Is NCT04725617 recruiting in Tucson, AZ?

Yes, NCT04725617 is currently recruiting participants at its Tucson, AZ location. This hiv clinical trial is actively enrolling qualified participants.

How do I join the hiv clinical trial in Tucson?

To join this clinical trial in Tucson, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tucson clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV Clinical Trial in Tucson, AZ

About This HIV Study in Tucson

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).

Sponsor: University of Arizona

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tucson?

Yes, this clinical trial (NCT04725617) has an active research site in Tucson, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV Treatment Options in Tucson, AZ

If you're searching for hiv treatment options in Tucson, AZ, this clinical trial (NCT04725617) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tucson research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hiv specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv clinical trials near you to find additional studies recruiting in your area.

HIV Clinical Trial in Tucson, AZ

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