Impact of Containment and the Current Epidemic on the Sex... | NCT04772326

Studies
Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.

NCT04772326

Sponsor

Tourcoing Hospital

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

96Actual

Phase

Not provided

Conditions

PREP

Interventions

Questionnaire

Countries

France

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

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2021Actual

Primary Completion Date

Mar 16, 2022Actual

Completion Date

Sep 2022Estimated

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Feb 23, 2021

First Posted Date

Feb 26, 2021Actual

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

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

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

People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs.

Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows:

A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted.
An increase in sexual violence and the use of psychoactive substances.
An impact on PrEP monitoring and compliance.
An increase in the incidence of STIs when the confinement is lifted.

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

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PrEP patients undergoing follow-up at Tourcoing hospital			Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire	PrEP patients undergoing follow-up at Tourcoing hospital

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of the current epidemic on sexual risk taking of Prep users in the number of partners per month		At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the number of sexual encounters per month		At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the frequency of condom use during anal intercourse		At day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People using PrEP for HIV prevention being followed up at Tourcoing hospital
Having given their consent to participate in this study
Beneficiary of a social insurance plan or entitled person

Exclusion Criteria:

Minor patient
Refusal to participate
Trusteeship
Curatorship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study will be conducted in all persons using PrEP as prevention against HIV infection undergoing follow-up at Tourcoing Hospital and receiving counseling during months of inclusion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnes Meybeck, MD	CH TOURCOING	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Tourcoing		Tourcoing			France

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided