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.

摘要 南非是全世界艾滋病毒/艾滋病负担最重的国家（成人患病率为19.5%），约有8.2 到2021年，艾滋病毒/艾滋病（PLWHA）感染者人数将达到100万。可燃香烟（CC）具有深远的健康 对PLWHA的影响。在PLWHA中吸烟会增加他们感染一系列严重艾滋病毒的风险- 与不吸烟的PLWHA相比，相关的合并症和过早死亡。迫切需要 应对这些挑战的新的可行和有效的CC停止和危害减少策略 在艾滋病毒感染者和艾滋病患者中间，特别是在南非。这项建议旨在满足以下未得到满足的需求： 在南非减少艾滋病毒感染者和艾滋病患者使用CC的可行和有效的战略， 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，并通过我们正在进行的研究提供信息。使用 同时嵌入式混合方法的方法，我们将评估远程医疗计划针对CC伤害 减少，将电子烟（EC）与尼古丁替代疗法（NRT）进行比较， 生态瞬时干预（EMI）短信。因此，这项建议将大大提高研究能力， 在南非使用创新的电子医疗方法进行远程保健烟草治疗干预 加强参与者的参与以及最先进的评价方法。 具体目标是：1）调整现有的远程保健干预措施，以减少南方的CC危害 2）确定适应性干预措施的可行性和可接受性（主要成果）， 估计和比较EC和NRT对CC减少的初步影响（次要结局） 采用先导性随机对照试验（RCT）设计。我们将调整现有的CC危害减少协议。 从南非西开普省提供抗逆转录病毒疗法的八个医疗机构招募艾滋病毒感染者/艾滋病患者吸烟者 对于PLWHA，我们将完善并最终确定干预措施，以在试点RCT 3组设计（N=90）中进行评估。 第1组（对照）：转诊至戒烟热线;第2组：电话咨询+ EMI +联合NRT（贴剂+ 第3组：电话咨询+ EMI + EC。与试点RCT一致，主要结局将是：A） 根据招募率、完成率和随访率定义的干预可行性，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。次要结局包括1）IMB 基于理论的变化机制，2）达到7天时点患病率的CC吸烟者比例 禁欲，通过3个月和6个月时呼出的一氧化碳（<6 ppm）来验证，3）每次吸烟量减少 与基线相比，以及4）健康结果的变化。这项建议将建设能力， 在南非帮助减少艾滋病毒感染者和艾滋病患者吸烟的基础工作。