Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-23 @ 8:46 AM
Study NCT ID:
NCT01838005
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2013-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of women who were adherent to all conditionalities and received the most effective ARV intervention they were eligible to receive and delivered at an affiliated maternity', 'timeFrame': '6 weeks postpartum', 'description': 'At each monthly visit starting at randomization (28 weeks), participants will be evaluated for the following conditionalities:\n\n1. attended the scheduled visit on time (+/- 5 days)\n2. accept HIV status and services proposed to them\n3. return to deliver in the clinic At the end of the follow-up (6 weeks post-partum)the proportion of participants who adhered to all these conditions will be calculated for each study group'}], 'secondaryOutcomes': [{'measure': 'Mother to child transmission rate at six weeks and HIV-free survival.', 'timeFrame': '6 weeks post partum', 'description': 'Proportion of HIV-exposed infant who tested positive at 6 week postpartum'}, {'measure': 'HIV-free survival at 18 month.', 'timeFrame': '18 months porstpartum', 'description': 'Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV'}, {'measure': 'Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test', 'timeFrame': '6 weeks Postpartum', 'description': 'Proportion of infants born to HIV-infected participants who at 6 weeks postpartum are receiving the extended nevirapine prophylaxis and have been tested for HIV'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contingency management', 'conditional cash transfer', 'PMTCT', 'Retention', 'HIV'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '27787342', 'type': 'RESULT', 'citation': 'Yotebieng M, Moracco KE, Thirumurthy H, Edmonds A, Tabala M, Kawende B, Wenzi LK, Okitolonda EW, Behets F. Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):150-157. doi: 10.1097/QAI.0000000000001219.'}, {'pmid': '26847230', 'type': 'RESULT', 'citation': 'Yotebieng M, Thirumurthy H, Moracco KE, Kawende B, Chalachala JL, Wenzi LK, Ravelomanana NL, Edmonds A, Thompson D, Okitolonda EW, Behets F. Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e85-93. doi: 10.1016/S2352-3018(15)00247-7.'}, {'pmid': '27819151', 'type': 'RESULT', 'citation': 'Yotebieng KA, Fokong K, Yotebieng M. Depression, retention in care, and uptake of PMTCT service in Kinshasa, the Democratic Republic of Congo: a prospective cohort. AIDS Care. 2017 Mar;29(3):285-289. doi: 10.1080/09540121.2016.1255708. Epub 2016 Nov 6.'}, {'pmid': '33691667', 'type': 'DERIVED', 'citation': 'Saleska JL, Turner AN, Gallo MF, Shoben A, Kawende B, Ravelomanana NLR, Thirumurthy H, Yotebieng M. Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade. BMC Public Health. 2021 Mar 10;21(1):477. doi: 10.1186/s12889-021-10499-0.'}]}, 'descriptionModule': {'briefSummary': 'The goals of the proposed study are to: 1) test whether small, increasing cash payments to HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible for by the time of delivery, and 2) elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade, and to what extent the conditional cash payment program addresses these factors.\n\nThis intervention will be implemented and evaluated within our well-established PMTCT program in Kinshasa, Democratic Republic of Congo (DRC),'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed as HIV-positive\n* Pregnant between 28 and 32 weeks of gestation (\\>27 and \\<32 completed weeks of pregnancy)\n* Intend to stay in Kinshasa through delivery and six weeks postpartum\n* Able and willing to participate (provide informed consent)\n\nExclusion Criteria:\n\n* Women will be excluded from the study if they are severely ill and require extended hospitalization or need to be cared for at a referral hospital out of the PMTCT network'}, 'identificationModule': {'nctId': 'NCT01838005', 'briefTitle': 'Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services', 'orgStudyIdInfo': {'id': '12-1676'}, 'secondaryIdInfos': [{'id': '1R01HD075171-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD075171-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO\'s "Option A"'}, {'type': 'EXPERIMENTAL', 'label': 'Conditional Cash Transfer', 'description': 'Financial incentive to attend regular clinic visits and receive PMTCT care', 'interventionNames': ['Behavioral: Conditional cash transfer']}], 'interventions': [{'name': 'Conditional cash transfer', 'type': 'BEHAVIORAL', 'otherNames': ['Contingency management'], 'description': 'Eligible women randomized to the intervention group will receive the standard of care plus small and increasing cash payments, on the condition that they attend scheduled clinic visits on time (+/-5days), accept HIV services, deliver in a health facility, and at six weeks postpartum adhere to prescribed infant prophylactic drugs (cotrimoxazole, extended NVP) and provide blood sample for DNA PCR infant early HIV diagnosis.', 'armGroupLabels': ['Conditional Cash Transfer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kinshasa', 'state': 'Kinshasa', 'country': 'Republic of the Congo', 'facility': 'Kinshasa School of Public Health'}], 'overallOfficials': [{'name': 'Marcel Yotebieng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Emile W Okitolonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kinshasa School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Kinshasa School of Public Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}