Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 9:40 PM
Study NCT ID:
NCT04285905
Status:
TERMINATED
Last Update Posted:
2021-02-25
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Due to Covid-19, fnding period expired and Phase 2 was not possible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TB screening', 'timeFrame': 'Within 14 days of recruitment of female participant', 'description': 'The proportion of male partners that complete TB screening'}], 'secondaryOutcomes': [{'measure': 'TB case detection', 'timeFrame': 'Within 14 days of recruitment of female participant', 'description': 'The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment'}, {'measure': 'Acceptability', 'timeFrame': 'Within 14 days of recruitment of female participant', 'description': 'The proportion of primary household male partners who report that they would be "very likely" or "likely" to recommend the interventions they received to their families or friends'}, {'measure': 'Completion of HIV testing', 'timeFrame': 'Within 14 days of recruitment of female participant', 'description': 'The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis'], 'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The overall aim of the mPATCH-TB Study is to identify potentially cost-effective, feasible and scalable interventions that could increase rates of completion of screening for tuberculosis and HIV among male partners of women attending primary health care in Blantyre, Malawi.\n\nEligible women who consent to participate - and who have a primary male partner with cough at home -will be randomly allocated, by day of clinic attendance, into a standard of care group or one of up to four intervention groups. They will be asked to identify their primary male partner and will be offered interventions according to their allocated group.\n\nThe primary outcome will compare the proportion of primary male partner that complete TB screening (defined as receipt of result of a sputum Xpert or smear result) within 14 days of recruitment in each intervention group compared to the enhanced standard of care group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria for female participants\n\n* Female\n* Attends study health centre with an acute care episode\n* 18 years of age or older on the day of clinic attendance\n* Has a primary male partner living within their household\n* Reports that primary male partner has symptoms of pulmonary tuberculosis (cough)\n* Is resident within urban Blantyre\n\nInclusion criteria for male partner participants\n\n* Male\n* Aged 18 years of age or older on the day of clinic attendance\n* Has cough\n* Is living with the female participant (defined as sleeping in the same dwelling on most nights during the previous 14 days)\n\nExclusion criteria for primary male partner participants in trial (applied on the same day the female participant is recruited)\n\n* Currently taking treatment for tuberculosis\n* Has taken any treatment for tuberculosis in the 6-months prior to the female participant's clinic attendance\n* Is taking isoniazid preventive therapy\n* Plans to move out of Blantyre to live elsewhere in the following 2-months"}, 'identificationModule': {'nctId': 'NCT04285905', 'acronym': 'mPATCH-TB', 'briefTitle': 'Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool School of Tropical Medicine'}, 'officialTitle': 'Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial', 'orgStudyIdInfo': {'id': '18-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced standard of care', 'description': '* Access to Fast Track TB Clinic\n* Information leaflet for primary male partner', 'interventionNames': ['Other: Access to Fast Track TB clinic', 'Other: Information leaflet for male partner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '* Access to Fast Track TB Clinic\n* Information leaflet for primary male partner\n* Female participant sputum collection from male partners', 'interventionNames': ['Other: Access to Fast Track TB clinic', 'Other: Information leaflet for male partner', 'Other: Home sputum collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '* Access to Fast Track TB Clinic\n* Information leaflet for primary male partner\n* Female participant sputum collection from male partners\n* Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic', 'interventionNames': ['Other: Access to Fast Track TB clinic', 'Other: Information leaflet for male partner', 'Other: Home sputum collection', 'Other: Financial incentive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': '* Access to Fast Track TB Clinic\n* Information leaflet for primary male partner\n* Female participant sputum collection from male partners\n* Female partner delivered oral HIV self-testing kits for primary male partner', 'interventionNames': ['Other: Access to Fast Track TB clinic', 'Other: Information leaflet for male partner', 'Other: Home sputum collection', 'Other: Home HIV testing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5', 'description': '* Access to Fast Track TB Clinic\n* Information leaflet for primary male partner\n* Female participant sputum collection from male partners\n* Female partner delivered oral HIV self-testing kits for primary male partner\n* Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic', 'interventionNames': ['Other: Access to Fast Track TB clinic', 'Other: Information leaflet for male partner', 'Other: Home sputum collection', 'Other: Home HIV testing', 'Other: Financial incentive']}], 'interventions': [{'name': 'Access to Fast Track TB clinic', 'type': 'OTHER', 'description': 'Male partner can attend clinic with dedicated services for men', 'armGroupLabels': ['Enhanced standard of care', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}, {'name': 'Information leaflet for male partner', 'type': 'OTHER', 'description': 'Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening', 'armGroupLabels': ['Enhanced standard of care', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}, {'name': 'Home sputum collection', 'type': 'OTHER', 'description': 'Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner', 'armGroupLabels': ['Group 2', 'Group 3', 'Group 4', 'Group 5']}, {'name': 'Home HIV testing', 'type': 'OTHER', 'description': 'Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use', 'armGroupLabels': ['Group 4', 'Group 5']}, {'name': 'Financial incentive', 'type': 'OTHER', 'description': 'Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing', 'armGroupLabels': ['Group 3', 'Group 5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'state': 'Southern Region', 'country': 'Malawi', 'facility': 'Bangwe Health Centre', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'As soon as possible', 'ipdSharing': 'YES', 'description': 'To facilitate reproducibility of analysis, an anonymised minimal final dataset and all code required to reproduce analysis will be published in the trial GitHub repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool School of Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'University of Liverpool', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}