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OpenTrials
Completed

NCT Number: NCT04431154

Incentives to Promote Sustained Linkage to HIV Care

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Viral suppression at 6 months

    Time frame: approximately 6 months

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

Secondary outcomes

  1. Confirmatory testing

    Time frame: approximately 4 weeks

    Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.

  2. ART initiation

    Time frame: approximately 4 weeks

    ART initiation within approximately 4 weeks after for those newly diagnosed with HIV

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Wits Reproductive Health and HIV Institute

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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