Health TrialsbyHealthPanel

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

ConditionsHivTobacco Use
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Varenicline

    Drug

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

  • 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).

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: EX+/HRExperimental treatment 3 interventions
Group B: EX+/TAUActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to 9 months
2

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.

Time frame
Up to 9 months
3

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.

Time frame
From baseline to 9 months
4

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.

Time frame
From baseline to 9 months

Secondary outcomes

1

Occurrence of Cardiometabolic Clinic appointment

Occurrence of Cardiometabolic Clinic appointment. Participants will be referred to Cardiometabolic (CM) Clinic for management of HTN \[systolic BP\>130mmHg\] and/or hyperlipidemia \[LDL cholesterol\>100mg/dl\]. Patient Navigators (PNs) will arrange for these appointments. The CM Clinic meets weekly in the MMC outpatient department. The number/percentage of participants who are referred to the CM clinic and attend their appointment will be summarized by study arm.

Time frame
9 months
2

Proportion of participants at target systolic blood pressure

Proportion of participants achieving target systolic blood pressure will be evaluated. The target SBP is \<=130mm/Hg. All participants will have blood pressure checked at 9 months. Results will be summarized by study arm using basic descriptive statistics.

Time frame
9 months
3

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

Proportion of participants achieving target low dose low-density lipoprotein (LDL) cholesterol will be evaluated. The target LDL cholesterol is \<=100mg/dl. Blood samples will be collected as part of the lipid profile at 9 months and samples will be submitted for laboratory analysis. Results will be summarized by study arm using basic descriptive statistics.

Time frame
9 months
4

Change in CD4+ lymphocyte count

Change in CD4+ lymphocyte count from baseline will be evaluated. Blood samples will be collected as part of the CD4+ count at 9 months and samples will be submitted for laboratory analysis. Results will be summarized by study arm using basic descriptive statistics.

Time frame
From baseline to 9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now