Human Immunodeficiency VirusNCT03898557

Plan and Pledge, HIV Self-testing in South Africa

A study testing Provision of HIV self-test with Commitment and planning prompts and Provision of HIV self-test in people with Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Provision of HIV self-test with Commitment and planning prompts and Provision of HIV self-test
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,479 participants
Where: 1 siteUnited States
Study dates: 28 May 2019to 18 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

19 years of age or older

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

Read the 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.

Conditions: Human Immunodeficiency Virus
Being tested: Provision of HIV self-test with Commitment and planning prompts, Provision of HIV self-test
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03898557
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Provision of HIV self-test with Commitment and planning prompts

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: approximately 3 months

Secondary outcomes (1)

Report of Positive HIV Self-test Result
The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.
Measured: approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 201918 Jun 2019

First posted2 Apr 2019
Study start28 May 2019
Primary completion18 Jun 2019
Study completion18 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 1,479 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03898557
Sponsor's protocol ID: 1195218
Status last verified: Jun 2024
First submitted: 29 Mar 2019
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24777472
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.
PubMed 29137506
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.
PubMed 21670283
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.
PubMed 36962680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Commitment and Planning Nudges to Increase HIV Self-testing in South Africa, "Plan and Pledge"
ClinicalTrials.gov ID: NCT03898557
Acronym / sponsor ID: 1195218
Conditions: Human Immunodeficiency Virus
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,479 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Wits Reproductive Health and HIV Institute
Study start: 28 May 2019 (actual)
Primary completion: 18 Jun 2019 (actual)
Study completion: 18 Jun 2019 (actual)
First posted: 2 Apr 2019 (actual)
Results: Posted 26 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Usual Care	Experimental	Behavioral: Provision of HIV self-testParticipants 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.
Plan and Pledge	Experimental	Behavioral: Provision of HIV self-test with Commitment and planning promptsParticipants 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.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

19 years of age or older

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Provision of HIV self-test with Commitment and planning promptsThe interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing	Behavioural	Plan and Pledge
Provision of HIV self-testThis arm will receive a HIV self-test	Behavioural	Usual Care

Primary outcome

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

1 secondary outcome

Report of Positive HIV Self-test Result
Time frame: approximately 3 months

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	747	747
Plan and Pledge	731	731

Primary outcome: Report of HIV Self-test Result

Time frame: approximately 3 months. Count of participants. Unit: Participants

Measure	Usual Care n = 747	Plan and Pledge n = 731
Reported	59	63
Not Reported	688	668

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over 24 day time period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 747 (0%)	0 of 747 (0%)	0 of 747
Plan and Pledge	0 of 731 (0%)	0 of 731 (0%)	0 of 731

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24777472Rogers 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.
Background: PubMed 29137506Cohen 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.
Background: PubMed 21670283Milkman 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.
Derived from this study: PubMed 36962680Buttenheim 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harsha Thirumurthy, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Report of HIV Self-test Result (time frame: approximately 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03898557, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.