Plan and Pledge, HIV Self-testing in South Africa

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT03898557
• Lead Sponsor: University of Pennsylvania

Brief Summary

The Plan and Pledge pilot will incorporate behavioral economics approaches (nudges) into the pre-existing STAR self-test fixed-site distribution program, implemented by Wits Reproductive Health and HIV Institute (Wits RHI) at the University of Witwatersrand, Johannesburg, South Africa. The objective of this pilot is to examine the use of commitment strategies to increase uptake of HIV self-testing in South Africa.

Detailed Description

This study will use a cluster randomized trial design to test the effectiveness of interventions designed to increase usage of self-test and reporting of results by HIV self-tests recipients. Specifically, this study will examine the use of commitment and planning prompts to increase the uptake of HIV self-testing in the Tshwane district in South Africa. The intervention will build on the implementation procedures of STAR program (HIV Self-Testing Africa). The two arms in the study will be: 1) Usual care, "Promote": A card with information to report results via WhatsApp, similar to the existing card used in the STAR program. with a dedicated Usual care WhatsApp number (different from the existing campaign numbers). 2) Plan and Pledge: A card with the information from the Usual Care card plus a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the test. The card will include a dedicated Pledge and Plan WhatsApp number.

Self-test distribution team-day pair will serve as the unit of randomization (i.e. two pairs of STAR field staff will be randomized by arm and by day. Clusters of individuals will receive self-tests at a distribution site from a pair of STAR field staff on an individual day). Computer-generated randomization will be used to assign site-day clusters to the 2 study arms. The study will take place at the STAR community fixed-point distribution sites in Tshwane District, South Africa.

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Study Start: 2019-05-28
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Results First Submitted: 2023-11-21
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Results First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1479

Inclusion Criteria

• 19 years of age or older

Exclusion Criteria

• Intoxication as this effects the result of the HIV self-test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Report of HIV Self-test Result	approximately 3 months	The percent of self-test recipients who report self-test result on the dedicated WhatsApp number and are HIV positive, by study arm and compared to the standard of care arm of the STAR program

Secondary Outcome Measures

Name	Time	Method
Report of Positive HIV Self-test Result	approximately 3 months	The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States