Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid ((UMC))

February 8, 2021 updated by: Pablo Ryan, Hospital Universitario Infanta Leonor

Data on the prevalence of hepatitis C virus (HCV) for other vulnerable groups in Madrid, such as homeless persons and migrants, are scarce, and it is now necessary to implement intervention and elimination plans.

Vulnerable groups have poor access to healthcare and are therefore not systematically screened for HCV. On the occasions they are shown to be positive, subsequent follow-up in the health system and the possibility of cure are poor.

The use of a mobile unit to approach vulnerable populations is essential for better characterization of risk behaviors and of the magnitude of HCV. The integration of healthcare personnel in mobile units enables counseling on prevention and intervention when needed.

Primary objective Evaluate the impact of the HCV care cascade on vulnerable populations who gather at hot spots in Madrid (shantytowns, homeless shelters and places were street prostitution is practiced) by means of a multilevel outreach project.

SURVEILLANCE:

Active screening for HCV among vulnerable individuals in populations with a high prevalence of HCV will be carried out in hot spots in Madrid, namely, Cañada Real shanty town, mobile harm reduction units, institutions providing social assistance, public areas, homeless shelters and places where street prostitution is practiced. An agreement with the Madrid Council (MCC) is under way to provide social centers for HCV screening.

A mobile unit will approach the hot spots following a predefined schedule. The mobile unit consists of a van adapted for the project and a car. HCV screening of vulnerable individuals will be performed by a nurse and an educator hired specifically for that purpose.

Active HCV screening and prevention in vulnerable individuals should be a priority and a responsibility shared by both the MCC and the SERMAS (Servicio Madridleño de Salud). The investigators plan to establish an agreement with public health authorities to give continuity to this project and to carry out proactive HCV screening through integration with various centers and networks dependent on the MCC and SERMAS.

The project will establish the foundations of integrated cooperation between an HCV clinic in a hospital setting and harm reduction units and other resources and networks dependent on the institutions mentioned above. As has been observed with other interventions, the functional objective of this project is to provide continuity of care from the institutions.

Study Duration (in months) 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Unidad Movil de Cribado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons who inject drugs (PWID), homeless people, migrants and sex workers are vulnerable populations that have a high prevalence of active hepatitis C virus (HCV) infection. According to local data, the prevalence of HCV in drug users ranges from 20% to 60%, depending on whether they inject drugs or not. Data on the HCV prevalence for the other vulnerable groups (homeless, migrants…) in Madrid is scarce and necessary to implement intervention and elimination plans.

Description

Inclusion Criteria:

  • Vulnerable populations who include one or more of the following:

    • Persons who inject drugs,
    • Homeless,
    • Migrants
    • Sex workers

Exclusion Criteria:

  • Not signing inform consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCV or HIV negative
Individuals who test negative for HCV or HIV are given information regarding ways of transmission.
Diagnostic test: HCV rapid test
Individuals who test positive for either HIV or HCV are offered PCR (polymerase chain reaction) testing with the xpert technology. Patients with a confirmed active infection are offered delivery and are taken into hospital.
Other Names:
  • HIV rapid test
  • Xpert HCV viral load
  • Xpert HIV viral load
  • Linkage to care
HCV and HIV positive
Individuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care.
Diagnostic test: HCV rapid test
Individuals who test positive for either HIV or HCV are offered PCR (polymerase chain reaction) testing with the xpert technology. Patients with a confirmed active infection are offered delivery and are taken into hospital.
Other Names:
  • HIV rapid test
  • Xpert HCV viral load
  • Xpert HIV viral load
  • Linkage to care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who have a positive RNA HCV test
Time Frame: 1 year
Percentage of those participants screened for HCV, Who hace a positive RNA HCV test using a Genexpret test onsite.
1 year
Percentage of Participants Who have a positive HIV rapid test
Time Frame: 1 year
Percentage of those participants screened for HIV, Who hace a positive test
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who have an active HCV infection and start HCV therapy.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Infanta Leonor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2019

Primary Completion (ACTUAL)

March 15, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (ACTUAL)

August 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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