Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06136702
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ELEVATE Acceptability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], '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'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-30', 'size': 518400, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-31T07:37', 'hasProtocol': True}, {'date': '2022-08-05', 'size': 525267, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-14T04:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Longitudinal'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1048}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of cervical cancer screening', 'timeFrame': 'First encounter (day 0) and 3 months follow-up (day 90)', 'description': 'Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)'}], 'secondaryOutcomes': [{'measure': 'Attitudes towards HPV self-sampling', 'timeFrame': 'First encounter (day 0)', 'description': 'Attitudes towards self-sampling: reasons to accept/decline the self-sample; advantages and disadvantages versus conventional screening.'}, {'measure': "User's experiences of HPV self-sampling", 'timeFrame': 'First encounter (day 0)', 'description': 'User experiences among those who took a self-sample (easy/difficult; painless/painfull; trustworthy/untrusty; etc.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'screening', 'self-sampling', 'HPV', 'acceptability', 'hard-to-reach', 'underscreened', 'community-based'], 'conditions': ['Cervical Cancer', 'HPV Infection', 'Acceptability of Health Care']}, 'descriptionModule': {'briefSummary': "This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).", 'detailedDescription': "ELEVATE, a five-year project conducted by an international research alliance led by Ghent University, aims to develop a new test and approach for cervical cancer screening in hard-to-reach populations. The test will combine self-sampling with a new low-cost, portable measurement device and will be validated in dedicated screening trials in Belgium, Brazil, Ecuador, and Portugal. The ELEVATE project targets women in Europe and Latin America who have never been screened or are not regularly screened. These women have a higher risk of developing cervical cancer. The project is supported by the European Union's Horizon 2020 Framework Programme for Research and Innovation Action, project number 825747.\n\nTo address the gaps in cervical cancer screening, the ELEVATE project is developing a screening strategy to make cervical screening more accessible to hard-to-reach women. This strategy will include the introduction of a new on-site HPV self-sampling screening tool and a portable testing device, able to detect the presence of HPV and cancer biomarker proteins. This portable, low-cost, on-site HPV testing tool will allow to streamline follow-up care for women at risk of developing cervical cancer.\n\nThis study is part of the ELEVATE project and takes place in hard-to-reach communities, focusing on socio-economically vulnerable women to assess the acceptability of educational sessions and self-sampling in these communities. This study includes a two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are between the ages of 25 to 65 years of age, in line with the European Guidelines for initiating and stopping cervical cancer screening\n* (ever been) sexually active;\n* not diagnosed or in treatment for cervical cancer;\n* not having had a hysterectomy\n* not being pregnant\n* Speaking the local language\n\nExclusion Criteria:\n\n* younger than 25 years old or older than 65 years old\n* diagnosed or in treatment for cervical cancer\n* having had a hysterectomy\n* being pregnant'}, 'identificationModule': {'nctId': 'NCT06136702', 'acronym': 'ELEVATE AS', 'briefTitle': 'ELEVATE Acceptability Study', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study', 'orgStudyIdInfo': {'id': 'ONZ-2022-0326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Educational session and follow-up assessment', 'description': 'A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. Women will be informed about cervical cancer screening (pap smear) and about where they can obtain these services off-site (health facilities). Furthermore, a self-administrated questionnaire is applied to assess current knowledge, willingness to get screened (clinically collected sample) and uptake', 'interventionNames': ['Behavioral: Educational session', 'Behavioral: Follow-up assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Educational session, self-sampling and follow-up assessment', 'description': 'A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. In addition, women will receive information about self-sampling and will be instructed by the community-based researcher on how to take a self-sample using an illustrative cartoon. Women will then be invited to take a sample on-site. The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time.', 'interventionNames': ['Behavioral: Educational session', 'Behavioral: Self-sampling', 'Behavioral: Follow-up assessment']}], 'interventions': [{'name': 'Educational session', 'type': 'BEHAVIORAL', 'description': 'A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. Women will be informed about cervical cancer screening (pap smear) and about where they can obtain these services off-site (health facilities). Furthermore, a self-administrated questionnaire is applied to assess current knowledge, willingness to get screened (clinically collected sample) and uptake.', 'armGroupLabels': ['Educational session and follow-up assessment', 'Educational session, self-sampling and follow-up assessment']}, {'name': 'Self-sampling', 'type': 'BEHAVIORAL', 'description': "Women will receive information about self-sampling and will be instructed by the community-based researcher on how to take a self-sample using an illustrative cartoon. Women will then be invited to take a sample on-site, to measure the uptake of the self-sampling test (% of women who take the self-sample). Furthermore, two self-administrated questionnaires are applied to 1) assess attitudes regarding self-sampling (pre-intervention), and 2) assess users' experience regarding self-sampling (post-intervention). The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time. All women will be contacted 1-2 weeks after the self-sample taking to inform them on their test result.", 'armGroupLabels': ['Educational session, self-sampling and follow-up assessment']}, {'name': 'Follow-up assessment', 'type': 'BEHAVIORAL', 'description': 'To gauge the knowledge on cervical cancer screening after the educational session and to verify whether they got a pap smear, a 3-month follow-up is proposed for all women receiving an educational session (arm 1) and all women receiving an educational session and a self-sample (arm 2), because all women, whether or not invited for self-sampling, are provided information on where to get screened, although there is no formal referral to screening services.', 'armGroupLabels': ['Educational session and follow-up assessment', 'Educational session, self-sampling and follow-up assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'COMPLETED', 'country': 'Belgium', 'facility': 'International centre for reproductive health', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Barretos', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Adhemar Longatto Filho', 'role': 'CONTACT', 'email': 'longatto@med.uminho.pt'}, {'name': 'Priscila Grecca Pedrão', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Karolina da Silva Oliveira', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ricardo dos Reis', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rui Manuel Reis', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adhemar Longatto Filho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barretos Cancer Hospital - Fundação Pio XII', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'city': 'Cuenca', 'status': 'COMPLETED', 'country': 'Ecuador', 'facility': 'Universidad de Cuenca', 'geoPoint': {'lat': -2.8953, 'lon': -78.9963}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Sónia Dias', 'role': 'CONTACT', 'email': 'sonia.dias@ensp.unl.pt', 'phone': '217512100'}, {'name': 'Sónia Dias', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ana Gama', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Escola Nacional de Saúde Pública da Universidade NOVA de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Heleen Vermandere, PhD', 'role': 'CONTACT', 'email': 'heleen.vermandere@ugent.be', 'phone': '+32-9-332.35.64'}, {'name': 'Marie Hendrickx, MSC', 'role': 'CONTACT', 'email': 'marie.hendrickx@ugent.be', 'phone': '+32-9-332.35.64'}], 'overallOfficials': [{'name': 'Bernardo Vega Crespo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Cuenca'}, {'name': 'Adhemar Longatto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barretos Cancer Hospital'}, {'name': 'Sónia Dias', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Nova de Lisboa'}, {'name': 'Olivier Degomme', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Horizon 2020 - European Commission', 'class': 'OTHER'}, {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}, {'name': 'Universidad de Cuenca', 'class': 'OTHER'}, {'name': 'Hospital de Cancer de Barretos - Fundacao Pio XII', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}