Clinical trial NCT05863923: Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam
Official title: mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Cessation
Keywords: mHealth
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Institute of Population, Health and Development, Vietnam
First posted: 2023-05-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Smoking Cessation Rate
timeFrame: At 6 months post-randomization
Secondary outcomes:
measure: Self-Efficacy
timeFrame: 0-month (baseline) and 6-months post-randomization
measure: HIV-Related Stigma
timeFrame: 0-month (baseline) and 6-months post-randomization
measure: Quitline Use
timeFrame: 6-months post-randomization
measure: NRT Use
timeFrame: 6-months post-randomization
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
city: Hanoi
country: Vietnam
facility: Institute of Population, Health, and Development (PHAD)
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Rajani S Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Chan Medical School
name: Hoa T Nguyen, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: