[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584000":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":24,"locations":29,"responsibleParty":43,"collaborators":45,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":24,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Centre for Infectious Disease Research in Zambia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TB treatment ARM","ACTIVE_COMPARATOR","Beginning February 2022, we offered ATT via 2-month MMD during intensive and 4-month MMD during continuation phases.\n\nIn-clinic visits during 6-months of ATT were reduced from 7 under standard of care to 3 visits in DSD, while ensuring robust adherence and adverse event screening.\n\nRemote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. If SMS were not returned, a phone or home visit was triggered.",[13],"Behavioral: Differentiated service delivery approach (DSD) in TB treatment and prevention.",{"label":15,"type":10,"description":16,"interventionNames":17},"TPT DSD","Beginning February 2022, we offered TPT aligned to 6MMD ART model following standard of care processes with added support (See below).\n\nRemote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects.\n\nROCs that did not respond to the SMS within 2 days were further contacted via phone and if not reachable a home visit was done.\n\nROCs that reported at least one side effect or more were followed up with virtual reviews by clinicians.\n\nAt enrollment ROCs reading language of preference was documented and the SMS was sent in their preferred language.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Differentiated service delivery approach (DSD) in TB treatment and prevention.","Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Mwanza Wa Mwanza, MD","STUDY_DIRECTOR",[30],{"facility":31,"status":24,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":24},"Lusaka and Livingstone districts","Lusaka","Lusaka Province","10101","Zambia","ZM",{"type":38,"coordinates":39},"Point",[40,41],28.28713,-15.40669,{"lat":41,"lon":40},{"type":44,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[46,49],{"name":47,"class":48},"Ministry of Health, Zambia","OTHER_GOV",{"name":50,"class":51},"Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding","UNKNOWN","100584000","adoption-of-innovative-approaches-to-ensure-continuity-of-quality-tb-services-during-covid-19-pandemic-in-lusaka-and-livingstone-zambia-telemedicine-in-tb-100584000",false,"NCT06883643","Adoption of Innovative Approaches to Ensure Continuity of Quality TB Services During COVID-19 Pandemic in Lusaka and Livingstone, Zambia. (Telemedicine in TB)","Telemed TB","Inclusion Criteria:\n\nTB ARM\n\n* All ROCs presenting to chest clinic for TB treatment between February 2022 and September 2022 were considered for inclusion if:\n\nDiagnosed with TB (new cases or retreatment cases) 18 years and above Willing and able to provide consent Not pregnant or breastfeeding No MDR TB\n\nTPT ARM\n\nAll ROCs presenting to the ART clinic between February 2022 and September 2022 were considered for inclusion if they were:\n\n18 years or above virally supressed with no symptoms or diagnosis suggestive of TB on ART for more than 6 months on 6MMD Consented to participate in the project did not receive TPT in the last 3 years not pregnant or breastfeeding women not incarcerated\n\nExclusion Criteria:\n\nATT ARM\n\n* RoCs those TB diagnosis is not confirmed\n* RoCs who are less than 18 years old\n* RoCs not able to provide consent for program evaluation participation\n* RoCs with MDR TB\n\nTPT ARM\n\n* RoCs with symptoms suggestive of TB, diagnosed or confirmed with TB diagnosis\n\n  * RoCs who received TPT in the last 3 years\n  * RoCs who are less than 18 years old\n  * RoCs not able to provide consent for program evaluation participation\n  * Pregnant and breastfeeding women\n  * Incarcerated persons","ALL","18 Years",{"count":62,"type":63},3318,"ACTUAL","INTERVENTIONAL",[66],"NA","Following the negative impact of public health program services including TB services by the COVID-19 Pandemic in 2020, CIDRZ conducted a program evaluation for remote patient follow up for TB treatment and prevention through a differentiated service delivery model (DSD), offering clinical monitoring and psychosocial support while minimizing contact with the health facilities. The project was implemented between February 2022 to March 2023 and was funded through Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding. While DSD models have been widely adopted in HIV programs , DSD is a relatively new and exciting approach for TB treatment and prevention programs.",[69],"Focus of the Study is to Evaluate DSD Models for Both TB Treatment and TPT Usiing Key Performance Indicators",[71],"DSD TB","COMPLETED","2025-03-17",{"date":75,"type":63},"2025-03-19",{"date":77,"type":63},"2022-02-04",{"date":79,"type":63},"2023-03-31",{"name":5,"class":6},1]