Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-79
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Concurrent receipt of other cessation treatments
Trial design
Treatments tested in this trial
- EX+
- Varenicline
- HR
- TAU
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Montefiore Medical Center
Lead sponsor
Westat
Collaborator
Massachusetts General Hospital
Collaborator
Truth Initiative
Collaborator
National Cancer Institute (NCI)
Collaborator
Red Planet Testing
Collaborator
Source ClinicalTrials.gov