A phone-based tobacco use cessation program for people living with HIV in Uganda and Zambia: study protocol for a randomized controlled trial.

A phone-based tobacco use cessation program for people living with HIV in Uganda and Zambia: study protocol for a randomized controlled trial.
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乌干达和赞比亚艾滋病毒感染者基于电话的烟草使用戒烟计划:随机对照试验的研究方案

DOI:
10.1186/s13722-024-00438-w
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发表时间:
2024-01-19
影响因子:
3.7
通讯作者:
Tucker, Joan S.
Tucker, Joan S.
中科院分区:
医学2区
文献类型:
--
作者:
Wipfli, Heather;Arinaitwe, Jim;Goma, Fastone;Atuyambe, Lynn;Guwatudde, David;Phiri, Masauso Moses;Rutebemberwa, Elizeus;Wabwire-Mangen, Fred;Zulu, Richard;Zyambo, Cosmas;Guy, Kyra;Kusolo, Ronald;Mukupa, Musawa;Musasizi, Ezekiel;Tucker, Joan S.

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尼古丁替代疗法(NRT)和基于短信服务(SMS)的戒烟干预措施在减少许多人口中的烟草使用方面证明了有效性,但需要证据表明,在应对撒哈拉以南非洲艾滋病毒携带者(PLWH)面临的复杂医疗和心理社会因素方面,哪种量身定制的治疗最有效。这篇论文描述了一项在乌干达和赞比亚的PLWH中测试NRT和基于短信的量身定制的戒烟干预措施的有效性的研究方案。在一项随机对照试验中,800名吸烟的成年PLWH将被艾滋病治疗中心的卫生保健专业人员招募,他们将在那里接受护理。参与者将被随机分配到四个研究小组中的一个:(1)标准护理[SOC;结合艾滋病毒教育和旨在鼓励遵守艾滋病毒治疗(不提及烟草)的信息通过短信提供的简短临床医生建议];(2)SOC + 12周的NRT;(3)SOC + 6周的短信支持戒烟(短信);或(4)SOC + 非RT + 短信。参与者将获得一部手机和太阳能电池板,太阳能电池板用于为手机充电。主要结果是研究参与者在登记后6个月通过尿可替宁(< 15 ng/mL)证实停止吸烟。作为二次烟草使用的结果,我们将在注册后4周、8周和3个月通过自我报告和生化验证来测量7天点戒烟盛行率(连续7天不使用烟草)。我们的研究将深入了解在两个拥有不同烟草使用模式、政策环境和卫生保健资源的国家,通过卫生保健专业人员结合定制的戒烟短信提供戒烟干预措施的有效性、可行性和适用性,并为寻求成本效益高的戒烟干预措施的提供者和政策制定者提供必要的信息。我们研究中使用的以前测试过的短信平台具有独特的定位,可以在全球低收入和中等收入国家进行推广,在这种情况下,即使是在降低公共卫生部门烟草消费流行率方面取得微小成功的证据,也可能带来巨大的健康和经济利益。试验注册:ClinicalTrials.gov标识符NCT05487807。注册于2022年8月4日,https://clinicaltrials.gov/ct2/show/record/NCT05487807
Nicotine replacement therapy (NRT) and short messaging service (SMS)-based tobacco cessation interventions have demonstrated effectiveness in reducing tobacco use in many populations, but evidence is needed on which tailored treatments are most efficacious in meeting the complex medical and psychosocial factors confronting people living with HIV (PLWH) in sub-Saharan Africa (SSA). This paper describes the protocol of a study to test the efficacy of both NRT and a tailored SMS-based tobacco use cessation intervention among PLWH in Uganda and Zambia. In a randomized controlled trial, 800 adult PLWH who use tobacco will be recruited by health care professionals at HIV treatment centers where they are receiving care. Participants will be randomized to one of the four study arms: (1) standard of care [SOC; brief clinician advice to quit combined with HIV education and information aimed at encouraging HIV treatment adherence (with no mention of tobacco) delivered via text messages]; (2) SOC + 12 weeks of NRT; (3) SOC + 6 weeks of SMS text messages to support quitting tobacco use (SMS); or (4) SOC + NRT + SMS. Participants will receive a cell phone and solar panel with power bank for charging the phone. The main outcome is cessation of tobacco use by study participants verified by urinary cotinine (< 15 ng/mL) at 6 months post-enrollment. As a secondary tobacco use outcome, we will measure 7-day point-prevalence abstinence (7 consecutive days of no tobacco use) measured by self-report and biochemically-verified at 4 weeks, 8 weeks, and 3 months post enrollment. Our study will provide insight into the efficacy, feasibility and applicability of delivering tobacco cessation interventions through health care professionals combined with tailored tobacco cessation SMS text messaging in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions. The previously tested SMS-platform to be used in our study is uniquely positioned to be scaled in low- and middle-income countries worldwide, in which case evidence of even modest success in reducing the prevalence of tobacco consumption among PLWH could confer enormous health and economic benefits. Trial registration: ClinicalTrials.gov Identifier NCT05487807. Registered August 4, 2022, https://clinicaltrials.gov/ct2/show/record/NCT05487807
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