NCT04772326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

February 23, 2021

Last Update Submit

May 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

PrEP patients undergoing follow-up at Tourcoing hospital

Other: Questionnaire

Interventions

Questionnaire

PrEP patients undergoing follow-up at Tourcoing hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Minor patient
  • Refusal to participate
  • Trusteeship
  • Curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Tourcoing

Tourcoing, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Agnes Meybeck, MD

    CH TOURCOING

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

February 16, 2021

Primary Completion

March 16, 2022

Study Completion

September 1, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations