HIVCare_ChemSNCT03546140
Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex
An observational study of HIV, run by Fundacion Clinic per a la Recerca Biomédica.
Trial summary
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Men MSM that come from HIV, urgency service and other from the hospital and from a local ONG
Who may be able to join
- Adults (≥ 18 years)
- Men MSM/transgender referred from PEP office
- Men MSM/transgender referred from urgency service attended for acute intoxication or an STD
- Men MSM/transgender referred from STD office
- Men MSM/transgender referred from a local ONG attended for chemsex use
- Specifically drug use for having sexual relations, at least once in a month in the lasts 6 months or more than 10 times the last year
Show all 11Show fewer
- Reading and understanding ability
- Patients should be given written informed consent
- Negative HIV and HCV men
- HIV positive men but HIC negative referred from HIV daily hospital
- Disposal of sanitary card from CatSalut
Who cannot join
- Men that not accomplish inclusion criteria
- Drug use for another purposes not sexual
- Drug use for having occasional sexual relations, least than once in the past 6 months
Trial locations and contacts
No sites are listed yet.
About this study
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex
Read the detailed description
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group (MSM users of Chemsex) with the purpose of conduct diagnosis, early treatment and monitoring of this infections and reduce the incidence rate of the same ones
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV,
HIV positive serology
Measured: 2 years
number of HCV seroconversion
HCV positive serology
Measured: 2 years
number STD seroconversion
positive serology
Measured: 2 years
Secondary outcomes (5)
type of consumer drug
number and name ( Visual Analog Score for drug)
Measured: 2 years
clinical outcomes
number of hospital admissions for acute intoxications
Measured: 2 years
analytical outcomes
VDRL serology
Measured: 2 years
analytical outcomes
PCR CT/GN(pharynx / urethra / anus)
Measured: 2 years
weight
in kilograms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546140
- Sponsor's protocol ID
- Care_ChemS_ClinC -001-2017
- Acronym
- Care_ChemS
- Status last verified
- Jun 2018
- First submitted
- 9 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex
- ClinicalTrials.gov ID
- NCT03546140
- Acronym / sponsor ID
- Care_ChemS / Care_ChemS_ClinC -001-2017
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 Jun 2018 (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.
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex
Detailed description
The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group (MSM users of Chemsex) with the purpose of conduct diagnosis, early treatment and monitoring of this infections and reduce the incidence rate of the same ones
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men MSM that come from HIV, urgency service and other from the hospital and from a local ONG
Key inclusion criteria (11 listed)
- Adults (≥ 18 years)
- Men MSM/transgender referred from PEP office
- Men MSM/transgender referred from urgency service attended for acute intoxication or an STD
- Men MSM/transgender referred from STD office
- Men MSM/transgender referred from a local ONG attended for chemsex use
Key exclusion criteria (3 listed)
- Men that not accomplish inclusion criteria
- Drug use for another purposes not sexual
- Drug use for having occasional sexual relations, least than once in the past 6 months
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
Number of HIV,
Time frame: 2 years
HIV positive serology
number of HCV seroconversion
Time frame: 2 years
HCV positive serology
number STD seroconversion
Time frame: 2 years
positive serology
5 secondary outcomes
type of consumer drug
Time frame: 2 years
clinical outcomes
Time frame: 2 years
analytical outcomes
Time frame: 2 years
analytical outcomes
Time frame: 2 years
weight
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Fundacion Clinic per a la Recerca Biomédica.
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 11 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Cruceta, MD (932275400 ext. 4380, acruceta@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HIV, (time frame: 2 years). The study lists 3 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 6 Jun 2018.