Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
Overview
- Phase
- Phase 4
- Intervention
- Truvada
- Conditions
- HIV
- Sponsor
- HIV Prevention Trials Network
- Enrollment
- 451
- Locations
- 3
- Primary Endpoint
- Number of Participants With High Adherence at Six Months
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
Detailed Description
A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to \~25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Young women who meet all of the following criteria are eligible for inclusion in this study:
- •Female at birth
- •Age 16-25 years
- •Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
- •Literate in one or more of the study languages
- •Willing and able to provide informed consent or assent (if parental consent is required per local regulations)
- •If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing
- •Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs)
- •Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool
- •Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures \[SSP\] Manual)
Exclusion Criteria
- •Young women who meet any of the following criteria will be excluded from this study:
- •Planning to relocate in the next 12 months
- •Has a job or other obligations that would require long absences from the area (\> 4 weeks at a time) for 12 months
- •Any health condition that may interfere with participation, including any debilitating or life-threatening conditions
- •Currently pregnant or planning to become pregnant in the next 12 months
- •Any reactive or positive HIV test at Screening or Enrollment, even if subsequent testing indicates that the person is HIV-uninfected
- •Renal dysfunction (Creatinine Clearance \< 60 ml/min, Schwartz Equation)
- •Any reported PrEP use within the last 12 months
- •Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
- •Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
Arms & Interventions
Enhanced Adherence Support
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided: * Cognitive Behavioral Theory adherence support sessions * Two-way SMS communications * Optional monthly adherence support clubs * Drug level counseling at Weeks 8 and 13
Intervention: Truvada
Enhanced Adherence Support
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided: * Cognitive Behavioral Theory adherence support sessions * Two-way SMS communications * Optional monthly adherence support clubs * Drug level counseling at Weeks 8 and 13
Intervention: Drug level counseling at Weeks 8 and 13
Standard Adherence Support
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided: * Cognitive Behavioral Theory adherence support sessions * Two-way SMS communications * Optional monthly adherence support clubs
Intervention: Truvada
Outcomes
Primary Outcomes
Number of Participants With High Adherence at Six Months
Time Frame: at month 6 from start of the study
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
Secondary Outcomes
- Number of Participants With High Adherence at Twelve Months(12 months from the start of the study)