NCT03123575

Brief Summary

This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 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

April 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

April 17, 2017

Last Update Submit

June 8, 2017

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

  • the number of Co-meds in HIV-infected individuals on ART

    number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender.

    6 months

  • number of Co-meds between the ART-treated population and HIV-uninfected

    the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

    6 months

  • prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals

    prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals, with description of the types of harm expected from each different potential CSDIs identified

    6 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ART-treated patients who picked up ARVs and of all HIV-uninfected individuals who picked up Co-meds in the study period.

You may qualify if:

  • patients who picked-up Co-meds in the study period

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Juan Berenguer, PhD

CONTACT

+34620038850jbb4@me.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 21, 2017

Study Start

June 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share