Concurrent participation in an HIV vaccine study or other investigational drug study; or
• Known allergy/sensitivity to the study drug or its components.
• Use of disallowed medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FTC/TDF as PrEP; Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention	Drug: 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.; Behavioral: 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.
PLACEBO_COMPARATOR: Placebo Pill Control; Blinded administration of placebo pill; HIV behavioral intervention	Behavioral: 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.; Drug: Placebo; Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
ACTIVE_COMPARATOR: No Pill Control; Subjects receive HIV behavioral intervention but no pill.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual Number of Study Visits Completed by 24 Weeks	This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.	24 weeks
Acceptability of Size of Pill		Week 24
Acceptability of the Taste of the Pill		Week 24
Acceptability of the Color of the Pill		Week 24
Acceptability of Taking the Pill Everyday		Week 24
Acceptability of Taking Part in the Study		Week 24
Acceptability of Participating in Group Sessions		Week 24
Acceptability of Being Randomly Assigned to a Group		Week 24
Acceptability of Having an HIV Test at Every Visit		Week 24
Acceptability of Risk Reduction Counseling at Every Visit		Week 24
Acceptability of Questions About Sexual Behavior at Every Visit		Week 24
Acceptability of Being Contacted by the Research Team in Between Visits		Week 24
Acceptability of Physical Examination by a Doctor		Week 24
Acceptability of Health Clinic for Study Visits		Week 24
Number of Missed Doses Based on Self-Report Calendar Data-Week 4	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.	4 weeks
Number of Missed Doses Based on Self-Report Calendar Data-Week 8	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.	Week 8
Number of Missed Doses Based on Self-Report Calendar Data-Week 12	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.	Week 12
Number of Missed Doses Based on Self-Report Calendar Data-Week 16	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.	Week 16
Number of Missed Doses Based on Self-Report Calendar Data-Week 20	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.	Week 20
Number of Missed Doses Based on Self-Report Calendar Data-Week 24	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.	Week 24
Number of Missed Doses Over Time Based on Self-Report Calendar Data	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.	24 weeks
Number of Missed Doses Based on Medication Refill Dates-Week 4	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.	Week 4
Number of Missed Doses Based on Medication Refill Dates-Week 8	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.	Week 8
Number of Missed Doses Based on Medication Refill Dates-Week 12	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.	Week 12
Number of Missed Doses Based on Medication Refill Dates-Week 16	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.	Week 16
Number of Missed Doses Based on Medication Refill Dates-Week 20	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.	Week 20
Number of Missed Doses Based on Medication Refill Dates-Overall	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.	20 Weeks
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline	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.	Baseline
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4	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.	Week 4
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8	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.	Week 8
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12	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.	Week 12
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16	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.	Week 16
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20	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.	Week 20
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24	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.	Week 24
Frequency of Missing Study Pills Because Participant Was Away From Home		24 Weeks
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things		24 Weeks
Frequency of Missing Study Pills Because Participant Simply Forgot		24 Weeks
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take		24 weeks
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects		24 weeks
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications		24 weeks
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine		24 weeks
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful		24 weeks
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time		24 weeks
Frequency of Missing Study Pills Because Participant Felt Sick or Ill		24 weeks
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed		24 weeks
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills		24 weeks
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex		24 weeks
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4		Week 4
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8		Week 8
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12		Week 12
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16		Week 16
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20		Week 20
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24		Week 24
Perceived Risk of Becoming HIV Positive at Week 4	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".	Week 4
Perceived Risk of Becoming HIV Positive at Week 8	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".	Week 8
Perceived Risk of Becoming HIV Positive at Week 12	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".	Week 12
Perceived Risk of Becoming HIV Positive at Week 16	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".	Week 16
Perceived Risk of Becoming HIV Positive at Week 20	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".	Week 20
Perceived Risk of Becoming HIV Positive at Week 24	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".	Week 24
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".	Week 4
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".	Week 8
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".	Week 12
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".	Week 16
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".	Week 20
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study."	Week 24
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 4
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 8
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 12
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 16
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 20
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."	Week 24
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 4
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 8
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 12
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 16
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 20
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."	Week 24
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 4
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 8
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 12
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 16
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 20
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."	Week 24
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."	Week 4
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."	Week 8
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been on this study."	Week 12
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."	Week 16
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."	Week 20
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Baseline
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 4
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 8
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 12
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 16
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 20
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24	A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?	Week 24

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sybil Hosek, PhD, Adolescent Trials Network

Publications and helpful links

Helpful Links

• Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Website

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (ESTIMATE): December 17, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: HIV Seronegativity; Truvada; HIV Prevention; Pre-exposure prophylaxis; Emtricitabine; Young men who have sex with men; Tenofovir disoproxil fumarate; Many Men, Many Voices
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: ATN 082