Tobacco SmokingNCT04566159
Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention
A study testing CBI-CHW in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- CBI-CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18,
- A patient admitted to the Johns Hopkins Hospital
- Smoked >100 cigarettes in their lifetime
- Current smoker
- English speaking
Who cannot join
- Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Tobacco Smoking
- Being tested
- CBI-CHW, Standard Care
- Keywords
- HIV
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBI-CHWBehavioural
2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks
Standard CareOther
Standard tobacco treatment care offered by the inpatient care
| Study group | Role | What they receive |
|---|---|---|
| CBI + CHW | Experimental | 2 Session Computer Delivered Intervention with use of Nicotine Replacement Therapy and Community Health Worker Follow Up Receives: Behavioral: CBI-CHW |
| Routine Care | Other | Routine Tobacco Cessation Advice to Stop Smoking and Nicotine Replacement Therapy as offered by the inpatient team Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility as assessed by the Feasibility of Intervention Measure
4 item scale, maximum score of 20 with higher score indicating greater feasibility
Measured: 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
Measured: 3 months
Secondary outcomes (3)
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
Measured: immediately post intervention
Uptake of nicotine replacement therapy
Dichotomous yes/no.
Measured: immediately post intervention
Continued use of nicotine replacement therapy 1 month post intervention
Dichotomous yes/no.
Measured: 30 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start11 Jan 2021
- Primary completion7 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geetanjali Chander, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566159
- Sponsor's protocol ID
- IRB00117151-2
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2020
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As this is a very small pilot, we will share de-identified data on request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention for Hospitalized Persons With HIV
- ClinicalTrials.gov ID
- NCT04566159
- Acronym / sponsor ID
- IRB00117151-2
- Conditions
- Tobacco Smoking
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBI + CHW | Experimental | Behavioral: CBI-CHW2 Session Computer Delivered Intervention with use of Nicotine Replacement Therapy and Community Health Worker Follow Up |
| Routine Care | Other | Other: Standard CareRoutine Tobacco Cessation Advice to Stop Smoking and Nicotine Replacement Therapy as offered by the inpatient team |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18,
- A patient admitted to the Johns Hopkins Hospital
- Smoked >100 cigarettes in their lifetime
- Current smoker
- English speaking
Key exclusion criteria (1 listed)
- Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBI-CHW2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks | Behavioural | CBI + CHW |
| Standard CareStandard tobacco treatment care offered by the inpatient care | Other | Routine Care |
Primary outcome
Intervention Feasibility as assessed by the Feasibility of Intervention Measure
Time frame: 3 months
4 item scale, maximum score of 20 with higher score indicating greater feasibility
Intervention Acceptability as assessed by the Acceptability of an Intervention Measure
Time frame: 3 months
Noted as continuous score on 4 item scale, maximum value of 20 with higher score indicating greater acceptability
3 secondary outcomes
Readiness to quit smoking as assessed by a Visual analog scale
Time frame: immediately post intervention
Uptake of nicotine replacement therapy
Time frame: immediately post intervention
Continued use of nicotine replacement therapy 1 month post intervention
Time frame: 30 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. As this is a very small pilot, we will share de-identified data on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geetanjali Chander, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI-CHW in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility as assessed by the Feasibility of Intervention Measure (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.