Kenya HIV Self-Testing in PrEP Delivery

Not Applicable

Completed

Conditions: HIV-1-infection

Interventions: Combination Product: 6-month PrEP + blood-based HIV self-test
Combination Product: 6-month PrEP + oral fluid HIV self-test

Registration Number: NCT03593629

Lead Sponsor: University of Washington

Brief 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.

Detailed Description: Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.

The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).

In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)

Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 790

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood-based HIV self-testing	6-month PrEP + blood-based HIV self-test	Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
Oral fluid HIV self-testing	6-month PrEP + oral fluid HIV self-test	Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.

Primary Outcome Measures

Name	Time	Method
HIV-1 Testing	Month 6	Self-reported HIV-1 testing in the past 6 months
Persistence in Refilling PrEP	Month 6	The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Number of Participants With Adherence to PrEP at 6 Months	Month 6	Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.

Secondary Outcome Measures

Name	Time	Method
HIV-1 Testing	Month 12	Self-reported HIV-1 testing in the past 6 months
PrEP Adherence	Month 12	Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Persistence in Refilling PrEP	Month 12	The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.