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 男性不太可能报告结核病相关症状，得到诊断，涂片转换，或完成治疗， 这表明男性结核病级联的结果沿着更糟。尽管男性的结核病负担更重， 治疗结果较差，没有制定任何干预措施来解决这些性别差异。建筑 在我们确定男性对结核病护理支持干预的偏好的初步研究中，我们发现 Coach Mpilo（CM）是一项由南非男性开发的同伴支持艾滋病毒治疗干预措施， 专为男性结核病感染者量身定制。我们研究的目的是评估CM对男性的可行性， 治疗完成和HIV病毒抑制的次要结局，为混合I型干预提供信息。在 目标1，CM将进一步针对开始结核病治疗的男性（CM-TB）和艾滋病毒合并感染的男性（CM-TB/HIV）。 使用ADAPT-IIT模型指导的混合方法，我们将进行访谈，CM模拟和 预测试，以评估男性的可用性CM-TB和CM-TB/艾滋病毒在这种情况下。我们将执行目标2和3 同时。在目标2中，将对CM-TB进行评价，以评估其在男性中的可行性和 保持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）启动TBT的患者将随机接受CM或基于诊所的标准护理依从性支持。的 主要结局是男性的可行性、可接受性、意愿和安全性，次要结局是完成 在目标3中，CM-TB/HIV对于合并感染TB和HIV的男性（n=120）的可行性 将予以评估。主要结局是可行性、可接受性、意愿和安全性，次要结局是 测量在TBT完成时坚持抗逆转录病毒治疗的男性比例， (SVL)每个研究组加载ART启动后6个月和TBT完成后。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局的有效性， 在南非和全球范围内，在非传染性疾病的背景下，适应改善男性健康。