Clinical trial NCT04490057: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Official title: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Tobacco Use Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-28
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential multiple assignment randomized trial
Primary purpose: TREATMENT

Brief summary: Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.

Detailed description: Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 320 adult PWH who smoke cigarettes and receive care in one of three health systems (targeted enrollment changed from 632 to 320 with NCI approval and IRB protocol amendment). At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide \[eCO\] or collateral verification) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule \["CM plus"\] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcomes will be self-reported reduction in average cigarettes smoked per day at 24 weeks and 12 weeks (primary outcome changed from eCO-confirmed abstinence to self-reported abstinence with NCI approval and IRB protocol amendment). The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote reduced tobacco use (changed from eCO-confirmed smoking abstinence with NCI approval and protocol amendment) (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

Eligibility criteria: Inclusion Criteria:

* HIV positive;
* \>= 18 years old
* Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
* Have smoked \>= 100 cigarettes in lifetime;
* Currently smokes some days or every day;
* Smokes, on average, \>= 5 cigarettes per day;
* Able to provide written informed consent.

Exclusion Criteria:

* Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
* Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
* Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
* Life-threatening or unstable medical, surgical, or psychiatric condition;
* Inability to provide at least one collateral contact (family member or friend);
* Living out of state;
* Unable to read or understand English (except at Mount Sinai site).

Primary outcomes:
measure: Self reported reduction in average cigarettes smoked per day at 24 weeks
timeFrame: 24 weeks from baseline
measure: Self reported reduction in average cigarettes smoked per day at 12 weeks
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: VACS index 2.0
timeFrame: 24 weeks from baseline
measure: CD4 Count
timeFrame: 24 weeks from baseline
measure: HIV Viral Load
timeFrame: 24 weeks from baseline
measure: eCO confirmed smoking abstinence at 24 weeks
timeFrame: 24 weeks from baseline
measure: eCO confirmed smoking abstinence at 12 weeks
timeFrame: 12 weeks from baseline
Other outcomes:
measure: Identification of Barriers and Facilitators
timeFrame: Baseline and Up to 4 years
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital Infectious Disease Clinic
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Brooklyn
country: United States
facility: SUNY Downstate STAR Clinic
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Yale University
name: E. Jennifer Edelman, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Steven Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.