N/A N=786 Randomized Health Services Research

Kenya HIV Self-Testing in PrEP Delivery

HIV-1-infection

Bottom Line

View on ClinicalTrials.gov: NCT03593629 ↗

Enrolled (actual)

786

Serious AEs

0.6%

Results posted

Sep 2022

Primary outcome: Primary: Number of Participants With Adherence to PrEP at 6 Months — 95; 106; 94 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 6-month PrEP + blood-based HIV self-test (Combination_product); 6-month PrEP + oral fluid HIV self-test (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Dec 2020

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.