Clinical trial NCT03593629: Kenya HIV Self-Testing in PrEP Delivery
Official title: HIV Self-Testing to Improve the Efficiency of PrEP Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Keywords: HIV
AIDS
PrEP
Truvada
Public Health
Global Health
Infectious Disease
Self-Testing
Kenya
Africa
Low and/or Middle Income Countries (LMIC)
Cost-Effectiveness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-07-20
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Number of Participants With Adherence to PrEP at 6 Months
timeFrame: Month 6
measure: Persistence in Refilling PrEP
timeFrame: Month 6
measure: HIV-1 Testing
timeFrame: Month 6
Secondary outcomes:
measure: PrEP Adherence
timeFrame: Month 12
measure: Persistence in Refilling PrEP
timeFrame: Month 12
measure: HIV-1 Testing
timeFrame: Month 12
Other outcomes:
measure: Recent Abuse by a Sexual Partner
timeFrame: Month 6
measure: Recent Abuse by a Sexual Partner
timeFrame: Month 12
measure: Prevalence of Depression
timeFrame: Month 6
measure: Prevalence of Depression
timeFrame: Month 12
measure: Participant's Self-reported Self-efficacy
timeFrame: Month 6
measure: Participant's Self-reported Self-efficacy
timeFrame: Month 12
measure: Number of Sexual Partners
timeFrame: Month 6
measure: Number of Sexual Partners
timeFrame: Month 12
measure: Inconsistent Condom Use
timeFrame: Month 6
measure: Inconsistent Condom Use
timeFrame: Month 12
measure: PrEP Disclosure
timeFrame: Month 6
measure: PrEP Disclosure
timeFrame: Month 12
measure: HIV Testing Preferences
timeFrame: Month 6
measure: HIV Testing Preferences
timeFrame: Month 12
measure: Number of Participants That Test HIV-1 Positive Since Trial Enrollment
timeFrame: Month 12
Locations:
city: Thika
country: Kenya
facility: Partners in Health Research and Development - Thika House
Study officials:
affiliation: University of Washington
name: Jared Baeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jomo Kenyatta University of Agriculture and Technology
name: Kenneth Ngure, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngure K, Ortblad KF, Mogere P, Bardon AR, Thomas KK, Mangale D, Kiptinness C, Gakuo S, Mbaire S, Nyokabi J, Mugo NR, Baeten JM. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Lancet HIV. 2022 Jul;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6.
citation: Ortblad KF, Kearney JE, Mugwanya K, Irungu EM, Haberer JE, Barnabas RV, Donnell D, Mugo NR, Baeten JM, Ngure K. HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. Trials. 2019 Jul 4;20(1):396. doi: 10.1186/s13063-019-3521-2.