Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes (NCT05642715) | Clinical Trial Compass
RecruitingNot Applicable
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
United States400 participantsStarted 2024-04-04
Plain-language 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.
Who can participate
Age range40 Years – 79 Years
SexALL
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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
✕. Pregnancy
✕. 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
What they're measuring
1
Change in cigarettes smoked per day (CPD)
Timeframe: From baseline to 9 months
2
Occurrence of low-dose CT (LDCT) screening for lung cancer
Timeframe: Up to 9 months
3
Change in systolic blood pressure (SBP)
Timeframe: From baseline to 9 months
4
Change in total cholesterol
Timeframe: From baseline to 9 months
5
Change in American College of Cardiology/American Heart Association Pooled Cohort Equation score (ACC/PCEs)