Durham Housing Authority (DHA) Community Health Advisor (CHA) Smoking Cessation Project

NCT04114526 | Completed

• 1 other identifier: Pro00100099
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Recent policy from the U.S. Department of Housing and Urban Development (HUD) mandates that all public housing units go smoke-free by August 2018. Residents in public housing units have little access to proven cessation interventions and support is imperative to increase quitting success and is currently lacking in these communities;' thus this mandate is causing stress without providing resources to quit. Using a Community Engaged Research (CEnR) approach, we propose to partner the Durham County Department of Public Health and the Durham Housing Authority to develop sustainable Community Health Advisor tobacco cessation program that can be implemented in public housing communities. To achieve this goal, we plan to build on our previous collaborations to 1) form a team of previously identified DHA residents who are activated to support smoking cessation among public housing residents who can serve as Community Health Advisors and deliver cessation interventions in DHA properties, and 2) co-develop and pilot test a Community Health Advisor smoking cessation program to promote linkages with cessation services and to provide cessation education to DHA residents. This collaboration builds on our previous work to understand barriers and identify solutions for supporting smoking cessation among DHA residents. We will work with Community Health Advisors to develop an intervention and conduct a pilot study with up to 30 participants, Our primary outcomes are feasibility and acceptability of the co-development cessation intervention. We will collect survey data for the pilot in REDCap. Potential risks of study participation include breach of confidentiality with regard to identifiable personal information and questions that might make participants feel uncomfortable.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (7)

• Number of people who enroll in the study as measured by enrollment log.

  4 months

• Number of people that interact with community health advisors

  5 months

• Number of participants who rate the intervention as helpful for quitting based on survey questionnaire.

  5 months

• Change in number of cigarettes smoked per day as measured by questionnaire

  Baseline and day 28

• Change in smoking cessation motivation will be self-reported on a 7-point scale.

  1=not at all motivated and 7=completely motivated.

  Baseline and day 28

• Change in smoking status as measured by self-reports.

  Participants will be asked on a questionnaire, "Have you smoked in the last 7 days even a puff" and will have the option of answering "yes" or "no".

  Baseline and day 28

• Frequency of interaction with community health advisors during intervention period will be calculated from self-reports.

  Day 28

Study Arms (1)

Community Health Advisor 4-step Program

EXPERIMENTAL

Other: Nicotine Replacement Therapy

Interventions

Nicotine Replacement Therapy OTHER

CHAs meet with all interested residents to discuss taking steps towards quitting. The CHAs follow a four step program with all participant 1) get to know the resident and their smoking, 2) Assess what the resident is ready to do to take steps towards quitting, 3) discuss using nicotine replacement therapy (NRT) in the form of patches, gum or lozenges, 4) set one goal for taking steps towards quitting. CHAs will attempt to follow up with participants after the initial encounter. There is no limit on the number of times the CHA may talk with the participants. Some follow interactions will be brief encounters in the neighborhood, while others will be at scheduled. All contacts with each participant will be tracked. We will provide up to 6 weeks of NRT patches, gum and lozenges to participants who are interested in using NRT to help them quit.

Community Health Advisor 4-step Program

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age
• current smoker (smoked in the last seven days)
• planning on quitting in the next 6 months
• speak English
• currently living in DHA property

You may not qualify if:

• less than18 years of
• cognitive impairment
• planning to move from the property in the next 2 months

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Laura J Fish, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: July 19, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

Locations

US (1)