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

NCT05642715 | Recruiting DMC

• 2 other identifiers: 2022-14572R01CA275521
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Tobacco Use

Keywords

HIV; Tobacco; Cigarette; Smoking; Harm reduction

Outcome Measures

Primary Outcomes (6)

• Change in cigarettes smoked per day (CPD)

  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.

  From baseline to 9 months

• Occurrence of low-dose CT (LDCT) screening for lung cancer

  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.

  Up to 9 months

• Change in systolic blood pressure (SBP)

  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.

  From baseline to 9 months

• Change in total cholesterol

  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.

  From baseline to 9 months

• Change in American College of Cardiology/American Heart Association Pooled Cohort Equation score (ACC/PCEs)

  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.

  From baseline to 9 months

• Biochemically-confirmed 7-day point-prevalence abstinence (PPA)

  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.

  9 months

Secondary Outcomes (5)

• Occurrence of Cardiometabolic Clinic appointment

  9 months

• Proportion of participants at target systolic blood pressure

  9 months

• Proportion of participants at target low dose low-density lipoprotein (LDL) cholesterol

  9 months

• Change in CD4+ lymphocyte count

  From baseline to 9 months

• Proportion with undetectable HIV-1 viral load

  9 months

Study Arms (2)

EX+/HR

EXPERIMENTAL

The harm reduction arm (described in detail elsewhere)

Behavioral: EX+; Drug: Varenicline; Behavioral: HR

EX+/TAU

ACTIVE COMPARATOR

The treatment as usual arm

Behavioral: EX+; Drug: Varenicline; Behavioral: TAU

Interventions

EX+ BEHAVIORAL

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.

Also known as: BecomeAnEX+

EX+/HR; EX+/TAU

Varenicline DRUG

All participants, regardless of study arm, will be offered: A 12-week course of varenicline dosed according to product label.

EX+/HR; EX+/TAU

HR BEHAVIORAL

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).

Also known as: Harm Reduction

EX+/HR

TAU BEHAVIORAL

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

Also known as: Treatment As Usual

EX+/TAU

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Westat: collaborator
• Massachusetts General Hospital: collaborator
• Truth Initiative: collaborator
• National Cancer Institute (NCI): collaborator
• Red Planet Testing: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tobacco Use; Smoking; Harm Reduction

Interventions

Varenicline; Therapeutics

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Jonathan Shuter, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Shuter, MD

CONTACT

718-920-7845; jshuter@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The treatment allocation will be concealed from the individual completing study assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: April 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)