HIV self-testing to improve the efficiency of PrEP delivery: JiPime JiPrEP Study
Phase 4
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202004903331089
- Lead Sponsor
- niversity of Washington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 495
Inclusion Criteria
Age =18 years HIV-1 uninfected based on negative HIV-1 rapid testing
-Not currently enrolled in an HIV-1 prevention clinical trial
-Taking PrEP and planning to continue
-Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self testing
-Note: Women who are pregnant at screening/enrollment are still eligible
For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:
-Age =18
-Able and willing to provide written informed consent
Exclusion Criteria
-Unable to provide written informed consent
-Contraindication to use TDF/FTC/3TC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence outcome. Adherence by PrEP in dried blood spots is defined as the primary trial outcome for the purposes of sample size calculations. Cumulative and recent adherence to PrEP will be measured by concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP).
- Secondary Outcome Measures
Name Time Method Testing and safety outcomes. HIV-1 testing will be measured as the combination of in-clinic tests and home tests, recorded by self-report and by requesting that completed self-test cartridges be returned to the clinic for validation of self-report.