Kenya HIV Self-Testing in PrEP Delivery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- PrEP adherence [Month 6]
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.
- Persistence in refilling PrEP [Month 6]
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
- HIV-1 testing [Month 6]
Self-reported HIV-1 testing in the past 6 months
Secondary Outcome Measures
- PrEP adherence [Month 12]
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.
- Persistence in refilling PrEP [Month 12]
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
- HIV-1 testing [Month 12]
Self-reported HIV-1 testing in the past 6 months
Other Outcome Measures
- Recent abuse by a sexual partner [Month 6]
Self-reported verbal, physical or emotional abuse by a sexual partner
- Recent abuse by a sexual partner [Month 12]
Self-reported verbal, physical or emotional abuse by a sexual partner
- Prevalence of depression [Month 6]
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.
- Prevalence of depression [Month 12]
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.
- Participant's self-reported self-efficacy [Month 6]
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.
- Participant's self-reported self-efficacy [Month 12]
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.
- Number of sexual partners [Month 6]
Self-reported number of sexual partners in the past month
- Number of sexual partners [Month 12]
Self-reported number of sexual partners in the past month
- Inconsistent condom use [Month 6]
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.
- Inconsistent condom use [Month 12]
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.
- PrEP disclosure [Month 6]
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
- PrEP disclosure [Month 12]
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
- HIV testing preferences [Month 6]
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
- HIV testing preferences [Month 12]
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
- HIV Incidence [Month 12]
The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing
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Not currently enrolled in an HIV-1 prevention clinical trial
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Taking PrEP and planning to continue
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Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing
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Note: Women who are pregnant at screening/enrollment are still eligible
Exclusion Criteria:
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Unable to provide written informed consent
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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:
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Age ≥18
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Able and willing to provide written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Partners in Health Research and Development - Thika House | Thika | Kenya |
Sponsors and Collaborators
- University of Washington
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Jared Baeten, MD, PhD, University of Washington
- Principal Investigator: Kenneth Ngure, PhD, MPH, Jomo Kenyatta University of Agriculture and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00003750
- 1R01MH113572