mHealth Messaging for Tobacco Cessation in People Living With HIV

(M2Q2-HIV Trial)

Recruiting 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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment M2Q2-HIV for tobacco cessation in people living with HIV?

Research shows that using cell phone interventions can help people living with HIV quit smoking by reducing anxiety and depression and boosting confidence in their ability to quit. This suggests that mobile health messaging, like M2Q2-HIV, could be effective for tobacco cessation in this group. ^{1 2 3 4 5}

Is mHealth Messaging for Tobacco Cessation in People Living With HIV safe for humans?

The research articles provided do not contain specific safety data for mHealth Messaging for Tobacco Cessation in People Living With HIV or its related interventions. ^{1 2 4 5 6}

How is the M2Q2-HIV treatment different from other smoking cessation treatments for people living with HIV?

M2Q2-HIV is unique because it uses mobile health (mHealth) messaging to help people with HIV quit smoking, leveraging the widespread use of mobile phones to reach more individuals at a low cost. This approach is different from traditional face-to-face interventions and aims to provide a more accessible and scalable solution for smoking cessation among this population. ^{1 2 5 7 8}

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

Eligibility Criteria

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

I have been diagnosed with HIV.

Current smoker

Be able to receive texts and read text (literate)

Exclusion Criteria

Family member of another participant in the study

Pregnant or planning to become pregnant during the next six months

Unable or unwilling to provide informed consent

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are smokers with HIV using information and communication technology? Implications for behavioral interventions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Is It Feasible to Impact on Smoking Habits in HIV-Infected Patients? Mission Impossible From the STOPSHIV Project Cohort. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Impact of a cell phone intervention on mediating mechanisms of smoking cessation in individuals living with HIV/AIDS. [2019]

4. England pubmed.ncbi.nlm.nih.gov

HIV-positive smokers considering quitting: differences by race/ethnicity. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Vaporized nicotine use among patients in HIV care who smoke tobacco: perceived health effects and effectiveness as a smoking cessation tool. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Comparison of mHealth and Face-to-Face Interventions for Smoking Cessation Among People Living With HIV: Meta-Analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. [2022]