NCT05123547

Brief Summary

This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 18, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

October 18, 2021

Last Update Submit

May 18, 2022

Conditions

Keywords

HIVDental care

Outcome Measures

Primary Outcomes (1)

  • description of oral disease linked to HIV or not.

    percentage of patients with oral disease linked to HIV and percentage of patients with oral disease not linked to HIV

    During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

Secondary Outcomes (4)

  • Study the factors associated with the presence of oral pathologies linked to HIV.

    During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

  • Study the factors associated with the presence of oral pathologies unrelated to HIV.

    During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

  • Compare the prevalence of oral pathologies linked or not to HIV with that found in a previous study carried out in 2003.

    During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

  • List the course of dental care of these people during the last 3 years.

    During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand

Eligibility Criteria

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

people living with HIV

You may qualify if:

  • Adult patient infected with HIV or co-infected with HIV / HBV or HIV / HCV followed in the Infectious Diseases department of Clermont-Ferrand University Hospital and affiliated to a social security scheme.

You may not qualify if:

  • Minor patient
  • Adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Christine JACOMET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 18, 2021

First Posted

November 17, 2021

Study Start

October 21, 2021

Primary Completion

April 21, 2022

Study Completion

April 21, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations