Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-02 @ 5:06 AM
Study NCT ID:
NCT06166420
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Cervical Cancer Screening Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms randomised controlled cluster trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2079}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization', 'timeFrame': '3 months', 'description': 'The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm'}], 'secondaryOutcomes': [{'measure': 'Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm', 'timeFrame': '3 months from sensitization', 'description': 'The number and percentage of participants who will do an HPV test in each arm of the study.'}, {'measure': 'Number and percentage of participants once tested HPVpositive who will link to the pelvic exam for visual assessment and treatment (if needed) within 3 months.', 'timeFrame': '3 months from HPV self sample collection', 'description': 'The number and percentage of participants once tested HPV positive who link to the hospital for visual assessment of the cervix and treatment if needed.'}, {'measure': 'Identify barriers and enablers to the home-HPV self-sampling test.', 'timeFrame': '4 months', 'description': 'Factors that prevent and motivate women to participate to a home-based HPV self-test.'}, {'measure': 'Identify barriers and enablers of linkage to VIA for HPV positive women', 'timeFrame': '4 months', 'description': 'Factors that prevent and motivate participants who did a home-based HPV self-test to link to the hospital for visual assesment of the cervix using acetic acid and lugol (VIA/VILI).'}, {'measure': 'Number of pre-cancers and/or cancers diagnosed in each study arm.', 'timeFrame': '2 years', 'description': 'The number of pre-cancers and cancers diagnosed per study arm.'}, {'measure': 'Cost of each screening strategy.', 'timeFrame': '2 years', 'description': 'The cost of each strategy and make a cost-effectiveness analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'human papillomavirus', 'screening', 'home-based'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '41044580', 'type': 'DERIVED', 'citation': 'Moukam AMD, Salah N, Tankeu Happi GW, Metchehe LDD, Makajio SL, Wisniak A, Sormani J, Kenfack B, Vassilakos P, Socpa A, Petignat P, Schmidt NC. Acceptability of home-based HPV self-sampling for cervical cancer screening among users and providers in the West region of Cameroon: a cross-sectional study. BMC Health Serv Res. 2025 Oct 3;25(1):1303. doi: 10.1186/s12913-025-13467-1.'}]}, 'descriptionModule': {'briefSummary': 'Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.', 'detailedDescription': 'In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women\'s Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.\n\nPrimary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.\n\nSecondary objectives:\n\n* To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.\n* To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.\n* To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.\n* To determine predictors of non-adherence to care-seeking for HPV positive women.\n* To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.\n* To calculate the economic cost of both strategies.\n\nMixed method design, quantitative and qualitative informations will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 30-49 years\n* Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).\n\nNon-inclusion criteria:\n\n* Pregnancy at the time of screening\n* History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).\n* Intra-vaginal treatment\n\nExclusion Criteria:\n\n* Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)\n* Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)\n* Women who are not able to comply with the study protocol.\n* Previous hysterectomy\n* Known cervical cancer'}, 'identificationModule': {'nctId': 'NCT06166420', 'acronym': 'CASAHO', 'briefTitle': 'Home-based Cervical Cancer Screening Project', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial', 'orgStudyIdInfo': {'id': 'N°2022/10/1494/CE/CNERSH/SP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'home-based', 'description': "A team made up of a Community Health Worker (CHW) and a nurse will do door-to-door sensitization and propose to eligible women to undergo HPV self-sampling test at home. Samples collected will be taken by the nurse to the hospital for HPV testing . Participants will receive a phone call: disclosure of the HPV test's result will be by phone call for HPV-negative participants; HPV-positive participants will be invited to the hospital for disclosure of their results. At the hospital, HP-positive participants will undergo visual assessment of their cervix and treatment if needed.", 'interventionNames': ['Other: Experimental']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hospital-based', 'description': 'Community Health Worker (CHW) will do door-to-door sensitization and invite eligible women to attend cervical cancer screening at District Hospital Dschang. At the hospital they will do HPV self-sampling test. HPV-negative women will be advised to repeat the test after 5 years while HPV positive women will undergo visual assessment of the cervix with acetic acid and lugol (VIA/VILI) and treatment if needed.', 'interventionNames': ['Other: Active comparator']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.', 'armGroupLabels': ['home-based']}, {'name': 'Active comparator', 'type': 'OTHER', 'description': 'Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.', 'armGroupLabels': ['hospital-based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dschang', 'state': 'Menoua', 'country': 'Cameroon', 'facility': 'Dschang District Hospital', 'geoPoint': {'lat': 5.44397, 'lon': 10.05332}}], 'overallOfficials': [{'name': 'Patrick Petignat, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised data may be shared upon reasonable request at the end of the study period.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Patrick Petignat', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dschang District Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Patrick Petignat', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}