BridgeMD
New treatment option for HIV
Official title Wellness Intervention for Smoking and HIV
ClinicalTrials.gov ID: NCT04725617
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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...
- 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;
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.