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: 10426171
• 负责人: JONATHAN E. GOLUB
• 金额: $ 57.19万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10426171
• 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; Persons; 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; Tuberculosis diagnosis; 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 evaluation; 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.

项目摘要 尽管结核病是一种可预防和可治疗的疾病，但每年造成不到200万人死亡， 和弱势群体，特别是艾滋病毒感染者，患病风险最高， 死亡在巴西，艾滋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，在这方面， 我们之前在里约热内卢的工作估计，每年只有12%的符合条件的艾滋病毒携带者接受结核病预防治疗 并确定了在PLWH中提供有效的结核病预防治疗的两个关键限制因素：结核菌素 潜伏性结核感染（LTBI）的皮肤试验（TST）和坚持6个月的异烟肼预防性治疗 （IPT）。使用QFT+，第四代干扰素γ释放测定，LTBI状态可作为 常规抽血，而无需患者返回诊所。这一战略有可能 大大改善结核病/艾滋病毒预防的连续性。PREVINE-TB（事件：评估 在巴西艾滋病毒感染者中实施预防结核病的新战略）将测试 使用QFT+并比较依从性策略，以优化结核病预防的实施 在巴西的艾滋病诊所里。从每日异烟肼转换为新的3 HP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， 不是日常生活的一部分。3 HP方案最近被添加到PLWH指南中， 替代6个月的IPT课程在巴西，但实施3 HP的最佳方法还没有 测定PREVINE-TB有可能在以下环境中增加这一高危人群的摄入： PLWH已被证明（我们的团队）从预防性治疗中显着受益。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， 在巴西的艾滋病毒携带者中预防结核病。目标1将侧重于QFT+作为增加LTBI筛查的战略， 对PLWH的日常护理的一部分。我们将确定与常规病毒相关的QFT+的有效性和成本 通过对结核病患者的血液样本进行CD 4检测，优化结核病/艾滋病预防护理的连续性。目标2将决定 有效性和成本效益的三个可扩展的方法，以优化患者遵守3 HP。我们 将对符合3 HP条件的PLWH进行一项依从性的个体随机非劣效性试验，以比较 基于临床的直接观察治疗（DOT，当前的标准治疗）与自我给药治疗（SAT） 优化的文本消息。最后，我们将利用（目标3）《综合执行框架》 研究（CFIR），以优化干预过程，并描述成功的关键要素 实施QFT+和3 HP战略，为扩大规模和维护提供信息。使用混合方法 方法，我们将从三个利益相关者群体（患者、提供者和项目）探讨观点 管理人员/政策制定者）建立和改进最佳干预措施的实施。这项评估将有助于 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。