HepatitisNCT02342821
Empowering Immigrants in the Greater Boston Area to Connect to HBV Care
An observational study of Hepatitis, run by Massachusetts General Hospital.
Trial summary
This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2017
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: immigrants and other persons at HBV risk in Greater Boston area
Who may be able to join
None listed.
Who cannot join
- -
About this study
This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area.
Read the detailed description
Specific Aims
- Provide HBV education at community sites where immigrants at risk for HBV could be informed of the risks related to HBV, in a culturally and linguistically sensitive manner.
- Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education
- Senegalese Community Center: community meeting, posters, and pamphlets
- African Students' Association, Suffolk University: community meeting, posters, and pamphlets
- Revere Cambodian Community Centers: community meeting, posters, and pamphlets
- Provide at-risk persons with the tools to develop an HBV diagnosis plan with his / her provider.
- Provide counseling on the significance of different testing results prior to testing
- Connect to testing, and appropriate post-test follow-up appointments
- Provide an education hub for patients and providers to return to with questions regarding: test interpretation, available treatments for those who test positive, and screening for hepatocellular carcinoma in those who are infected.
- Provide copy of an easy to understand US HBV treatment algorithm in native languages
- Provide information related to genotype-specific risks for HCC (increased with GT C).
- Conditions
- Hepatitis
- Medical subject headings
- Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved understanding of HBV by Questionnaire
Participants will be provided questionnaires by D. Fusco
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Fusco, Dahlene N.,M.D.,Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342821
- Sponsor's protocol ID
- IN-US-174-1254
- Status last verified
- Mar 2017
- First submitted
- 16 Jan 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Immigrants in the Greater Boston Area to Connect to HBV Care
- ClinicalTrials.gov ID
- NCT02342821
- Acronym / sponsor ID
- IN-US-174-1254
- Conditions
- Hepatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Feb 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Jan 2015 (estimated)
- 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.
This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area.
Detailed description
Specific Aims
- Provide HBV education at community sites where immigrants at risk for HBV could be informed of the risks related to HBV, in a culturally and linguistically sensitive manner.
- Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education
- Senegalese Community Center: community meeting, posters, and pamphlets
- African Students' Association, Suffolk University: community meeting, posters, and pamphlets
- Revere Cambodian Community Centers: community meeting, posters, and pamphlets
- Provide at-risk persons with the tools to develop an HBV diagnosis plan with his / her provider.
- Provide counseling on the significance of different testing results prior to testing
- Connect to testing, and appropriate post-test follow-up appointments
- Provide an education hub for patients and providers to return to with questions regarding: test interpretation, available treatments for those who test positive, and screening for hepatocellular carcinoma in those who are infected.
- Provide copy of an easy to understand US HBV treatment algorithm in native languages
- Provide information related to genotype-specific risks for HCC (increased with GT C).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- immigrants and other persons at HBV risk in Greater Boston area
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improved understanding of HBV by Questionnaire
Time frame: 1 year
Participants will be provided questionnaires by D. Fusco
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, run by Massachusetts General Hospital.
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 0 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: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Improved understanding of HBV by Questionnaire (time frame: 1 year). 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 28 Mar 2017.