AIDSReTarDNCT03661203
Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
An observational study of AIDS and HIV Seropositivity, run by French National Agency for Research on AIDS and Viral Hepatitis at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- AIDS, HIV Seropositivity
- What is being tested?
- Focus group, Individual interview and online self questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,190 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: MSM: men who have sex with men.
Who may be able to join
- 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
Who cannot join
- Primary infection
Trial locations and contacts
4 sites in 1 country.
France4 sites
Le 190
Paris, 75003
Michel Ohayon, DM, +331 48 04 30 34, mohayon@le190.fr
Hopital Saint-Antoine
Paris, 75012
Jessica Krause, DM, +331 71 97 07 83, jessica.krause@aphp.fr
Hôpital Pitié-Salpêtrière
Paris, 75651
Romain Palich, DM, +331.42.16.01.19, romain.palich@aphp.fr
Hôpital Bichat Claude-Bernard
Paris, 75876
Roland Landman, DM, +331 40 25 88 93, landman.roland@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- AIDS, HIV Seropositivity
- Being tested
- Focus group, Individual interview, online self questionnaire, self questionnaire
- Keywords
- MSM population, Hindrances HIV screening, Late recourse HIV test, Healt social psychology
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupBehavioural
Focus group for qualitative group only
Individual interviewBehavioural
Individual interview for qualitative group only
online self questionnaireBehavioural
online self questionnaire
self questionnaireBehavioural
online self questionnaire following focus group or individual interview For qualitative group only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Focus group; Behavioral: Individual interview; Behavioral: 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. Receives: Behavioral: online self questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-representational elements associated with the very late use of the HIV test
Imbrication of representations and tests related to HIV
Measured: 3 years
Secondary outcomes (3)
Means of risk management
Use of screening in the management of the risk of seroconversion
Measured: 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.
Measured: 3 years
Sense of community belonging
Understand the interaction links between community belonging and the use of the screening test.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startSep 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- University of Lyon
- Responsible party
- Sponsor
- Investigators
- Marie Préau, PR, Principal investigator, Université Lumière Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661203
- Sponsor's protocol ID
- ANRS ReTarD VIH
- Other IDs
- 2018-A00825-50
- Acronym
- ReTarD
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36798044
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03661203
- Acronym / sponsor ID
- ReTarD / ANRS ReTarD VIH
- Conditions
- AIDS, HIV Seropositivity
- Keywords
- MSM population, Hindrances HIV screening, Late recourse HIV test, Healt social psychology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,190 participants (estimated)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- University of Lyon
- Study start
- Sep 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative cohort | – | Behavioral: Focus group, Behavioral: Individual interview, Behavioral: self questionnaireThe 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. |
| Quantitative cohort | – | Behavioral: online self questionnaireMSM community will be invited to participate to an online self questionnaire established from the information gathered from the previous cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSM: men who have sex with men.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Primary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupFocus group for qualitative group only | Behavioural | Qualitative cohort |
| Individual interviewIndividual interview for qualitative group only | Behavioural | Qualitative cohort |
| online self questionnaireonline self questionnaire | Behavioural | Quantitative cohort |
| self questionnaireonline self questionnaire following focus group or individual interview For qualitative group only | Behavioural | Qualitative cohort |
Primary outcome
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
3 secondary outcomes
Means of risk management
Time frame: 3 years
Representation and Knowledge of prevention methods
Time frame: 3 years
Sense of community belonging
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 36798044Mabire-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Préau, PR principal investigator
Université Lumière Lyon 2
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS and HIV Seropositivity, run by French National Agency for Research on AIDS and Viral Hepatitis at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Préau, PR (+33 4 78 77 31 63, marie.preau@univ-lyon2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-representational elements associated with the very late use of the HIV test (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.