RECRUITING

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Conditions

Hiv Tobacco Use Tobacco Cigarette Smoking Harm reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Quick Facts

Study Start:2024-04-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05642715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range). 2. Current cigarette smoking ("Yes" to: "Have you smoked more than 100 cigarettes in your lifetime?" AND "Have you smoked a cigarette, even a puff, in the past 7 days?" and have exhaled carbon monoxide (ECO) level ≥ 6ppm 3. Lab-confirmed HIV infection 4. Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline 5. Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program). 6. Willingness to be randomized to one of the two study conditions	1. Pregnancy 2. Lack of insurance for specialty referral (we expect this exclusion to be rare because the great majority of people with HIV (PWH) at the Montefiore Medical Center have Medicaid or AIDS Drug Assistance Program (ADAP) 3. Contraindication to varenicline 4. Concurrent receipt of other cessation treatments 5. Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment 6. To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded

Inclusion Criteria

Exclusion Criteria

1. Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range).
2. Current cigarette smoking ("Yes" to: "Have you smoked more than 100 cigarettes in your lifetime?" AND "Have you smoked a cigarette, even a puff, in the past 7 days?" and have exhaled carbon monoxide (ECO) level ≥ 6ppm
3. Lab-confirmed HIV infection
4. Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline
5. Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program).
6. Willingness to be randomized to one of the two study conditions

1. Pregnancy
2. Lack of insurance for specialty referral (we expect this exclusion to be rare because the great majority of people with HIV (PWH) at the Montefiore Medical Center have Medicaid or AIDS Drug Assistance Program (ADAP)
3. Contraindication to varenicline
4. Concurrent receipt of other cessation treatments
5. Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
6. To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded

Contacts and Locations

Study Contact

Jonathan Shuter, MD

CONTACT

718-920-7845

jshuter@montefiore.org

Principal Investigator

Jonathan Shuter, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center

The Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Jonathan Shuter, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

HIV
Tobacco
Cigarette
Smoking
Harm reduction

Additional Relevant MeSH Terms

Hiv
Tobacco Use