NCT05642715 · Montefiore Medical Center
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
What this study is about
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.
View original scientific 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.
Interventions
BEHAVIORAL
EX+
All participants, regardless of study arm, will be offered: BecomeAnEX, an online tobacco treatment with support community PLUS Positively Smoke Free on the Web (an intervention targeting people with HIV who smoke) integrated into the BecomeAnEX site.
DRUG
Varenicline
All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.
BEHAVIORAL
HR
Participants allocated to the EX+/HR arm will be offered: 30-minute video urging smokers who cannot or will not quit to cut down on cigarettes, and also to control their risk for lung cancer and cardio or cerebrovascular disease by undergoing low-dose CT screening for lung cancer (for those meeting prespecified criteria), and referral to Cardiometabolic Clinic (for those meeting prespecified criteria).
BEHAVIORAL
TAU
Participants allocated to the EX+/TAU arm will be offered: Medical treatment as usual from their regular providers after completing Stage 1 of the study
Primary outcome measures
Change in cigarettes smoked per day (CPD)
Time frame: From baseline to 9 months
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.
Occurrence of low-dose CT (LDCT) screening for lung cancer
Time frame: Up to 9 months
Occurrence of low-dose CT screening for lung cancer will be assessed by determining the number/percentage of participants who complete LDCT screening for lung cancer. Results will be summarized by study arm/group. The study will have 80% power to detect a difference in percentage completing screening between the two study conditions if ≥ 9.8% of the EX+/HR participants complete screening.
Change in systolic blood pressure (SBP)
Time frame: From baseline to 9 months
Change in systolic blood pressure (SBP) will be evaluated. All participants will have blood pressure checked at baseline, 6 months, and 9 months. Results will be summarized by study arm using basic descriptive statistics. The study will have 94.5% power to detect the expected difference of 7.7mmHg in SBP between the two study conditions.
Change in total cholesterol
Time frame: From baseline to 9 months
Change in total cholesterol from baseline will be evaluated. Blood samples will be collected as part of the lipid profile and samples will be submitted for laboratory analysis. Results will be summarized by study arm using basic descriptive statistics. The study will have 98.6% power to detect the expected difference of 21.5mg/dl in total cholesterol between the two study conditions.
Change in American College of Cardiology/American Heart Association Pooled Cohort Equation score (ACC/PCEs)
Time frame: From baseline to 9 months
Change in cardiovascular risk score from baseline will be determined based on American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equation (PCE) score for risk of atherosclerotic cardiovascular disease (ASCVD). PCE score will be assessed at baseline, 6 months, and 9 months. The ACC/AHA PCEs are calculators used to estimate the 10-year risk of ASCVD (i.e., heart attack, stroke) for primary prevention, using factors like age, sex, race, cholesterol, blood pressure, diabetes, and smoking status. Results will be summarized by study arm using basic descriptive statistics. The study will have 80% power to detect a difference of 3.0 in PCEs score between the two study conditions.
Biochemically-confirmed 7-day point-prevalence abstinence (PPA)
Time frame: 9 months
Abstinence from tobacco smoking will be evaluated based on biochemically-confirmed 7 day PPA. Results will be summarized by study arm using basic descriptive statistics.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range).
- 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?"
- Lab-confirmed HIV infection
- Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline
- Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program).
- Willingness to be randomized to one of the two study conditions
Exclusion criteria
- 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)
- Contraindication to varenicline
- Concurrent receipt of other cessation treatments
- Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
- To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded
Where
- The Bronx, New York
Collaborators
Westat, Massachusetts General Hospital, Truth Initiative, National Cancer Institute (NCI), Red Planet Testing
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations