Clinical trial NCT01033942: Pre-Exposure Prophylaxis in YMSM
Official title: Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2009-12-17
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Actual Number of Study Visits Completed by 24 Weeks
timeFrame: 24 weeks
measure: Acceptability of Size of Pill
timeFrame: Week 24
measure: Acceptability of the Taste of the Pill
timeFrame: Week 24
measure: Acceptability of the Color of the Pill
timeFrame: Week 24
measure: Acceptability of Taking the Pill Everyday
timeFrame: Week 24
measure: Acceptability of Taking Part in the Study
timeFrame: Week 24
measure: Acceptability of Participating in Group Sessions
timeFrame: Week 24
measure: Acceptability of Being Randomly Assigned to a Group
timeFrame: Week 24
measure: Acceptability of Having an HIV Test at Every Visit
timeFrame: Week 24
measure: Acceptability of Risk Reduction Counseling at Every Visit
timeFrame: Week 24
measure: Acceptability of Questions About Sexual Behavior at Every Visit
timeFrame: Week 24
measure: Acceptability of Being Contacted by the Research Team in Between Visits
timeFrame: Week 24
measure: Acceptability of Physical Examination by a Doctor
timeFrame: Week 24
measure: Acceptability of Health Clinic for Study Visits
timeFrame: Week 24
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 4
timeFrame: 4 weeks
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 8
timeFrame: Week 8
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 12
timeFrame: Week 12
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 16
timeFrame: Week 16
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 20
timeFrame: Week 20
measure: Number of Missed Doses Based on Self-Report Calendar Data-Week 24
timeFrame: Week 24
measure: Number of Missed Doses Over Time Based on Self-Report Calendar Data
timeFrame: 24 weeks
measure: Number of Missed Doses Based on Medication Refill Dates-Week 4
timeFrame: Week 4
measure: Number of Missed Doses Based on Medication Refill Dates-Week 8
timeFrame: Week 8
measure: Number of Missed Doses Based on Medication Refill Dates-Week 12
timeFrame: Week 12
measure: Number of Missed Doses Based on Medication Refill Dates-Week 16
timeFrame: Week 16
measure: Number of Missed Doses Based on Medication Refill Dates-Week 20
timeFrame: Week 20
measure: Number of Missed Doses Based on Medication Refill Dates-Overall
timeFrame: 20 Weeks
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
timeFrame: Week 20
measure: Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
timeFrame: Week 24
measure: Frequency of Missing Study Pills Because Participant Was Away From Home
timeFrame: 24 Weeks
measure: Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
timeFrame: 24 Weeks
measure: Frequency of Missing Study Pills Because Participant Simply Forgot
timeFrame: 24 Weeks
measure: Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
timeFrame: 24 weeks
measure: Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Felt Sick or Ill
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
timeFrame: 24 weeks
measure: Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
timeFrame: 24 weeks
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
timeFrame: Week 4
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
timeFrame: Week 8
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
timeFrame: Week 12
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
timeFrame: Week 16
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
timeFrame: Week 20
measure: Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
timeFrame: Week 24
measure: Perceived Risk of Becoming HIV Positive at Week 4
timeFrame: Week 4
measure: Perceived Risk of Becoming HIV Positive at Week 8
timeFrame: Week 8
measure: Perceived Risk of Becoming HIV Positive at Week 12
timeFrame: Week 12
measure: Perceived Risk of Becoming HIV Positive at Week 16
timeFrame: Week 16
measure: Perceived Risk of Becoming HIV Positive at Week 20
timeFrame: Week 20
measure: Perceived Risk of Becoming HIV Positive at Week 24
timeFrame: Week 24
measure: Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 4
measure: Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 8
measure: Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 12
measure: Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 16
measure: Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 20
measure: Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
timeFrame: Week 24
measure: Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 4
measure: Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 8
measure: Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 12
measure: Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 16
measure: Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 20
measure: Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
timeFrame: Week 24
measure: Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 4
measure: Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 8
measure: Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 12
measure: Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 16
measure: Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 20
measure: Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
timeFrame: Week 24
measure: Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 4
measure: Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 8
measure: Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 12
measure: Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 16
measure: Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 20
measure: Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
timeFrame: Week 24
measure: Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 4
measure: Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 8
measure: Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 12
measure: Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 16
measure: Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 20
measure: Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
timeFrame: Baseline
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
timeFrame: Week 4
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
timeFrame: Week 8
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
timeFrame: Week 12
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
timeFrame: Week 16
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
timeFrame: Week 20
measure: Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
state: Illinois
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
Study officials:
affiliation: Adolescent Trials Network
name: Sybil Hosek, PhD
role: PRINCIPAL_INVESTIGATOR
References: