Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-03 @ 6:34 PM
Study NCT ID:
NCT04160169
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Counseling on Injectable Contraception and HIV Risk in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of clients obtaining an injectable during their family planning appointment', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Injectable uptake of interviewed clients'}, {'measure': 'Percent of clients obtaining an injectable during their family planning appointment', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Injectable uptake of interviewed clients'}, {'measure': 'Monthly total number of family planning clients by method obtained', 'timeFrame': 'September 2017 through November 2018', 'description': 'Contraceptive uptake during pilot intervention'}], 'secondaryOutcomes': [{'measure': 'Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Knowledge of hormonal contraception and HIV risk messages'}, {'measure': 'Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Knowledge of hormonal contraception and HIV risk messages'}, {'measure': 'Number of correct True/False statements on hormonal contraception and HIV (11 total)', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Knowledge of hormonal contraception and HIV risk messages'}, {'measure': 'Percent of correct True/False statements on hormonal contraception and HIV (11 total)', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Knowledge of hormonal contraception and HIV risk messages'}, {'measure': 'Number of interviewed clients reporting an intention to use condoms as a dual method', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Intention to use condoms as a dual method'}, {'measure': 'Percent of interviewed clients reporting an intention to use condoms as a dual method', 'timeFrame': 'After implementation of counseling messages, up to 13 weeks', 'description': 'Intention to use condoms as a dual method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Counseling', 'Tanzania'], 'conditions': ['Contraception']}, 'referencesModule': {'availIpds': [{'id': 'doi:10.15139/S3/XEXQXO', 'url': 'https://dataverse.unc.edu/dataset.xhtml?persistentId=doi:10.15139/S3/XEXQXO', 'type': 'Individual Participant Data Set'}], 'seeAlsoLinks': [{'url': 'http://apps.who.int/iris/bitstream/handle/10665/254662/WHO-RHR-17.04-eng.pdf;jsessionid=035D4751CFD8B1A20F3DF079DD896C81?sequence=1', 'label': 'Hormonal contraceptive eligibility for women at high risk of HIV: Guidance statement. 2017'}, {'url': 'http://healthcommcapacity.org/hc3resources/strategic-communication-framework-for-hormonal-contraceptive-methods-and-potential-hiv-related-risks/', 'label': 'Strategic communication framework for hormonal contraceptive methods and potential HIV-related risks. 2017.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.', 'detailedDescription': 'The evaluation assessed the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention. The intervention was conducted September-November 2018 in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania. Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention. Univariate and bivariate analyses were used to assess quantitative interview data. Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. Interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women attending a participating healthcare facility during the three month intervention period and who met eligibility criteria received the hormonal contraception and HIV risk messages.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expressed interest in injectable use\n* HIV-negative or unknown HIV status\n\nExclusion Criteria:\n\n* Positive HIV status known to healthcare provider'}, 'identificationModule': {'nctId': 'NCT04160169', 'briefTitle': 'Counseling on Injectable Contraception and HIV Risk in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania', 'orgStudyIdInfo': {'id': '18-1049'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Counseling messages on injectable use and HIV acquisition risk', 'type': 'OTHER', 'description': 'Counseling messages based on 2017 World Health Organization guidance, a review of the Strategic Communication Framework for Hormonal Contraceptive Methods and Potential HIV-related Risks, and the Family Planning Global Handbook were provided to clients expressing interest in injectables during regular family planning appointments.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ilula', 'state': 'Iringa', 'country': 'Tanzania', 'facility': 'Ilula Hospital', 'geoPoint': {'lat': -7.6766, 'lon': 36.03658}}, {'city': 'Mafinga', 'state': 'Iringa', 'country': 'Tanzania', 'facility': 'Mafinga Hospital', 'geoPoint': {'lat': -8.30019, 'lon': 35.29366}}, {'city': 'Iringa', 'country': 'Tanzania', 'facility': 'Ihongole Health Center', 'geoPoint': {'lat': -7.76667, 'lon': 35.7}}, {'city': 'Iringa', 'country': 'Tanzania', 'facility': 'Ipogolo Health Center', 'geoPoint': {'lat': -7.76667, 'lon': 35.7}}, {'city': 'Iringa', 'country': 'Tanzania', 'facility': 'Kimande Health Center', 'geoPoint': {'lat': -7.76667, 'lon': 35.7}}, {'city': 'Njombe', 'country': 'Tanzania', 'facility': 'Ipelele Health Center', 'geoPoint': {'lat': -9.34917, 'lon': 34.77167}}, {'city': 'Njombe', 'country': 'Tanzania', 'facility': 'Kibena Regional Referral Hospital', 'geoPoint': {'lat': -9.34917, 'lon': 34.77167}}, {'city': 'Njombe', 'country': 'Tanzania', 'facility': 'Makambako Hospital', 'geoPoint': {'lat': -9.34917, 'lon': 34.77167}}, {'city': 'Njombe', 'country': 'Tanzania', 'facility': 'Makete Hospital', 'geoPoint': {'lat': -9.34917, 'lon': 34.77167}}, {'city': 'Njombe', 'country': 'Tanzania', 'facility': 'Njombe Health Center', 'geoPoint': {'lat': -9.34917, 'lon': 34.77167}}], 'overallOfficials': [{'name': "Janine Barden-O'Fallon, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'url': 'https://dataverse.unc.edu/dataset.xhtml?persistentId=doi:10.15139/S3/XEXQXO', 'infoTypes': ['CSR'], 'timeFrame': 'Data are currently available and will remain on Dataverse.org', 'ipdSharing': 'YES', 'description': 'Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format. The study report is also available on Dataverse.', 'accessCriteria': 'Site registration required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Ministry of Health, Tanzania', 'class': 'OTHER_GOV'}, {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}