HIV(WISH)NCT04725617
Wellness Intervention for Smoking and HIV
A study testing Varenicline, Smoking Cessation Counseling and Health Approach 1 to Reduce Smoking in people with HIV and Sleep, run by University of Arizona at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV, Sleep, Smoking Cessation
- What is being tested?
- Varenicline, Smoking Cessation Counseling and Health Approach 1 to Reduce Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2021to 28 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Gabriela Montenegro, 520-626-7873, mgmonten@arizona.edu
Hannah Gannon, 520-626-7814, hannahgannon@arizona.edu
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Jose Elizondo, 520-848-4042, joselizondo5@arizona.edu
About this study
Official title: Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults
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).
Read the detailed description
Cigarette smoking among adults living with HIV (ALHIV) is a significant public health problem, leading to substantial morbidity and mortality in this population. Existing smoking cessation interventions are not sufficient, as success rates are relatively low. Poor sleep is more prevalent among smokers, more prevalent among ALHIV, can be caused by smoking cessation attempts, predicts relapse to former smoking patterns, and represents a parallel pathway to morbidity including increased cardiovascular disease (CVD) among ALHIV. Thus, unhealthy sleep may make smoking cessation more difficult and increase cardiovascular risk and other poor health conditions in ALHIV. The proposed study will supplement an empirically-supported smoking cessation program (8-session, 13-week counseling program with varenicline tartrate) with a pre-determined behavioral health approach to reducing smoking intervention developed for smokers. The investigators will test the efficacy of behavioral health approach 1 versus behavioral health approach 2 as an active comparator. The investigators will also explore the impact of smoking cessation and changes in sleep on changes in inflammatory biomarkers of cardiovascular disease risk. Approximately 400 ALHIV treatment seeking smokers who have no history of sleep disorders will be screened (through history, physical examination, laboratory studies and an overnight sleep test) to identify 200 eligible subjects to randomize to Intervention Approach 1 versus Intervention Approach 2. All participants will concurrently receive standard smoking cessation treatment including counseling and 12-weeks of varenicline tartrate. Screening and treatment sessions will take place at the University of Arizona's Clinical and Translational Sciences Research Center, which is well equipped with private examination rooms and phlebotomists. Successful smoking cessation will be assessed at end of therapy (13 weeks) and again 6 months later by self reports, carbon monoxide breath test, and urine and serum cotinine, a stringent objective marker of tobacco use. Sleep will be assessed through sleep diaries, questionnaires and actigraphy (activity sensors worn on the wrist). Other markers of CVD risk including lipids, 24 hour blood pressure monitoring, and HgbA1C, and biomarkers (IL-6, hsCRP, TNFalpha,ICAM-1, VCAM-1, sCD14, D-dimer) will be determined at baseline, end of therapy, and 6 months follow up. Cognitive function will be assessed through N-Back (uses images), Psychomotor Vigilance Test (PVT), Abstract Matching (AM), Digital Symbol Substitution Task (DSST), Visual Object Learning Task (VOLT), Motor Praxis Task (MPT), Balloon Analog Risk Task (BART), and Line Orientation Task (LOT).
Ultimately, the impact of this work will be to transform clinical guidelines for the treatment of nicotine dependence, as well as to provide insights into mechanisms by which improved sleep enhances tobacco cessation.
- Conditions
- HIV, Sleep, Smoking Cessation, Cardiovascular Diseases
- Being tested
- Varenicline, Smoking Cessation Counseling, Health Approach 1 to Reduce Smoking, Health Approach 2 to Reduce Smoking
- Keywords
- HIV, Sleep, Smoking Cessation, Cardiovascular Diseases
- Medical subject headings
- Smoking Cessation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Standard smoking cessation treatment.
Smoking Cessation CounselingBehavioural
Standard smoking cessation treatment
Health Approach 1 to Reduce SmokingBehavioural
Behavioral health intervention option 1
Health Approach 2 to Reduce SmokingOther
Behavioral health intervention option 2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Varenicline; Behavioral: Smoking Cessation Counseling; Other: Health Approach 2 to Reduce Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in smoking cessation
Cessation of smoking determined via self-report and biochemical verification of carbon monoxide breath test and urine cotinine.
Measured: 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
Measured: Change in sleep duration from baseline to end of 13-week timeline and 6 month follow up
Secondary outcomes (7)
Change in sleep efficiency
Amount of sleep per night divided by time in bed, assessed with sleep diary and actigraphy
Measured: Change in sleep efficiency from baseline to end of 13-week timeline and 6 month follow up
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI) score. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep. In addition, a total score will be evaluated in addition to the individual items. A score of 5 has been identified as a cutoff for "poor" sleep.
Measured: Change in sleep quality from baseline to end of 13-week timeline and 6 month follow up
Change in sleep continuity
Sleep latency, wake after sleep onset, awakenings, sleep regularity, sleep timing. Assessed with sleep diary and actigraphy
Measured: Change in sleep continuity from baseline to end of 13-week timeline and 6 month follow up
Change in blood pressure
Assessment of blood pressure (24 hour blood pressure monitoring) as a marker of Cardiovascular Disease (CVD) risk.
Measured: 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
Assessment of lipids as a marker of Cardiovascular Disease (CVD) risk.
