Pre-Exposure Prophylaxis in YMSM

NCT01033942 | Completed Phase 2 Results DMC

• 1 other identifier: ATN 082
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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). 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

Keywords

Pre-exposure prophylaxis; HIV Prevention; Truvada; Many Men, Many Voices; Emtricitabine; Tenofovir disoproxil fumarate; Young men who have sex with men; HIV Seronegativity

Outcome Measures

Primary Outcomes (89)

• Actual Number of Study Visits Completed by 24 Weeks

  This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.

  24 weeks

• Acceptability of Size of Pill

  Week 24

• Acceptability of the Taste of the Pill

  Week 24

• Acceptability of the Color of the Pill

  Week 24

• Acceptability of Taking the Pill Everyday

  Week 24

• Acceptability of Taking Part in the Study

  Week 24

• Acceptability of Participating in Group Sessions

  Week 24

• Acceptability of Being Randomly Assigned to a Group

  Week 24

• Acceptability of Having an HIV Test at Every Visit

  Week 24

• Acceptability of Risk Reduction Counseling at Every Visit

  Week 24

• Acceptability of Questions About Sexual Behavior at Every Visit

  Week 24

• Acceptability of Being Contacted by the Research Team in Between Visits

  Week 24

• Acceptability of Physical Examination by a Doctor

  Week 24

• Acceptability of Health Clinic for Study Visits

  Week 24

• Number of Missed Doses Based on Self-Report Calendar Data-Week 4

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  4 weeks

• Number of Missed Doses Based on Self-Report Calendar Data-Week 8

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 8

• Number of Missed Doses Based on Self-Report Calendar Data-Week 12

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 12

• Number of Missed Doses Based on Self-Report Calendar Data-Week 16

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 16

• Number of Missed Doses Based on Self-Report Calendar Data-Week 20

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 20

• Number of Missed Doses Based on Self-Report Calendar Data-Week 24

  Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 24

• Number of Missed Doses Over Time Based on Self-Report Calendar Data

  The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.

  24 weeks

• Number of Missed Doses Based on Medication Refill Dates-Week 4

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 4

• Number of Missed Doses Based on Medication Refill Dates-Week 8

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 8

• Number of Missed Doses Based on Medication Refill Dates-Week 12

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 12

• Number of Missed Doses Based on Medication Refill Dates-Week 16

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 16

• Number of Missed Doses Based on Medication Refill Dates-Week 20

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  Week 20

• Number of Missed Doses Based on Medication Refill Dates-Overall

  Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.

  20 Weeks

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Baseline

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 4

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 8

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 12

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 16

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 20

• Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24

  Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.

  Week 24

• Frequency of Missing Study Pills Because Participant Was Away From Home

  24 Weeks

• Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things

  24 Weeks

• Frequency of Missing Study Pills Because Participant Simply Forgot

  24 Weeks

• Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take

  24 weeks

• Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects

  24 weeks

• Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications

  24 weeks

• Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine

  24 weeks

• Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful

  24 weeks

• Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time

  24 weeks

• Frequency of Missing Study Pills Because Participant Felt Sick or Ill

  24 weeks

• Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed

  24 weeks

• Frequency of Missing Study Pills Because Participant Ran Out of Study Pills

  24 weeks

• Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex

  24 weeks

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4

  Week 4

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8

  Week 8

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12

  Week 12

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16

  Week 16

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20

  Week 20

• Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24

  Week 24

• Perceived Risk of Becoming HIV Positive at Week 4

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 4

• Perceived Risk of Becoming HIV Positive at Week 8

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 8

• Perceived Risk of Becoming HIV Positive at Week 12

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 12

• Perceived Risk of Becoming HIV Positive at Week 16

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 16

• Perceived Risk of Becoming HIV Positive at Week 20

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 20

• Perceived Risk of Becoming HIV Positive at Week 24

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive".

  Week 24

• Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".

  Week 4

• Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".

  Week 8

• Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".

  Week 12

• Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".

  Week 16

• Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study".

  Week 20

• Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study."

  Week 24

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 4

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 8

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 12

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 16

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 20

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

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."

  Week 24

• Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 4

• Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 8

• Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 12

• Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 16

• Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 20

• Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex."

  Week 24

• Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 4

• Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 8

• Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 12

• Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 16

• Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 20

• Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study."

  Week 24

• Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."

  Week 4

• Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."

  Week 8

• Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been on this study."

  Week 12

• Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."

  Week 16

• Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."

  Week 20

• Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

  Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study."

  Week 24

Secondary Outcomes (7)

• Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline

  Baseline

• Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4

  Week 4

• Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8

  Week 8

• Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12

  Week 12

• Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16

  Week 16

Study Arms (3)

FTC/TDF as PrEP

EXPERIMENTAL

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; Behavioral: Many Men, Many Voices (3MV)

Placebo Pill Control

PLACEBO COMPARATOR

Blinded administration of placebo pill; HIV behavioral intervention

Drug: Placebo; Behavioral: Many Men, Many Voices (3MV)

No Pill Control

ACTIVE COMPARATOR

Subjects receive HIV behavioral intervention but no pill.

Behavioral: Many Men, Many Voices (3MV)

Interventions

coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP DRUG

Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

FTC/TDF as PrEP

Placebo DRUG

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

Placebo Pill Control

Many Men, Many Voices (3MV) BEHAVIORAL

Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

FTC/TDF as PrEP; No Pill Control; Placebo Pill Control

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Links

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

MeSH Terms

Interventions

Racivir; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

After release of Pre-exposure Prophylaxis Initiative efficacy results, the Data and Safety Monitoring Board recommended that subjects be unblinded, enrollment stopped, all be offered option of PrEP, subjects on PrEP arm continued as scheduled.

Results Point of Contact

• Title: Dr. Bob Harris
• Organization: Westat

bobharris@westat.com

301-251-1500

Study Officials

• Sybil Hosek, PhD

  Adolescent Trials Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 17, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (2)