Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
Condition: HIV Prevention
Intervention: Text Messaging; Adherence Counseling; Daily Oral PrEP
Intervention description: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.; All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.; All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
Masking: None (Open Label)
Enrollment: 136.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PrEP; Pre-exposure Prophylaxis; HIV Prevention

Summary:

      The purpose of this study is to test a program that uses drug level monitoring, text
      messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP
      (medicine that can help prevent HIV infection when taken daily).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female at birth and identifies as female gender

          -  Age 18 years or older

          -  Able to understand and provide consent in English or Spanish

          -  HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay
             (EIA) and HIV RNA

          -  Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)

        At-Risk Criteria (at least one):

          -  Condomless sex in the last 3 months with one or more male partners of unknown HIV
             status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods,
             recently incarcerated, from a country with HIV prevalence >1%, interpersonal Partner
             Violence);

          -  STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.

          -  Previous post-exposure prophylaxis (PEP) use during the last 12 months.

          -  Has at least one HIV-infected sexual partner for ≥4 weeks.

          -  Sex for exchange of money, goods or services

        Exclusion Criteria:

          -  Pregnancy at enrollment.

          -  Any condition, which in the opinion of the provider, will seriously compromise the
             participant's ability to comply with the protocol, including adherence to PrEP
             medication dosing, such as active, untreated or unstable major mental illness (i.e.
             untreated psychotic disorder).

          -  Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs
             slow in renal excretion.

          -  Previous participation in an HIV vaccine trial. Participants that were documented to
             have received only placebo are not excluded.

          -  Signs or symptoms suspicious for Primary HIV Infection (PHI).