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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03661203
Other study ID # ANRS ReTarD VIH
Secondary ID 2018-A00825-50
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2020
Est. completion date March 2022

Study information

Verified date January 2020
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact Marie Préau, PR
Phone +33 4 78 77 31 63
Email marie.preau@univ-lyon2.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The late recourse to HIV testing, among the population in general way and among MSM population in a more specific way, participates in the dissemination of the HIV epidemic. Actually, there is no cure for HIV infection, but treatments that reduce viral charge to undetectable level exists. When diagnosed and treated earlier, seropositive people will be less communicating the virus because of the reduction of their viral charge.

This study aims to uncover the reasons behind the late recourse to HIV testing in MSM population facing a high risk of contamination.

The study hypothesis, is that late recourse to HIV testing is probably related to social and economics factors like age, social standing, accessibility to the diagnosis or even to a traditional beliefs or a fear of stigma etc. To shed the light on these factors, the main objectives of the investigator will try to investigate and analyze the psycho-social hindrances and levers through a quantitative and qualitative approach. This plurality of approaches is a part of a methodological triangulation method described by Kalampalikis & Apostolidis, 2016.

People among MSM community having had a late or very late HIV test (as defined by biological parameters :CD4≤200/mm3 or having been diagnosed with AIDS), will be recruited in this study. During the first phase of the study, the eligible population will participate to individual or group interview . This qualitative part of the project will allow the set up of a questionnaire that will be diffused widely to the MSM community to have quantitative results.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1190
Est. completion date March 2022
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Primary infection

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Focus group
Focus group for qualitative group only
Individual interview
Individual interview for qualitative group only
online self questionnaire
online self questionnaire
self questionnaire
online self questionnaire following focus group or individual interview For qualitative group only

Locations

Country Name City State
France Hôpital Bichat Claude-Bernard Paris
France Hôpital Pitié-Salpêtrière Paris
France Hopital Saint-Antoine Paris
France Le 190 Paris

Sponsors (2)

Lead Sponsor Collaborator
French National Agency for Research on AIDS and Viral Hepatitis University of Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Socio-representational elements associated with the very late use of the HIV test Imbrication of representations and tests related to HIV 3 years
Secondary Means of risk management Use of screening in the management of the risk of seroconversion 3 years
Secondary Representation and Knowledge of prevention methods To understand the links between the different uses or non-uses of the biomedical prevention methods TasP (Treatment as Prevention), PrEP (Pre-Exposure Prohylaxis) and the methods of recourse to the screening test. 3 years
Secondary Sense of community belonging Understand the interaction links between community belonging and the use of the screening test. 3 years
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