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

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.

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.

Study Overview

• Status: Unknown
• Conditions: HIV Seropositivity; AIDS
• Intervention / Treatment: Behavioral: Focus group; Behavioral: Individual interview; Behavioral: self questionnaire; Behavioral: online 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.

• Study Type: Observational
• Enrollment (Anticipated): 1190

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hôpital Saint-Antoine
  • Paris, France, 75651
    • Hôpital Pitié-Salpétrière
  • Paris, France, 75003
    • Le 190
  • Paris, France, 75876
    • Hopital Bichat Claude-Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

MSM: men who have sex with men.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-representational elements associated with the very late use of the HIV test	Imbrication of representations and tests related to HIV	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Means of risk management	Use of screening in the management of the risk of seroconversion	3 years
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
Sense of community belonging	Understand the interaction links between community belonging and the use of the screening test.	3 years

Collaborators and Investigators

• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: University of Lyon
• Investigators: Principal Investigator: Marie Préau, PR, Université Lumière Lyon 2

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: MSM population; Hindrances HIV screening; Late recourse HIV test; Healt social psychology
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: ANRS ReTarD VIH; 2018-A00825-50 (Other Identifier: French FDA Registration Number (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No