Incentives to Promote Sustained Linkage to HIV Care

Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Ezintsha Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Experimental: Usual care; Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. 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.
EXPERIMENTAL: Experimental: 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.	Behavioral: Provision of HIV self-screen kit with incentives and linkage promotion; This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral suppression at 6 months	Viral suppression (plasma HIV RNA <400 copies/mL) at approximately 6 months after a positive HIV result	approximately 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Bill and Melinda Gates Foundation; Wits Reproductive Health and HIV Institute
• Investigators: Principal Investigator: Mohammed Majam, MBA, Ezintsha, sub-division of Wits Reproductive Health and HIV Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): December 17, 2020
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Viral suppression; HIV self-testing; Behavioral sciences; Financial incentives
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HSTAR013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No