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临床试验/NCT04062253
NCT04062253已完成不适用

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

Hospital Universitario Infanta Leonor1 个研究点 分布在 1 个国家目标入组 2,001 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,001
试验地点
1
主要终点
Percentage of Participants Who have a positive HIV rapid test

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Vulnerable populations who include one or more of the following:
  • Persons who inject drugs,
  • Homeless,
  • Sex workers

排除标准

  • Not signing inform consent.

结局指标

主要结局

Percentage of Participants Who have a positive HIV rapid test

时间窗: 1 year

Percentage of those participants screened for HIV, Who hace a positive test

Percentage of Participants Who have a positive RNA HCV test

时间窗: 1 year

Percentage of those participants screened for HCV, Who hace a positive RNA HCV test using a Genexpret test onsite.

次要结局

  • Percentage of Participants Who have an active HCV infection and start HCV therapy.(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Ryan

Principal Investigator

Hospital Universitario Infanta Leonor

研究点 (1)

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