Plan and Pledge, HIV Self-testing in South Africa

Human Immunodeficiency Virus Clinical Trial

Official title:

Behavioral Commitment and Planning Nudges to Increase HIV Self-testing in South Africa, "Plan and Pledge"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898557
• Other study ID #: 1195218
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: June 18, 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1479
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 19 years of age or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• Provision of HIV self-test with Commitment and planning prompts
The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
• Provision of HIV self-test
This arm will receive a HIV self-test

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Wits Reproductive Health and HIV Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cohen J, Rothschild C, Golub G, Omondi GN, Kruk ME, McConnell M. Measuring The Impact Of Cash Transfers And Behavioral 'Nudges' On Maternity Care In Nairobi, Kenya. Health Aff (Millwood). 2017 Nov;36(11):1956-1964. doi: 10.1377/hlthaff.2017.0537. — View Citation

Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13. — View Citation

Rogers T, Milkman KL, Volpp KG. Commitment devices: using initiatives to change behavior. JAMA. 2014 May;311(20):2065-6. doi: 10.1001/jama.2014.3485. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	consent for follow-up	The percent of self-test recipients who consent to phone/SMS follow-up by study arm and compared to the standard of care arm of the STAR program.	approximately 3 months
Other	Complete follow-up	The percent of self-test recipients who are successfully reached for follow-up by phone about 7 days after receiving the HIV self-test, by study arm and compared to the standard of care arm of the STAR program	approximately 3 months
Other	on-site testing	Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program.	approximately 3 months
Other	Confirmatory testing	The percent of self-test recipients who seek confirmatory testing by study arm and compared to the standard of care arm of the STAR program.	approximately 3 months
Primary	use of HIV self-test kit	percent of self-test recipients reporting use of HIV self-test kits to dedicated WhatsApp number by arm and compared to the standard of care arm of the STAR program	approximately 3 months
Secondary	report of HIV self-test result	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	approximately 3 months
Secondary	report of positive HIV self-test result	The Ratio of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.	approximately 3 months