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NCT04725617 · ClinicalTrials.gov registry record · NA
Wellness Intervention for Smoking and HIV
A NA study of HIV and Cardiovascular Diseases, sponsored by University of Arizona.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT04725617 is a NA study of HIV and Cardiovascular Diseases that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 200 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04725617, a NA study of HIV and Cardiovascular Diseases, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Varenicline
- BEHAVIORAL Smoking Cessation Counseling
- BEHAVIORAL Health Approach 1 to Reduce Smoking
- OTHER Health Approach 2 to Reduce Smoking
Study Locations (2)
Arizona
- Banner University Medical Center Phoenix - Phoenix
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2025-09-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04725617
The ClinicalTrials.gov registry entry for NCT04725617 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with HIV appearing as the primary indexed condition, and to 4 interventions - of which Varenicline is the first listed.
NCT04725617 reports 2 study locations spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT04725617 about?
NCT04725617 is a clinical study titled "Wellness Intervention for Smoking and HIV". 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 cardio...
What is the current status of trial NCT04725617?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-11-16. Estimated completion is 2025-09-28.
What conditions does trial NCT04725617 study?
This clinical trial studies the following conditions: HIV, Cardiovascular Diseases, Smoking Cessation, Sleep.
What interventions are being tested in trial NCT04725617?
The interventions under investigation include: Varenicline (DRUG), Smoking Cessation Counseling (BEHAVIORAL), Health Approach 1 to Reduce Smoking (BEHAVIORAL), Health Approach 2 to Reduce Smoking (OTHER).
Who is sponsoring clinical trial NCT04725617?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04725617 being conducted?
This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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