Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework: The Tlogela Trial protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-19 DOI:10.1016/j.cct.2025.107985

Leisha P. Genade , Laura Steiner , Firdaus Nabeemeeah , Raymond S. Niaura , Bareng A.S. Nonyane , Christopher J. Hoffmann , Hojoon Sohn , Christopher G. Kemp , Kate Guastaferro , Lebohang Mlambo , Deshan Chetty , Ziyaad Waja , Neil Martinson , Jonathan E. Golub , Jessica L. Elf

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引用次数: 0

Abstract

Background

Human immunodeficiency virus (HIV) remains an important cause of morbidity and mortality in South Africa (SA) with a gradual shift from opportunistic illness to pulmonary and cardiovascular disease among people living with HIV (PLWH). This shift is exacerbated by increases in prevalence of tobacco smoking and also few resources to support smoking cessation. Evidence-based smoking cessation strategies are yet to be fully evaluated among PLWH in this setting.

Objective

This project will optimize a smoking cessation treatment package for PLWH that can be integrated into existing HIV care in SA. We will identify the most effective and/or combination of the interventions and evaluate their potential for implementation and cost-effectiveness.

Methods

A balanced 2⁴ full factorial clinical trial will randomise 660 PLWH who smoke tobacco into one of 16 combinations of four intervention components (behavioural counselling, peer counselling, varenicline, and combination nicotine replacement therapy). Participants will be recruited from four healthcare facilities in SA, receive 12 weeks of intervention and the primary outcome will be 7-day point prevalence tobacco abstinence from smoking at one year, measuring both exhaled breath carbon monoxide (CO) and urinary cotinine. A mixed methods approach will be used to evaluate implementation using the Reach, Effectiveness, Adoptions, Implementation, Maintenance framework. Cost, cost-effectiveness, and budget impact of each intervention combination will be evaluated.

Conclusion

Results will inform which intervention components, and in what combination, are most efficacious in supporting smoking abstinence among PLWH in SA and those that have the greatest potential for effectiveness when brought to scale.

Clinical Trial Registration Number

South African National Clinical Trials Registry.

Trial No: DOH-27-062023-9076.

ClinicalTrials.gov ID: NCT05413122

查看原文本刊更多论文

在南非使用多阶段优化策略（MOST）框架评估艾滋病毒感染者戒烟干预措施的一项因子随机临床试验：Tlogela试验方案。

背景：人类免疫缺陷病毒（HIV）仍然是南非（SA）发病率和死亡率的重要原因，HIV感染者（PLWH）逐渐从机会性疾病转变为肺部和心血管疾病。吸烟流行率的上升以及支持戒烟的资源匮乏加剧了这一转变。在这种情况下，基于证据的戒烟策略尚未在PLWH中得到充分评估。目的：该项目将优化艾滋病患者的戒烟治疗方案，该方案可整合到南非现有的艾滋病毒护理中。我们将确定最有效的干预措施和/或干预措施的组合，并评估其实施潜力和成本效益。方法：一项平衡的24全因子临床试验将660名吸烟的PLWH随机纳入4种干预成分（行为咨询、同伴咨询、伐尼克兰和联合尼古丁替代疗法）的16种组合之一。参与者将从南澳大利亚州的四家医疗机构招募，接受12 周的干预，主要结果将是一年内7天的点烟率戒烟，测量呼出的一氧化碳（CO）和尿可替宁。将使用混合方法方法来评估使用范围、有效性、采用、实施和维护框架的实施情况。将评估每种干预组合的成本、成本效益和预算影响。结论：结果将告知哪些干预成分，以及以何种组合，在支持SA的PLWH戒烟方面最有效，哪些干预成分在大规模推广时具有最大的有效性潜力。临床试验注册号：南非国家临床试验注册中心。试验号：DOH-27-062023-9076。临床试验：gov ID: NCT05413122。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.