HIV/AIDS
Conditions
Interventions
Standard of Care
Blood based HIV self testing
Oral fluid based HIV self testing
Sponsors
University of Washington
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Unable to provide written informed consent - Contraindication to use TDF/FTC/3TC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Kenya
Contacts
Public ContactPeter Mogere
Study Coordinator
Outcome results
None listed