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Incentives to Promote Sustained Linkage to HIV Care

Primary Purpose

Human Immunodeficiency Virus, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Provision of HIV self-screen kit with incentives and linkage promotion
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Human Immunodeficiency Virus focused on measuring HIV self-testing, Behavioral sciences, Financial incentives, Viral suppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ezintsha Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Experimental: Usual care

Experimental: Incentives and linkage promotion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Confirmatory testing
Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.
ART initiation
ART initiation within approximately 4 weeks after for those newly diagnosed with HIV

Full Information

First Posted
June 10, 2020
Last Updated
July 19, 2022
Sponsor
University of Pennsylvania
Collaborators
Wits Reproductive Health and HIV Institute, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04431154
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Wits Reproductive Health and HIV Institute, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, HIV/AIDS
Keywords
HIV self-testing, Behavioral sciences, Financial incentives, Viral suppression

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental: Incentives and linkage promotion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provision of HIV self-screen kit with incentives and linkage promotion
Intervention Description
This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care
Primary Outcome Measure Information:
Title
Viral suppression at 6 months
Description
Viral suppression (plasma HIV RNA <400 copies/mL) at approximately 6 months after a positive HIV result
Time Frame
approximately 6 months
Secondary Outcome Measure Information:
Title
Confirmatory testing
Description
Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.
Time Frame
approximately 4 weeks
Title
ART initiation
Description
ART initiation within approximately 4 weeks after for those newly diagnosed with HIV
Time Frame
approximately 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harsha Thirumurthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed Majam, MBA
Organizational Affiliation
Ezintsha, sub-division of Wits Reproductive Health and HIV Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ezintsha Clinical Research Center
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Incentives to Promote Sustained Linkage to HIV Care

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