An interventional study of The intervention is TB treatment delivery via community pharmacies for people with TB/HIV and Control Arm - standard of care in TB - Tuberculosis and HIV - Human Immunodeficiency Virus, sponsored by Makerere University. Not yet recruiting at 2 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Makerere University · Not applicable, Interventional, and Health services research
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/HIV in Kampala, Uganda.
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.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's planned enrollment of 124 is below the median of 300 across 110 interventional studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People with TB/HIV receive both ART and TB drug refills through community pharmacies.
Other: The intervention is TB treatment delivery via community pharmacies for people with TB/HIV
People with TB/HIV continue to receive both ART and TB drug refills through health facilities (routine care)
Other: Control Arm - standard of care
Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE/4RH) 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.
Before randomization (months 0-2), all participants will receive standard TB treatment (2RHZE/4RH) 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.
Acceptability of integration of TB treatment into community pharmacies
Proportion of people with TB/HIV willing to receive treatment at community pharmacies.
Time frame: 6 months
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.
Time frame: 6 months
Fidelity of implementation of community pharmacy TB treatment integration
Proportion of people with TB/HIV who return for expected refills.
Time frame: 6 months
TB treatment success rate
Proportion of people with TB/HIV with treatment outcomes of cure or treatment completion at 6 months
Time frame: 6 months
Viral load suppression
Proportion of people with TB/HIV with viral load \<1,000 copies/ml at 6 months or TB treatment completion
Time frame: 6 months
Plan to share: Yes — Datsets
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: June 2029
Access criteria: Any individual with a reasonable request will have access to the datasets, along with the codebook.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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