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

Last updated: June 6, 2024
Sponsor: University of Massachusetts, Worcester
Overall Status: Active - Enrolling

Phase

N/A

Condition

Smoking Cessation

Treatment

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

M2Q2-HIV Comparison

Clinical Study ID

NCT05863923
H00023608
U01CA261604
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed HIV infection (prevalent and incident HIV).

  2. At least 18 years old.

  3. Current smoker.

  4. Be able to receive texts and read text (literate).

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant during the next six months.

  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.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • UMass Chan Medical School

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Institute of Population, Health, and Development (PHAD)

    Hanoi,
    Vietnam

    Site Not Available

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