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Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM (ReTarD)

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ClinicalTrials.gov Identifier: NCT03661203
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
University of Lyon
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )

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.


Condition or disease Intervention/treatment
AIDS HIV Seropositivity Behavioral: Focus group Behavioral: Individual interview Behavioral: online self questionnaire Behavioral: self questionnaire

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 1190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Issue of Late Recourse to HIV Testing. A Study of the Psychosocial Factors at Play Within Men Who Have Sex With Men in France.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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 group
Focus group for qualitative group only

Behavioral: Individual interview
Individual interview for qualitative group only

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

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
online self questionnaire




Primary Outcome Measures :
  1. Socio-representational elements associated with the very late use of the HIV test [ Time Frame: 3 years ]
    Imbrication of representations and tests related to HIV


Secondary Outcome Measures :
  1. Means of risk management [ Time Frame: 3 years ]
    Use of screening in the management of the risk of seroconversion

  2. Representation and Knowledge of prevention methods [ Time Frame: 3 years ]
    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. Sense of community belonging [ Time Frame: 3 years ]
    Understand the interaction links between community belonging and the use of the screening test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-determination
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSM: men who have sex with men.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661203


Contacts
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Contact: Marie Préau, PR +33 4 78 77 31 63 marie.preau@univ-lyon2.fr

Locations
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France
Le 190 Not yet recruiting
Paris, France, 75003
Contact: Michel Ohayon, DM    +331 48 04 30 34    mohayon@le190.fr   
Hopital Saint-Antoine Not yet recruiting
Paris, France, 75012
Contact: Jessica Krause, DM    +331 71 97 07 83    jessica.krause@aphp.fr   
Hôpital Pitié-Salpêtrière Not yet recruiting
Paris, France, 75651
Contact: Romain Palich, DM    +331.42.16.01.19    romain.palich@aphp.fr   
Hôpital Bichat Claude-Bernard Not yet recruiting
Paris, France, 75876
Contact: Roland Landman, DM    +331 40 25 88 93    landman.roland@gmail.com   
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
University of Lyon
Investigators
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Principal Investigator: Marie Préau, PR Université Lumière Lyon 2

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Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT03661203     History of Changes
Other Study ID Numbers: ANRS ReTarD VIH
2018-A00825-50 ( Other Identifier: French FDA Registration Number (ANSM) )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ):
MSM population
Hindrances HIV screening
Late recourse HIV test
Healt social psychology

Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases