PREVINE-TB: PRevent: EValuating the implementation of NEw strategies for preventive TB among people living with HIV in Brazil

PREVINE-TB：预防：评估巴西艾滋病毒感染者预防结核病新战略的实施情况

• 批准号: 10179305
• 负责人: JONATHAN E. GOLUB
• 金额: $ 56.9万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10179305
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adherence; Adult; Americas; Behavioral; Biological Assay; Blood; Blood Tests; Brazil; Caring; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinic; Clinical Treatment; Clinical Trials; Consolidated Framework for Implementation Research; Continuity of Patient Care; Data; Diagnosis; Directly Observed Therapy; Disease; Dose; Elements; Ensure; Epidemiologist; Evaluation; Generations; Goals; Gold; Guidelines; HIV; HIV/TB; Incidence; Individual; Interferon Type II; Intervention; Laboratories; Link; Maintenance; Measures; Methods; Monitor; Participant; Patients; Policies; Policy Maker; Populations at Risk; Prevalence; Prevention; Prevention strategy; Preventive; Preventive therapy; Process; Provider; Quality-Adjusted Life Years; Randomized; Reading; Regimen; Reporting; Research; Scientist; Self Administration; Surveys; Test Result; Testing; Text Messaging; Translating; Tuberculin Test; Tuberculosis; Urine; Viral Load result; Vulnerable Populations; Work; World Health Organization; antiretroviral therapy; arm; base; co-infection; compliance behavior; cost; cost effective; cost effectiveness; cost estimate; disorder risk; effectiveness evaluation; experience; high risk; implementation intervention; implementation science; improved; isoniazid; multidisciplinary; novel; novel strategies; prevent; primary outcome; programs; rifapentine; routine care; scale up; screening; standard of care; uptake

PROJECT SUMMARY Despite being a preventable and treatable disease, tuberculosis (TB) kills just under 2 million people annually, and vulnerable populations, especially people living with HIV (PLWH), are at highest risk for disease and death. In Brazil, TB rates are markedly higher in PLWH and preventing TB for PLWH is a top priority. However, our prior work in Rio de Janeiro estimated only 12% of eligible PLWH receiving TB preventive therapy annually and identified two critical constraints to delivery of effective TB preventive therapy among PLWH: tuberculin skin testing (TST) for latent TB infection (LTBI) and adherence to 6 months of isoniazid preventive therapy (IPT). With QFT+, a 4th generation Interferon Gamma Release Assay, LTBI status can be determined as part of routine blood draws without the patient having to return to the clinic. This strategy has the potential to substantially improve the TB/HIV prevention continuum. PREVINE-TB (PRevent: EValuating the Implementation of NEw strategies for preventing TB among people living with HIV in Brazil) will test use of QFT+ and compare adherence strategies to optimize implementation of the TB prevention continuum in HIV clinics in Brazil. A switch from daily isoniazid to the novel 3HP regimen (once weekly for 12 weeks), now recommended by the CDC, may improve patient adherence, but may also be a challenge in not being part of a daily routine. The 3HP regimen was recently added to guidelines for PLWH as an alternative to the 6-month course of IPT in Brazil, but the best method for implementing 3HP is yet to be determined. PREVINE-TB has the potential to increase uptake for this at-risk population in a setting where PLWH have been shown (by our team) to significantly benefit from preventive therapy. Our goal is to assess the implementation by the Brazilian National Tuberculosis Program (NTP) of a novel strategy to prevent TB among PLWH in Brazil. Aim 1 will focus on QFT+ as a strategy to increase screening for LTBI as part of routine care for PLWH. We will determine the effectiveness and costs of QFT+ linked to routine viral load and CD4 blood draws to optimize the TB/HIV prevention care continuum. Aim 2 will determine effectiveness and cost-effectiveness of three scalable methods for optimizing patient adherence to 3HP. We will conduct an individually randomized non-inferiority trial of adherence for PLWH eligible for 3HP to compare clinic-based directly observed therapy (DOT, the current standard-of-care) vs self-administered therapy (SAT) with optimized text messaging. Finally, we will utilize (Aim 3) the Consolidated Framework for Implementation Research (CFIR) to optimize intervention processes and describe key elements for the successful implementation of the QFT+ and 3HP strategies to inform scale-up and maintenance. Using a mixed methods approach, we will explore perspectives from three stakeholder groups (patients, providers, and program managers/policy makers) to build and improve optimal intervention implementation. This evaluation will help ensure study results are directly translated into policy in the most appropriate and cost-effective manner.

项目概要 尽管结核病 (TB) 是一种可预防和可治疗的疾病，但每年仍导致近 200 万人死亡， 弱势群体，尤其是艾滋病毒感染者 (PLWH)，感染疾病的风险最高， 死亡。在巴西，艾滋病病毒感染者的结核病发病率明显较高，预防艾滋病毒感染者的结核病是当务之急。然而， 我们之前在里约热内卢开展的工作估计，每年只有 12% 的符合资格的感染者接受结核病预防治疗 并确定了在 PLWH 中提供有效结核病预防治疗的两个关键制约因素：结核菌素 潜伏性结核感染 (LTBI) 皮试 (TST) 并坚持 6 个月的异烟肼预防性治疗 （IPT）。通过 QFT+（第四代干扰素伽马释放检测），可以确定 LTBI 状态 常规抽血，患者无需返回诊所。该策略有潜力 显着改善结核病/艾滋病毒预防连续性。 PREVINE-TB（预防：评估 巴西艾滋病毒感染者预防结核病新战略的实施将进行测试 使用 QFT+ 并比较依从策略以优化结核病预防的实施 巴西艾滋病毒诊所的连续统一体。从每日异烟肼改为新型 3HP 方案（每周一次） 12 周），现在由 CDC 推荐，可能会提高患者的依从性，但也可能是一个挑战 不成为日常生活的一部分。 3HP 方案最近被添加到 PLWH 指南中，作为一种 巴西 6 个月 IPT 课程的替代方案，但实施 3HP 的最佳方法尚未确定 决定。在以下环境中，PREVINE-TB 有可能增加这一高危人群的吸收率 （我们的团队）已证明艾滋病毒感染者可以从预防性治疗中获益匪浅。我们的目标是评估 巴西国家结核病规划 (NTP) 实施了一项新战略 在巴西的感染者中预防结核病。目标 1 将重点关注 QFT+ 作为增加 LTBI 筛查的策略 PLWH 日常护理的一部分。我们将确定 QFT+ 与常规病毒相关的有效性和成本 负荷和 CD4 抽血以优化结核病/艾滋病毒预防护理连续性。目标 2 将决定 优化患者对 3HP 依从性的三种可扩展方法的有效性和成本效益。我们 将针对符合 3HP 资格的 PLWH 进行单独随机非劣效性试验，以进行比较 基于临床的直接观察治疗（DOT，当前的护理标准）与自我管理治疗（SAT） 具有优化的短信功能。最后，我们将利用（目标 3）综合实施框架 研究（CFIR）以优化干预流程并描述成功的关键要素 实施 QFT+ 和 3HP 策略，为规模扩大和维护提供信息。使用混合方法 方法中，我们将探讨三个利益相关者群体（患者、提供者和项目）的观点 管理者/政策制定者）​​建立和改进最佳干预实施。此评估将有助于 确保研究结果以最适当和最具成本效益的方式直接转化为政策。