PrOMOTE Program for Smoking Cessation in HIV

Overseen By Chloe Morone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Nicotine replacement

Disqualifiers: Pregnancy, Imprisonment, Non-English speaking, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

231 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people living with HIV quit smoking by testing a new support approach. Participants in the experimental group will receive direct contact from a clinical pharmacist for medication and counseling through the PrOMOTE Smoking Cessation Intervention, while the control group will follow the usual clinic processes. The goal is to determine if this proactive method is more effective than the standard approach. The trial seeks current smokers with an HIV diagnosis who are open to trying different support methods to quit smoking. As an unphased trial, it offers a unique opportunity for participants to explore innovative support methods for quitting smoking.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be part of another tobacco treatment program or use cessation medications.

What prior data suggests that the PrOMOTE Smoking Cessation Intervention is safe for people living with HIV?

Research has shown that smoking cessation programs for people with HIV are generally well-tolerated. While specific side effect information for the PrOMOTE program is unavailable, smoking cessation efforts typically include counseling and medication, both considered safe.

In the PrOMOTE program, participants receive counseling and support from clinical pharmacists. These elements are common in many smoking cessation plans and have a strong safety record. Although direct safety data for PrOMOTE is lacking, the involvement of clinical pharmacists suggests a careful approach to treatment.

Overall, despite the absence of specific safety data for PrOMOTE, treatments like counseling and pharmacist support in smoking cessation are typically safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrOMOTE Program for smoking cessation in individuals with HIV because it offers a personalized approach through direct contact with a clinical pharmacist. Unlike traditional methods, which may involve standard clinic visits without additional support, PrOMOTE includes three specific interactions for medication management and counseling. This targeted engagement, combined with motivational interviewing, aims to enhance support and effectiveness, potentially leading to better quitting outcomes for participants.

What evidence suggests that the PrOMOTE Smoking Cessation Intervention is effective for smoking cessation in people living with HIV?

Research has shown that personalized programs to help people with HIV quit smoking can be very effective. In this trial, participants in the PrOMOTE group will receive a combination of medication and counseling, which studies have found greatly increases the chances of quitting. For example, one study discovered that people who received this personalized support did better than those who followed regular care. This method combines medication with short counseling sessions and motivational talks to address both the physical and mental challenges of quitting. This approach not only helps reduce smoking but also improves overall health for people living with HIV. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21 or older who are living with HIV and currently smoke cigarettes. Participants must be willing to be randomly assigned to different treatment groups. People cannot join if they're already in another tobacco treatment program, using cessation medications, pregnant, or incarcerated.

Inclusion Criteria

I am 21 years old or older.

English speaking

I am currently diagnosed with HIV.

Exclusion Criteria

I am not currently in any tobacco treatment programs or using cessation medication.

You are pregnant.

Currently imprisoned

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the ProMOTE intervention or Treatment as Usual (TAU) for smoking cessation support

12 weeks

3 visits (in-person or virtual) for ProMOTE group

Follow-up

Participants are monitored for smoking cessation outcomes and implementation fidelity

12 weeks

Study Completion

Final assessment of intervention acceptability, fidelity, and perceived barriers

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PrOMOTE

Trial Overview

The study is testing a proactive approach called PrOMOTE that reaches out to patients directly for smoking cessation support versus the standard care which relies on traditional clinic visits. The goal is to find the best way to help people with HIV quit smoking.

How Is the Trial Designed?

Group I: ProMOTE Experimental Treatment 1 Intervention

In the PrOMOTE group, the participants will be contacted by the clinical pharmacist on the tobacco treatment staff three times for medication prescriptions and refills. They will also receive brief counseling and motivational interviewing by the clinical pharmacist.

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as Usual (TAU) participants will follow traditional clinic pathways for receiving tobacco treatment in the Medical University of South Carolina Health Infectious Disease outpatient clinic. All patients randomized to TAU will have the opportunity to access smoking cessation pharmacotherapy from the Infectious Disease clinical pharmacist.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Medi-Cal Incentives to Quit Smoking project effectively increased call volumes to the California Smokers' Helpline through direct-to-member mailings, especially when financial incentives were included in the messaging.

Individually targeted mailings, which identified smokers through medical codes, resulted in a higher percentage of activated calls compared to household mailings, suggesting that personalized approaches may enhance engagement in tobacco cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Member Household or Targeted Mailings: Incentivizing Medicaid Calls for Quitline Services. Hood-Medland, EA., Dove, MS., Stewart, SL., et al.[2019]

A novel web-based smoking cessation program called Positively Smoke Free on the Web (PSFW+) significantly increased quit rates among people with HIV, with 14.9% achieving abstinence compared to 8.8% in the control group, based on a study of 506 participants.

The PSFW+ program combines interactive support and empirically tested content, making it a scalable and effective tool for helping individuals with HIV quit smoking, which is crucial given their higher smoking rates compared to the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes. Shuter, J., Chander, G., Graham, AL., et al.[2023]

Pharmaceutical aids for smoking cessation can boost success rates by 50% for heavier smokers seeking help, and their usage has significantly increased alongside quitline services that offer support.

Despite the rise in quit attempts and the availability of aids, overall population success rates for quitting smoking have not improved, suggesting a need to reassess public health policies and marketing strategies related to smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quitlines and nicotine replacement for smoking cessation: do we need to change policy? Pierce, JP., Cummins, SE., White, MM., et al.[2018]

A nontraditional tobacco cessation program led by a pharmacist at a Coast Guard facility showed that out of 20 participants who completed counseling, 4 successfully quit tobacco after one year, indicating a 20% success rate.

This approach provides an alternative to traditional group behavioral modification classes, which may not be suitable for everyone, highlighting the potential effectiveness of pharmacist-led interventions in tobacco cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMOKED: a pharmacist-monitored tobacco cessation program. Huntzinger, PE.[2017]

Behavioral interventions for smoking cessation significantly increase abstinence rates among HIV-infected smokers, with a moderate effect size based on a review of 8 studies involving 1822 participants.

Interventions that included 8 or more sessions showed even greater efficacy, with a relative risk of 2.88 for achieving abstinence, indicating that more intensive programs are particularly beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions for Tobacco Use in HIV-Infected Smokers: A Meta-Analysis. Keith, A., Dong, Y., Shuter, J., et al.[2022]

In a study of 716 patients living with HIV, 39% were active smokers, highlighting a significant need for targeted smoking cessation interventions in this population.

The smoking cessation program was effective, with 57% of participants who completed the intervention quitting smoking after 6 months, particularly benefiting from the use of varenicline, although retention strategies are needed for specific groups like intravenous drug users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Tobacco Screening and Referral for Smoking Cessation Program among HIV-Infected Patients in France. Parienti, JJ., Merzougui, Z., de la Blanchardière, A., et al.[2023]

Combination antiretroviral therapy has transformed HIV from a terminal illness into a manageable chronic disease, significantly improving the life expectancy and quality of life for those infected.

Cigarette smoking is common among HIV-infected individuals, and tailored smoking-cessation interventions could greatly enhance their health, yet no specific studies have been conducted to evaluate the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus infection, AIDS, and smoking cessation: the time is now. Niaura, R., Shadel, WG., Morrow, K., et al.[2005]

Recruiting smoking parents into cessation support through primary schools is challenging, but once engaged, they respond positively to the support offered, with 88% of those in quitline support accepting counseling calls.

Cessation support was well-utilized, with high satisfaction rates of 81% for quitline support and 69% for self-help materials, indicating that targeted outreach can effectively engage smoking parents in quitting efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based promotion of cessation support: reach of proactive mailings and acceptability of treatment in smoking parents recruited into cessation support through primary schools. Schuck, K., Otten, R., Kleinjan, M., et al.[2021]

HIV providers were less effective at recognizing current smoking among their patients, with a sensitivity of only 65%, compared to 82% for non-HIV providers, indicating a significant gap in awareness.

Only 39% of HIV providers felt confident in their ability to help patients quit smoking, highlighting the need for targeted interventions to improve smoking cessation support in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased awareness of current smoking among health care providers of HIV-positive compared to HIV-negative veterans. Crothers, K., Goulet, JL., Rodriguez-Barradas, MC., et al.[2022]

In a worksite smoking cessation program involving 98 active participants and 350 randomly sampled employees, smoking cessation rates among participants ranged from 21% to 41% after 12 to 24 months, highlighting the program's effectiveness.

The study found that social support was more crucial for quitting than the program's materials or procedures, with 10% to 25% of nonparticipants also remaining abstinent, indicating that fostering a supportive environment can enhance the success of smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support in worksite smoking cessation: qualitative analysis of the EASE project. Fisher, EB., Bishop, DB., Levitt-Gilmour, T., et al.[2018]

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