[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642967":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":18,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Differentiated service delivery (DSD) of TPT","EXPERIMENTAL","In the household contact (HHC) population DSD TPT will be delivered at home in a single dispense of a full course of TPT; in the people living with HIV (PWH) population DSD TPT will be delivered at the clinic in a single dispense of a full course of TPT.",[13],"Other: Differentiated service delivery (DSD) of TB preventive therapy (TPT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Clinic-based standard of care","NO_INTERVENTION","Both the household contact (HHC) population and the people living with HIV (PWH) population have TPT dispensed at the clinic according to standard practice, typically one month at a time.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Differentiated service delivery (DSD) of TB preventive therapy (TPT)","TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT. By doing the Kulindana study, the investigators hope to learn which way of delivering TPT to participants (through usual clinic practice, or all at once) is best for helping participants finish a full course of TPT.",[9],[25],{"name":26,"affiliation":5,"role":27},"Adrienne Shapiro, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Gillian O'Bryan","CONTACT","240-444-0098","gilliano@uw.edu",{"name":26,"role":31,"phone":18,"phoneExt":18,"email":35},"aeshapir@uw.edu",[37],{"facility":38,"status":18,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital","Kisumu","Kenya","KE",{"type":43,"coordinates":44},"Point",[45,46],34.76171,-0.10221,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":51,"phoneExt":18,"email":52},"Celestine Atieno","+254 713 053766","catien00@uw.edu",{"type":27,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Adrienne E Shapiro","Assistant Professor in the Departments of Global Health and Medicine (Infectious Diseases)",[57],{"name":58,"class":59},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100642967","kulindana-community-friendly-delivery-and-monitoring-of-tpt-to-improve-uptake-and-reduce-tb-transmission-100642967",false,"NCT07628140","Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Inclusion Criteria:\n\n* Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).\n* People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.\n\nExclusion Criteria:\n\n* HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational\u002Finterventional HIV or TB study.\n* PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational\u002Finterventional HIV or TB study.","ALL",{"count":69,"type":70},1500,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:\n\n* Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?\n* Does community-based and DSD TPT reduce household and community TB transmission?\n\nResearchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.\n\nParticipants will:\n\n* Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.\n* If eligible, receive DSD TPT service delivery or SoC TPT service delivery.\n* Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.\n* Have TPT completion assessed at 12 weeks following enrolment.\n* A subset of participants will be assess for TB incidence at 9 months following enrolment.",[76,77],"Tuberculosis Prevention","HIV",[79,80,81,82,77,83,84,85],"tuberculosis","household contact","TB preventive therapy","3HP","contact investigation","multi-month dispensing","differentiated service delivery","NOT_YET_RECRUITING","2026-06-25",{"date":89,"type":90},"2026-06-30","ACTUAL",{"date":92,"type":70},"2026-07",{"date":94,"type":70},"2031-07",{"name":5,"class":6},1]