Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:45 AM
Study NCT ID:
NCT07318532
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25', 'submissionTracking': {'submissionInfos': [{'resetDate': '2026-01-21', 'releaseDate': '2026-01-06'}], 'estimatedResultsFirstSubmitDate': '2026-01-06'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-03', 'size': 193712, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-12-23T10:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Note, this is a clinic-level intervention. Thus the "participant" is the clinic.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach', 'timeFrame': 'Each study visit within the 4 month intervention period', 'description': '* Percentage of eligible patients who received introduction to pre-exposure prophylaxis (PrEP) by navigators (by comparison of the navigators counseling log to the electronic health record (EHR)\n* Percentage of eligible patients counseled about PrEP by providers (by EHR review)\n* Percentage of eligible patients counseled by either the PrEP navigator or a provider'}], 'secondaryOutcomes': [{'measure': 'Adoption', 'timeFrame': 'Two-month intervention training period', 'description': '* Percentage of clinic-team members who participated in training (by attendance log)\n* Percentage of change in PrEP knowledge and PrEP best practices (pre-/post-clinic-wide training questionnaire)'}, {'measure': 'Intervention characteristics: organizational and patient perspectives', 'timeFrame': '6 months (four month intervention and two months of follow-up)', 'description': '* Perceived feasibility of implementing the intervention and identified barriers (by in depth interviews (IDI) with the clinic team and navigators)\n* Satisfaction with training and intervention usability/complexity among clinic team and navigators (by IDIs with the clinic team and navigators)\n* Acceptability of the provider or navigator PrEP education/counseling, focusing on burden and addressing patient barriers (by IDI with patients)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV pre-exposure prophylaxis (PrEP)', 'HIV prevention', 'Women'], 'conditions': ['HIV Prevention Program']}, 'referencesModule': {'references': [{'pmid': '41337677', 'type': 'RESULT', 'citation': 'Scott R, Hull SJ, Kerrigan D, Wang Y, Pratt-Chapman M, Mathias-Prabhu T, Unwala N, Sadauskas M, Hose BZ, Smith M, Moriarty P, Hanson T, Tedla A, Lotke P, Ye P, Arem H. "The Women\'s PrEP Project," a Clinic-Based, Socio-Structural Intervention to Improve the Provision of Preexposure Prophylaxis for Cisgender Women: Interrupted Time Series Pilot. JMIR Form Res. 2025 Dec 3;9:e80653. doi: 10.2196/80653.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the "PrEP CGW" pilot study is evaluate the feasibility and acceptability of a clinic-level intervention to improve HIV prevention and Pre-exposure Prophylaxis (PrEP) services for women. The intervention includes clinic wide trainings, provider and clinic staff tool kits, PrEP navigation, and patient-facing educational resources. The overarching goal of the program is to determine if the intervention improves PrEP uptake among women.\n\nPatients who attend the study-site clinic will be exposed to the intervention. Patients will be invited to participate in post-visit questionnaires; approximately 20 patients will be invited to participate in interviews.', 'detailedDescription': 'The goal of the "PrEP CGW" pilot study is evaluate the feasibility and acceptability of a clinic-level intervention to improve HIV prevention and Pre-exposure Prophylaxis (PrEP) services for women. Feasibility testing additionally includes assessing the appropriateness of the study measures (e.g., questionnaires, interviews, collection of electronic health record data) to assess the outcomes of interest in the planned full scale trial. The intervention includes clinic wide trainings, provider and clinic staff tool kits, PrEP navigation, and patient-facing educational resources developed and/or collated as part of the R34 award. The overarching goal of the program is to determine if the intervention improves PrEP uptake among women.\n\nPatients who attend the study-site clinic will be exposed to the clinic level intervention. Patients will be invited to participate in post-visit questionnaires; approximately 20 patients will be invited to participate in interviews. Electronic health data from the intervention period will be compared with a historical control period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Cisgender women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving care at the study-site clinic\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT07318532', 'acronym': 'PrEP CGW', 'briefTitle': 'Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis Services for Cisgender Women', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Socio-Structural Intervention to Improve Pre-Exposure Prophylaxis (PrEP) Services for Cisgender Women (CGW) (PrEP-CGW)', 'orgStudyIdInfo': {'id': 'MedstarRI'}, 'secondaryIdInfos': [{'id': 'R34MH128046', 'link': 'https://reporter.nih.gov/quickSearch/R34MH128046', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrEP CGW Pilot: W-PrEP intervention arm', 'description': 'W-PrEP intervention arm included exposure to trained providers and clinic staff, PrEP navigation, and patient-facing educational resources such as videos, pamphlets, posters, and an educational website.\n\nThis arm was compared to historical controls from the same calendar year.', 'interventionNames': ["Behavioral: The women's PrEP Project (W-PrEP)"]}], 'interventions': [{'name': "The women's PrEP Project (W-PrEP)", 'type': 'BEHAVIORAL', 'otherNames': ['W-PrEP'], 'description': 'W-PrEP intervention included exposure to trained providers and clinic staff, PrEP navigation, and patient-facing educational resources such as videos, pamphlets, posters, and an educational website.', 'armGroupLabels': ['PrEP CGW Pilot: W-PrEP intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2026-01-06', 'type': 'RELEASE'}, {'date': '2026-01-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Medstar Health Research Institute'}}}}