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NCT05642715 · ClinicalTrials.gov registry record · NA
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
A NA study of HIV and Tobacco Use, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT05642715: Recruiting NA study of HIV and Tobacco Use, sponsored by Montefiore Medical Center.
NCT05642715 is a NA study of HIV and Tobacco Use that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 400 participants, roughly in line with the 439-participant average among 303 other HIV trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05642715, a NA study of HIV and Tobacco Use, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates. An "all or none" approach to smoking cessation in PWH offers little benefit to the large majority of PWH who are unable or unwilling to quit. In this proposal we argue that a harm reduction approach (i.e., cut down, get screened for lung cancer, control your blood pressure and cholesterol) has the potential to yield significant benefits in terms of the private and public health of PWH in the US.
Primary Outcome
Change in the number of cigarettes smoked per day (CPD) from baseline will be determined. Results will be summarized by study arm using basic descriptive statistics. The study will have 80% power to detect a difference of 3.4 CPD between the two study conditions.
Conditions Studied
Interventions
- DRUG Varenicline
- BEHAVIORAL TAU
- BEHAVIORAL EX+
- BEHAVIORAL HR
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2027-03 |
| Phase | NA |
What NCT05642715 shows while recruiting
NCT05642715 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 439-participant average among 303 other HIV trials with a reported enrollment target.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 4 interventions - of which Varenicline is the first listed.
NCT05642715 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05642715 about?
NCT05642715 is a clinical study titled "Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes". Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates. An "all or none" approach to smoking cessation in PWH offers little benefit to the large majority of PWH who are unable or unwilli...
What is the current status of trial NCT05642715?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-04-04. Estimated completion is 2027-03.
What conditions does trial NCT05642715 study?
This clinical trial studies the following conditions: HIV, Tobacco Use.
What interventions are being tested in trial NCT05642715?
The interventions under investigation include: Varenicline (DRUG), TAU (BEHAVIORAL), EX+ (BEHAVIORAL), HR (BEHAVIORAL).
Who is sponsoring clinical trial NCT05642715?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05642715 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05642715's enrollment target sits among peer trials
400 39th of 303 higher than 257 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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