Pre-Exposure Prophylaxis in YMSM
Condition: HIV
Intervention: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Placebo; Many Men, Many Voices (3MV)
Intervention description: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.; Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.; Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
Intervention MeSH terms: Tenofovir; Emtricitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: Male
Minimum age: 18 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pre-exposure prophylaxis; HIV Prevention; Truvada; Many Men, Many Voices; Emtricitabine; Tenofovir disoproxil fumarate; Young men who have sex with men; HIV Seronegativity

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