Kenya HIV Self-Testing in PrEP Delivery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

790 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2021-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Streamlining the Efficiency of PrEP Implementation

NCT04424524

HIV Prevention HIV Preexposure Prophylaxis Implementation

COMPLETED NA

HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics

NCT07089966

Human Immunodeficiency Virus (HIV) HIV Pre-exposure Prophylaxis

NOT_YET_RECRUITING NA

Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya

NCT04982250

HIV Prevention

COMPLETED NA

One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project

NCT05905640

HIV Infections

RECRUITING NA

Pharmacy-based PrEP Delivery in Kenya

NCT05842122

Hiv

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1-infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Blood-based HIV self-testing

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

Group Type EXPERIMENTAL

6-month PrEP + blood-based HIV self-test

Intervention Type COMBINATION_PRODUCT

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.

Oral fluid HIV self-testing

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

Group Type EXPERIMENTAL

6-month PrEP + oral fluid HIV self-test

Intervention Type COMBINATION_PRODUCT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

6-month PrEP + blood-based HIV self-test

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.

Intervention Type COMBINATION_PRODUCT

6-month PrEP + oral fluid HIV self-test

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes