Clinical Trials

MainTitle

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 (Care_ChemS)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified June 2018 by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Sponsor
Fundacion Clinic per a la Recerca Biomédica


Information provided by (Responsible Party)
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

ClinicalTrials.gov Identifier
NCT03546140

First received: May 9, 2018
Last updated: June 4, 2018
Last Verified: June 2018
History of Changes
Purpose

Purpose

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

Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • type of consumer drug [ Time Frame: 2 years ]
    number and name ( Visual Analog Score for drug)
  • clinical outcomes [ Time Frame: 2 years ]
    number of hospital admissions for acute intoxications
  • analytical outcomes [ Time Frame: 2 years ]
    VDRL serology
  • analytical outcomes [ Time Frame: 2 years ]
    PCR CT/GN(pharynx / urethra / anus)
  • weight [ Time Frame: 2 years ]
    in kilograms

Biospecimen Retention: Samples With DNA
blood samples and fixed tissues

Estimated Enrollment: 500
Study Start Date: June 2018
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Men MSM that come from HIV, urgency service and other from the hospital and from a local ONG

Criteria

Inclusion Criteria:

  • 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
  • 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


Exclusion Criteria:
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03546140

Contacts

Contact:   Anna Cruceta, MD 932275400 ext 4380 acruceta@clinic.ub.es

Sponsors and Collaborators

Fundacion Clinic per a la Recerca Biomédica
More Information

More Information


Responsible Party: Anna Cruceta, Project manager Clinical Trials Unit, Fundacion Clinic per a la Recerca Biomédica  
ClinicalTrials.gov Identifier: NCT03546140   History of Changes  
Other Study ID Numbers: Care_ChemS_ClinC -001-2017  
Study First Received: May 9, 2018  
Last Updated: June 4, 2018  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.