Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 12:35 PM
Study NCT ID:
NCT03351556
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2017-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants in the cash transfer arms will be masked to the knowledge that there are two cash value arms.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2017-11-19', 'studyFirstSubmitQcDate': '2017-11-19', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV viral suppression at 6 months', 'timeFrame': '6 months', 'description': '\\<1000 copies/ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS', 'Adherence, Medication', 'Adherence, Patient']}, 'referencesModule': {'references': [{'pmid': '37301833', 'type': 'DERIVED', 'citation': 'Winters S, Sabasaba A, Fahey CA, Packel L, Katabaro E, Ndungile Y, Njau PF, McCoy SI. Increased prevalence of depression and anxiety among adults initiating antiretroviral therapy during the COVID-19 pandemic in Shinyanga region, Tanzania. AIDS Res Ther. 2023 Jun 10;20(1):36. doi: 10.1186/s12981-023-00534-y.'}, {'pmid': '34556176', 'type': 'DERIVED', 'citation': 'Packel L, Fahey C, Kalinjila A, Mnyippembe A, Njau P, McCoy SI. Preparing a financial incentive program to improve retention in HIV care and viral suppression for scale: using an implementation science framework to evaluate an mHealth system in Tanzania. Implement Sci Commun. 2021 Sep 23;2(1):109. doi: 10.1186/s43058-021-00214-w.'}, {'pmid': '32891234', 'type': 'DERIVED', 'citation': 'Fahey CA, Njau PF, Katabaro E, Mfaume RS, Ulenga N, Mwenda N, Bradshaw PT, Dow WH, Padian NS, Jewell NP, McCoy SI. Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial. Lancet HIV. 2020 Nov;7(11):e762-e771. doi: 10.1016/S2352-3018(20)30230-7. Epub 2020 Sep 3.'}]}, 'descriptionModule': {'briefSummary': '1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months\n2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (\\<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).', 'detailedDescription': "Participants in the control group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS.\n\nThe study has two active intervention arms:\n\n1. The opportunity to earn 10,000 TZS/month (\\~$4.50) for up to 6 months conditional on visit attendance, and\n2. The opportunity to earn 22,500 TZS/month (\\~$10.00) for up to 6 months conditional on visit attendance\n\nIn both intervention arms, cash transfers will be delivered a maximum of once monthly, spaced ≥28 days apart, for up to six months and delivered via an automatic mobile money system linked to a biometric identification system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years\n* Living with HIV infection\n* Initiated antiretroviral therapy ≤1 month prior to enrollment in the study\n\nExclusion Criteria:\n\n\\- Participants who do no provide informed consent'}, 'identificationModule': {'nctId': 'NCT03351556', 'briefTitle': 'Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'R01MH112432-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01MH112432-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH112432-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01MH112432-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Comparison Arm', 'description': "Participants in the comparison group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS."}, {'type': 'EXPERIMENTAL', 'label': 'Active Intervention 1', 'description': "Participants will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month (\\~$4.50) for up to 6 months conditional on visit attendance.", 'interventionNames': ['Behavioral: Active Arm 1']}, {'type': 'EXPERIMENTAL', 'label': 'Active Intervention 2', 'description': "Participants will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month (\\~$10.00) for up to 6 months conditional on visit attendance.", 'interventionNames': ['Behavioral: Active Arm 2']}], 'interventions': [{'name': 'Active Arm 1', 'type': 'BEHAVIORAL', 'description': "Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month conditional on visit attendance.", 'armGroupLabels': ['Active Intervention 1']}, {'name': 'Active Arm 2', 'type': 'BEHAVIORAL', 'description': "Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month conditional on visit attendance.", 'armGroupLabels': ['Active Intervention 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kahama', 'state': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Kahama Hospital', 'geoPoint': {'lat': -3.83333, 'lon': 32.6}}, {'city': 'Shinyanga', 'state': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Kagongwa Health Center', 'geoPoint': {'lat': -3.66393, 'lon': 33.42118}}, {'city': 'Shinyanga', 'state': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Kambarage Health Center', 'geoPoint': {'lat': -3.66393, 'lon': 33.42118}}, {'city': 'Shinyanga', 'state': 'Shinyanga', 'country': 'Tanzania', 'facility': 'Shinyanga Regional Referral Hospital', 'geoPoint': {'lat': -3.66393, 'lon': 33.42118}}], 'overallOfficials': [{'name': 'Sandra I McCoy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}, {'name': 'Prosper Njau, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Rasello', 'class': 'INDUSTRY'}, {'name': 'Health for a Prosperous Nation', 'class': 'OTHER'}, {'name': 'Management and Development for Health in Tanzania', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Sandra McCoy', 'investigatorAffiliation': 'University of California, Berkeley'}}}}