Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda
2 other identifiers
interventional
124
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
September 25, 2026
September 1, 2026
11 months
September 19, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability of integration of TB treatment into community pharmacies
Proportion of people with TB/HIV willing to receive treatment at community pharmacies.
6 months
Secondary Outcomes (4)
Feasibility of integration of TB treatment into community pharmacies
6 months
Fidelity of implementation of community pharmacy TB treatment integration
6 months
TB treatment success rate
6 months
Viral load suppression
6 months
Study Arms (2)
Community pharmacy refill arm
EXPERIMENTALPeople with TB/HIV receive both ART and TB drug refills through community pharmacies.
Health facility refill arm
PLACEBO COMPARATORPeople with TB/HIV continue to receive both ART and TB drug refills through health facilities (routine care)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kawaala HC III
Kampala, Uganda
Kisenyi HC IV
Kampala, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adithya Cattamanchi, MD, MAS
University of California, Irvine
- STUDY DIRECTOR
Christine Sekaggya-Wiltshire, MD, PhD
Infectious Diseases Institute, Makerere University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2026
First Posted
September 25, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- June 2029
- Access Criteria
- Any individual with a reasonable request will have access to the datasets, along with the codebook.
Datsets