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

May 9, 2022 updated by: Tourcoing Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tourcoing, France
        • Ch Tourcoing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PrEP patients undergoing follow-up at Tourcoing hospital
Other: Questionnaire
Questionnaire

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourcoing Hospital

Investigators

  • Principal Investigator: Agnes Meybeck, MD, Ch Tourcoing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Actual)

March 16, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH_2020_10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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