Evaluating Smoking Cessation and Harm Reduction Approaches among People Living with HIV/AIDS in South Africa

评估南非艾滋病毒/艾滋病感染者的戒烟和减少危害方法

• 批准号: 10537967
• 负责人: Omar El-Shahawy
• 金额: $ 19万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10537967
• 关键词: AIDS/HIV problem; Abstinence; Address; Adult; Behavior; Behavioral; Belief; Carbon Monoxide; Cardiovascular Diseases; Cessation of life; Cigarette; Cigarette Smoker; Client satisfaction; Clinic; Collaborations; Complex; Consumption; Data; Dependence; Ecological momentary assessment; Electronic cigarette; Evaluation; Exhalation; Focus Groups; Future; Goals; HIV; Harm Reduction; Health; Health care facility; Health system; Individual; Intervention; Interview; Life Expectancy; Longevity; Malignant neoplasm of lung; Measures; Methods; Modeling; Motivation; Nicotine; Outcome; Participant; Patients; Pattern; Persons; Pharmaceutical Preparations; Population; Prevalence; Protocols documentation; Questionnaires; Randomized Controlled Trials; Regimen; Research; Respiratory Signs and Symptoms; Risk; Risk Factors; Ritual compulsion; Self Efficacy; Smoker; Smoking; South Africa; South African; Surveys; Therapeutic; Time; Tobacco; Treatment Efficacy; Variant; Work; acceptability and feasibility; arm; attributable mortality; base; cigarette smoke; cigarette smoking; combustible cigarette; comorbidity; craving; design; e-cigarette cessation; effective intervention; electronic cigarette use; evidence base; follow-up; group intervention; improved; innovation; interest; nicotine replacement; nicotine use; non-smoking; novel; novel strategies; patient engagement; post intervention; premature; primary outcome; programs; psychological distress; quitline; recruit; secondary outcome; skills; smoking abstinence; smoking cessation; telehealth; telephone coaching; text messaging intervention; theories; trial design; virtual

ABSTRACT South Africa has the greatest burden of HIV/AIDS worldwide (19.5% adult prevalence) with approximately 8.2 million people living with HIV/AIDS (PLWHA) in 2021. Combustible cigarettes (CC) has profound health implications among PLWHA. CC smoking in PLWHA puts them at increased risk for a host of serious HIV- related co-morbidities and premature death compared to nonsmoking PLWHA. There is an urgent need for novel feasible and efficacious strategies for CC cessation and harm reduction addressing these challenges among PLWHA in general, and in South Africa in particular. This proposal aims to address the unmet need for feasible and efficacious strategies for reducing CC use among PLWHA in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. The proposed intervention is based on the Information-Motivation-Behavioral Skills (IMB) model, and informed by our ongoing research. Using a simultaneous embedded mixed methods approach, we will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants’ engagement, as well as state-of-the art evaluation approaches. The Specific Aims are to: 1) Adapt an existing telehealth intervention for CC harm reduction to the South African context, and 2) Determine the feasibility and acceptability of adapted intervention (primary outcomes), and Estimate and Compare the preliminary effects of EC and NRT on CC reduction (secondary outcomes) using a pilot randomized controlled trial (RCT) design. We will adapt an existing CC harm reduction protocol. Recruiting PLWHA smokers from eight healthcare facilities in the Western Cape in South Africa providing ART to PLWHA, we will refine and finalize the intervention to be evaluated in a pilot RCT 3-group design (N=90). Arm 1 (Control): Referral to quit-line; Arm 2: Telephone counseling + EMI + combination NRT (patch + lozenge); Arm 3: Telephone counseling + EMI + EC. Consistent with a pilot RCT, primary outcomes will be: A) Feasibility of the intervention as defined by Recruitment, completion, and follow-up rates, and B) Acceptability as assessed by the Client Satisfaction Questionnaire and interviews. Secondary outcomes include 1) IMB theory-based mechanisms of change, 2) proportion of CC smokers achieving 7-day point prevalence abstinence, verified by exhaled carbon monoxide (<6 ppm) at 3- and 6-months, 3) reductions in cigarettes per day compared to baseline, and 4) changes in health outcomes. This proposal will build capacity and lay the groundwork to help decrease CC smoking among PLWHA in South Africa.

抽象的 南非是全球艾滋病毒/艾滋病负担最重的国家（成人患病率为 19.5%），大约为 8.2 到 2021 年，全球将有 100 万艾滋病毒/艾滋病感染者 (PLWHA)。可燃香烟 (CC) 具有深远的健康意义 对 PLWHA 的影响。艾滋病毒感染者中吸烟者吸烟会增加他们感染多种严重艾滋病毒的风险 与不吸烟的感染者相比，相关的合并症和过早死亡。迫切需要 针对这些挑战的戒断和减少危害的新颖可行且有效的策略 总体而言，艾滋病毒感染者，特别是南非的感染者。该提案旨在解决未满足的需求 减少南非 PLWHA 中 CC 使用的可行且有效的策略，具有潜力 显着改善 PLWHA CC 吸烟者的健康和长期生存。拟议的干预措施是 基于信息-动机-行为技能 (IMB) 模型，并以我们正在进行的研究为基础。使用 同时嵌入混合方法方法，我们将评估针对 CC 危害的远程医疗计划 将电子烟 (EC) 与通过整合增强的尼古丁替代疗法 (NRT) 进行比较 生态瞬时干预（EMI）短信。因此，该提案将显着增强研究能力 在南非使用创新的 EMI 方法进行远程医疗烟草治疗干预 提高参与者的参与度以及最先进的评估方法。 具体目标是： 1) 调整现有的远程医疗干预措施，以减少南方的 CC 伤害 非洲背景，以及 2) 确定适应性干预措施的可行性和可接受性（主要结果）， 估计并比较 EC 和 NRT 对 CC 减少的初步效果（次要结果） 使用试点随机对照试验（RCT）设计。我们将调整现有的 CC 伤害减少协议。 从南非西开普省的八个医疗机构招募 PLWHA 吸烟者，提供 ART 对于 PLWHA，我们将完善并最终确定干预措施，并在试点随机对照试验 3 组设计（N=90）中进行评估。 第 1 组（对照）：转介至戒烟热线；第 2 组：电话咨询 + EMI + 组合 NRT（贴剂 + 菱形）;第 3 组：电话咨询 + EMI + EC。与试点随机对照试验一致，主要结果将是：A) 干预的可行性，定义为招募率、完成率和随访率，以及 B) 可接受性 通过客户满意度调查问卷和访谈进行评估。次要结果包括 1) IMB 基于理论的变化机制，2) CC 吸烟者达到 7 天点患病率的比例 戒烟，通过 3 个月和 6 个月时呼出的一氧化碳 (<6 ppm) 进行验证，3) 每人吸烟量减少 与基线相比的天数，以及 4) 健康结果的变化。该提案将建设能力并奠定 为帮助减少南非感染者中的 CC 吸烟奠定基础。