Clinical trial NCT04431154: Incentives to Promote Sustained Linkage to HIV Care
Official title: Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
HIV/AIDS
Keywords: HIV self-testing
Behavioral sciences
Financial incentives
Viral suppression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Wits Reproductive Health and HIV Institute
name: Bill and Melinda Gates Foundation
First posted: 2020-06-16
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral suppression at 6 months
timeFrame: approximately 6 months
Secondary outcomes:
measure: Confirmatory testing
timeFrame: approximately 4 weeks
measure: ART initiation
timeFrame: approximately 4 weeks
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Ezintsha Clinical Research Center
state: Gauteng
Study officials:
affiliation: University of Pennsylvania
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ezintsha, sub-division of Wits Reproductive Health and HIV Institute
name: Mohammed Majam, MBA
role: PRINCIPAL_INVESTIGATOR
References: