HIV Prevention During Chemsex | NCT03956758

Studies
HIV Prevention During Chemsex

NCT03956758

Sponsor

University Hospital, Montpellier

Status

Withdrawn

Last Update Posted

Nov 19, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Men Having Sex With Other Men

Interventions

Semi-directed interview

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Reclassification by Ethics Committee

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Apr 1, 2019Actual

First Submitted Date

May 16, 2019

First Submission Date that Met QC Criteria

May 16, 2019

First Posted Date

May 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. These practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. In the "PREVAGAY study" conducted in Montpellier in 2015, about 30% of MSM included said they had consumed at least one psychoactive product before or during sex during the last 12 months. In addition, this percentage was significantly higher among HIV-positive men (51% versus 24% of HIV-negative men) and 1% (N = 9) had practiced Slam (Sexual Injection). The results of this study also showed that PreP (Prophylaxis Pre-exposure to HIV) was known by 52% of MSM included and 4% (N = 4) had already used it in the last 12 months. Several observations are needed: many ChemSex users do not use the PreP despite the fact that its effectiveness has been proven in many studies.

The social sciences have been studying the HIV epidemic since its emergence. In the era of HIV chronic disease, the sociologist Gabriel Girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. Some contradictory logics explains this epidemiology of HIV which is maintained, particularly in Montpellier despite the arrival of the PreP.

The main objective of our study is to explore the reflexive logic structuring the report to HIV prevention by MSM practicing ChemSex in Montpellier, in the context of the appearance and dissemination of the PreP.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semi-directed interview	Other	Semi-directed interview on ChemSex practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
report to HIV	report to HIV contamination during Chemsex	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men who have sex with men (MSM)
living in Montpellier
using chemsex drugs at least one during sexual intercourse

Exclusion Criteria:

under 18 years
seropositive HIV

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

MSM living in Montpellier with negative HIV status, having at least one sexual intercourse under drug use during the last 12 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clemence GIRARD, Medical intern	University Hospital, Montpellier	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided