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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04566159
Other study ID # IRB00117151-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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