Wellness Intervention for Smoking and HIV

NCT04725617 | Recruiting DMC

• 1 other identifier: 2005630160
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

HIV; Sleep; Smoking Cessation; Cardiovascular Diseases

Keywords

HIV; Sleep; Smoking Cessation; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Change in smoking cessation

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

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

• Change in sleep duration

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

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

Secondary Outcomes (7)

• Change in sleep efficiency

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

• Change in sleep quality

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

• Change in sleep continuity

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

• Change in blood pressure

  Change in blood pressure as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up

• Change in lipids

  Change in lipids as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up

Other Outcomes (6)

• Mediation of Cognitive Function (Working Memory) on Smoking Cessation

  Change in mediation of working memory on smoking cessation from baseline to end of 13-week timeline and 6 month follow up

• Mediation of Cognitive Function (Sustained Attention) on Smoking Cessation

  Change in mediation of sustained attention on smoking cessation from baseline to end of 13-week timeline and 6 month follow up

• Mediation of Cognitive Function (Executive Function) on Smoking Cessation

  Change in mediation of executive function on smoking cessation from baseline to end of 13-week timeline and 6 month follow up

Study Arms (2)

Health Intervention Approach 1

ACTIVE COMPARATOR

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.

Drug: Varenicline; Behavioral: Smoking Cessation Counseling; Behavioral: Health Approach 1 to Reduce Smoking

Health Intervention Approach 2

ACTIVE COMPARATOR

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.

Drug: Varenicline; Behavioral: Smoking Cessation Counseling; Other: Health Approach 2 to Reduce Smoking

Interventions

Varenicline DRUG

Standard smoking cessation treatment.

Health Intervention Approach 1; Health Intervention Approach 2

Smoking Cessation Counseling BEHAVIORAL

Standard smoking cessation treatment

Health Intervention Approach 1; Health Intervention Approach 2

Health Approach 1 to Reduce Smoking BEHAVIORAL

Behavioral health intervention option 1

Health Intervention Approach 1

Health Approach 2 to Reduce Smoking OTHER

Behavioral health intervention option 2

Health Intervention Approach 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 -75 years;
• Documented HIV infection;
• CD4+ T cell count ≥ 200 cells/mm3;
• On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start;
• Smoke at least 5 cigarettes/day;
• Report wanting to quit smoking in the next month;
• Have no sleep disorders (with the exception of insomnia or mild to moderate obstructive sleep apnea (STOP-Bang score of 4 or less; apnea-hypopnea index (AHI) of less than 30);
• Able to communicate in English and provide written informed consent for study procedures;
• Able to use varenicline tartrate safely;
• Will be residing in the geographic area for at least 10 months;
• Willing to attend 8 in-person sessions and one 6-month follow up assessment.

You may not qualify if:

• Regular use of chewing tobacco, snuff, cigars, e-cigarettes, unless willing to stop;
• Current enrollment or plans to enroll in another smoking cessation program or use other smoking cessation products for the duration of the study;
• Women of childbearing potential who are pregnant, lactating, or likely to become pregnant during the trial and unwilling to use contraception during the study;
• Unstable alcohol use that precludes reliable study participation as assessed by study physician;
• Unstable drug use that precludes reliable study participation as assessed by study physician;
• Unstable mental illness that precludes reliable study participation as assessed by study physician;
• A history of a suicide attempt within the last two years, and/or current nonspecific suicidal thoughts as defined by the Columbia Suicide Severity Rating Scale;
• Unstable or untreated moderate or severe depression as assessed by the Patient Health Questionnaire 9 (PHQ-9) scale. A participant with a score of ≥ 15 will be referred to one of the study's mental health clinicians (Dr. Michael Grandner or Dr. Susan Gorovoy) for further assessment of their depression
• Serious or unstable disease within the past 6 months (e.g., cancer, seizure disorder, end-stage liver disease, end-stage renal disease, uncontrolled diabetes, pulmonary disease requiring oxygen);
• Any prior history of seizure disorder within the past year;
• Unstable cardiac condition (i.e., angina, myocardial infarction, or coronary angioplasty) within the past 6 months or a clinically significant EKG that may present a health or safety risk as assessed by the study physician;
• Currently working night/rotating shift and/or use of a sleep medication, or a medication that could influence sleep;
• Prior history of adult somnambulism;
• Use of a sleep medication that will interfere with study results
• Inability to complete any of the study tasks as determined by the investigators.

Sponsors & Collaborators

• University of Arizona: lead
• University of Delaware: collaborator

Study Sites (2)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Cardiovascular Diseases

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Elizabeth Connick, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Michael Grandner, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Montenegro

CONTACT

(520) 626-7873; mgmonten@arizona.edu

Jose Elizondo

CONTACT

(520) 621-0316; joselizondo5@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychiatry

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 27, 2021
• Study Start: November 16, 2021
• Primary Completion: September 28, 2025
• Study Completion: September 28, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (2)