Kenya HIV Self-Testing in PrEP Delivery

Study Overview
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Brief Summary
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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
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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).

Official Title
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HIV Self-Testing to Improve the Efficiency of PrEP Delivery

Conditions
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HIV-1-infection

Intervention / Treatment
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* Combination Product: 6-month PrEP + blood-based HIV self-test
* Combination Product: 6-month PrEP + oral fluid HIV self-test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months | |
| Experimental: Blood-based HIV self-testing<br>Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing. | Combination Product: 6-month PrEP + blood-based HIV self-test<br>* Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.<br>|
| Experimental: Oral fluid HIV self-testing<br>Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing. | Combination Product: 6-month PrEP + oral fluid HIV self-test<br>* Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adherence to PrEP at 6 Months | 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. | Month 6 | 
| Persistence in Refilling PrEP | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. | Month 6 | 
| HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | 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. | Month 12 | 
| Persistence in Refilling PrEP | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. | Month 12 | 
| HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, PrEP, Truvada, Public Health, Global Health, Infectious Disease, Self-Testing, Kenya, Africa, Low and/or Middle Income Countries (LMIC), Cost-Effectiveness