NCT03546140

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

May 9, 2018

Last Update Submit

June 4, 2018

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • type of consumer drug

    2 years

  • clinical outcomes

    2 years

  • analytical outcomes

    2 years

  • analytical outcomes

    2 years

  • weight

    2 years

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Drug use for another purposes not sexual
  • Drug use for having occasional sexual relations, least than once in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and fixed tissues

Central Study Contacts

Anna Cruceta, MD

CONTACT

932275400acruceta@clinic.ub.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project manager Clinical Trials Unit

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 6, 2018

Study Start

June 1, 2018

Primary Completion

August 1, 2020

Study Completion

June 1, 2021

Last Updated

June 6, 2018

Record last verified: 2018-06