NCT03661203

Brief Summary

The present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late HIV testing among the MSM population. This study is divided in two parts. The first one will consist of individual and groups interviews. Then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. Finally, a questionnaire build from the collected information will be sent to MSM community in order to obtain quantitative results.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,190

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

4 active sites

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

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 8, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

September 5, 2018

Last Update Submit

July 7, 2020

Conditions

AIDSHIV Seropositivity

Keywords

MSM populationHindrances HIV screeningLate recourse HIV testHealt social psychology

Outcome Measures

Primary Outcomes (1)

  • Socio-representational elements associated with the very late use of the HIV test

    Imbrication of representations and tests related to HIV

    3 years

Secondary Outcomes (3)

  • Means of risk management

    3 years

  • Representation and Knowledge of prevention methods

    3 years

  • Sense of community belonging

    3 years

Study Arms (2)

Qualitative cohort

The cohort consists of MSM with late HIV diagnosis. The person from this cohort will participate to round table called also focus group or individual interview.

Behavioral: Focus groupBehavioral: Individual interviewBehavioral: self questionnaire

Quantitative cohort

MSM community will be invited to participate to an online self questionnaire established from the information gathered from the previous cohort.

Behavioral: online self questionnaire

Interventions

Focus groupBEHAVIORAL

Focus group for qualitative group only

Qualitative cohort
Individual interviewBEHAVIORAL

Individual interview for qualitative group only

Qualitative cohort
online self questionnaireBEHAVIORAL

online self questionnaire

Quantitative cohort
self questionnaireBEHAVIORAL

online self questionnaire following focus group or individual interview For qualitative group only

Qualitative cohort

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-determination
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSM: men who have sex with men.

You may qualify if:

  • HIV-positive
  • Self-reported homo-or bisexual contamination mode
  • TCD4 + / mm3 200 200 lymphocyte count or Have an AIDS classifying event
  • Diagnosis of HIV positive for at least two months and for a maximum of 24 months

You may not qualify if:

  • Primary infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Le 190

Paris, 75003, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75651, France

Location

Hôpital Bichat Claude-Bernard

Paris, 75876, France

Location

Related Publications (1)

  • Mabire-Yon R, Di Ciaccio M, Picard H, Palich R, Supervie V, Preau M. Psychosocial factors involved in the very infrequent use of HIV testing among French MSM: a cross-sectional study. Int J STD AIDS. 2023 Aug;34(9):603-607. doi: 10.1177/09564624231155762. Epub 2023 Feb 16.

    PMID: 36798044DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Seropositivity

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie Préau, PR

    Université Lumière Lyon 2

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Préau, PR

CONTACT

+33 4 78 77 31 63marie.preau@univ-lyon2.fr

Study Design

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

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

July 8, 2020

Record last verified: 2020-01

Locations

FR(4)