NCT05863923

Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam

mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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). This project builds upon a long-standing, successful collaboration between institutions in Vietnam (Ministry of Health, Bach Mai Quitline, Institute of Population Health and Development, Hanoi Medical University) and UMass Chan Medical School. The study team has expertise in smoking cessation, HIV intervention, including stigma related to concomitant substance use, and implementation of complex interventions. If proven effective, the Vietnam Ministry of Health is committed to incorporating M2Q2-HIV as a permanent part of the national infrastructure.

Conditions

• Tobacco Cessation

Interventions

Type	Name	Description
BEHAVIORAL	mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)	Participants in the intervention group will be exposed to the texting intervention through a series of culturally tailored assessments and motivational text messages from the text messaging system sent throughout the 6 months of duration of the study.
BEHAVIORAL	M2Q2-HIV Comparison	Participants in the comparison group will be exposed to a brief set of five texts with facts about smoking risks and assessment messages that are not culturally tailored from the text messaging system.

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-03-31
• Completion: 2026-08-31
• First posted: 2023-05-18
• Last updated: 2025-07-22

Locations

2 sites across 2 countries: United States, Vietnam