Measured: Change in lipids as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Change in HgbA1c
Assessment of HgbA1c as a marker of Cardiovascular Disease (CVD) risk
Measured: Change in HgbA1c as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Change in inflammatory markers of Cardiovascular Disease (CVD) risk
Assessment of inflammatory biomarkers, including IL6, CRP, and TNFa,ICAM-1, VCAM-1, sCD14, D-dimer, which will be combined to assess change in inflammatory markers.
Measured: Change in inflammatory markers of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start16 Nov 2021
- Primary completion28 Sep 2025 (estimated)
- Study completion28 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
- Investigators
- Elizabeth Connick, MD, Principal investigator, University of ArizonaMichael Grandner, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725617
- Sponsor's protocol ID
- 2005630160
- Acronym
- (WISH)
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2021
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults
- ClinicalTrials.gov ID
- NCT04725617
- Acronym / sponsor ID
- (WISH) / 2005630160
- Conditions
- HIV, Sleep, Smoking Cessation, Cardiovascular Diseases
- Keywords
- HIV, Sleep, Smoking Cessation, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 28 Sep 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cigarette smoking among adults living with HIV (ALHIV) is a significant public health problem, leading to substantial morbidity and mortality in this population. Existing smoking cessation interventions are not sufficient, as success rates are relatively low. Poor sleep is more prevalent among smokers, more prevalent among ALHIV, can be caused by smoking cessation attempts, predicts relapse to former smoking patterns, and represents a parallel pathway to morbidity including increased cardiovascular disease (CVD) among ALHIV. Thus, unhealthy sleep may make smoking cessation more difficult and increase cardiovascular risk and other poor health conditions in ALHIV. The proposed study will supplement an empirically-supported smoking cessation program (8-session, 13-week counseling program with varenicline tartrate) with a pre-determined behavioral health approach to reducing smoking intervention developed for smokers. The investigators will test the efficacy of behavioral health approach 1 versus behavioral health approach 2 as an active comparator. The investigators will also explore the impact of smoking cessation and changes in sleep on changes in inflammatory biomarkers of cardiovascular disease risk. Approximately 400 ALHIV treatment seeking smokers who have no history of sleep disorders will be screened (through history, physical examination, laboratory studies and an overnight sleep test) to identify 200 eligible subjects to randomize to Intervention Approach 1 versus Intervention Approach 2. All participants will concurrently receive standard smoking cessation treatment including counseling and 12-weeks of varenicline tartrate. Screening and treatment sessions will take place at the University of Arizona's Clinical and Translational Sciences Research Center, which is well equipped with private examination rooms and phlebotomists. Successful smoking cessation will be assessed at end of therapy (13 weeks) and again 6 months later by self reports, carbon monoxide breath test, and urine and serum cotinine, a stringent objective marker of tobacco use. Sleep will be assessed through sleep diaries, questionnaires and actigraphy (activity sensors worn on the wrist). Other markers of CVD risk including lipids, 24 hour blood pressure monitoring, and HgbA1C, and biomarkers (IL-6, hsCRP, TNFalpha,ICAM-1, VCAM-1, sCD14, D-dimer) will be determined at baseline, end of therapy, and 6 months follow up. Cognitive function will be assessed through N-Back (uses images), Psychomotor Vigilance Test (PVT), Abstract Matching (AM), Digital Symbol Substitution Task (DSST), Visual Object Learning Task (VOLT), Motor Praxis Task (MPT), Balloon Analog Risk Task (BART), and Line Orientation Task (LOT).
Ultimately, the impact of this work will be to transform clinical guidelines for the treatment of nicotine dependence, as well as to provide insights into mechanisms by which improved sleep enhances tobacco cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Intervention Approach 1 | Active comparator | Drug: Varenicline, Behavioral: Smoking Cessation Counseling, Behavioral: Health Approach 1 to Reduce SmokingSubjects 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. |
| Health Intervention Approach 2 | Active comparator | Drug: Varenicline, Behavioral: Smoking Cessation Counseling, Other: Health Approach 2 to Reduce SmokingSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineStandard smoking cessation treatment. | Drug | Health Intervention Approach 1, Health Intervention Approach 2 |
| Smoking Cessation CounselingStandard smoking cessation treatment | Behavioural | Health Intervention Approach 1, Health Intervention Approach 2 |
| Health Approach 1 to Reduce SmokingBehavioral health intervention option 1 | Behavioural | Health Intervention Approach 1 |
| Health Approach 2 to Reduce SmokingBehavioral health intervention option 2 | Other | Health Intervention Approach 2 |
Primary outcome
Change in smoking cessation
Time frame: Change 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 duration
Time frame: Change 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
7 secondary outcomes
Change in sleep efficiency
Time frame: Change in sleep efficiency from baseline to end of 13-week timeline and 6 month follow up
Change in sleep quality
Time frame: Change in sleep quality from baseline to end of 13-week timeline and 6 month follow up
Change in sleep continuity
Time frame: Change in sleep continuity from baseline to end of 13-week timeline and 6 month follow up
Change in blood pressure
Time frame: 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
Time frame: Change in lipids as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Change in HgbA1c
Time frame: Change in HgbA1c as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Change in inflammatory markers of Cardiovascular Disease (CVD) risk
Time frame: Change in inflammatory markers of CVD risk from baseline to end of 13-week timeline and 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Connick, MD principal investigator
University of Arizona
Michael Grandner, PhD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varenicline, Smoking Cessation Counseling and Health Approach 1 to Reduce Smoking in people with HIV and Sleep, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Montenegro ((520) 626-7873, mgmonten@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.