Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- 7-day point prevalence tobacco abstinence at 52 weeks
研究概览
简要总结
The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.
详细描述
This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) peer support, (3) combination nicotine replacement therapy (c-NRT), and (4) varenicline. The investigators will also evaluate the implementation and cost-effectiveness of these interventions. This study is a balanced full factorial randomised trial of 660 adults with HIV and will be implemented in two diverse sites in Gauteng, South Africa representing both peri-urban and urban settings.
Participants will be recruited via health care worker-referral or self-referral. Interested patients will be further screened for eligibility. Eligible participants will be administered written informed consent (see "Informed Consent and Assent" section below), and participants will be randomized into one of 16 study conditions for a 12-week intervention period. This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age, and
- •attend one of the selected study clinics, and
- •have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and
- •have been taking ART for at least three consecutive months or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and
- •are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and
- •either own or have household access to a mobile phone, and
- •provide written informed consent.
排除标准
- •Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
- •are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
- •have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
- •have generalized eczema or psoriasis, or
- •have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or
- •have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or
- •are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or
- •have a history of adverse reactions to varenicline or nicotine patch, or
- •are not planning to continue to receive care at the clinic for the next 52 weeks, or
- •are a household member of a currently enrolled participant in this trial, or
- •In the opinion of the attending investigator are not a candidate for the clinical trail.
研究组 & 干预措施
c-NRT
A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package. Participants will be provided with education on its use, including where and how to place a patch, strength of patches to use and how to taper, not smoking while using the patch, and using gum ad hoc; the investigators will also discuss possible side effects. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and monitor adherence; calls will taper to every other week after four weeks.
干预措施: Nicotine patch (Drug)
c-NRT
A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package. Participants will be provided with education on its use, including where and how to place a patch, strength of patches to use and how to taper, not smoking while using the patch, and using gum ad hoc; the investigators will also discuss possible side effects. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and monitor adherence; calls will taper to every other week after four weeks.
干预措施: Nicotine gum (Drug)
Varenicline
At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician according to randomization into the varenicline condition and participants will be provided with education on its use. Participants will be instructed to begin taking varenicline one week prior to participants' quit date and for 11 weeks following quit date. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and to monitor adherence; calls will taper to every other week after four weeks.
干预措施: Varenicline (Drug)
Varenicline & c-NRT
Varenicline & c-NRT
干预措施: Varenicline (Drug)
Varenicline & c-NRT
Varenicline & c-NRT
干预措施: Nicotine patch (Drug)
Varenicline & c-NRT
Varenicline & c-NRT
干预措施: Nicotine gum (Drug)
Peer Support & Varenicline
Peer Support & Varenicline
干预措施: Varenicline (Drug)
c-NRT & Peer Support
c-NRT & Peer Support
干预措施: Nicotine patch (Drug)
c-NRT & Peer Support
c-NRT & Peer Support
干预措施: Nicotine gum (Drug)
c-NRT & Peer Support & Varenicline
c-NRT & Peer Support & Varenicline
干预措施: Varenicline (Drug)
c-NRT & Peer Support & Varenicline
c-NRT & Peer Support & Varenicline
干预措施: Nicotine patch (Drug)
c-NRT & Peer Support & Varenicline
c-NRT & Peer Support & Varenicline
干预措施: Nicotine gum (Drug)
Intensive Behavioral Counseling & Varenicline
Intensive Behavioral Counseling & Varenicline
干预措施: Varenicline (Drug)
Intensive Behavioral Counseling & c-NRT
Intensive Behavioral Counseling & c-NRT
干预措施: Nicotine patch (Drug)
Intensive Behavioral Counseling & c-NRT
Intensive Behavioral Counseling & c-NRT
干预措施: Nicotine gum (Drug)
Intensive Behavioral Counseling & Varenicline
Intensive Behavioral Counseling & Varenicline
干预措施: Intensive Behavioral Counselling (Behavioral)
c-NRT & Peer Support & Varenicline
c-NRT & Peer Support & Varenicline
干预措施: Peer Counselling (Behavioral)
Intensive Behavioral Counseling & Varenicline & c-NRT
Intensive Behavioral Counseling & Varenicline & c-NRT
干预措施: Varenicline (Drug)
Intensive Behavioral Counseling & Varenicline & c-NRT
Intensive Behavioral Counseling & Varenicline & c-NRT
干预措施: Nicotine patch (Drug)
Intensive Behavioral Counseling & Varenicline & c-NRT
Intensive Behavioral Counseling & Varenicline & c-NRT
干预措施: Nicotine gum (Drug)
Intensive Behavioral Counseling & Peer Support & c-NRT
Intensive Behavioral Counseling & Peer Support & c-NRT
干预措施: Nicotine patch (Drug)
Intensive Behavioral Counseling & Peer Support & Varenicline
Intensive Behavioral Counseling & Peer Support & Varenicline
干预措施: Varenicline (Drug)
Intensive Behavioral Counseling & Peer Support
Intensive Behavioral Counseling & Peer Support
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support
Intensive Behavioral Counseling & Peer Support
干预措施: Peer Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & c-NRT
Intensive Behavioral Counseling & Peer Support & c-NRT
干预措施: Nicotine gum (Drug)
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
干预措施: Varenicline (Drug)
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
干预措施: Nicotine patch (Drug)
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
干预措施: Nicotine gum (Drug)
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counselling
Participants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (~45 minutes) behavioural counselling in the clinic at enrolment/baseline and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice. ].
干预措施: Intensive Behavioral Counselling (Behavioral)
Peer Support
Participants randomized to receive Peer Support will be engaged by participants' own peer counsellor assigned from Day 0-12 weeks, with in-person visits at least at baseline, weeks 2, 4, 8 and 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during baseline, weeks 2, 4, 8 and 12; additional in-person contact will be provided upon participant request.
干预措施: Peer Counselling (Behavioral)
Peer Support & Varenicline
Peer Support & Varenicline
干预措施: Peer Counselling (Behavioral)
c-NRT & Peer Support
c-NRT & Peer Support
干预措施: Peer Counselling (Behavioral)
Intensive Behavioral Counseling & c-NRT
Intensive Behavioral Counseling & c-NRT
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counseling & Varenicline & c-NRT
Intensive Behavioral Counseling & Varenicline & c-NRT
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & Varenicline
Intensive Behavioral Counseling & Peer Support & Varenicline
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & Varenicline
Intensive Behavioral Counseling & Peer Support & Varenicline
干预措施: Peer Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & c-NRT
Intensive Behavioral Counseling & Peer Support & c-NRT
干预措施: Intensive Behavioral Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & c-NRT
Intensive Behavioral Counseling & Peer Support & c-NRT
干预措施: Peer Counselling (Behavioral)
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
干预措施: Peer Counselling (Behavioral)
结局指标
主要结局
7-day point prevalence tobacco abstinence at 52 weeks
时间窗: 52 weeks
Verified by exhaled breath CO \< 7ppm and a negative urine cotinine test.
次要结局
- 7-day point prevalence tobacco abstinence at 26 weeks(26 weeks)
- 7-day point prevalence tobacco abstinence at 12 weeks(12 weeks)