Wellness Intervention for Smoking and HIV

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Arizona
Study ID
NCT04725617
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases
  • HIV
  • Sleep
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Varenicline — DRUG
    Standard smoking cessation treatment.
  • Smoking Cessation Counseling — BEHAVIORAL
    Standard smoking cessation treatment
  • Health Approach 1 to Reduce Smoking — BEHAVIORAL
    Behavioral health intervention option 1
  • Health Approach 2 to Reduce Smoking — OTHER
    Behavioral health intervention option 2

Study Details

The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions \[weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13\]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

Key Dates

Start date
Nov 16, 2021
Status verified
Aug 2025
Primary completion
Sep 28, 2025
Completion
Sep 28, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Health Intervention Approach 1
    Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.
  • Active Comparator: Health Intervention Approach 2
    Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.

Primary Outcome Measure

Change in smoking cessation [ Time Frame: Change in smoking cessation from baseline to end of 13-week timeline and 6 month follow up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Banner University Medical Center PhoenixPhoenixArizona85006
Gabriela Montenegro
[email protected]
520-626-7873
Hannah Gannon
[email protected]
520-626-7814
University of ArizonaTucsonArizona85724
Jose Elizondo
[email protected]
520-848-4042

Find similar trials in Phoenix, AZ

By condition
HIV
By specialty
Infectious disease
By research site
Banner University Medical Center Phoenix· Phoenix, AZUniversity of Arizona· Tucson, AZ

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