Assessing the Feasibility of Coach Mpilo for Men with TB and HIV in Eastern Cape, South Africa

评估 Coach Mpilo 在南非东开普省为患有结核病和艾滋病毒的男性提供服务的可行性

• 批准号: 10762792
• 负责人: Joseph Daniels
• 金额: $ 20.97万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762792
• 关键词: Address; Adherence; Adult; Caring; Cities; Clinic; Collaborations; Communities; Diagnosis; Disease; Effectiveness; Family; Feasibility Studies; Food; Friends; Future; Gender; Goals; Grant; HIV; HIV/TB; Health; Hybrids; Intervention; Interview; Life Expectancy; Linguistics; Methods; Modeling; Outcome; Outcome Measure; Pilot Projects; Population; Prevalence; Psyche structure; Randomized; Randomized, Controlled Trials; Reporting; Research; Resources; Safety; Sex Differences; Social support; South Africa; Specific qualifier value; Survivors; Symptoms; Techniques; Testing; Time; Training; Treatment outcome; Tuberculosis; United States National Institutes of Health; Viral; Viral Load result; Woman; Work; advocacy organizations; antiretroviral therapy; arm; co-infection; effectiveness evaluation; effectiveness study; experience; gender disparity; improved; male health; men; motivational enhancement therapy; peer support; preference; primary outcome; resilience; satisfaction; secondary outcome; service delivery; simulation; skills; standard of care; therapy design; therapy development; treatment adherence; treatment comparison; trend; trial design; tuberculosis treatment; usability; willingness

Project Abstract Men are less likely to report TB-related symptoms, get diagnosed, smear convert, or complete treatment, suggesting that outcomes along the TB cascade are worse for men. Despite men's greater burden of TB and poorer treatment outcomes, no interventions have been developed to address these gendered disparities. Building on our preliminary research that identified men's preferences for a TB care support intervention, we identified Coach Mpilo (CM), a peer-support HIV treatment intervention that was developed by men for men in South Africa, and tailored for men TB infection. The aims of our study are to assess the feasibility of CM for men and assess secondary outcomes for treatment completion and HIV viral suppression to inform a Hybrid Type I intervention. In Aim 1, CM will be further tailored to men initiating TB treatment (CM-TB) and for with HIV co-infection (CM-TB/HIV). Using a mixed methods approach guided by ADAPT-IIT model, we will conduct interviews, CM simulations, and a pre-test to assess men's usability of CM-TB and CM-TB/HIV in this setting. We will conduct Aims 2 and 3 concurrently. In Aim 2, CM-TB will be evaluated to assess feasibility among men and secondary outcomes for retention in care and successful TB treatment (TBT) outcomes. Using a randomized controlled trial design, men (N=120) initiating TBT will be randomized to receive CM or clinic-based standard of care adherence support. The primary outcome is feasibility, acceptability, willingness and safety for men with secondary outcomes for completing TBT within 180 days per arm. In Aim 3, the feasibility of CM-TB/HIV for men (n=120) co-infected with TB and HIV will be assessed. The primary outcome is feasibility, acceptability, willingness and safety with secondary outcomes measured for proportion of men adherent to anti-retroviral therapy at TBT completion and with a suppressed viral (SVL) load 6 months post-ART initiation and post-TBT completion per study arm. If shown to be feasible, we will propose an randomized controlled trial to assess effectiveness in improving men's TB and HIV outcomes and adapted to improve men's health in the context of non-communicable diseases in South Africa and globally.

项目摘要 男性不太可能报告与结核病有关的症状、得到诊断、涂片转换或完成治疗， 这表明结核病的一连串结果对男性来说更糟。尽管男性的结核病负担更重，而且 尽管治疗结果较差，但还没有制定任何干预措施来解决这些性别差异。建房 我们的初步研究确定了男性对结核病护理支持干预的偏好，我们发现 Coach Mpio(CM)是一种同伴支持的艾滋病毒治疗干预措施，由南非男性开发， 并为男性结核病感染量身定做。我们研究的目的是评估CM对男性的可行性，并评估 治疗完成和HIV病毒抑制的次要结果为混合I型干预提供信息。在……里面 目标1，CM将进一步适用于开始治疗结核病的男性(CM-TB)和艾滋病毒合并感染(CM-TB/HIV)。 使用Adapt-IIT模型指导的混合方法方法，我们将进行访谈、CM模拟和 用于评估男性在这种情况下对CM-TB和CM-TB/HIV的可用性的预测试。我们将实施目标2和目标3 同时。在目标2中，将对CM-TB进行评估，以评估在男性中的可行性和次要结果 保留护理和成功的结核病治疗(TBT)结果。采用随机对照试验设计，男性 (n=120)发起TBT将随机接受CM或基于临床的标准护理依从性支持。这个 主要结果是男性完成的可行性、可接受性、意愿和安全性，次要结果是完成 每只手臂180天内发生TBT。在目标3中，对同时感染结核病和艾滋病毒的男性(n=120)实施CM-TB/HIV的可行性 将会被评估。主要结果是可行性、可接受性、意愿和安全性，次要结果是 测量男性在TBT完成时坚持接受抗逆转录病毒治疗和病毒被抑制的比例 (SVL)每个研究组在ART开始后6个月和TBT完成后6个月加载。如果证明可行，我们将 提出一项随机对照试验，以评估改善男性结核病和艾滋病毒结果的有效性，并 适应在南非和全球非传染性疾病的背景下改善男性健康。