Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
Study NCT ID:
NCT03898557
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2019-03-29
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Plan and Pledge, HIV Self-testing in South Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abutt@nursing.upenn.edu', 'phone': '215.573.5314', 'title': 'Alison M. Buttenheim, PhD MBA', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over 24 day time period.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': '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).\n\nPotential 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:\n\n1\\. 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.\n\nProvision of HIV self-test: This arm will receive a HIV self-test', 'otherNumAtRisk': 747, 'deathsNumAtRisk': 747, 'otherNumAffected': 0, 'seriousNumAtRisk': 747, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Plan and Pledge', 'description': '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.\n\nPotential 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.\n\nProvision 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', 'otherNumAtRisk': 731, 'deathsNumAtRisk': 731, 'otherNumAffected': 0, 'seriousNumAtRisk': 731, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Report of HIV Self-test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': '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).\n\nPotential 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:\n\n1\\. 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.\n\nProvision of HIV self-test: This arm will receive a HIV self-test'}, {'id': 'OG001', 'title': 'Plan and Pledge', 'description': '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.\n\nPotential 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.\n\nProvision 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'}], 'classes': [{'categories': [{'title': 'Reported', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Not Reported', 'measurements': [{'value': '688', 'groupId': 'OG000'}, {'value': '668', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 3 months', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Report of Positive HIV Self-test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': '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).\n\nPotential 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:\n\n1\\. 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.\n\nProvision of HIV self-test: This arm will receive a HIV self-test'}, {'id': 'OG001', 'title': 'Plan and Pledge', 'description': '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.\n\nPotential 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.\n\nProvision 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'}], 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 3 months', 'description': 'The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Consent for Follow-up', 'timeFrame': 'approximately 3 months', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Complete Follow-up', 'timeFrame': 'approximately 3 months', 'description': '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'On-site Testing', 'timeFrame': 'approximately 3 months', 'description': 'Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmatory Testing', 'timeFrame': 'approximately 3 months', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': '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).\n\nPotential 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 (participants) will be instructed to message the WhatsApp number for the following reasons:\n\n1\\. To message study staff, so they know that self-test recipients(participants) used the test and it went ok. 2. So study staff can help the self-test recipients (participants) understand the results of the test. 3. If the self-test recipients (participants) need support from study staff to access care and services.\n\nProvision of HIV self-test: This arm will receive a HIV self-test'}, {'id': 'FG001', 'title': 'Plan and Pledge', 'description': '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.\n\nPotential self-tester recipients (participants) 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 (participants) that the Plan and Pledge process and card do not change the confidentiality of testing in any way.\n\nProvision 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '747'}, {'groupId': 'FG001', 'numSubjects': '731'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '747'}, {'groupId': 'FG001', 'numSubjects': '731'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Field staff were not considered enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': '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).\n\nPotential 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:\n\n1\\. 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.\n\nProvision of HIV self-test: This arm will receive a HIV self-test'}, {'id': 'BG001', 'title': 'Plan and Pledge', 'description': '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.\n\nPotential 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.\n\nProvision 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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}], 'categories': [{'title': '18-24', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '785', 'groupId': 'BG002'}]}, {'title': '25-39', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': '>= 40', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/ Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '763', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '361', 'groupId': 'BG001'}, {'value': '709', 'groupId': 'BG002'}]}, {'title': 'Transgender/Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Most Recent HIV Test', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '1478', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Tested', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': '0-3 Months', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '3-12 Months', 'measurements': [{'value': '372', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '740', 'groupId': 'BG002'}]}, {'title': 'More than 12 months', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-03', 'size': 247767, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-17T15:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1479}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2019-03-29', 'resultsFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-24', 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Consent for Follow-up', 'timeFrame': 'approximately 3 months', 'description': '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.'}, {'measure': 'Complete Follow-up', 'timeFrame': 'approximately 3 months', 'description': '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'}, {'measure': 'On-site Testing', 'timeFrame': 'approximately 3 months', 'description': 'Percent of on-site testers by study arm and compared to the standard of care arm of the STAR program.'}, {'measure': 'Confirmatory Testing', 'timeFrame': 'approximately 3 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Report of HIV Self-test Result', 'timeFrame': 'approximately 3 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Report of Positive HIV Self-test Result', 'timeFrame': 'approximately 3 months', 'description': 'The count of negative:positive test results reported by study arm and compared to the standard of care arm of the STAR program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '24777472', 'type': 'BACKGROUND', 'citation': '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': '29137506', 'type': 'BACKGROUND', 'citation': "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': '21670283', 'type': 'BACKGROUND', 'citation': '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': '36962680', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSelf-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age or older\n\nExclusion Criteria:\n\n* Intoxication as this effects the result of the HIV self-test'}, 'identificationModule': {'nctId': 'NCT03898557', 'briefTitle': 'Plan and Pledge, HIV Self-testing in South Africa', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Behavioral Commitment and Planning Nudges to Increase HIV Self-testing in South Africa, "Plan and Pledge"', 'orgStudyIdInfo': {'id': '1195218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Usual Care', 'description': '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).\n\nPotential 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:\n\n1\\. 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.', 'interventionNames': ['Behavioral: Provision of HIV self-test']}, {'type': 'EXPERIMENTAL', 'label': 'Plan and Pledge', 'description': '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.\n\nPotential 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.', 'interventionNames': ['Behavioral: Provision of HIV self-test with Commitment and planning prompts']}], 'interventions': [{'name': 'Provision of HIV self-test with Commitment and planning prompts', 'type': 'BEHAVIORAL', 'description': 'The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing', 'armGroupLabels': ['Plan and Pledge']}, {'name': 'Provision of HIV self-test', 'type': 'BEHAVIORAL', 'description': 'This arm will receive a HIV self-test', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Harsha Thirumurthy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wits Reproductive Health and HIV Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}