Kenya HIV Self-Testing in PrEP Delivery

HIV-1-infection Clinical Trial

Official title:

HIV Self-Testing to Improve the Efficiency of PrEP Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593629
• Other study ID #: STUDY00003750
• Secondary ID: 1R01MH113572
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: May 25, 2021

Study information

• Verified date: August 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: May 25, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Kenya	Partners in Health Research and Development - Thika House	Thika

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recent Abuse by a Sexual Partner	Self-reported verbal, physical or emotional abuse by a sexual partner	Month 6
Other	Recent Abuse by a Sexual Partner	Self-reported verbal, physical or emotional abuse by a sexual partner	Month 12
Other	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
Other	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
Other	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
Other	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
Other	Number of Sexual Partners	Self-reported number of sexual partners in the past month	Month 6
Other	Number of Sexual Partners	Self-reported number of sexual partners in the past month	Month 12
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	HIV-1 Testing	Self-reported HIV-1 testing in the past 6 months	Month 6
Secondary	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
Secondary	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
Secondary	HIV-1 Testing	Self-reported HIV-1 testing in the past 6 months	Month 12