Integrating Tuberculosis Treatment Into Community Pharmacies for People With TB/HIV in Kampala, Uganda: a Pilot Randomized Trial With a Type 2 Hybrid Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Acceptability of integration of TB treatment into community pharmacies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Individuals with extrapulmonary TB as their treatment often exceeds 6 months, and those likely to transfer to other health facilities.
研究组 & 干预措施
Community pharmacy refill arm
People with TB/HIV receive both ART and TB drug refills through community pharmacies.
干预措施: 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)
干预措施: Control Arm - standard of care (Other)
结局指标
主要结局
Acceptability of integration of TB treatment into community pharmacies
时间窗: 6 months
Proportion of people with TB/HIV willing to receive treatment at community pharmacies.
次要结局
- 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)