Incentives to Promote Sustained Linkage to HIV Care

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; HIV/AIDS
• Interventions: Behavioral: Provision of HIV self-screen kit with incentives and linkage promotion

• Registration Number: NCT04431154
• Lead Sponsor: University of Pennsylvania

Brief Summary

This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.

Detailed Description

This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute (WRHI) in South Africa. This study will leverage on the existing research infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test Africa), as well as HIV positive persons identified through other Ezintsha research studies and at Eztinsha affiliated health clinics.

This study will use a randomized trial design to test the effectiveness of incentives to increase confirmatory testing, linkage to care and viral suppression. The aim of this study is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV virologic suppression if offered financial incentives vs. no incentives (standard of care).

Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV reactive test in another research study or at a affiliated clinic, will be randomized into one of two groups: a) a control group that receives the standard of care (SOC) for linkage to care; and b) an intervention group that receives financial incentives for confirmatory testing, linkage to care, and viral suppression.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-16
• Study Start: 2020-07-20
• Primary Completion: 2020-12-17
• Study Completion: 2021-07-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Reported HIV positive
• Have a personal and/or valid phone number, that will remain active for 6 months
• Have a phone with WhatsApp, or text message feature
• Understand the Informed Consent form

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Exclusion Criteria

• Unwilling to provide informed consent
• Any condition which would make the participant unsuitable or unsafe for enrollment, i.e. being unable to see or read by forgetting to bring reading glasses, being intoxicated or acute sickness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Incentives and linkage promotion	Provision of HIV self-screen kit with incentives and linkage promotion	Participants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing.

Primary Outcome Measures

Name	Time	Method
Viral suppression at 6 months	approximately 6 months	Viral suppression (plasma HIV RNA \<400 copies/mL) at approximately 6 months after a positive HIV result

Secondary Outcome Measures

Name	Time	Method
Confirmatory testing	approximately 4 weeks	Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.
ART initiation	approximately 4 weeks	ART initiation within approximately 4 weeks after for those newly diagnosed with HIV

Trial Locations

Locations (1)

Ezintsha Clinical Research Center; 🇿🇦 Johannesburg, Gauteng, South Africa