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

Tobacco Cessation Clinical Trial

— M2Q2-HIV  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05863923
• Other study ID #: H00023608
• Secondary ID: U01CA261604
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts
Vietnam	Institute of Population, Health, and Development (PHAD)	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Institute of Population, Health and Development, Vietnam, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation Rate	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.	At 6 months post-randomization
Secondary	Self-Efficacy	Self-Efficacy, as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) questionnaire. The score for each question ranges on a 4-point Likert scale from 0-3. SEQ-12 score ranges from 0-36, with higher values indicating higher self-efficacy for smoking cessation. The aggregate score will only be computed if no more than 2 out of the 12 questionnaire items had missing or 'not applicable' responses.	0-month (baseline) and 6-months post-randomization
Secondary	HIV-Related Stigma	HIV-related stigma, measured using a survey assessing five indicators of HIV/AIDS-related stigma according to USAID: (1) blame, judgment; (2) shame; (3) enacted stigma/discrimination; (4) disclosure; and (5) fear of casual transmission and refusal of contact. Survey response options include (1) Yes, (2) No, and (3) No answer. A response of "yes" to one or more survey questions will indicate the presence of HIV-related stigma.	0-month (baseline) and 6-months post-randomization
Secondary	Quitline Use	The quitline staff will record details of intake assessment (time on call, readiness to quit, quit date, and goal-setting) and fidelity of follow-up call completion.	6-months post-randomization
Secondary	NRT Use	The quitline staff will document the distribution of NRT lozenge and smoker use of NRT during follow-up.	6-months post-randomization