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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04431154
Other study ID # HSTAR013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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