search
Back to results

Epidemiology of Viral Hepatitis Among Subjects in Precarious

Primary Purpose

Social Insecurity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
capillary sampling
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Social Insecurity

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Population homeless (SDF)
  • Population living in slums.

Exclusion Criteria:

  • Pregnant or lactating women

Sites / Locations

  • DUCOS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Population homeless or living in slum

Arm Description

Population homeless or living in slum realizing realizing a capillary sampling

Outcomes

Primary Outcome Measures

serology HBV
Study prevalence HBV in these precarious populations
serology HCV
Study prevalence HCV in these precarious populations
serology HAV
Study prevalence HAV in these precarious populations

Secondary Outcome Measures

Full Information

First Posted
September 12, 2016
Last Updated
August 10, 2022
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT02907905
Brief Title
Epidemiology of Viral Hepatitis Among Subjects in Precarious
Official Title
Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water. We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.
Detailed Description
Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water. We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene. The sampling system as part of a consultation in routine care (will be in DBS (blotter) only alternative to invasive venous sample and requiring heavier care facility. The capillary sampling on filter will also detect a marker of malnutrition . Thus in live in large social precariousness adult this study should show which interventions in public health and management proposals are most appropriate for this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Insecurity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Population homeless or living in slum
Arm Type
Other
Arm Description
Population homeless or living in slum realizing realizing a capillary sampling
Intervention Type
Biological
Intervention Name(s)
capillary sampling
Intervention Description
After elution in buffer (PBS-Tween azide and thiamol) eluate 200 microliter is processed on automated techniques (Siemens Centaur XL and Diasorin) after adjustment of the figures according to ISO 15189 scope B. The results are qualitatively made and sent to the teams. The return of results, a proposal for appropriate care in the event of contact with virus (anti-HAV HCV HBV) through a rendering consultation results
Primary Outcome Measure Information:
Title
serology HBV
Description
Study prevalence HBV in these precarious populations
Time Frame
1 day
Title
serology HCV
Description
Study prevalence HCV in these precarious populations
Time Frame
1 day
Title
serology HAV
Description
Study prevalence HAV in these precarious populations
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Population homeless (SDF) Population living in slums. Exclusion Criteria: Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Ducos, MD PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
DUCOS
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Epidemiology of Viral Hepatitis Among Subjects in Precarious

We'll reach out to this number within 24 hrs