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Pre-Exposure Prophylaxis in YMSM

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01033942
First received: December 16, 2009
Last updated: April 14, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
HIV Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP Drug: Placebo Behavioral: Many Men, Many Voices (3MV) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Prevention
Official Title: Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Actual Number of Study Visits Completed by 24 Weeks [ Time Frame: 24 weeks ]
    This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.

  • Acceptability of Size of Pill [ Time Frame: Week 24 ]
  • Acceptability of the Taste of the Pill [ Time Frame: Week 24 ]
  • Acceptability of the Color of the Pill [ Time Frame: Week 24 ]
  • Acceptability of Taking the Pill Everyday [ Time Frame: Week 24 ]
  • Acceptability of Taking Part in the Study [ Time Frame: Week 24 ]
  • Acceptability of Participating in Group Sessions [ Time Frame: Week 24 ]
  • Acceptability of Being Randomly Assigned to a Group [ Time Frame: Week 24 ]
  • Acceptability of Having an HIV Test at Every Visit [ Time Frame: Week 24 ]
  • Acceptability of Risk Reduction Counseling at Every Visit [ Time Frame: Week 24 ]
  • Acceptability of Questions About Sexual Behavior at Every Visit [ Time Frame: Week 24 ]
  • Acceptability of Being Contacted by the Research Team in Between Visits [ Time Frame: Week 24 ]
  • Acceptability of Physical Examination by a Doctor [ Time Frame: Week 24 ]
  • Acceptability of Health Clinic for Study Visits [ Time Frame: Week 24 ]
  • Number of Missed Doses Based on Self-Report Calendar Data-Week 4 [ Time Frame: 4 weeks ]
    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.

  • Number of Missed Doses Based on Self-Report Calendar Data-Week 8 [ Time Frame: 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.

  • Number of Missed Doses Based on Self-Report Calendar Data-Week 12 [ Time Frame: 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.

  • Number of Missed Doses Based on Self-Report Calendar Data-Week 16 [ Time Frame: 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.

  • Number of Missed Doses Based on Self-Report Calendar Data-Week 20 [ Time Frame: 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.

  • Number of Missed Doses Based on Self-Report Calendar Data-Week 24 [ Time Frame: 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.

  • Number of Missed Doses Over Time Based on Self-Report Calendar Data [ Time Frame: 24 weeks ]
    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.

  • Number of Missed Doses Based on Medication Refill Dates-Week 4 [ Time Frame: 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.

  • Number of Missed Doses Based on Medication Refill Dates-Week 8 [ Time Frame: 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.

  • Number of Missed Doses Based on Medication Refill Dates-Week 12 [ Time Frame: 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.

  • Number of Missed Doses Based on Medication Refill Dates-Week 16 [ Time Frame: 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.

  • Number of Missed Doses Based on Medication Refill Dates-Week 20 [ Time Frame: 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.

  • Number of Missed Doses Based on Medication Refill Dates-Overall [ Time Frame: 20 Weeks ]
    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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 [ Time Frame: 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.

  • Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 [ Time Frame: 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.

  • Frequency of Missing Study Pills Because Participant Was Away From Home [ Time Frame: 24 Weeks ]
  • Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things [ Time Frame: 24 Weeks ]
  • Frequency of Missing Study Pills Because Participant Simply Forgot [ Time Frame: 24 Weeks ]
  • Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine [ Time Frame: 24 weeks ]
  • Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Felt Sick or Ill [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Ran Out of Study Pills [ Time Frame: 24 weeks ]
  • Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex [ Time Frame: 24 weeks ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 [ Time Frame: Week 4 ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 [ Time Frame: Week 8 ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 [ Time Frame: Week 12 ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 [ Time Frame: Week 16 ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 [ Time Frame: Week 20 ]
  • Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 [ Time Frame: Week 24 ]
  • Perceived Risk of Becoming HIV Positive at Week 4 [ Time Frame: 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".

  • Perceived Risk of Becoming HIV Positive at Week 8 [ Time Frame: 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".

  • Perceived Risk of Becoming HIV Positive at Week 12 [ Time Frame: 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".

  • Perceived Risk of Becoming HIV Positive at Week 16 [ Time Frame: 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".

  • Perceived Risk of Becoming HIV Positive at Week 20 [ Time Frame: 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".

  • Perceived Risk of Becoming HIV Positive at Week 24 [ Time Frame: 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".

  • Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 4 ]
    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".

  • Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 8 ]
    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".

  • Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 12 ]
    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".

  • Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 16 ]
    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".

  • Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 20 ]
    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".

  • Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study [ Time Frame: Week 24 ]
    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."

  • Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 4 ]
    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."

  • Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 8 ]
    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."

  • Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 12 ]
    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."

  • Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 16 ]
    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."

  • Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 20 ]
    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."

  • Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex [ Time Frame: Week 24 ]
    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."

  • Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 4 ]
    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."

  • Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 8 ]
    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."

  • Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 12 ]
    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."

  • Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 16 ]
    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."

  • Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 20 ]
    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."

  • Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP [ Time Frame: Week 24 ]
    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."

  • Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 4 ]
    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."

  • Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 8 ]
    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."

  • Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 12 ]
    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."

  • Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 16 ]
    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."

  • Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 20 ]
    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."

  • Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study [ Time Frame: Week 24 ]
    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."

  • Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 4 ]
    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."

  • Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 8 ]
    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."

  • Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 12 ]
    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."

  • Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 16 ]
    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."

  • Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 20 ]
    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."

  • Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study [ Time Frame: Week 24 ]
    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."


Secondary Outcome Measures:
  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 [ Time Frame: 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?


  • Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 [ Time Frame: 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?



Enrollment: 68
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
Subjects receive placebo 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033942

Locations
United States, Illinois
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sybil Hosek, PhD Adolescent Trials Network
  More Information

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01033942     History of Changes
Other Study ID Numbers: ATN 082
Study First Received: December 16, 2009
Results First Received: October 28, 2014
Last Updated: April 14, 2017

Keywords provided by University of North Carolina, Chapel Hill:
Pre-exposure prophylaxis
HIV Prevention
Truvada
Many Men, Many Voices
Emtricitabine
Tenofovir disoproxil fumarate
Young men who have sex with men
HIV Seronegativity

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 29, 2017