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)

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

Study Overview

• Status: Unknown
• Conditions: HIV

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Anna Cruceta, MD; Phone Number: 4380 932275400; Email: acruceta@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HIV,	HIV positive serology	2 years
number of HCV seroconversion	HCV positive serology	2 years
number STD seroconversion	positive serology	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: Care_ChemS_ClinC -001-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No