Study Results
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View full resultsBasic Information
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COMPLETED
NA
1479 participants
INTERVENTIONAL
2019-05-28
2019-06-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual Care
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.
Provision of HIV self-test
This arm will receive a HIV self-test
Plan and Pledge
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
ALL
Yes
Sponsors
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Wits Reproductive Health and HIV Institute
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Harsha Thirumurthy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1195218
Identifier Type: -
Identifier Source: org_study_id
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