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NCT Number: NCT07840651

Integrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda

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.

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Key information

Conditions

TB - Tuberculosis Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV - Human Immunodeficiency Virus HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Latent Infection Latent Tuberculosis Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kawaala HC III, Kampala, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.

Treatment and study plan

The intervention is TB treatment delivery via community pharmacies for people with TB/HIV

Other

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 care

Other

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.

Primary outcomes

  1. Acceptability of integration of TB treatment into community pharmacies

    Time frame: 6 months

    Proportion of people with TB/HIV willing to receive treatment at community pharmacies.

Secondary outcomes

  1. Feasibility of integration of TB treatment into community pharmacies

    Time frame: 6 months

    Proportion of community pharmacy workers reporting that the integration of TB treatment into community pharmacies was successful.

  2. Fidelity of implementation of community pharmacy TB treatment integration

    Time frame: 6 months

    Proportion of people with TB/HIV who return for expected refills.

  3. TB treatment success rate

    Time frame: 6 months

    Proportion of people with TB/HIV with treatment outcomes of cure or treatment completion at 6 months

  4. Viral load suppression

    Time frame: 6 months

    Proportion of people with TB/HIV with viral load <1,000 copies/ml at 6 months or TB treatment completion

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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