Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT04307433
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-29', 'releaseDate': '2022-10-14'}], 'estimatedResultsFirstSubmitDate': '2022-10-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The data collector who assesses the follow-up assessments will be blind to treatment condition'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The proposed study has two phases:\n\nPhase 1. Development of Narrative Video: The investigators will first develop culturally-grounded and human-centered storytelling narrative intervention videos in Chichewa, the local language to address sociocultural and individual factors which influence cervical cancer prevention behaviors. The video will be filmed in person in community organizations in Malawi.\n\nPhase 2: A Pilot Randomized Controlled Trial (RCT) of a Story Telling Narrative Intervention: The investigators will conduct a three-arm pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets \\[n=60\\] \\& Arm 2: a video with a voice over presenting didactic materials on tablets \\[n=60\\]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 \\[n=60\\]) will be read non-narrative educational materials'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participant with Cervical Cancer Screening Uptakes', 'timeFrame': 'six months post-intervention', 'description': 'will be measured through self-report and health passport record review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS']}, 'descriptionModule': {'briefSummary': 'To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of narrative intervention on cervical cancer screening prevention behavior.', 'detailedDescription': 'Design\n\nThis two year project will employ a holistic community-based approach for recruitment. The project will involve two phases: Phase 1: The investigators will produce culturally-grounded and human-centered storytelling narrative intervention videos to address sociocultural and individual factors which influence cervical cancer prevention behaviors. Phase 2: The investigator will conduct a pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets \\[n=60\\] \\& Arm 2: a video with a voice over presenting didactic materials on tablets \\[n=60\\]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 \\[n=60\\]) will be read non-narrative educational materials. Study measures of attitudes, knowledge, and cervical cancer screening intention will be assessed by pre-test and immediate post-test interviews, then again at 2 and 6-months following the intervention.\n\nSelection and Enrollment\n\nInclusion criteria are: 1) being confirmed HIV positive based on medical records, 2) women living with HIV infection (WLHIV) support group members, 3) ages 20-50 years, 4) no prior cervical cancer screening, 5) no history of invasive cervical cancer, and 6) willingness to participate in the study. The age range to 20-50 years for cervical cancer screening because there is limited evidence that this is the optimal upper age for cervical cancer screening of HIV-infected women (World Health Organization \\[WHO\\] 2013).\n\nThis study will use a sequential-stratified sampling method. Of the eligible support groups and among those expressing interest, the investigators will select 15 support groups from rural areas within the Lilongwe district and then randomly assign the selected groups into intervention and comparison arms. The computer-generated assignments will be stratified by support group size and the distance between intervention and control arms (at least 4 miles). Within each selected support group, 12 women who are eligible will be invited to participate in the study. The investigators have satisfactorily used these methods for recruitment of WLHIV by working with HIV support group leaders in our previous studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'females are biologically eligible because the research involves cervical cancer prevention. Inclusion of males in the study would be inappropriate due to lack of cervical cancer incidence.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen who:\n\n1. are confirmed HIV positive based on medical records\n2. are women living with HIV infection support group members\n3. are ages 20-50 years\n4. are no prior cervical cancer screening\n5. are no history of invasive cervical cancer\n6. are willingness to participate in the study\n\nExclusion Criteria:\n\n1. are not able to speak Chichewa or English\n2. self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)'}, 'identificationModule': {'nctId': 'NCT04307433', 'briefTitle': 'Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Boston'}, 'officialTitle': 'mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV', 'orgStudyIdInfo': {'id': '2019250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'ST Narrative + mHealth: Storytelling narrative video on tablets', 'interventionNames': ['Behavioral: Storytelling narrative videos on tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'mHealth: a video with a voice over presenting didactic materials on tablets', 'interventionNames': ['Behavioral: Storytelling narrative videos on tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'description': 'Control: non-narrative educational materials will be read', 'interventionNames': ['Behavioral: Storytelling narrative videos on tablets']}], 'interventions': [{'name': 'Storytelling narrative videos on tablets', 'type': 'BEHAVIORAL', 'description': 'The storytelling narrative episodes in the application will feature video clips of the multiple stories of women living with HIV infection, HIV support group leaders, community leaders, and health care professionals and a Learn More video of physician discussing cervical cancer.', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Community organization', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}], 'overallOfficials': [{'name': 'Haeok Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Boston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haeok Lee', 'investigatorAffiliation': 'University of Massachusetts, Boston'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-14', 'type': 'RELEASE'}, {'date': '2023-08-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Haeok Lee, Professor, University of Massachusetts, Boston'}}}}