HCV Infection(UMC)NCT04062253
Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
An observational study of HCV Infection and HIV Infections, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HCV Infection, HIV Infections, Drug Use
- What is being tested?
- HCV rapid test
- How many people
- 2,001 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2019to 15 Mar 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Vulnerable populations who include one or more of the following:
- Persons who inject drugs,
- Homeless,
- Migrants
- Sex workers
Who cannot join
- Not signing inform consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- HCV rapid test
- Keywords
- HIV, HCV, PWID (Persons who inject drugs), Screening, Diagnosis, Linkage to care, Treatment
- Medical subject headings
- Hepatitis C, HIV Infections, Hepatitis B, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV rapid testDiagnostic test
Also called HIV rapid test, Xpert HCV viral load, Xpert HIV viral load, Linkage to care
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.
| Study group | Role | What they receive |
|---|---|---|
| HCV or HIV negative | Individuals who test negative for HCV or HIV are given information regarding ways of transmission. Receives: Diagnostic Test: HCV rapid test | |
| HCV and HIV positive | Individuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care. Receives: Diagnostic Test: HCV rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Percentage of Participants Who have a positive HIV rapid test
Percentage of those participants screened for HIV, Who hace a positive test
Measured: 1 year
Secondary outcomes (1)
Percentage of Participants Who have an active HCV infection and start HCV therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start15 Feb 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,001 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Ryan, Hospital Universitario Infanta Leonor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062253
- Sponsor's protocol ID
- 19/05
- Acronym
- (UMC)
- Status last verified
- Feb 2021
- First submitted
- 10 May 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
- ClinicalTrials.gov ID
- NCT04062253
- Acronym / sponsor ID
- (UMC) / 19/05
- Keywords
- HIV, HCV, PWID (Persons who inject drugs), Screening, Diagnosis, Linkage to care, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV or HIV negative | – | Diagnostic Test: HCV rapid testIndividuals who test negative for HCV or HIV are given information regarding ways of transmission. |
| HCV and HIV positive | – | Diagnostic Test: HCV rapid testIndividuals with a positive test for HCV o HIV are offered delivery or accompaniment to specialist health care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Vulnerable populations who include one or more of the following:
Key exclusion criteria (1 listed)
- Not signing inform consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCV rapid testAlso: HIV rapid test, Xpert HCV viral load, Xpert HIV viral load, Linkage to careIndividuals 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. | Diagnostic test | HCV and HIV positive, HCV or HIV negative |
Primary outcome
Percentage of Participants Who have a positive RNA HCV test
Time frame: 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
Time frame: 1 year
Percentage of those participants screened for HIV, Who hace a positive test
1 secondary outcome
Percentage of Participants Who have an active HCV infection and start HCV therapy.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Itineraries and schedules of the project.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV Infection and HIV Infections, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who have a positive RNA HCV test (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.