TB - TuberculosisNCT07840651
Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda
A study testing The intervention is TB treatment delivery via community pharmacies for people with TB/HIV in people with TB - Tuberculosis and HIV - Human Immunodeficiency Virus, run by Makerere University at 2 sites in Uganda.
Trial summary
Community pharmacies (CPs) have emerged as promising differentiated service delivery models for refilling antiretroviral therapy (ART) among people with human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TB - Tuberculosis, HIV - Human Immunodeficiency Virus
- What is being tested?
- The intervention is TB treatment delivery via community pharmacies for people with TB/HIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesUganda
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with TB/HIV 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.
Who cannot join
- Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites
Kawaala HC III
Kampala
Mark Muhumuza, MD, 2560752632770, mmuhumuza@kcca.go.ug
Kisenyi HC IV
Kampala
Mary Ichumar, BNS, 256752619219, Imarym2021@gmail.com
About this study
Official title: Integrating Tuberculosis Treatment Into Community Pharmacies for People With TB/HIV in Kampala, Uganda: a Pilot Randomized Trial With a Type 2 Hybrid Design
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.
Read the detailed description
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.
- Being tested
- The intervention is TB treatment delivery via community pharmacies for people with TB/HIV, Control Arm - standard of care
- Keywords
- Tuberculosis, HIV, Community pharmacies, Differentiated Service Delivery Models, Uganda
- Medical subject headings
- Latent Tuberculosis, Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is TB treatment delivery via community pharmacies for people with TB/HIVOther
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.
Control Arm - standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community pharmacy refill arm | Experimental | People with TB/HIV receive both ART and TB drug refills through community pharmacies. Receives: Other: The intervention is TB treatment delivery via community pharmacies for people with TB/HIV |
| Health facility refill arm | Placebo comparator | People with TB/HIV continue to receive both ART and TB drug refills through health facilities (routine care) Receives: Other: Control Arm - standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of integration of TB treatment into community pharmacies
Proportion of people with TB/HIV willing to receive treatment at community pharmacies.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
Fidelity of implementation of community pharmacy TB treatment integration
Proportion of people with TB/HIV who return for expected refills.
Measured: 6 months
TB treatment success rate
Proportion of people with TB/HIV with treatment outcomes of cure or treatment completion at 6 months
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is TB treatment delivery via community pharmacies (private retail drug shops) for people with TB/HIV
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Adithya Cattamanchi, MD, MAS, Study director, University of California, IrvineChristine Sekaggya-Wiltshire, MD, PhD, Study director, Infectious Diseases Institute, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840651
- Sponsor's protocol ID
- IDI-REC-2024-98
- Other IDs
- K43TW012839
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datsets