Kenya HIV Self-Testing in PrEP Delivery

HIV Self-Testing to Improve the Efficiency of PrEP Delivery

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Combination product: 6-month PrEP + blood-based HIV self-test; Combination product: 6-month PrEP + oral fluid HIV self-test

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).

• Study Type: Interventional
• Enrollment (Actual): 790
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Thika, Kenya
    • Partners in Health Research and Development - Thika House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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; 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; 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.
Experimental: Oral fluid HIV self-testing; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recent Abuse by a Sexual Partner	Self-reported verbal, physical or emotional abuse by a sexual partner	Month 6
Recent Abuse by a Sexual Partner	Self-reported verbal, physical or emotional abuse by a sexual partner	Month 12
Prevalence of Depression	The Patient Health Questionnaire-9 item (PHQ-9) depression scale. A 0-27 point scale where scores 10 or greater can be categorized as likely depression.	Month 6
Prevalence of Depression	The Patient Health Questionnaire-9 item (PHQ-9) depression scale. A 0-27 point scale where scores 10 or greater can be categorized as likely depression.	Month 12
Participant's Self-reported Self-efficacy	Measured using the General Self-Efficacy Scale (GSE), which is correlated to emotion, optimism, work satisfaction, to measure self-efficacy. The scale ranges from 10-40 points - higher scores indicate more self-efficacy.	Month 6
Participant's Self-reported Self-efficacy	Measured using the General Self-Efficacy Scale (GSE), which is correlated to emotion, optimism, work satisfaction, to measure self-efficacy. The scale ranges from 10-40 points - higher scores indicate more self-efficacy.	Month 12
Number of Sexual Partners	Self-reported number of sexual partners in the past month	Month 6
Number of Sexual Partners	Self-reported number of sexual partners in the past month	Month 12
Inconsistent Condom Use	Participants were asked how many times they had sexual intercourse in the past month and how many times a condom was used. If condoms were not used at every time, condom use was categorized as inconsistent.	Month 6
Inconsistent Condom Use	Participants were asked how many times they had sexual intercourse in the past month and how many times a condom was used. If condoms were not used at every time, condom use was categorized as inconsistent.	Month 12
PrEP Disclosure	Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.	Month 6
PrEP Disclosure	Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.	Month 12
HIV Testing Preferences	Participants report their preference for HIV testing from the following options: blood-based HIV self-testing, oral HIV self-testing, testing for HIV at a standard healthcare facility	Month 6
HIV Testing Preferences	Participants report their preference for HIV testing from the following options: blood-based HIV self-testing, oral HIV self-testing, testing for HIV at a standard healthcare facility	Month 12
Number of Participants That Test HIV-1 Positive Since Trial Enrollment	The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured.	Month 12

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kenneth Ngure, PhD, MPH, Jomo Kenyatta University of Agriculture and Technology; Principal Investigator: Jared Baeten, MD, PhD, University of Washington

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: HIV; PrEP; Kenya; Truvada; AIDS; Africa; Infectious Disease; Public Health; Global Health; Cost-Effectiveness; Self-Testing; Low and/or Middle Income Countries (LMIC)
• Other Study ID Numbers: STUDY00003750; 1R01MH113572 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes