N/A
Completed N=786
Kenya HIV Self-Testing in PrEP Delivery
Source: ClinicalTrials.gov NCT03593629 ↗Enrolled (actual)
786
Serious AEs
0.6%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With Adherence to PrEP at 6 Months — 95; 106; 94 Participants
Summary
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adherence to PrEP at 6 Months |
95; 106; 94 | — |
| PRIMARY Persistence in Refilling PrEP |
— | — |
| PRIMARY HIV-1 Testing |
— | — |
| SECONDARY PrEP Adherence |
— | — |
| SECONDARY Persistence in Refilling PrEP |
— | — |
| SECONDARY HIV-1 Testing |
— | — |
Eligibility 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
Exclusion Criteria
- Unable to provide written informed consent
- Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC)
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
Data sourced from ClinicalTrials.gov (NCT03593629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.