Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 7:55 AM
Study NCT ID:
NCT05889533
Status:
TERMINATED
Last Update Posted:
2025-03-18
First Post:
2023-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eswatini Ring Study: Increasing PrEP Options for Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 904}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study was stopped due to the stop work order issued by USAID on January 27, 2025', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PEP users who acquire HIV following PrEP initiation.', 'timeFrame': '18 months', 'description': 'Proportion and rates of HIV infection among participants; proportion and rates of HIV drug resistance (DR) mutations among PrEP users who acquire HIV.'}], 'primaryOutcomes': [{'measure': 'Characterize implementation of the service delivery package for informed PrEP choice for women', 'timeFrame': '18 months', 'description': 'Health system feasibility and delivery acceptance among users/providers'}], 'secondaryOutcomes': [{'measure': 'Describe patterns of PrEP use in the context of informed PrEP choice', 'timeFrame': '18 months', 'description': 'Overall and method-specific PrEP uptake; continuation/switching/discontinuation of PrEP products; product acceptability among users.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV prevention', 'PrEP', 'AGYW', 'PrEP Ring', 'Eswatini'], 'conditions': ['HIV Prevention']}, 'descriptionModule': {'briefSummary': 'The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.', 'detailedDescription': 'The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.\n\nThe two main study components include the following:\n\n1. Prospective, observational cohort of eligible individuals interested in initiating PrEP or continuing PrEP with screening for entry at time of HIV testing and followed throughout the study period (up to 18 months). Data collection will involve quantitative methods and for a subset of participants, data will also be collected using qualitative means, namely in-depth interviews, and focus group discussions.\n2. Mixed methods process evaluation that will document implementation of the enhanced service delivery package, assess ongoing perceptions of service delivery (i.e., acceptability and feasibility, barriers and facilitators) among providers and end users, and document other important implementation considerations including the integration of PrEP and family planning.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those meeting eligibility criteria seeking PrEP services at study sites.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.'}, 'identificationModule': {'nctId': 'NCT05889533', 'briefTitle': 'Eswatini Ring Study: Increasing PrEP Options for Women', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring', 'orgStudyIdInfo': {'id': 'FHI 360'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dvokolwako', 'country': 'Eswatini', 'facility': 'Dvokolwako Health Centre', 'geoPoint': {'lat': -26.16037, 'lon': 31.58878}}, {'city': 'Manzini', 'country': 'Eswatini', 'facility': 'Manzini KP Community Centre', 'geoPoint': {'lat': -26.49884, 'lon': 31.38004}}, {'city': 'Matsapha', 'country': 'Eswatini', 'facility': 'Matsapha Mobile Clinic', 'geoPoint': {'lat': -26.50253, 'lon': 31.30795}}, {'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Mbabane Key Population (KP) Community Centre', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}, {'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Mbabane Public Health Unit', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}, {'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Motshane Clinic', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}, {'city': 'Siphofaneni', 'country': 'Eswatini', 'facility': 'Siphofaneni Inkhundla (DREAMS Outreach)', 'geoPoint': {'lat': -26.67779, 'lon': 31.68735}}, {'city': 'Velebantfu', 'country': 'Eswatini', 'facility': 'New Haven Clinic', 'geoPoint': {'lat': -27.05009, 'lon': 31.48987}}], 'overallOfficials': [{'name': 'Anita Hettema, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FHI 360'}, {'name': 'Sindy Matse, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After study completion and manuscript submission.', 'ipdSharing': 'YES', 'description': "In accordance with the USAID Automated Directives System 579, after acceptance of any knowledge product presenting study findings and after being cleaned of any information that could be used to personally identify participants, the quantitative survey dataset along with relevant documentation will be registered with USAID's Development Data Library (DDL) and made available publicly in an open data repository, to the extent permissible by Eswatini's data privacy and data sharing regulations."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}