Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention

Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention for Hospitalized Persons With HIV

The prevalence of tobacco smoking is high among persons with HIV (PWH). The investigators are piloting a two session computer-delivered intervention (CBI) with linkage to a community health worker (CHW) among hospitalized PWH with tobacco use 1a) To determine feasibility and acceptability of delivering this intervention and 2a) To determine intervention effect on 1) readiness to quit smoking and confidence in ability to quit smoking 2) uptake of smoking cessation therapy

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: CBI-CHW; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >=18,
• A patient admitted to the Johns Hopkins Hospital
• Smoked >100 cigarettes in their lifetime
• Current smoker
• English speaking

Exclusion Criteria:

• Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBI + CHW; 2 Session Computer Delivered Intervention with use of Nicotine Replacement Therapy and Community Health Worker Follow Up	Behavioral: CBI-CHW; 2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks
Other: Routine Care; Routine Tobacco Cessation Advice to Stop Smoking and Nicotine Replacement Therapy as offered by the inpatient team	Other: Standard Care; Standard tobacco treatment care offered by the inpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility as assessed by the Feasibility of Intervention Measure	4 item scale, maximum score of 20 with higher score indicating greater feasibility	3 months
Intervention Acceptability as assessed by the Acceptability of an Intervention Measure	Noted as continuous score on 4 item scale, maximum value of 20 with higher score indicating greater acceptability	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness to quit smoking as assessed by a Visual analog scale	Score of 10=Ready to Quit, Score of 1=Not ready to quit. Scale is from 1-10	immediately post intervention
Uptake of nicotine replacement therapy	Dichotomous yes/no.	immediately post intervention
Continued use of nicotine replacement therapy 1 month post intervention	Dichotomous yes/no.	30 days post intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Geetanjali Chander, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Use; Tobacco Smoking; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00117151-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As this is a very small pilot, we will share de-identified data on request.
• IPD Sharing Time Frame: Data will be available 12 months after study completion
• IPD Sharing Access Criteria: Information will be shared on request. Requests can be made to the study PI who will then work with the data manager to compile a de-identified data set.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No