Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566159
• Other study ID #: IRB00117151-2
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 1, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

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:
• Standard Care
Standard tobacco treatment care offered by the inpatient care

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Uptake of nicotine replacement therapy	Dichotomous yes/no.	immediately post intervention
Secondary	Continued use of nicotine replacement therapy 1 month post intervention	Dichotomous yes/no.	30 days post intervention