Incentives to Promote Sustained Linkage to HIV Care

NCT04431154 | Completed

• 1 other identifier: HSTAR013
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; HIV/AIDS

Keywords

HIV self-testing; Behavioral sciences; Financial incentives; Viral suppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Confirmatory testing

  approximately 4 weeks

• ART initiation

  approximately 4 weeks

Study Arms (2)

Experimental: Usual care

NO INTERVENTION

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: Incentives and linkage promotion

EXPERIMENTAL

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

Interventions

Provision of HIV self-screen kit with incentives and linkage promotion BEHAVIORAL

This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care

Experimental: Incentives and linkage promotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Wits Reproductive Health and HIV Institute: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Ezintsha Clinical Research Center

Johannesburg, Gauteng, 2193, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Mohammed Majam, MBA

  Ezintsha, sub-division of Wits Reproductive Health and HIV Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: July 20, 2020
• Primary Completion: December 17, 2020
• Study Completion: July 30, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

ZA (1)