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Completed

NCT Number: NCT05030766

Testing Integrative Smoking Cessation 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.

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Key information

Conditions

Smoking Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Smoking Cessation Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Replacement Therapy

Drug

6 weeks of Nicotine replacement patches

Mindfulness Training Smoking Cessation Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Number of Participants Reporting 7-day Point-prevalence Abstinence

    Time frame: 4 weeks (end of treatment), and 3 months

    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.

Secondary outcomes

  1. Retention Rate

    Time frame: 3 months

    Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.

  2. Treatment Specific Adherence Rates

    Time frame: 3 months

    Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2021
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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