Hepatitis CNCT06847958
HepC Micro-elimination on MSM and TGW Population.
An observational study of Hepatitis C and PrEP, run by Projecte dels NOMS Hispanosida at 1 site in Spain.
Trial summary
This is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for Hepatitis C will be offered. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, PrEP, Drugs of Abuse
- How many people
- 13,161 participants
- Where
- 1 siteSpain
- Study dates
- 23 Aug 2021to 30 Sep 2023
- How long will I take part?
- 2 Years
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men who have sex with other men or transgender women, that are HIV negative and comes to get tested in our center or are under controls in our center. Estimated enrollment first Phase 6000-7000 participants. Second phase 2000-3000 participants.
Who may be able to join
- All BCN Checkpoint and BCN PreP·Point clients.
- 18 years and older.
- HIV uninfected or diagnosticated in the center in the last 7 days prior to the study inclusion.
- Men that have sex with men or transgender women.
- Signature of written consent form.
- Ability to comply with the requirements of the study protocol.
Who cannot join
- Knowledge of HIV infection from more than 7 days
- Knowledge of active HCV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HepC Micro-elimination on MSM Comunity
This is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for Hepatitis C will be offered. Depending on the score obtained in the questionnaire, the screening will be carried out using a rapid serology test or viral load. During the first year, a SCORE will be developed to classify the risk of positive results. This SCORE will be used during phase 2 to offer users of the centres a targeted screening based on the Pre-test score.
- Conditions
- Hepatitis C, PrEP, Drugs of Abuse
- Keywords
- MSM, TGW, PrEP, Hepatitis C Transmision, micro-elimination
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MSM and TGW HIV negative PrEP User. | Not described | |
| MSM and TGW HIV negative non PrEP User. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C active infection
Confirmed Hepatitis C active infection
Measured: August 2021 o September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start23 Aug 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Prospective
- Enrolment
- 13,161 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Projecte dels NOMS Hispanosida
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Lluita contra les Infeccions, Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847958
- Sponsor's protocol ID
- MSM-HCV-MicroElimination
- Other IDs
- IN-ES-987-5997, PI-21-206
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data requisition will be individually evaluated. After that IEC will be required to evaluate data sharing.
Publications
Rivero A, Dalmau-Bueno A, Perez F, Coll P, Cabrera JM, Lucejko M, Fernandez J, Reguant J, Calderon J, Romero J, Caballero F, Marazzi G, Oro C, Michael Jacobs D, Vicioso H, Moises L, Taboada H, Saz J, Pujol F, Meulbroek M, Paredes R. HCV infection, risk factors and PrEP use among HIV-negative MSM and TW at a community health centre. J Infect Public Health. 2026 Feb;19(2):103086. doi: 10.1016/j.jiph.2025.103086. Epub 2025 Dec 4.
PubMed 41380408
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepC Micro-elimination on MSM Comunity
- ClinicalTrials.gov ID
- NCT06847958
- Acronym / sponsor ID
- MSM-HCV-MicroElimination
- Conditions
- Hepatitis C, PrEP, Drugs of Abuse
- Keywords
- MSM, TGW, PrEP, Hepatitis C Transmision, micro-elimination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,161 participants (actual)
- Lead sponsor
- Projecte dels NOMS HispanosidaUniversity, hospital or other
- Collaborators
- Fundació Lluita contra les Infeccions, Germans Trias i Pujol Hospital
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Feb 2025 (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.
This is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for Hepatitis C will be offered. Depending on the score obtained in the questionnaire, the screening will be carried out using a rapid serology test or viral load. During the first year, a SCORE will be developed to classify the risk of positive results. This SCORE will be used during phase 2 to offer users of the centres a targeted screening based on the Pre-test score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSM and TGW HIV negative PrEP User. | – | – |
| MSM and TGW HIV negative non PrEP User. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have sex with other men or transgender women, that are HIV negative and comes to get tested in our center or are under controls in our center. Estimated enrollment first Phase 6000-7000 participants. Second phase 2000-3000 participants.
Key inclusion criteria (6 listed)
- All BCN Checkpoint and BCN PreP·Point clients.
- 18 years and older.
- HIV uninfected or diagnosticated in the center in the last 7 days prior to the study inclusion.
- Men that have sex with men or transgender women.
- Signature of written consent form.
Key exclusion criteria (2 listed)
- Knowledge of HIV infection from more than 7 days
- Knowledge of active HCV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatitis C active infection
Time frame: August 2021 o September 2023
Confirmed Hepatitis C active infection
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 26 Feb 2025.
- Derived from this study: PubMed 41380408Rivero A, Dalmau-Bueno A, Perez F, Coll P, Cabrera JM, Lucejko M, Fernandez J, Reguant J, Calderon J, Romero J, Caballero F, Marazzi G, Oro C, Michael Jacobs D, Vicioso H, Moises L, Taboada H, Saz J, Pujol F, Meulbroek M, Paredes R. HCV infection, risk factors and PrEP use among HIV-negative MSM and TW at a community health centre. J Infect Public Health. 2026 Feb;19(2):103086. doi: 10.1016/j.jiph.2025.103086. Epub 2025 Dec 4.
- Individual participant dataSharing planned: Yes. Data requisition will be individually evaluated. After that IEC will be required to evaluate data sharing.
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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 Hepatitis C and PrEP, run by Projecte dels NOMS Hispanosida 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 6 inclusion and 2 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 26 Feb 2025. 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?
Hepatitis C active infection (time frame: August 2021 o September 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847958, which also lists 1 linked publication.
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 26 Feb 2025.