Recruiting

Wellness Intervention

Sponsor:

University of Arizona

Code:

NCT04725617

Conditions

HIV

Sleep

Smoking Cessation

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Varenicline

Smoking Cessation Counseling

Health Approach 1 to Reduce Smoking

Health Approach 2 to Reduce Smoking

Study Details

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

Study ID

NCT04725617

Start date

Nov 16, 2021

Status verified date

Aug, 2025

Completion date

Sep 28, 2025

Anticipated

Primary completion date

Sep 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females 18 -75 years;
2. Documented HIV infection;
3. CD4+ T cell count ≥ 200 cells/mm3;
4. On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start;
5. Smoke at least 5 cigarettes/day;
6. Report wanting to quit smoking in the next month;
7. 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);
8. Able to communicate in English and provide written informed consent for study procedures;
9. Able to use varenicline tartrate safely;
10. Will be residing in the geographic area for at least 10 months;
11. Willing to attend 8 in-person sessions and one 6-month follow up assessment.

Exclusion Criteria

1. Regular use of chewing tobacco, snuff, cigars, e-cigarettes, unless willing to stop;
2. Current enrollment or plans to enroll in another smoking cessation program or use other smoking cessation products for the duration of the study;
3. Women of childbearing potential who are pregnant, lactating, or likely to become pregnant during the trial and unwilling to use contraception during the study;
4. Unstable alcohol use that precludes reliable study participation as assessed by study physician;
5. Unstable drug use that precludes reliable study participation as assessed by study physician;
6. Unstable mental illness that precludes reliable study participation as assessed by study physician;
7. 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;
8. 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
9. 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);
10. Any prior history of seizure disorder within the past year;
11. 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;
12. Currently working night/rotating shift and/or use of a sleep medication, or a medication that could influence sleep;
13. Prior history of adult somnambulism;
14. Use of a sleep medication that will interfere with study results
15. Inability to complete any of the study tasks as determined by the investigators.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Varenicline

Standard smoking cessation treatment.

Smoking Cessation Counseling

Standard smoking cessation treatment

Health Approach 1 to Reduce Smoking

Behavioral health intervention option 1

Health Approach 2 to Reduce Smoking

Behavioral health intervention option 2

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

Central Contacts and Locations

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

More Information

Sponsor

University of Arizona

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • HIV
  • Sleep
  • Smoking Cessation
  • Cardiovascular Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-08-19.