HIVPhase 2NCT01033942
Pre-Exposure Prophylaxis in YMSM
A Phase 2 study testing coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP and Many Men, Many Voices (3MV) in people with HIV, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP and Many Men, Many Voices (3MV)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: 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.
- Conditions
- HIV
- Being tested
- coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP, Placebo, Many Men, Many Voices (3MV)
- Keywords
- Pre-exposure prophylaxis, HIV Prevention, Truvada, Many Men, Many Voices, Emtricitabine, Tenofovir disoproxil fumarate, Young men who have sex with men, HIV Seronegativity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEPDrug
Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
PlaceboDrug
Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV)Behavioural
Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FTC/TDF as PrEP | Experimental | Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention Receives: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Behavioral: Many Men, Many Voices (3MV) |
| Placebo Pill Control | Placebo comparator | Blinded administration of placebo pill; HIV behavioral intervention Receives: Drug: Placebo; Behavioral: Many Men, Many Voices (3MV) |
| No Pill Control | Active comparator | Subjects receive HIV behavioral intervention but no pill. Receives: Behavioral: Many Men, Many Voices (3MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Acceptability of Size of Pill
Measured: Week 24
Acceptability of the Taste of the Pill
Measured: Week 24
Acceptability of the Color of the Pill
Measured: Week 24
Acceptability of Taking the Pill Everyday
Measured: Week 24
Acceptability of Taking Part in the Study
Measured: Week 24
Acceptability of Participating in Group Sessions
Measured: Week 24
Acceptability of Being Randomly Assigned to a Group
Measured: Week 24
Acceptability of Having an HIV Test at Every Visit
Measured: Week 24
Acceptability of Risk Reduction Counseling at Every Visit
Measured: Week 24
Acceptability of Questions About Sexual Behavior at Every Visit
Measured: Week 24
Acceptability of Being Contacted by the Research Team in Between Visits
Measured: Week 24
Acceptability of Physical Examination by a Doctor
Measured: Week 24
Acceptability of Health Clinic for Study Visits
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Frequency of Missing Study Pills Because Participant Was Away From Home
Measured: 24 Weeks
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Measured: 24 Weeks
Frequency of Missing Study Pills Because Participant Simply Forgot
Measured: 24 Weeks
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Measured: 24 weeks
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Measured: 24 weeks
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Measured: 24 weeks
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Measured: Week 4
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Measured: Week 8
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Measured: Week 12
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Measured: Week 16
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Measured: Week 20
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Week 24
Secondary outcomes (7)
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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sybil Hosek, PhD, Principal investigator, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033942
- Sponsor's protocol ID
- ATN 082
- Status last verified
- Feb 2017
- First submitted
- 16 Dec 2009
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)
- ClinicalTrials.gov ID
- NCT01033942
- Acronym / sponsor ID
- ATN 082
- Conditions
- HIV
- Keywords
- Pre-exposure prophylaxis, HIV Prevention, Truvada, Many Men, Many Voices, Emtricitabine, Tenofovir disoproxil fumarate, Young men who have sex with men, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FTC/TDF as PrEP | Experimental | Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP, Behavioral: Many Men, Many Voices (3MV)Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention |
| Placebo Pill Control | Placebo comparator | Drug: Placebo, Behavioral: Many Men, Many Voices (3MV)Blinded administration of placebo pill; HIV behavioral intervention |
| No Pill Control | Active comparator | Behavioral: Many Men, Many Voices (3MV)Subjects receive HIV behavioral intervention but no pill. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEPSubjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. | Drug | FTC/TDF as PrEP |
| PlaceboSubjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. | Drug | Placebo Pill Control |
| 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. | Behavioural | FTC/TDF as PrEP, No Pill Control, Placebo Pill Control |
Primary outcome
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."
7 secondary outcomes
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
Time frame: Baseline
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
Time frame: Week 4
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
Time frame: Week 8
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
Time frame: Week 12
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
Time frame: Week 16
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
Time frame: Week 20
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) WebsiteLink provided by the sponsor.
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Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sybil Hosek, PhD principal investigator
Adolescent Trials Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP and Many Men, Many Voices (3MV) in people with HIV, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual Number of Study Visits Completed by 24 Weeks (time frame: 24 weeks). The study lists 89 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.