Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 1:18 PM
Study NCT ID:
NCT04000503
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic cluster randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2019}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost-effectiveness of each model of community-based cervical cancer screening', 'timeFrame': 'Modeled lifetime estimates after 1 year follow-up', 'description': 'Measured using years of lives saved compared between each study arm and the ICER'}, {'measure': 'Process evaluation for integrated community-based cervical cancer screening', 'timeFrame': 'Within 6 months of final recruitment', 'description': 'Evaluating reach, fidelity, barriers and facilitators of implementation in each arm from the community and health system perspective using mixed methods'}, {'measure': 'Male partner knowledge of cervical cancer screening', 'timeFrame': 'Baseline', 'description': "Assess men's knowledge level of HPV and cervical cancer and determine which factors impact the supportiveness towards a partner seeking screening."}], 'primaryOutcomes': [{'measure': 'VIA follow-up and treatment when indicated (screen and treat)', 'timeFrame': 'Outcome measured within 6 weeks of self-collection for HPV test', 'description': 'Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type'}], 'secondaryOutcomes': [{'measure': 'HPV prevalence', 'timeFrame': 'Baseline', 'description': 'Total number of women who test positive for HPV out of the total number of samples obtained'}, {'measure': 'STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)', 'timeFrame': 'Baseline', 'description': 'Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV'}, {'measure': 'HPV and co-morbid conditions', 'timeFrame': 'Baseline', 'description': 'Association (adjusted OR) estimated between HPV and HIV; other STIs'}, {'measure': 'Barriers and facilitators of engagement in care', 'timeFrame': 'FGDs within 3 months of recruitment completion', 'description': 'Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.'}, {'measure': 'Identify mediators of engagement of care', 'timeFrame': 'Outcome measured within 6 weeks of self-collection for HPV test', 'description': 'Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Papillomavirus DNA Tests', 'Visual inspection with acetic acid', 'Global Health', 'Developing Countries', 'Self-collection', 'Cervical Cancer Screening'], 'conditions': ['Human Papillomavirus 16', 'Human Papillomavirus 18', 'Papillomavirus Infections', 'Cervical Cancer', 'Pre-Cancerous Dysplasia']}, 'referencesModule': {'references': [{'pmid': '39681893', 'type': 'DERIVED', 'citation': "Leahy W, Abomoslim M, Booth A, Gottschlich A, Mwandacha N, Dau H, Naguti P, Payne B, Smith L, Nakisige C, Ogilvie G. Women's cellphone access and ownership in rural Uganda: implications for self-care interventions. BMC Glob Public Health. 2024 Feb 5;2(1):8. doi: 10.1186/s44263-024-00038-5."}, {'pmid': '37037880', 'type': 'DERIVED', 'citation': 'Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Pedersen H, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Orem J, Nakisige C, Ogilvie G. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nat Med. 2023 Apr;29(4):927-935. doi: 10.1038/s41591-023-02288-6. Epub 2023 Apr 10.'}, {'pmid': '36408923', 'type': 'DERIVED', 'citation': 'Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Orem J, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Nakisige C, Ogilvie G. Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial. Int J Cancer. 2023 Apr 15;152(8):1630-1639. doi: 10.1002/ijc.34369. Epub 2022 Nov 28.'}, {'pmid': '35384556', 'type': 'DERIVED', 'citation': 'Rawat A, Mithani N, Sanders C, Namugosa R, Payne B, Mitchell-Foster S, Orem J, Ogilvie G, Nakisige C. "We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men\'s Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry. J Cancer Educ. 2023 Apr;38(2):618-624. doi: 10.1007/s13187-022-02163-x. Epub 2022 Apr 6.'}, {'pmid': '32005202', 'type': 'DERIVED', 'citation': 'Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, Rawat A, Mithani N, Amuge C, Pedersen H, Orem J, Smith L, Ogilvie G. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol. BMC Public Health. 2020 Jan 31;20(1):142. doi: 10.1186/s12889-020-8216-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.\n\nThis study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.\n\nHypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.', 'detailedDescription': 'A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.\n\nThe unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with no previous history of hysterectomy\n* aged 25-49 years old\n* no previous history of treatment for cervical cancer\n* provided written informed consent.\n\nExclusion Criteria:\n\n* Women who are under 25 or over 49 years of age,\n* who have previously had a hysterectomy or been treated for cervical cancer\n* unable to provided informed consent.'}, 'identificationModule': {'nctId': 'NCT04000503', 'acronym': 'ASPIRE', 'briefTitle': 'Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial', 'orgStudyIdInfo': {'id': 'H17-03332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Health Worker Self-Collection', 'description': 'Door-to-door recruitment of women for self-collected HPV testing', 'interventionNames': ['Behavioral: Self-collected HPV testing for cervical cancer screening']}, {'type': 'EXPERIMENTAL', 'label': 'Community Health Meeting Self-Collection', 'description': 'Community health meeting recruitment of women for self-collected HPV testing', 'interventionNames': ['Behavioral: Self-collected HPV testing for cervical cancer screening']}], 'interventions': [{'name': 'Self-collected HPV testing for cervical cancer screening', 'type': 'BEHAVIORAL', 'description': 'Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.', 'armGroupLabels': ['Community Health Meeting Self-Collection', 'Community Health Worker Self-Collection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'country': 'Uganda', 'facility': 'Uganda Cancer Institute', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Gina Ogilvie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Health Research Institute of British Columbia"}, {'name': 'Sheona Mitchell-Foster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Northern British Columbia'}, {'name': 'Carolyn Nakisige, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uganda Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available on request through study investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uganda Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gina Ogilvie', 'investigatorAffiliation': 'University of British Columbia'}}}}