PrEP With TDF/FTC to Prevent HIV-1 Acquisition in Young MSM and Transgender Women of Color
Condition: HIV
Study type: Observational

Summary: 
      This is a 48-week prospective observational study that will allow testing of the hypothesis
      that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of color
      who have sex with men (yMSMc) in a community youth drop-in center in conjunction with a
      multifaceted behavioral intervention as well as standard HIV prevention interventions can
      achieve at least 70% retention, as well as a medication adherence rate significantly better
      than that previously reported in the literature. The proposed program evaluation can provide
      critical information for the enhancement and scale-up of successful PrEP programs at FIGHT
      and elsewhere in an effort to make PrEP available to a growing number of persons at risk of
      acquiring human immunodeficiency virus (HIV).
    

Detailed description: 
      PrEP for HIV prevention with once daily Truvada has been shown to be extremely safe and
      efficacious in multiple populations when taken consistently. Young men who have sex with men
      of color (yMSMc) comprise the group at the highest risk of new HIV infections and the only
      group whose HIV infection rates continue to increase. New data suggest interrupting
      transmission among MSM can reduce HIV acquisition among other risk groups as well. However,
      accessing, linking, and retaining yMSMc in a PrEP program is both critical to successful HIV
      prevention and historically difficult to achieve. Philadelphia FIGHT initiated a PrEP program
      at the youth site, Youth Health Empowerment Project (Y-HEP), for yMSMc approximately 1.5
      years ago that also gives all participants access to general primary care. Y-HEP utilizes a
      unique biomedical/biobehavioral approach to enhance adherence and retention of yMSMc
      receiving PrEP.

      The purpose of this protocol is to increase access to safe and effective PrEP to yMSMc in
      order to reduce incident HIV infections and health disparities in HIV incidence and
      prevalence through the use of a combined biomedical/behavioral intervention in a
      community-based setting servicing high-risk youth in Philadelphia. It is hypothesized this
      unique, combined biomedical/behavioral HIV prevention strategy will lead to high recruitment
      and retention rates in this community setting. All subjects will be offered primary care
      services as well as a package of HIV risk reduction interventions including once daily PrEP
      with tenofovir and emtricitabine (TDF/FTC), condoms, risk reduction counseling, HIV testing,
      and sexually transmitted infection (STI) screening and treatment. A weekly support group will
      aim to maximize medication adherence and retention by engaging subjects in prevention,
      risk-reduction and behavioral counseling, education about HIV, leadership training, and
      social networking.

      Subjects will consist of 50 HIV-negative biological males between the ages of 18 and 30 who
      meet eligibility criteria as defined below.

      All subjects will receive Truvada as PrEP on Monday evenings on an either weekly, biweekly,
      or monthly basis depending on an initial assessment of their need for adherence support, with
      provisions to obtain medication the following day(s) at Y-HEP if they are unable to attend
      the Monday night session. Study subjects will be considered to have picked up their
      medications if they come any time during the week designated as a medication pick-up week. In
      addition, all subjects will receive standard HIV prevention services including condom
      provision, risk reduction counseling, HIV testing, STI screening and treatment, as well as
      basic medical care and linkage to HIV care in the event of PrEP failure. Subjects will
      receive a behavioral intervention consisting of youth-focused men's wellness services
      centered around education about HIV, adherence counseling and knowledge of PrEP efficacy on
      risk behavior, general health services such as smoking cessation support and nutritional
      counseling, job and leadership training, and sexual health and well-being promotion.

      Subjects will be screened for HIV, STIs, and renal function at baseline and every three
      months, and will also have a rapid test for HIV on a monthly basis (Table 1). Treatment will
      be provided for all STIs diagnosed during this study, and non-immune subjects will be offered
      vaccines against hepatitis A and B. Adherence will be assessed by the percentage of
      medication pick-up visits attended as well as urine tenofovir levels every 2-4 weeks and
      plasma tenofovir levels at weeks 24 and 48. Risk behaviors will be assessed by STI rates and
      the adapted Risk Assessment Battery at baseline, and weeks 24 and 48. A qualitative interview
      will be conducted at the end of the study to assess program acceptability.
    

Intervention name(s): Emtricitabine and tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention description(s): This study will enroll 50 subjects who are offered TDF/FTC for 48 weeks as part of a combined biomedical/behavioral intervention offered in a community-based setting serving high-risk youth in an urban setting.
Other intervention name(s): Truvada; TDF/FTC
Intervention MeSH terms: Tenofovir; Emtricitabine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 biological males from urban Philadelphia who identify as men who have sex with men (MSM)
        ages 18-30 at risk of HIV acquisition
      
Biospecimen description: 
      urine and plasma samples for measurement of tenofovir concentration, blood samples for
      measurement of safety labs, and urine/plasma samples and rectal/pharyngeal swabs for sexually
      transmitted infection screening
    
Keywords: HIV prevention; PrEP; young men who have sex with men; Truvada