Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,920
- 试验地点
- 1
- 主要终点
- Effectiveness: TB Treatment Success
研究概览
简要总结
This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.
详细描述
Study Design
Aim 1. The investigators will conduct a parallel, cluster-randomized, hybrid Type 2, effectiveness-implementation trial at 16 sites in Uganda.
This clinical trials registration focuses on Aim 1.
In addition, we will pursue two additional non-interventional aims to better understand the implementation and outcomes of Aim 1:
Aim 2. Within the Aim 1 study, the investigators will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥18 years
- •Registered as a new, relapse, treatment failure, or previously lost-to-follow-up
- •TB case according to the on-site NTP TB Treatment Register
- •Screened and invited to participate within 30 days of TB treatment initiation
排除标准
- •Diagnosed with possible or confirmed drug-resistant TB
- •Transferring TB care into the clinic from an off-site facility
- •Residing >40 km from the enrolling clinic
- •Lacking mental capacity to provide informed consent
结局指标
主要结局
Effectiveness: TB Treatment Success
时间窗: Up to 12 months after TB treatment initiation
Defined according to criteria from the World Health Organization as either: 1. Treatment completion - completion of TB treatment without evidence of treatment failure as documented in the on-site TB treatment register; or 2. Cure - among participants with microbiologically confirmed TB, a negative smear or culture result in the final month of treatment and on at least one previous occasion. The outcome will be assessed as the proportion of participants achieving TB treatment success based on program treatment records.
Effectiveness: Antiretroviral Therapy (ART) Retention
时间窗: At month 6 after ART initiation (+/- 30 days)
Among participants living with HIV and initiated on antiretroviral therapy (ART), ART retention will be defined as being (1) alive and (2) receiving ART, as evidenced by a documented ART medication pickup or documented ART supply at a clinical visit recorded in the on-site ART register or on the ART treatment card. The outcome will be assessed as the proportion of participants living with HIV who are alive and receiving ART at 6 months after ART initiation.
次要结局
- Implementation: TB Medication Adherence(At month 5 after TB treatment initiation, ±30 days)
- Implementation: ART Adherence(At month 5 after TB treatment initiation, ±30 days)