An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: 3MV; PCC; Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Intervention description: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.; Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.; All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Male
Minimum age: 18 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV, PrEP, FTC/TDF, Truvada®

Summary:

      Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of
      acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all
      participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be
      assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized
      Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered
      at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir
      (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0,
      4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the
      study will be discontinued from the study agent and followed for an additional 24 weeks after
      the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or
      renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed
      for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of
      potential concerns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent;

          -  Male gender at birth;

          -  Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of
             signed informed consent;

          -  Self reports evidence of high risk for acquiring HIV infection including at least one
             of the following:

               -  At least one episode of unprotected anal intercourse with an HIV-infected male
                  partner or a male partner of unknown HIV status during the last 6 months;

               -  Anal intercourse with 3 or more male sex partners during the last 6 months;

               -  Exchange of money, gifts, shelter, or drugs for anal sex with a male partner
                  during the last 6 months;

               -  Sex with a male partner and has had a sexually transmitted infection (STI) during
                  the last 6 months or at screening;

               -  Sexual partner of an HIV-infected man with whom condoms were not consistently
                  used in the last 6 months; or

               -  At least one episode of anal intercourse where the condom broke or slipped off
                  during the last 6 months;

          -  Tests HIV antibody negative at time of screening;

          -  Willing to provide locator information to study staff;

          -  Willing to take pre-exposure prophylaxis (PrEP);

          -  Willing to participate in behavioral intervention;

          -  Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU)
             study area during the course of the study; and

          -  Does not have a job or other obligations that would require long absences from the
             AMTU study area (greater than 4 weeks at a time).

        Exclusion Criteria:

          -  Appears visibly distraught or presence of active serious psychiatric symptoms (e.g.,
             active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the
             time of consent;

          -  Intoxicated or under the influence of alcohol or other drugs at the time of consent;

          -  Any significant uncontrolled, active or chronic disease process that, in the judgment
             of the site investigator, would make participation in the study inappropriate.
             (Appropriately managed conditions, like well-controlled diabetes, would not preclude
             enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network
             for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty
             making the judgment.);

          -  History of bone fractures not explained by trauma;

          -  Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface
             antigen (sAg) test at time of screening;

          -  Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min, or serum
             creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or
             presence of only one kidney at time of screening;

          -  Confirmed ≥ Grade 2 hypophosphatemia at time of screening;

          -  Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute
             Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;

          -  Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase
             (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;

          -  Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening,
             regardless of urine protein to creatinine ratio(UP/C);

          -  UP/C > 0.37 g/g at time of screening, regardless of urine dipstick protein result;

          -  Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the
             presence of normal serum glucose (<120 mg/dL) at time of screening;

          -  A confirmed Grade ≥ 3 toxicity on any screening evaluations;

          -  Known allergy/sensitivity to the study agent or its components;

          -  Concurrent participation in an HIV vaccine study or other investigational drug study,
             including oral or topical PrEP (microbicide) studies;

          -  Use of disallowed medications ; or

          -  Inability to understand spoken English.