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

NCT ID: NCT04062253

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2001 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-03-15

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.

Conditions

HCV Infection; HIV Infections; Drug Use; HBV (Hepatitis B Virus); Viral Hepatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

HCV or HIV negative

Individuals who test negative for HCV or HIV are given information regarding ways of transmission.

HCV rapid test

Intervention Type: DIAGNOSTIC_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.

HCV and HIV positive

Individuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care.

HCV rapid test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

HIV rapid test; Xpert HCV viral load; Xpert HIV viral load; Linkage to care

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: lead

Responsible Party

Pablo Ryan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Unidad Movil de Cribado

Madrid, , Spain

Countries

Spain

Related Links

http://unidadmovil.es

Itineraries and schedules of the project.

Other Identifiers

19/05

Identifier Type: -

Identifier Source: org_study_id