[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657728":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":35,"studyPopulation":26,"armGroups":36,"interventions":49,"overallOfficials":58,"centralContacts":66,"locations":76,"responsibleParty":103,"collaborators":105,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":26,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":26,"enrollmentInfo":118,"targetDuration":26,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":133,"whyStopped":26,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Makerere University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Acceptability of integration of TB treatment into community pharmacies","Proportion of people with TB\u002FHIV willing to receive treatment at community pharmacies.","6 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Feasibility of integration of TB treatment into community pharmacies","Proportion of community pharmacy workers reporting that the integration of TB treatment into community pharmacies was successful.",{"measure":18,"description":19,"timeFrame":12},"Fidelity of implementation of community pharmacy TB treatment integration","Proportion of people with TB\u002FHIV who return for expected refills.",{"measure":21,"description":22,"timeFrame":12},"TB treatment success rate","Proportion of people with TB\u002FHIV with treatment outcomes of cure or treatment completion at 6 months",{"measure":24,"description":25,"timeFrame":12},"Viral load suppression","Proportion of people with TB\u002FHIV with viral load \\\u003C1,000 copies\u002Fml at 6 months or TB treatment completion",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","The intervention is TB treatment delivery via community pharmacies (private retail drug shops) for people with TB\u002FHIV","HEALTH_SERVICES_RESEARCH",{"masking":33,"maskingDescription":34,"whoMasked":26},"NONE","By design, it is difficult to conceal the intervention from the participants, research assistants, and the Principal Investigator at the time of randomization. However, the data collectors and the data analyst will be blinded to the study arms using unique codes to mitigate outcome ascertainment bias.","This two-arm, pilot, individually randomized trial with a type 2 hybrid effectiveness-implementation design will be conducted at two health facilities in Kampala, Uganda. Eligible participants will include people with drug-susceptible pulmonary TB and HIV, aged ≥18 years, who have been on TB treatment for ≤2 months, and are receiving first-line ART or its alternative. At month 2 of TB treatment, 124 participants will be randomized (1:1 ratio) to receive TB treatment refills either through CPs (intervention arm) or continue routine facility-based refills (control arm). Implementation outcomes include acceptability, feasibility, and fidelity, with acceptability as the primary outcome. Effectiveness outcomes include TB treatment success and viral suppression at month 6 of TB treatment. Effectiveness analysis will follow the intention-to-treat principle, with per-protocol analysis as a sensitivity analysis, and will use generalized linear models with a Poisson distribution and log link with robust standard errors, adjusting for pre-specified covariates and reported as adjusted risk ratio (RR) and 95% confidence interval (CI). This pilot trial helps generate evidence on the acceptability, feasibility, and fidelity of integrating TB treatment into CPs, including preliminary effectiveness data on TB treatment success and viral suppression. Findings will inform the design and conduct of a future adequately powered cluster randomized effectiveness-implementation hybrid trial.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Community pharmacy refill arm","EXPERIMENTAL","People with TB\u002FHIV receive both ART and TB drug refills through community pharmacies.",[42],"Other: The intervention is TB treatment delivery via community pharmacies for people with TB\u002FHIV",{"label":44,"type":45,"description":46,"interventionNames":47},"Health facility refill arm","PLACEBO_COMPARATOR","People with TB\u002FHIV continue to receive both ART and TB drug refills through health facilities (routine care)",[48],"Other: Control Arm - standard of care",[50,54],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"The intervention is TB treatment delivery via community pharmacies for people with TB\u002FHIV","Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE\u002F4RH) and ART according to national guidelines. They will attend the health facility for TB