mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Smoking Cessation Rate
研究概览
简要总结
The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.
详细描述
M2Q2-HIV [mHealth Messaging to Motivate Quitline Use and Quitting among Persons Living with HIV (PLWH) in Vietnam (M2Q2-HIV)] is an adaptation of a current computer-tailored smoking cessation intervention in Vietnam. Study investigators seek to promote underused government resources for public health (the Quitline) and Nicotine Replacement Therapy (NRT) among PLWH in a sustainable manner.
Investigators will test M2Q2-HIV by conducting a randomized control trial with 600 PLWH smokers in two provinces in Northern Vietnam (26 clinics; 9,877 HIV patients).
In Aim 1, study investigators will conduct formative work to prepare the M2Q2-HIV system for PLWH smokers.
In Aim 2, the study team will randomize and follow smokers for six months. The study's effectiveness hypothesis will evaluate carbon monoxide (CO) verified, six-month, seven-day point prevalence cessation. Process hypotheses will evaluate self-efficacy, Quitline, and NRT use and test our hypothesized model that specific measured processes will partially mediate observed intervention effectiveness.
Using qualitative interviews with key stakeholders and PLWH smokers, Aim 3 will support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors guided by the Practical, Robust Implementation and Sustainability Model (PRISM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed HIV infection (prevalent and incident HIV).
- •At least 18 years old.
- •Current smoker.
- •Be able to receive texts and read text (literate).
排除标准
- •Pregnant or planning to become pregnant during the next six months.
- •Unable or unwilling to provide informed consent.
- •Prior diagnosis of serious mental health illness.
- •Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1).
- •Family member of another participant in the study.
研究组 & 干预措施
Intervention
The M2Q2-HIV intervention includes 3 functions: 1) Extended CHW services, 2) M2Q2 computer-tailored peer messaging, and 3) texting facilitation to quitline use and the quitline intervention. Our goals are to promote the use of an underused, available, government-funded resource for public health (quitline) and NRT that the quitline provides, thus promoting smoking cessation among PLWH.
干预措施: mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV) (Behavioral)
Comparison
Comparison smokers will receive five brief "risk of smoking" texts as minimal texting intervention, to enhance blinding to knowledge of randomization group.
干预措施: M2Q2-HIV Comparison (Behavioral)
结局指标
主要结局
Smoking Cessation Rate
时间窗: At 6 months post-randomization
At six months, we will assess 7-day point prevalence cessation, based on the following question: "Do you currently smoke tobacco (smoked even 1 puff in the last 7 days)?" The Society of Nicotine and Tobacco Research has recommended this measure.
次要结局
- Self-Efficacy(0-month (baseline) and 6-months post-randomization)
- Quitline Use(6-months post-randomization)
- HIV-Related Stigma(0-month (baseline) and 6-months post-randomization)
- NRT Use(6-months post-randomization)
研究者
Rajani Sadasivam
Professor
University of Massachusetts, Worcester