Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

NCT03187730 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-02177
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.

Conditions

Smoking Cessation

Keywords

Smoking Cassation; Immigrants; Economic Disparity

Outcome Measures

Primary Outcomes (1)

• % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)

  Participants answered "In the past 7 days, have you smoked a cigarette? (yes/no)"; % of "yes" is reported per arm

  6 Months

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Behavioral: Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT)

Waitlist Control

PLACEBO COMPARATOR

Behavioral: Waitlist Integrated Smoking Cessation and Financial Counseling; Drug: Nicotine Replacement Therapy (NRT)

Interventions

Integrated Smoking Cessation and Financial Counseling BEHAVIORAL

Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.

Intervention Arm

Waitlist Integrated Smoking Cessation and Financial Counseling BEHAVIORAL

Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.

Waitlist Control

Nicotine Replacement Therapy (NRT) DRUG

Participants in both arms will be eligible to receive a free four-week supply of NRT.

Intervention Arm; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokes ≥5 cigarettes per day
• Born outside the U.S.
• Interested in receiving smoking and financial counseling
• Self-reported income below 200% of the current federal poverty level for a given household composition
• New York City resident
• English or Spanish language
• Able to provide informed consent, and
• Does not have a representative who manages his/her funds (to ensure the participant has the ability to manage household money). We will exclude participants who report being pregnant or breastfeeding (unable to receive NRT).
• Hospital staff participants:
• Must be current medical or non-medical provider or administrator at Bellevue Hospital or New York University Lutheran Medical Center

You may not qualify if:

• We will exclude participants who report being pregnant or breastfeeding.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (3)

• Rogers ES, Wysota CN, Sherman SE. Banking Status as a Moderator of Outcomes in a Randomized Controlled Trial Targeting Financial Stress and Smoking. J Gen Intern Med. 2025 Dec 2. doi: 10.1007/s11606-025-10064-0. Online ahead of print.

  PMID: 41331201 DERIVED

• Tempchin J, Vargas E, Sherman S, Rogers E. Predictors of Counseling Participation Among Low-Income People Offered an Integrated Intervention Targeting Financial Distress and Tobacco Use. Prev Sci. 2023 Apr;24(3):525-534. doi: 10.1007/s11121-022-01416-x. Epub 2022 Aug 6.

  PMID: 35932394 DERIVED

• Rogers ES, Rosen MI, Elbel B, Wang B, Kyanko K, Vargas E, Wysota CN, Sherman SE. Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial. J Gen Intern Med. 2022 Sep;37(12):2973-2981. doi: 10.1007/s11606-021-07209-2. Epub 2022 Jan 11.

  PMID: 35018561 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Elizabeth Vargas
• Organization: NYU Langone

elizabeth.varagas@nyulangone.org

310-486-9775

Study Officials

• Erin Rogers

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 15, 2017
• Study Start: September 22, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2021
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-06

Locations

US (1)