Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV), M2Q2-HIV Comparison.
- Who it may be relevant to
- Registry conditions: Tobacco Cessation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Smoking Cessation Rate [Time frame: At 6 months post-randomization]
Secondary outcome measures (4)
- Self-Efficacy [Time frame: 0-month (baseline) and 6-months post-randomization]
- HIV-Related Stigma [Time frame: 0-month (baseline) and 6-months post-randomization]
- Quitline Use [Time frame: 6-months post-randomization]
- NRT Use [Time frame: 6-months post-randomization]
Eligibility criteria
Inclusion criteria
- Diagnosed HIV infection (prevalent and incident HIV).
- At least 18 years old.
- Current smoker.
- Be able to receive texts and read text (literate).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UMass Chan Medical School — Worcester
Vietnam · 1 center
- Institute of Population, Health, and Development (PHAD) — Hanoi
Identifiers
NCT: NCT05863923 · H00023608 · U01CA261604