Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT05359016
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2022-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of women who will undergo Cervical Cancer Screening by HPV testing', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this operational research study is to develop, implement and test integrated CCS\\&PT and voluntary FP service delivery models to evaluate whether integrated service delivery can optimize uptake and health impact of both services. The study objectives and learning questions are listed below, along with key outcomes that will be measured.', 'detailedDescription': 'Objectives:\n\nThe study objectives are outlined below:\n\n1. To quantify the health impact of CCS\\&PT on the uptake of voluntary FP services.\n2. To quantify the health impact of voluntary FP on the uptake of CCS\\&PT services.\n3. To determine which promotional strategies are most effective to increase uptake of CCS\\&PT services.\n4. To identify cost to deliver high quality CCS\\&PT services integrated into existing voluntary FP programs.\n5. To determine client and provider acceptability of integrated CCS\\&PT and voluntary FP services using new screen and treat technologies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 30 - 49 years or all women living with HIV\n* Not currently pregnant\n* Patients with a cervix (women who have undergone a total hysterectomy with removal of the cervix are not eligible)\n* Living in Maputo or Gaza\n* Willing and able to provide informed consent for services.\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria\n* Physical or mental impairment that inhibits participation in the study\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT05359016', 'briefTitle': 'Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique', 'orgStudyIdInfo': {'id': '2020-0651'}, 'secondaryIdInfos': [{'id': 'NCI-2022-03767', 'type': 'OTHER', 'domain': 'NCI-CTRP-Clinical Trial Reporting Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPV testing of women for cervical cancer screening', 'description': 'Women enrolled in this study will receive HPV testing for cervical cancer screening. They will be offered self-sampling. And also they will be offered voluntary Family Planning services, as appropriate.', 'interventionNames': ['Behavioral: HPV testing of women for cervical cancer screening']}], 'interventions': [{'name': 'HPV testing of women for cervical cancer screening', 'type': 'BEHAVIORAL', 'description': 'Women enrolled in this study will receive HPV testing for cervical cancer screening. They will be offered self-sampling. And also they will be offered voluntary Family Planning services, as appropriate.', 'armGroupLabels': ['HPV testing of women for cervical cancer screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Schmeler, MD', 'role': 'CONTACT', 'email': 'kschmele@mdanderson.org', 'phone': '713-854-9150'}, {'name': 'Kathleen Schmeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mila Salecedo, MD, PHD', 'role': 'CONTACT', 'email': 'mpsalcedo@mdanderson.org', 'phone': '832-696-6794'}], 'overallOfficials': [{'name': 'Kathleen Schmeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Services International', 'class': 'OTHER'}, {'name': 'Eduardo Mondlane University', 'class': 'OTHER'}, {'name': 'William Marsh Rice University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}