Tobacco DependencePhase 4NCT06545669
C-Raven, a Virtual Tobacco Cessation Intervention in the Community
A Phase 4 study testing C-Raven Virtual Tobacco Cessation Counseling, Nicotine Replacement Product and Community Health Worker in people with Tobacco Dependence, run by Johns Hopkins University at 1 site in United States.
Trial summary
In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- C-Raven Virtual Tobacco Cessation Counseling, Nicotine Replacement Product and Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2024to 16 Jan 2026
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 or older Current tobacco use with >100 cigarettes smoked in their lifetime
- English speaking (intervention currently in English only and housing units are in largely English-speaking neighborhoods)
- Considering smoking cessation
- Planning to remain in current housing unit for 9 months
Who cannot join
- Current use of pharmacological treatment for tobacco cessation
- Contraindication to nicotine replacement therapy
- Current engagement in formal smoking cessation program
- Major cognitive or psychiatric impairment
- Severe hearing impairment
- Investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: C-Raven: Pilot Randomized Controlled Trial (RCT) of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City
In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control.
With a sample of participants from public housing units (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. At the 3-month time point, the investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.
Read the detailed description
The investigators will conduct a pilot randomized controlled trial of an avatar-delivered computerized intervention for tobacco cessation and CHW support to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, one month, three months, and six months. At the end of three months, the investigators will conduct follow-up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on the information collected in these efforts, the investigators will make iterative improvements to the existing intervention, aligned with user-experience design procedures.
Participants (N=30) will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.
Randomization: Following consent, participants will be randomized to the intervention group or a control group. The control group will not receive any intervention during the first 6 months of the study, but at the end of 6 months will receive the full computer intervention and abbreviated CHW support to ensure access to treatment for all participants.
Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise a number of questionnaires/assessments, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, participants will receive computer-delivered counseling via a study-provided iPad delivered in a private room. The CDI consists of 1) a menu-driven, web-based intervention that is delivered by a virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, the participant will be offered nicotine patches provided by the study (1 month supply, remainder given at follow-up visits). The initial dosing of the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility or appropriate dosing, the CHW will consult with a study physician. With the CHW, the participant will learn correct application, and will monitor the participants nicotine replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 month supply, remainder given at follow-up visits). This session also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow up with patients remotely via phone or video conference whenever possible, up to twice weekly for 12 weeks (4 weeks for control group receiving delayed intervention), to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review a video and decision-making guide for lung cancer screening and provide linkage to lung cancer screening if the participant is eligible and interested, including linkage to insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive findings on lung CT, work with participants to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end of the study, link to medical providers for additional tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the participants primary care physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional and will not be provided as part of the research study. The CHW will assist with linking patients without a PCP or existing specialist with resources to establish care. For participants who choose to proceed with screening, the investigators will request the results of the CT scan to track completion and general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal Needing Immediate Follow-Up).
- Conditions
- Tobacco Dependence
- Being tested
- C-Raven Virtual Tobacco Cessation Counseling, Nicotine Replacement Product, Community Health Worker, Lung Cancer Screening
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Raven Virtual Tobacco Cessation CounselingBehavioural
A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.
Nicotine Replacement ProductDrug
Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.
Community Health WorkerOther
A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.
Lung Cancer ScreeningOther
After participating in shared decision-making, eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| C-Raven + CHW Smoking Cessation Intervention | Experimental | Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months. Receives: Behavioral: C-Raven Virtual Tobacco Cessation Counseling; Drug: Nicotine Replacement Product; Other: Community Health Worker; Other: Lung Cancer Screening |
| No Intervention | No intervention | Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and Feasibility as assessed by number of barriers
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Measured: 1 month, 3 months, 6 months
Acceptability and Feasibility as assessed by completion of modules
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Measured: 1 month, 3 months, 6 months
Acceptability and Feasibility as assessed by number of sessions with CHW
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Measured: 1 month, 3 months, 6 months
Secondary outcomes (9)
Readiness to quit smoking as assessed by The Readiness Ruler
The Readiness Ruler is a brief measure of motivation, which prompts patients with a 10-point visual analog scale on which the participant rates readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready."
Measured: 1 month, 3 months, 6 months
Number of participants that start nicotine replacement therapy uptake
Number of participants that start using NRTs at any point during the study period
Measured: 1 month, 3 months, 6 months
Number of participants that continue use of nicotine replacement therapy
Number of participants that continue to use NRTs
Measured: 1 month, 3 months, 6 months
Number of participants that attempt to quit
Number of participants that attempt to quit
Measured: 1 month, 3 months, 6 months
Number of quit attempts
Number of quit attempts each participants makes during the study period
Measured: 1 month, 3 months, 6 months
Number of participants that maintain cessation
Number of participants that have maintained cessation for at least one week prior to the assessment
Measured: 1 month, 3 months, 6 months
Number of participants that utilize Quit Line services
Number of participants that chose to utilize Quit Line services at any point during the study
Measured: 1 month, 3 months, 6 months
Number and frequency of interactions with the community health worker
Engagement with community health worker
Measured: 1 month, 3 months, 6 months
Participant satisfaction as assessed by the C-Raven Satisfaction Scale
Overall satisfaction with the intervention. This will be measured with a 21-item questionnaire which uses a 5-item Likert Scale for each question (range 21-105). Higher scores indicate greater satisfaction. Answers of "agree" and "strongly agree" will be evaluated across the intervention components.
