Integrating Tuberculosis Treatment Into Community Pharmacies for People With TB/HIV in Kampala, Uganda: a Pilot Randomized Trial With a Type 2 Hybrid Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Makerere University
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Acceptability of integration of TB treatment into community pharmacies
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Community pharmacy refill arm
People with TB/HIV receive both ART and TB drug refills through community pharmacies.
Intervention: The intervention is TB treatment delivery via community pharmacies for people with TB/HIV (Other)
Health facility refill arm
People with TB/HIV continue to receive both ART and TB drug refills through health facilities (routine care)
Intervention: Control Arm - standard of care (Other)
Outcomes
Primary Outcomes
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
- 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)