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
1 other identifier
interventional
95
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2024
CompletedResults Posted
Study results publicly available
June 4, 2025
CompletedJune 4, 2025
May 1, 2025
2.4 years
August 26, 2021
May 16, 2025
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Retention Rate
3 months
Treatment Specific Adherence Rates
3 months
Study Arms (4)
MT plus NRT Group-Phase 1
EXPERIMENTALParticipants 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.
CM plus NRT Group-Phase1
EXPERIMENTALParticipants 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.
MT plus NRT with additional CM Group-Phase2
EXPERIMENTALParticipants 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.
CM plus NRT with additional MT Group-Phase2
EXPERIMENTALParticipants 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.
Interventions
6 weeks of Nicotine replacement patches
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Taghrid Asfar
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Taghrid A. Asfar, MD, MSPH
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
August 26, 2021
First Posted
September 1, 2021
Study Start
January 4, 2022
Primary Completion
May 23, 2024
Study Completion
May 23, 2024
Last Updated
June 4, 2025
Results First Posted
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share