Empowering Immigrants in the Greater Boston Area to Conne... | NCT02342821

Studies
Empowering Immigrants in the Greater Boston Area to Connect to HBV Care

NCT02342821

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Mar 28, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Hepatitis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

May 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Jan 16, 2015

First Submission Date that Met QC Criteria

Jan 20, 2015

First Posted Date

Jan 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2017

Last Update Posted Date

Mar 28, 2017Actual

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.
1. Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education
2. Senegalese Community Center: community meeting, posters, and pamphlets
3. African Students' Association, Suffolk University: community meeting, posters, and pamphlets
4. 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.
1. Provide counseling on the significance of different testing results prior to testing
2. 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.
1. Provide copy of an easy to understand US HBV treatment algorithm in native languages
2. Provide information related to genotype-specific risks for HCC (increased with GT C).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved understanding of HBV by Questionnaire	Participants will be provided questionnaires by D. Fusco	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: all persons interested in hearing more information about HBV -

Exclusion Criteria: children

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

immigrants and other persons at HBV risk in Greater Boston area

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006505	Hepatitis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided