Social InsecurityNCT02907905
Epidemiology of Viral Hepatitis Among Subjects in Precarious
A study testing capillary sampling in people with Social Insecurity, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Social Insecurity
- What is being tested?
- capillary sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 1 Dec 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Population homeless (SDF)
- Population living in slums.
Who cannot join
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population
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.
Read the 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.
- Conditions
- Social Insecurity
- Being tested
- capillary sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capillary samplingBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Population homeless or living in slum | Other | Population homeless or living in slum realizing realizing a capillary sampling Receives: Biological: capillary sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
serology HBV
Study prevalence HBV in these precarious populations
Measured: 1 day
serology HCV
Study prevalence HCV in these precarious populations
Measured: 1 day
serology HAV
Study prevalence HAV in these precarious populations
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InsecurityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Ducos, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907905
- Sponsor's protocol ID
- 9609
- Status last verified
- Aug 2022
- First submitted
- 12 Sep 2016
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population
- ClinicalTrials.gov ID
- NCT02907905
- Acronym / sponsor ID
- 9609
- Conditions
- Social Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 20 Sep 2016 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population homeless or living in slum | Other | Biological: capillary samplingPopulation homeless or living in slum realizing realizing a capillary sampling |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Population homeless (SDF)
- Population living in slums.
Key exclusion criteria (1 listed)
- Pregnant or lactating women
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 |
|---|---|---|
| capillary samplingAfter 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 | Biological | Population homeless or living in slum |
Primary outcome
serology HBV
Time frame: 1 day
Study prevalence HBV in these precarious populations
serology HCV
Time frame: 1 day
Study prevalence HCV in these precarious populations
serology HAV
Time frame: 1 day
Study prevalence HAV in these precarious populations
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 11 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jacques Ducos, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capillary sampling in people with Social Insecurity, run by University Hospital, Montpellier at 1 site in France.
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 2 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 11 Aug 2022. 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 France. 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?
serology HBV (time frame: 1 day). 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 11 Aug 2022.