Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention

NCT04566159 | Completed

• 1 other identifier: IRB00117151-2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Smoking

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Readiness to quit smoking as assessed by a Visual analog scale

  immediately post intervention

• Uptake of nicotine replacement therapy

  immediately post intervention

• Continued use of nicotine replacement therapy 1 month post intervention

  30 days post intervention

Study Arms (2)

CBI + CHW

EXPERIMENTAL

2 Session Computer Delivered Intervention with use of Nicotine Replacement Therapy and Community Health Worker Follow Up

Behavioral: CBI-CHW

Routine Care

OTHER

Routine Tobacco Cessation Advice to Stop Smoking and Nicotine Replacement Therapy as offered by the inpatient team

Other: Standard Care

Interventions

CBI-CHW BEHAVIORAL

2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks

CBI + CHW

Standard Care OTHER

Standard tobacco treatment care offered by the inpatient care

Routine Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Geetanjali Chander, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: January 11, 2021
• Primary Completion: October 7, 2021
• Study Completion: December 1, 2021
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion
• 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.

Locations

US (1)