mHealth Messaging for Tobacco Cessation in People Living With HIV

(M2Q2-HIV Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Nicotine replacement

Disqualifiers: Pregnancy, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people living with HIV quit smoking. Participants receive personalized text messages (M2Q2-HIV) that guide them to use Vietnam's free quitting resources, such as the Quitline and nicotine replacement therapies (NRT). The goal is to better support smokers in their efforts to quit by integrating these resources into their daily lives. This trial suits current smokers with HIV who can read and receive texts. As an unphased trial, it offers a unique opportunity to access innovative support methods for quitting smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation for people living with HIV.

What prior data suggests that this mHealth messaging intervention is safe for people living with HIV?

Research shows that the M2Q2-HIV treatment, which uses text messages to aid smoking cessation, is designed to be safe. However, specific safety data for this messaging approach is not available. The treatment assists people living with HIV in Vietnam to quit smoking by promoting a government-funded quitline and nicotine replacement therapy (NRT).

This trial is labeled as "Not Applicable" for phase, indicating minimal risk. Text messaging interventions are generally safe, as they do not involve new drugs or medical procedures but instead offer support for behavior change.

In similar cases, using text messages to help people quit smoking has been well-received. Reports of negative effects from such interventions are absent, making it a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the M2Q2-HIV intervention because it uniquely combines technology and peer support to help people living with HIV quit smoking. Unlike traditional methods like nicotine replacement therapy or counseling alone, M2Q2-HIV uses computer-tailored messaging and extended community health worker services to engage participants more personally and effectively. This approach not only promotes the use of government-funded quitlines but also enhances accessibility by integrating text messaging, making it easier for users to access support and nicotine replacement therapies. By leveraging digital tools and community resources, this intervention aims to make smoking cessation more achievable and sustainable for a population that often faces unique barriers.

What evidence suggests that the M2Q2-HIV intervention could be effective for smoking cessation in people living with HIV?

Research has shown that mobile health (mHealth) messages can assist people with HIV in quitting smoking. Studies have found that personalized text messages encourage the use of resources like the Quitline and Nicotine Replacement Therapy (NRT), both of which aid in quitting smoking. For instance, the Sense2Quit study discovered that a 12-week texting program helped participants smoke less by guiding them to use these resources effectively. Additionally, many individuals who regularly used a stop-smoking app experienced greater success in quitting. In this trial, the M2Q2-HIV program, which offers personalized messages and support for using the Quitline and NRT, is being tested as an intervention. These findings suggest that the M2Q2-HIV program could effectively help people with HIV stop smoking. ^{1 2 6 7 8}

Who Is on the Research Team?

Rajani Sadasivam, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Hoa T Nguyen, MD, MS, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults in Vietnam living with HIV who currently smoke and can read texts. They must not be pregnant, planning pregnancy soon, or have serious mental health issues. Family members of participants or those involved in creating the study's texts are excluded.

Inclusion Criteria

Current smoker

Be able to receive texts and read text (literate)

I have been diagnosed with HIV.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Work

Conduct formative work to prepare the M2Q2-HIV system for PLWH smokers

Not specified

Treatment

Participants receive the M2Q2-HIV intervention, including extended CHW services, computer-tailored peer messaging, and texting facilitation to quitline use

6 months

Follow-up

Participants are monitored for smoking cessation, self-efficacy, HIV-related stigma, NRT use, and quitline use

6 months

Dissemination

Support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors

Not specified

What Are the Treatments Tested in This Trial?

Interventions

• M2Q2-HIV

Trial Overview The study tests a computer-tailored texting intervention aimed at encouraging people with HIV to use Vietnam's Quitline and Nicotine Replacement Therapy to help them stop smoking.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Comparison Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Institute of Population, Health and Development, Vietnam

Collaborator

Trials

5

Recruited

3,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study of 444 HIV-positive smokers revealed that low self-efficacy in quitting smoking and a higher desire to quit are linked to greater nicotine dependence, highlighting psychological factors in smoking behavior.

The research found that older Hispanic Americans are less likely to be nicotine dependent, suggesting that smoking cessation interventions should be customized to address the unique needs of different racial and ethnic groups within the HIV-positive population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. Lloyd-Richardson, EE., Stanton, CA., Papandonatos, GD., et al.[2023]

A cell phone intervention (CPI) for smoking cessation in HIV-positive individuals led to greater reductions in anxiety and depression, and increased self-efficacy compared to standard care, suggesting it may be a more effective approach for this population.

The study involved 95 participants from an inner-city AIDS clinic, and the results indicate that improvements in mental health and self-efficacy may help explain the better cessation outcomes observed in the CPI group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a cell phone intervention on mediating mechanisms of smoking cessation in individuals living with HIV/AIDS. Vidrine, DJ., Arduino, RC., Gritz, ER.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05863923

Tobacco Cessation Texting Intervention for People Living ... The study team has expertise in smoking cessation, HIV intervention, including stigma related to concomitant substance use, and implementation of complex ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10623232/

Pilot Testing of an mHealth App for Tobacco Cessation in ... Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention but also inform ...

3. withpower.com withpower.com/trial/phase-cessation-tobacco-3-2023-4efab

mHealth Messaging for Tobacco Cessation in People Living With ... Trial Overview The study tests a computer-tailored texting intervention aimed at encouraging people with HIV to use Vietnam's Quitline and Nicotine Replacement ...

4. researchprotocols.org researchprotocols.org/2023/1/e49558/

Pilot Testing of an mHealth App for Tobacco Cessation in ... The Sense2Quit study is a 2-arm RCT among people living with HIV who are motivated to quit smoking. Sense2Quit is a 12-week pilot study to ...

5. formative.jmir.org formative.jmir.org/2022/8/e28626/

A Smoking Cessation Mobile App for Persons Living With HIV Results: Of the 40 participants enrolled, 37 completed the follow-up study assessments and 16 used the app every day during the 56-day period.

6. cancercontrol.cancer.gov cancercontrol.cancer.gov/brp/tcrb/tobacco-hiv

Tobacco and HIV | Division of Cancer Control and Population ... It is estimated that life expectancy among HIV-positive smokers is reduced by at least 16 years compared with HIV-positive nonsmokers, and that 94% of lung ...

7. reporter.nih.gov reporter.nih.gov/project-details/8515380

Improving adherence to smoking cessation medication ... DESCRIPTION (provided by applicant): Smoking rates among people living with HIV/AIDS (PLWHA) are two to three times that of the general population.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5103932/

Smoking Cessation for People Living With HIV/AIDS Cessation rates at the end of treatment ranged from 15% to 29% across conditions, but treatment differences in abstinence were not statistically ...