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

Completed

• Conditions: HBV (Hepatitis B Virus); HCV Infection; HIV Infections; Drug Use; Viral Hepatitis
• Interventions: Diagnostic Test: HCV rapid test

• Registration Number: NCT04062253
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-15
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2001

Inclusion Criteria

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

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

Read More

Exclusion Criteria

• Not signing inform consent.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV or HIV negative	HCV rapid test	Individuals who test negative for HCV or HIV are given information regarding ways of transmission.
HCV and HIV positive	HCV rapid test	Individuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who have a positive RNA HCV test	1 year	Percentage of those participants screened for HCV, Who hace a positive RNA HCV test using a Genexpret test onsite.
Percentage of Participants Who have a positive HIV rapid test	1 year	Percentage of those participants screened for HIV, Who hace a positive test

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who have an active HCV infection and start HCV therapy.	1 year

Trial Locations

Locations (1)

Unidad Movil de Cribado; 🇪🇸 Madrid, Spain