Clinical trial NCT04062253: Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
Official title: Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV Infection
HIV Infections
Drug Use
HBV (Hepatitis B Virus)
Viral Hepatitis
Keywords: HIV
HCV
PWID (Persons who inject drugs)
Screening
Diagnosis
Linkage to care
Treatment
Lead sponsor: Hospital Universitario Infanta Leonor
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 2001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.


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.

Primary outcomes:
measure: Percentage of Participants Who have a positive RNA HCV test
timeFrame: 1 year
measure: Percentage of Participants Who have a positive HIV rapid test
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Participants Who have an active HCV infection and start HCV therapy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Unidad Movil de Cribado
Study officials:
References: