Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam (M2Q2-HIV)

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Tobacco Cessation

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05863923

U01CA261604 (U.S. NIH Grant/Contract)

H00023608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

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

Comparison

Active Comparator group

Description:

Comparison smokers will receive five brief "risk of smoking" texts as minimal texting intervention, to enhance blinding to knowledge of randomization group.

Treatment:

Behavioral: M2Q2-HIV Comparison