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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03546140
Other study ID # Care_ChemS_ClinC -001-2017
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2018
Est. completion date June 2021

Study information

Verified date June 2018
Source Fundacion Clinic per a la Recerca Biomédica
Contact Anna Cruceta, MD
Phone 932275400
Email acruceta@clinic.ub.es
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Clinic per a la Recerca Biomédica

Outcome

Type Measure Description Time frame Safety issue
Primary Number of HIV, HIV positive serology 2 years
Primary number of HCV seroconversion HCV positive serology 2 years
Primary number STD seroconversion positive serology 2 years
Secondary type of consumer drug number and name ( Visual Analog Score for drug) 2 years
Secondary clinical outcomes number of hospital admissions for acute intoxications 2 years
Secondary analytical outcomes VDRL serology 2 years
Secondary analytical outcomes PCR CT/GN(pharynx / urethra / anus) 2 years
Secondary weight in kilograms 2 years
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