南非耐多药结核病和艾滋病毒新治疗方案的移动健康与传统依从性支持干预措施的适应性评估以优化结果（ADAP-TIV）：一项适应性随机对照试验的研究方案

Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): Study protocol for an adaptive randomized controlled trial.

作者信息

Ross Jesse E, Perumal Rubeshan, Wolf Allison, Zulu Mbali, Guzman Kevin, Seepamore Boitumelo, Reis Karl, Nyilana Hlengiwe, Hlathi Senzo, Narasimmulu Radhamoney, Cheung Ying Keun K, Amico K Rivet, Friedland Gerald, Daftary Amrita, Zelnick Jennifer, Naidoo Kogieleum, O'Donnell Max R

机构信息

Columbia University Department of Medicine.

CAPRISA: Centre for the Aids Programme of Research in South Africa.

出版信息

Res Sq. 2023 Jun 9:rs.3.rs-2841179. doi: 10.21203/rs.3.rs-2841179/v1.

DOI:10.21203/rs.3.rs-2841179/v1

PMID:37333087

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10274958/

Abstract

BACKGROUND

Highly effective, short course, bedaquiline-containing treatment regimens for multidrug-resistant tuberculosis (MDR-TB) and integrase strand transfer inhibitor (INSTI)-containing fixed dose combination antiretroviral therapy (ART) have radically transformed treatment for MDR-TB and HIV. However, without advances in adherence support, we may not realize the full potential of these therapeutics. The primary objective of this study is to compare the effect of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.

METHODS

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of four adherence support strategies on a composite clinical outcome in adults with MDR-TB and HIV initiating bedaquiline-containing MDR-TB treatment regimens and receiving ART in KwaZulu-Natal, South Africa. Trial arms include 1) enhanced standard of care; 2) psychosocial support; 3) mHealth using cellular- enabled electronic dose monitoring; 4) combined mHealth and psychosocial support. The level of support will be titrated using a differentiated service delivery (DSD)-informed assessment of treatment support needs. The composite primary outcome will be include survival, negative TB culture, retention in care and undetectable HIV viral load at month 12. Secondary outcomes will include individual components of the primary outcome and quantitative evaluation of adherence on TB and HIV treatment outcomes.

DISCUSSION

This trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support.

摘要

背景

含贝达喹啉的高效短程治疗方案用于耐多药结核病（MDR-TB），以及含整合酶链转移抑制剂（INSTI）的固定剂量复方抗逆转录病毒疗法（ART），已彻底改变了MDR-TB和HIV的治疗方式。然而，如果在依从性支持方面没有进展，我们可能无法充分发挥这些疗法的潜力。本研究的主要目的是使用适应性随机平台比较依从性支持干预措施对临床和生物学终点的影响。

方法

这是一项前瞻性、适应性随机对照试验，比较四种依从性支持策略对南非夸祖鲁-纳塔尔省开始接受含贝达喹啉的MDR-TB治疗方案并接受ART的成年MDR-TB和HIV患者复合临床结局的有效性。试验组包括：1）强化标准治疗；2）心理社会支持；3）使用具备手机功能的电子剂量监测的移动健康（mHealth）；4）联合移动健康和心理社会支持。将根据基于差异化服务提供（DSD）的治疗支持需求评估来调整支持水平。复合主要结局将包括生存、结核培养转阴、持续接受治疗以及在第12个月时HIV病毒载量检测不到。次要结局将包括主要结局的各个组成部分，以及对结核病和HIV治疗结局依从性的定量评估。