Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
(UMC)
1 other identifier
observational
2,001
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedFebruary 9, 2021
February 1, 2021
1.1 years
May 10, 2019
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who have a positive RNA HCV test
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
Percentage of those participants screened for HIV, Who hace a positive test
1 year
Secondary Outcomes (1)
Percentage of Participants Who have an active HCV infection and start HCV therapy.
1 year
Study Arms (2)
HCV or HIV negative
Individuals who test negative for HCV or HIV are given information regarding ways of transmission.
HCV and HIV positive
Individuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Vulnerable populations who include one or more of the following:
- Persons who inject drugs,
- Homeless,
- Migrants
- Sex workers
You may not qualify if:
- Not signing inform consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad Movil de Cribado
Madrid, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2019
First Posted
August 20, 2019
Study Start
February 15, 2019
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
February 9, 2021
Record last verified: 2021-02