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: 10653226
• 负责人: Omar El-Shahawy
• 金额: $ 20.97万
• 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/10653226
• 关键词: Abstinence; Acquired Immunodeficiency Syndrome; Address; Adult; Behavior; Behavioral; Belief; Carbon Monoxide; Cardiovascular Diseases; Cessation of life; Cigarette; Cigarette Smoker; Client satisfaction; Clinic; Collaborations; Complex; Consumption; Data; Dependence; Disease; Disparity; Ecological momentary assessment; Electronic cigarette; Evaluation; Exhalation; Focus Groups; Future; Goals; HIV; HIV/AIDS; 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; cigarette smoke; cigarette smoking; combustible cigarette; comorbidity; comparison control; craving; design; 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 南非的艾滋病毒/艾滋病负担是世界上最大的(19.5%的成人流行率)，约为8.2 2021年有100万艾滋病毒/艾滋病患者(PLWHA)。可燃香烟(CC)具有深远的健康意义 PLWHA之间的影响。在PLWHA中吸烟CC会增加他们感染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停止CC和减少危害的战略 在整个世界卫生大会中，特别是在南非。这项提议旨在解决未得到满足的 在南非的PLWHA中减少CC使用量的可行和有效的战略，这具有潜力 显著改善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，并由我们正在进行的研究提供信息。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 减少，比较电子烟(EC)和尼古丁替代疗法(NRT)，后者通过整合 生态瞬时干预(EMI)短信。因此，这项提议将显著提高研究能力 在南非使用创新的EMI方法进行远程保健烟草治疗干预 提高参与者的参与度，以及最新的评估方法。 具体目标是：1)使现有的远程保健干预措施适用于南方的减少CC伤害 2)确定适应性干预的可行性和可接受性(主要成果)， 并评估和比较EC和NRT在降低CC方面的初步效果(次要结果) 采用先导随机对照试验(RCT)设计。我们将修改现有的CC减少危害协议。 从南非西开普省的八家医疗机构招募PLWHA吸烟者，提供ART 对于PLWHA，我们将在试验性随机对照试验3组设计(N=90)中改进和最终确定要评估的干预措施。 手臂1(对照)：转诊至戒毒线；手臂2：电话咨询+EMI+联合NRT(Patch+ 含片)；手臂3：电话咨询+EMI+EC。与试点随机对照试验相一致，主要成果将是：a) 根据招聘、完成率和随访率确定的干预措施的可行性，以及B)可接受性 通过客户满意度调查问卷和面谈进行评估。次要结果包括1)IMB 基于理论的改变机制，2)CC吸烟者达到7天点流行率的比例 戒烟，通过在3个月和6个月时呼出的一氧化碳(&lt；6ppm)来验证，3)每 4)健康结果的变化。这项提议将建设能力，并为 基础工作，以帮助减少在南非PLWHA中的CC吸烟。