Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam
NCT ID: NCT05863923
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
600 participants
INTERVENTIONAL
2023-04-17
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Comparison
Comparison smokers will receive five brief "risk of smoking" texts as minimal texting intervention, to enhance blinding to knowledge of randomization group.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years old.
3. Current smoker.
4. Be able to receive texts and read text (literate).
Exclusion Criteria
2. Unable or unwilling to provide informed consent.
3. Prior diagnosis of serious mental health illness.
4. Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1).
5. Family member of another participant in the study.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Institute of Population, Health and Development, Vietnam
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Rajani Sadasivam
Professor
Principal Investigators
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Rajani S Sadasivam, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Hoa T Nguyen, MD, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Locations
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UMass Chan Medical School
Worcester, Massachusetts, United States
Institute of Population, Health, and Development (PHAD)
Hanoi, , Vietnam
Countries
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Other Identifiers
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H00023608
Identifier Type: -
Identifier Source: org_study_id
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