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相关的症状，被诊断，涂抹转换或完整治疗， 暗示男性沿着结核病级联的结果更糟。尽管男人对结核病负担更大， 较差的治疗结果，尚未制定干预措施来解决这些性别差异。建筑 关于我们确定男性对结核病护理支持干预偏好的初步研究，我们确定了 MPILO教练（CM），一种同伴支持的HIV治疗干预措施，由男性为南非男性开发 并针对男性TB感染量身定制。我们研究的目的是评估CM的可行性并评估 治疗完成和HIV病毒抑制的次要结果，以告知I型干预措施。在 AIM 1，CM将进一步量身定制为启动结核病治疗（CM-TB）和HIV共同感染（CM-TB/HIV）的男性。 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A 预先测试在这种情况下评估男性CM-TB和CM-TB/HIV的可用性。我们将进行目标2和3 同时。在AIM 2中，将评估CM-TB以评估男性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。使用随机对照试验设计，男人 （n = 120）启动TBT将随机分配以接收CM或基于诊所的护理依从性支持。这 主要结果是具有次要结果的男性的可行性，可接受性，意愿和安全性 TBT在每只手臂180天内。在AIM 3中，与TB和HIV共同感染的男性CM-TB/HIV的可行性（n = 120） 将被评估。主要结果是可行性，可接受性，意愿和安全以及次要结果 测量在TBT完成时遵守抗逆转录病毒疗法的男性比例 （SVL）在图表开始后6个月和TBT完成后每个研究部门完成。如果证明是可行的，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以及 适应在南非和全球的非传染性疾病的背景下改善男性健康。