Plan and Pledge, HIV Self-testing in South Africa

NCT03898557 | Completed Results

• 1 other identifier: 1195218
• Study Type: interventional
• Target: 1,479
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Report of Positive HIV Self-test Result

  approximately 3 months

Other Outcomes (4)

• Consent for Follow-up

  approximately 3 months

• Complete Follow-up

  approximately 3 months

• On-site Testing

  approximately 3 months

Study Arms (2)

Usual Care

EXPERIMENTAL

Participants randomized to this arm will receive a card with information to report results via WhatsApp, similar to the existing card used in the STAR program. This card will have a dedicated Usual Care WhatsApp number (different from the existing STAR program numbers). Potential self-test recipients will be shown the WhatsApp card and instructed on how to anonymously report use of self-test to the WhatsApp number. Recipients will be instructed to message the WhatsApp number for the following reasons: 1\. So study staff know the self-test recipients used the test and it went ok. 2. So study staff can help the self-test recipients understand the results of the test. 3. If the self-test recipients need support from study staff to access care and services.

Behavioral: Provision of HIV self-test

Plan and Pledge

EXPERIMENTAL

Participants randomized to this arm will revive the Usual Care WhatsApp card and and a brief template to "make a plan" and "make a pledge" for test completion and results reporting, to take the HIV self-test. The card will include a dedicated Plan and Pledge WhatsApp number. Potential self-tester recipients will be shown the WhatsApp card, including Plan and Pledge statements, and will be encouraged by STAR field staff to use the card in their own time to make a plan and sign the pledge as part of receiving the test kit and instructions for how to complete the card. Importantly, testers will be able to keep the card for themselves. There is no expectation to share the plan or the pledge signature with the STAR field staff who distribute self-tests. Field staff will clarify for self-tests recipients that the Plan and Pledge process and card do not change the confidentiality of testing in any way.

Behavioral: Provision of HIV self-test with Commitment and planning prompts

Interventions

Provision of HIV self-test with Commitment and planning prompts BEHAVIORAL

The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing

Plan and Pledge

Provision of HIV self-test BEHAVIORAL

This arm will receive a HIV self-test

Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Wits Reproductive Health and HIV Institute: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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. No abstract available.

  PMID: 24777472 BACKGROUND

• 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.

  PMID: 29137506 BACKGROUND

• 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.

  PMID: 21670283 BACKGROUND

• Buttenheim AM, Schmucker L, Marcus N, Phatsoane M, Msolomba V, Rhagnath N, Majam M, Venter F, Thirumurthy H. Planning and commitment prompts to encourage reporting of HIV self-test results: A cluster randomized pragmatic trial in Tshwane District, South Africa. PLOS Glob Public Health. 2022 Oct 24;2(10):e0001196. doi: 10.1371/journal.pgph.0001196. eCollection 2022.

  PMID: 36962680 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Alison M. Buttenheim, PhD MBA
• Organization: University of Pennsylvania

abutt@nursing.upenn.edu

215.573.5314

Study Officials

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HIV self-test kits will be distributed at fixed-point distribution sites in the Tshwane district of South Africa and will be grouped into clusters to randomly receive intervention or control. About 44 clusters with an average of 30 participants per cluster, will be selected for the study.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: May 28, 2019
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)