Wellness Intervention for Smoking and HIV

This study is looking at new ways to help adults living with HIV (ALHIV) quit smoking and improve their sleep. It's testing two different behavioral health approaches to reduce smoking, called "Health Approach 1" and "Health Approach 2." Both approaches will be combined with standard smoking cessation treatments, which include the medication varenicline and counseling. The study wants to see if these approaches help people stop smoking and sleep better over 13 weeks, with a follow-up at 6 months. You might be able to join if you are 18-75 years old, have HIV, smoke at least 5 cigarettes a day, and want to quit. The study is currently recruiting 200 participants.

Study design
This is a randomized controlled trial involving 200 participants. Participants will be randomly assigned to either Health Approach 1 or Health Approach 2.
What's involved
You would undergo phone and in-person eligibility assessments, including a physical exam, lab tests, and an overnight sleep assessment. If eligible, you would participate in a 13-week program.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be checked at the end of the 13-week program and again 6 months later.

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NCT04725617

Wellness Intervention for Smoking and HIV

Recruiting
NAAges 18–75InterventionalTreatment
University of Arizona
~200 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:VareniclineSmoking Cessation CounselingHealth Approach 1 to Reduce SmokingHealth Approach 2 to Reduce Smoking

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in smoking cessation
Measured over Change in smoking cessation from baseline to end of 13-week timeline and 6 month follow up
+1 more outcome measured
HIV
Sleep
Smoking Cessation
Cardiovascular Diseases
2 sites across 1 states
Arizona2
  • Elizabeth Connick, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
  • Michael Grandner, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona

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  • Change in smoking cessationChange in smoking cessation from baseline to end of 13-week timeline and 6 month follow up

    Cessation of smoking determined via self-report and biochemical verification of carbon monoxide breath test and urine cotinine.

  • Change in sleep durationChange in sleep duration from baseline to end of 13-week timeline and 6 month follow up

    Amount of sleep per night, assessed with sleep diary and actigraphy