care, treatment-stability assessments, standardized counseling and health education. TB and ART medications will be refilled biweekly, and participants with bacteriologically confirmed pulmonary TB will undergo sputum smear examination at month 2, per national guidelines. Eligible participants will then be randomized 1:1 to community pharmacy-based refills or treatment as usual. Accordingly, participants in the community pharmacy-based refill (intervention) arm will receive TB and ART refills through participating community pharmacies in 2-month supplies (months 3-4 and 5-6). At month 6, bacteriologically confirmed participants will undergo sputum smear examination at the health facility. Those discontinuing community pharmacy-based refills will return to routine care.",[38],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"Control Arm - standard of care","Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE\u002F4RH) and ART according to national guidelines. They will attend the health facility for TB care, treatment-stability assessments, standardized counseling and health education. TB and ART medications will be refilled biweekly, and participants with bacteriologically confirmed pulmonary TB will undergo sputum smear examination at month 2, per national guidelines. Eligible participants will then be randomized 1:1 to community pharmacy-based refills or treatment as usual. Participants randomized to the treatment as usual (control) arm will receive TB refills monthly and ART refills every 2-3 months at the facility.",[44],[59,63],{"name":60,"affiliation":61,"role":62},"Adithya Cattamanchi, MD, MAS","University of California, Irvine","STUDY_DIRECTOR",{"name":64,"affiliation":65,"role":62},"Christine Sekaggya-Wiltshire, MD, PhD","Infectious Diseases Institute, Makerere University",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":26,"email":71},"Jonathan Izudi, MPH, MSc, Ph.D.","CONTACT","256782097744","jonahzd@gmail.com",{"name":73,"role":69,"phone":74,"phoneExt":26,"email":75},"Stephen Okoboi, MPH, MSc, Ph.D.","256704817590","sokoboi@idi.co.ug",[77,93],{"facility":78,"status":26,"city":79,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Kawaala HC III","Kampala","Uganda","UG",{"type":83,"coordinates":84},"Point",[85,86],32.58219,0.31628,{"lat":86,"lon":85},[89],{"name":90,"role":69,"phone":91,"phoneExt":26,"email":92},"Mark Muhumuza, MD","2560752632770","mmuhumuza@kcca.go.ug",{"facility":94,"status":26,"city":79,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Kisenyi HC IV",{"type":83,"coordinates":96},[85,86],{"lat":86,"lon":85},[99],{"name":100,"role":69,"phone":101,"phoneExt":26,"email":102},"Mary Ichumar, BNS","256752619219","Imarym2021@gmail.com",{"type":104,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[106],{"name":107,"class":108},"Fogarty International Center of the National Institute of Health","NIH","100657728","integrating-tuberculosis-treatment-into-community-pharmacies-to-improve-tbhiv-outcomes-in-uganda-100657728",false,"NCT07840651","Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB\u002FHIV Outcomes in Uganda","Integrating Tuberculosis Treatment Into Community Pharmacies for People With TB\u002FHIV in Kampala, Uganda: a Pilot Randomized Trial With a Type 2 Hybrid Design","Inclusion Criteria:\n\n* People with TB\u002FHIV aged ≥18 years, receiving treatment for bacteriologically confirmed or clinically diagnosed drug-susceptible pulmonary TB, on a first-line ART regimen or its alternative, and receiving TB treatment for ≤2 months.\n\nExclusion Criteria:\n\n* Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.","ALL","18 Years",{"count":119,"type":120},124,"ESTIMATED","INTERVENTIONAL",[123],"NA","Community pharmacies (CPs) have emerged as promising differentiated service delivery models for refilling antiretroviral therapy (ART) among people with human immunodeficiency virus (HIV). Documented benefits of CP-based refills include improved treatment adherence and viral suppression, reduced healthcare provider workload, and reduced facility congestion. This trial will evaluate the acceptability, feasibility, fidelity, and preliminary effectiveness of integrating TB treatment into CPs among people with TB\u002FHIV in Kampala, Uganda.",[126,127],"TB - Tuberculosis","HIV - Human Immunodeficiency Virus",[129,130,131,132,80],"Tuberculosis","HIV","Community pharmacies","Differentiated Service Delivery Models","NOT_YET_RECRUITING","2026-09-24",{"date":136,"type":137},"2026-09-25","ACTUAL",{"date":139,"type":120},"2026-10",{"date":141,"type":120},"2028-03",{"name":5,"class":6},2]