Kenya HIV Self-Testing in PrEP Delivery

University of Washington

Status: Completed

Conditions: HIV-1-infection

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03593629

1R01MH113572 (U.S. NIH Grant/Contract)

STUDY00003750

Details and patient eligibility

About

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.

Full 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).

Enrollment: 790 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

790 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months

Blood-based HIV self-testing

Experimental group

Description:

Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.

Treatment:

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

Oral fluid HIV self-testing

Experimental group

Description:

Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.

Treatment:

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