Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral
      (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure
      prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study
      is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a
      comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of
      age.
    

Detailed description: 
      Truvada PrEP is an approach used to protect HIV-uninfected adults against possible infection
      with HIV. The approach involves taking Truvada every day to prevent HIV infection in case the
      person is exposed to HIV (for example, through sex with an HIV-infected person). The purpose
      of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part
      of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19
      years old. In addition to Truvada PrEP, the HIV prevention package will include HIV testing,
      management of sexually transmitted infections (STIs), risk reduction counseling, access to
      condoms, post-exposure prophylaxis (PEP), and circumcision counseling and referral for male
      participants.

      The study will enroll 150 healthy, HIV-uninfected adolescents 15 to 19 years of age. The
      study will last for 12 months (52 weeks) and involve scheduled clinic visits at study entry
      (Week 0) and Weeks 4, 8, 12, 24, 36, 48, and 52.

      For the first 12 weeks of the study, all participants will be provided with a supply of
      Truvada tablets to take once daily as part of the comprehensive HIV prevention package. At
      Weeks 12, 24, 36, and 48, participants will be offered the following options: to continue
      with the full HIV prevention package plus Truvada PrEP, to stop Truvada PrEP and continue
      with rest of the HIV prevention package, or to re-start Truvada PrEP if previously stopped.
      After Week 12 of the study, Truvada tablets will be given only to those participants who
      decide to take PrEP and who do not have any medical reasons not to do so. Regardless whether
      they choose to use Truvada PrEP after Week 12, all study participants will be followed
      through Week 52 of the study.

      All study visits will include blood collection, counseling before and after HIV testing,
      urine collection for pregnancy testing (female participants only), completion of a sexual
      risk behavior questionnaire, receipt of a supply of condoms, contraceptive counseling, a
      medical history review, and disclosure of available test results. Select study visits may
      include a physical exam, blood and urine collection, testing and treatment of STIs, adherence
      counseling, and an acceptability assessment. Between Months 11 and 12 of the study, some
      participants will be randomly selected to participate in focus groups to discuss their
      experiences while taking Truvada PrEP.
    

Intervention name(s): Truvada
Intervention type(s): Drug
Intervention description(s): Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Other intervention name(s): emtricitabine/tenofovir disoproxil fumarate, FTC/TDF
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention