Testing Integrative Smoking Cessation for HIV Patients

A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients

The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Smoking; Smoking Cessation
• Intervention / Treatment: Drug: Nicotine Replacement Therapy; Behavioral: Mindfulness Training Smoking Cessation Intervention; Behavioral: Contingency Management Smoking Cessation Intervention

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with HIV (based on self-report).
• Be 18 years and older
• Have smoked ≥ 5 cigarettes/day in the past year
• Be interested in making a quit attempt in the next 30 days
• Own a smartphone (apple/android), and plan to keep it active for the next 6 months
• Able to consent
• Have no plans to move in the next 6 months
• Are not pregnant or planning to be pregnant in the following 6 months
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Exclusion Criteria:

• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Are currently being treated for a psychiatric condition.
• Are currently being treated for smoking cessation, alcoholism, or illicit drug use
• Are adults unable to consent
• Are individuals who are not yet adults
• Are pregnant women
• Are prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT plus NRT Group-Phase 1; Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.	Drug: Nicotine Replacement Therapy; 6 weeks of Nicotine replacement patches; Behavioral: Mindfulness Training Smoking Cessation Intervention; Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.
Experimental: CM plus NRT Group-Phase1; Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.	Drug: Nicotine Replacement Therapy; 6 weeks of Nicotine replacement patches; Behavioral: Contingency Management Smoking Cessation Intervention; Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.
Experimental: MT plus NRT with additional CM Group-Phase2; Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.	Drug: Nicotine Replacement Therapy; 6 weeks of Nicotine replacement patches; Behavioral: Mindfulness Training Smoking Cessation Intervention; Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.; Behavioral: Contingency Management Smoking Cessation Intervention; Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.
Experimental: CM plus NRT with additional MT Group-Phase2; Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.	Drug: Nicotine Replacement Therapy; 6 weeks of Nicotine replacement patches; Behavioral: Mindfulness Training Smoking Cessation Intervention; Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.; Behavioral: Contingency Management Smoking Cessation Intervention; Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting 7-day Point-prevalence Abstinence	Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of < 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.	4 weeks (end of treatment), and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rate	Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.	3 months
Treatment Specific Adherence Rates	Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).	3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Taghrid A. Asfar, MD, MSPH, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): May 23, 2024

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Contingency Management; Mindfulness Training
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20201296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No