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Clinical Trials/NCT05863923
NCT05863923
Enrolling By Invitation
Not Applicable

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

University of Massachusetts, Worcester2 sites in 2 countries600 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Cessation
Sponsor
University of Massachusetts, Worcester
Enrollment
600
Locations
2
Primary Endpoint
Smoking Cessation Rate
Status
Enrolling By Invitation
Last Updated
9 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
August 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Rajani Sadasivam

Professor

University of Massachusetts, Worcester

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.

Outcomes

Primary Outcomes

Smoking Cessation Rate

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

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