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

HIV Infections Clinical Trial

— (UMC)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062253
• Other study ID #: 19/05
• Status: Completed
• Start date: February 15, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2021
• Source: Hospital Universitario Infanta Leonor
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2001
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Drug Use
• HBV (Hepatitis B Virus)
• HCV Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections
• Infection
• Viral Hepatitis

Intervention

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.

Locations

Country	Name	City	State
Spain	Unidad Movil de Cribado	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Infanta Leonor

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants Who have an active HCV infection and start HCV therapy.		1 year

External Links

•   Itineraries and schedules of the project.