Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 4:32 AM
Study NCT ID:
NCT07015957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability of the implementation strategies', 'timeFrame': 'Months 1-9', 'description': 'Health workers will be asked a set of questions to assess their perceived acceptability of the implementation strategies, based on the Theoretical Framework of Acceptability questionnaire, and these will be combined into an acceptability score (ranging from 0-27 with a higher score indicating greater acceptability). We will compare the average acceptability score between groups with and without each intervention component.'}], 'primaryOutcomes': [{'measure': 'Difference in prevalence of discussions surrounding methods of cervical cancer prevention', 'timeFrame': 'Months 7-18', 'description': 'Discussions about methods of cervical cancer prevention will be reported by clients following each routine HIV care visit. This rate is defined as the percentage of visits during which there is a discussion about methods of cervical cancer prevention. This rate will be compared between the groups with and without each intervention component.'}], 'secondaryOutcomes': [{'measure': 'Difference in prevalence of completing a cervical cancer prevention program', 'timeFrame': 'Months 7-18', 'description': 'Completing a cervical cancer prevention program will be reported by clients following each routine HIV care visit. This prevalence is defined as the percentage of clients who complete a cervical cancer prevention program. This prevalence will be compared between the groups with and without each intervention component.'}, {'measure': 'Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated', 'timeFrame': 'Months 7-18', 'description': 'This prevalence is defined among those who have not begun a cervical cancer prevention program at study entry. This prevalence will be compared between the groups with and without each intervention component.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer Prevention']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:\n\n1. Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care.\n2. What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.\n3. What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health workers: People who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and/or their parents/caregivers.\n* Clients: Non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent/guardian will also be eligible for participation) who present for HIV care at a participating health facility during the study period.\n\nExclusion Criteria:\n\n* Health workers: Less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent.\n* Clients: \\<9 or \\>24 years old, or pregnancy, or unable or unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07015957', 'briefTitle': 'Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention', 'orgStudyIdInfo': {'id': 'IRB-FY2025-9686'}, 'secondaryIdInfos': [{'id': '1U01CA294756', 'link': 'https://reporter.nih.gov/quickSearch/1U01CA294756', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Condition 1: In-person training', 'interventionNames': ['Behavioral: In-person training']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 2: In-person training + Prompt', 'interventionNames': ['Behavioral: In-person training', 'Behavioral: Prompts']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 3: In-person training + Coaching', 'interventionNames': ['Behavioral: In-person training', 'Behavioral: Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 4: In-person training + Prompt + Coaching', 'interventionNames': ['Behavioral: In-person training', 'Behavioral: Coaching', 'Behavioral: Prompts']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 5: Virtual training', 'interventionNames': ['Behavioral: Virtual training']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 6: Virtual training + Prompt', 'interventionNames': ['Behavioral: Virtual training', 'Behavioral: Prompts']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 7: Virtual training + Coaching', 'interventionNames': ['Behavioral: Virtual training', 'Behavioral: Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 8: Virtual training + Prompt + Coaching', 'interventionNames': ['Behavioral: Virtual training', 'Behavioral: Coaching', 'Behavioral: Prompts']}], 'interventions': [{'name': 'In-person training', 'type': 'BEHAVIORAL', 'description': 'An in-person educational session.', 'armGroupLabels': ['Condition 1: In-person training', 'Condition 2: In-person training + Prompt', 'Condition 3: In-person training + Coaching', 'Condition 4: In-person training + Prompt + Coaching']}, {'name': 'Virtual training', 'type': 'BEHAVIORAL', 'description': 'A virtual educational session.', 'armGroupLabels': ['Condition 5: Virtual training', 'Condition 6: Virtual training + Prompt', 'Condition 7: Virtual training + Coaching', 'Condition 8: Virtual training + Prompt + Coaching']}, {'name': 'Coaching', 'type': 'BEHAVIORAL', 'description': 'Short video vignettes plus reinforcing messages', 'armGroupLabels': ['Condition 3: In-person training + Coaching', 'Condition 4: In-person training + Prompt + Coaching', 'Condition 7: Virtual training + Coaching', 'Condition 8: Virtual training + Prompt + Coaching']}, {'name': 'Prompts', 'type': 'BEHAVIORAL', 'description': 'Visual aide to remind providers to discuss cervical cancer prevention methods.', 'armGroupLabels': ['Condition 2: In-person training + Prompt', 'Condition 4: In-person training + Prompt + Coaching', 'Condition 6: Virtual training + Prompt', 'Condition 8: Virtual training + Prompt + Coaching']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Partners in Hope', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Corrina Moucheraud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}, {'name': 'Risa M Hoffman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Sam Phiri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Partners in Hope, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'Fully deidentified survey data and focus group discussion transcripts', 'accessCriteria': 'Survey data will be deposited into a data repository after it has been fully de-identified. De-identified focus group discussion data will be available on a by-request basis via a data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Partners in Hope, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}