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Oct 2024
- Primary completion17 Oct 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants are randomly assigned to intervention or no intervention. Outcomes for those who receive the intervention will be compared to outcomes for those who do not receive the intervention. Those who do not receive the intervention during the initial study period will receive it at the end, to ensure access to treatment for all participants.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund, Walgreens
- Responsible party
- Sponsor
- Investigators
- Alejandra Ellison-Barnes, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545669
- Sponsor's protocol ID
- IRB00450397
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Raven: Pilot Randomized Controlled Trial (RCT) of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City
- ClinicalTrials.gov ID
- NCT06545669
- Acronym / sponsor ID
- IRB00450397
- Conditions
- Tobacco Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund, Walgreens
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 9 Aug 2024 (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.
In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control.
With a sample of participants from public housing units (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. At the 3-month time point, the investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.
Detailed description
The investigators will conduct a pilot randomized controlled trial of an avatar-delivered computerized intervention for tobacco cessation and CHW support to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, one month, three months, and six months. At the end of three months, the investigators will conduct follow-up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on the information collected in these efforts, the investigators will make iterative improvements to the existing intervention, aligned with user-experience design procedures.
Participants (N=30) will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.
Randomization: Following consent, participants will be randomized to the intervention group or a control group. The control group will not receive any intervention during the first 6 months of the study, but at the end of 6 months will receive the full computer intervention and abbreviated CHW support to ensure access to treatment for all participants.
Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise a number of questionnaires/assessments, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, participants will receive computer-delivered counseling via a study-provided iPad delivered in a private room. The CDI consists of 1) a menu-driven, web-based intervention that is delivered by a virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, the participant will be offered nicotine patches provided by the study (1 month supply, remainder given at follow-up visits). The initial dosing of the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility or appropriate dosing, the CHW will consult with a study physician. With the CHW, the participant will learn correct application, and will monitor the participants nicotine replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 month supply, remainder given at follow-up visits). This session also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow up with patients remotely via phone or video conference whenever possible, up to twice weekly for 12 weeks (4 weeks for control group receiving delayed intervention), to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review a video and decision-making guide for lung cancer screening and provide linkage to lung cancer screening if the participant is eligible and interested, including linkage to insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive findings on lung CT, work with participants to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end of the study, link to medical providers for additional tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the participants primary care physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional and will not be provided as part of the research study. The CHW will assist with linking patients without a PCP or existing specialist with resources to establish care. For participants who choose to proceed with screening, the investigators will request the results of the CT scan to track completion and general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal Needing Immediate Follow-Up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants are randomly assigned to intervention or no intervention. Outcomes for those who receive the intervention will be compared to outcomes for those who do not receive the intervention. Those who do not receive the intervention during the initial study period will receive it at the end, to ensure access to treatment for all participants.
| Arm | Type | Receives |
|---|---|---|
| C-Raven + CHW Smoking Cessation Intervention | Experimental | Behavioral: C-Raven Virtual Tobacco Cessation Counseling, Drug: Nicotine Replacement Product, Other: Community Health Worker, Other: Lung Cancer ScreeningParticipants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months. |
| No Intervention | No intervention | –Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50 or older Current tobacco use with >100 cigarettes smoked in their lifetime
- English speaking (intervention currently in English only and housing units are in largely English-speaking neighborhoods)
- Considering smoking cessation
- Planning to remain in current housing unit for 9 months
Key exclusion criteria (6 listed)
- Current use of pharmacological treatment for tobacco cessation
- Contraindication to nicotine replacement therapy
- Current engagement in formal smoking cessation program
- Major cognitive or psychiatric impairment
- Severe hearing impairment
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 |
|---|---|---|
| C-Raven Virtual Tobacco Cessation CounselingA two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete. | Behavioural | C-Raven + CHW Smoking Cessation Intervention |
| Nicotine Replacement ProductParticipants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges. | Drug | C-Raven + CHW Smoking Cessation Intervention |
| Community Health WorkerA community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed. | Other | C-Raven + CHW Smoking Cessation Intervention |
| Lung Cancer ScreeningAfter participating in shared decision-making, eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening. | Other | C-Raven + CHW Smoking Cessation Intervention |
Primary outcome
Acceptability and Feasibility as assessed by number of barriers
Time frame: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Acceptability and Feasibility as assessed by completion of modules
Time frame: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Acceptability and Feasibility as assessed by number of sessions with CHW
Time frame: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
9 secondary outcomes
Readiness to quit smoking as assessed by The Readiness Ruler
Time frame: 1 month, 3 months, 6 months
Number of participants that start nicotine replacement therapy uptake
Time frame: 1 month, 3 months, 6 months
Number of participants that continue use of nicotine replacement therapy
Time frame: 1 month, 3 months, 6 months
Number of participants that attempt to quit
Time frame: 1 month, 3 months, 6 months
Number of quit attempts
Time frame: 1 month, 3 months, 6 months
Number of participants that maintain cessation
Time frame: 1 month, 3 months, 6 months
Number of participants that utilize Quit Line services
Time frame: 1 month, 3 months, 6 months
Number and frequency of interactions with the community health worker
Time frame: 1 month, 3 months, 6 months
Participant satisfaction as assessed by the C-Raven Satisfaction Scale
Time frame: 1 month, 3 months, 6 months
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Alejandra Ellison-Barnes, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing C-Raven Virtual Tobacco Cessation Counseling, Nicotine Replacement Product and Community Health Worker in people with Tobacco Dependence, 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 4 inclusion and 6 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 2 Feb 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acceptability and Feasibility as assessed by number of barriers (time frame: 1 month, 3 months, 6 months). The study lists 3 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 2 Feb 2026.