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

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

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

Sponsors & Collaborators

• Westat

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Truth Initiative

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Red Planet Testing

  collaborator UNKNOWN

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Jonathan Shuter, MD · Montefiore Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-04

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United States

Study Locations