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

基本信息

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
项目类别：
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

项目摘要

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/艾滋病的最大伯恩（19.5％的成人患病率），约为8.2 2021年有艾滋病毒/艾滋病（PLWHA）的百万人。 PLWHA之间的含义。 CC在PLWHA中吸烟使他们面临着许多严重的艾滋病毒的风险与非吸烟的PLWHA相比，相关的合并症和过早死亡。迫切需要新颖的可行和高效策略，以解决这些挑战，以解决这些挑战在PLWHA一般，尤其是在南非。该建议旨在满足未满足的需求可行，有效的策略，用于减少南非PLWHA中CC的使用，这有潜力为了显着改善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，并由我们正在进行的研究所告知。使用同时嵌入混合方法方法，我们将评估针对CC HARG的远程医疗计划还原，将电子烟（EC）与尼古丁替代疗法（NRT）进行比较，并通过整合而增强生态瞬时干预（EMI）发短信。因此，该建议将大大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措施增强参与者的参与度以及最先进的评估方法。具体目的是：1）适应现有的远程医疗干预措施，以减少南方的伤害非洲背景，以及2）确定适应干预的可行性和可接受性（主要结果），并估算并比较EC和NRT对CC降低的初步影响（次要结果）使用飞行员随机对照试验（RCT）设计。我们将调整现有的CC危害减少协议。来自南非西开普省八个医疗机构的招募PLWHA吸烟者提供艺术对于PLWHA，我们将完善并最终确定在PILOT RCT 3组设计（n = 90）中评估的干预措施。手臂1（控制）：转介到退出行；手臂2：电话咨询 + EMI +组合NRT（补丁 + 菱形）;手臂3：电话咨询 + EMI + EC。与飞行员RCT一致，主要结果将是：a）由招聘，完成和随访率定义的干预措施的可行性，b）可接受性由客户满意度问卷和访谈评估。次要结果包括1）IMB 基于理论的变化机制，2）CC吸烟者的比例达到7天患病率禁欲，通过3个月和6个月的一氧化碳（<6 ppm）验证，3）卷烟减少与基线相比，日子和4）健康结果的变化。该提议将建立能力并建立帮助减少南非PLWHA中CC吸烟的基础。