[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555368":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":34,"collaborators":36,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":10,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":10},{"fullName":5,"class":6},"The Aurum Institute NPC","OTHER",[8,12,15,17,19,22],{"label":9,"type":10,"description":11,"interventionNames":10},"Children \u003C12 years who are eligible for TPT - HHC",null,"No intervention. Clinic record review: Data will be retrospectively abstracted from routine medical files using a standardised data collection tool that will document TPT uptake and outcomes",{"label":13,"type":10,"description":14,"interventionNames":10},"Policy makers\u002FProgram managers","No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.",{"label":16,"type":10,"description":14,"interventionNames":10},"Healthcare Workers",{"label":18,"type":10,"description":14,"interventionNames":10},"Caregivers",{"label":20,"type":10,"description":21,"interventionNames":10},"Pharmacy managers\u002Fpharmacists","No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child.",{"label":23,"type":10,"description":21,"interventionNames":10},"Procurement managers\u002FSupply managers",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Violet Chihota","CONTACT","+27 (0) 82 319 1559","vchihota@auruminstitute.org",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Rachel Mukora","+27 (0) 83 784 3107","rmukora@auruminstitute.org",{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[37,39,41],{"name":38,"class":6},"Johns Hopkins University",{"name":40,"class":6},"KNCV Tuberculosis Foundation",{"name":42,"class":6},"Clinton Health Access Initiative Inc.","100555368","introduction-of-dispersible-3hp-formulations-for-tb-preventive-treatment-in-children-a-multi-country-evaluation-100555368",false,"NCT06511180","Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation","Clinic record review\n\nInclusion Criteria:\n\n* Medical records of children \\\u003C12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT\n\nExclusion Criteria:\n\n* Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment\n\nQualitative study\n\nInclusion Criteria:\n\n* Adult caregiver (\\>18 years) of a child \\\u003C12 years of age who is eligible for TPT\n* Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children\n* Policy maker or program manager who manages or is involved in PMTCT, TB and\u002For pediatric programming\n\nExclusion Criteria:\n\n* Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.",true,"ALL",{"count":52,"type":53},1200,"ESTIMATED","OBSERVATIONAL","The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.\n\nOverall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.\n\nThis evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.",[57,58,59,60],"TB - Tuberculosis","Household Contact","HIV","Children, Only","NOT_YET_RECRUITING","2024-07-16",{"date":64,"type":65},"2024-07-19","ACTUAL",{"date":67,"type":53},"2024-08",{"date":69,"type":53},"2025-06",{"name":5,"class":6}]