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Completed

NCT Number: NCT03898557

Plan and Pledge, HIV Self-testing in South Africa

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19 years of age or older

Exclusion criteria

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

Treatment and study plan

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

Provision of HIV self-test

Behavioral

This arm will receive a HIV self-test

Primary outcomes

  1. Report of HIV Self-test Result

    Time frame: 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 outcomes

  1. Report of Positive HIV Self-test Result

    Time frame: 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.

Other outcomes

  1. Consent for Follow-up

    Time frame: approximately 3 months

    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.

  2. Complete Follow-up

    Time frame: approximately 3 months

    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

  3. On-site Testing

    Time frame: approximately 3 months

    Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program.

  4. Confirmatory Testing

    Time frame: approximately 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Wits Reproductive Health and HIV Institute

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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