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Plan and Pledge, HIV Self-testing in South Africa

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ClinicalTrials.gov Identifier: NCT03898557
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Wits Reproductive Health and HIV Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Provision of HIV self-test with Commitment and planning prompts Behavioral: Provision of HIV self-test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Commitment and Planning Nudges to Increase HIV Self-testing in South Africa, "Plan and Pledge"
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.

Behavioral: Provision of HIV self-test
This arm will receive a HIV self-test

Experimental: 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.

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




Primary Outcome Measures :
  1. use of HIV self-test kit [ Time Frame: approximately 3 months ]
    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


Secondary Outcome Measures :
  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

  2. report of positive HIV self-test result [ Time Frame: approximately 3 months ]
    The Ratio of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19 years of age or older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898557


Contacts
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Contact: Noora Marcus, MA 2157454429 noora.marcus@pennmedicine.upenn.edu
Contact: Harsha Thirumurthy, PhD hthirumu@upenn.edu

Sponsors and Collaborators
University of Pennsylvania
Wits Reproductive Health and HIV Institute
Investigators
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Principal Investigator: Harsha Thirumurthy, PhD University of Pennsylvania

Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03898557     History of Changes
Other Study ID Numbers: 1195218
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases