Incentives to Promote Sustained Linkage to HIV Care

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431154
• Other study ID #: HSTAR013
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: July 30, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 30, 2021
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
South Africa	Ezintsha Clinical Research Center	Johannesburg	Gauteng

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Bill and Melinda Gates Foundation, Wits Reproductive Health and HIV Institute

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Confirmatory testing	Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.	approximately 4 weeks
Secondary	ART initiation	ART initiation within approximately 4 weeks after for those newly diagnosed with HIV	approximately 4 weeks