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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062253
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pablo Ryan, Hospital Universitario Infanta Leonor

Brief Summary:

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.


Condition or disease Intervention/treatment
HCV Infection HIV Infections Drug Use HBV (Hepatitis B Virus) Viral Hepatitis Diagnostic Test: HCV rapid test

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Percentage of Participants Who have an active HCV infection and start HCV therapy. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062253


Contacts
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Contact: Pablo Ryan, PhD 0034616832148 pabloryan@gmail.com

Locations
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Spain
Unidad Movil de Cribado Recruiting
Madrid, Spain
Contact: Pablo Ryan Murua    0034616832148 ext 0034616832148    pabloryan@gmail.com   
Contact: Pablo Ryan    0034616832148 ext 0034616832148    pabloryan@gmail.com   
Sponsors and Collaborators
Hospital Universitario Infanta Leonor

Additional Information:
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Responsible Party: Pablo Ryan, Principal Investigator, Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier: NCT04062253    
Other Study ID Numbers: 19/05
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pablo Ryan, Hospital Universitario Infanta Leonor:
HIV
HCV
PWID (Persons who inject drugs)
Screening
Diagnosis
Linkage to care
Treatment
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections