NCT03671291

Brief Summary

Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
596

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2021

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

September 5, 2018

Last Update Submit

April 8, 2026

Conditions

Virus-HIV

Keywords

VIHPrEPrisk factorsPreventionAccess to care

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients eligible for PrEP at the time of HIV infection

    Quantify and describe among newly diagnosed people with HIV the missed opportunities for PrEP treatment for HIV infection prevention

    The needed time to answer to the questionnaire : 40 min to 1 hour.

Secondary Outcomes (4)

  • Taking a risky behaviour for HIV infection

    The needed time to answer to the questionnaire : 40 min to 1 hour.

  • Awareness and level of knowledge of the PrEP strategy

    The needed time to answer to the questionnaire : 40 min to 1 hour.

  • Access to care

    The needed time to answer to the questionnaire : 40 min to 1 hour.

  • Availability of PrEP

    The needed time to answer to the questionnaire : 40 min to 1 hour.

Study Arms (1)

Recently infected with HIV

EXPERIMENTAL

Men and women recently infected with HIV and have been eligible for PrEP based on the recommendation of french national regulatory agency regarding the prescription of Truvada® in prophylaxis to HIV exposure. The potential reasons behind these missed opportunity of Pre-exposure prophylaxis will be studied through a self-administrated questionnaire.

Behavioral: self-administrated questionnaire

Interventions

self-administrated questionnaireBEHAVIORAL

Persons who the biological parameters or past screening show that they were recently infected with HIV cf. eligibility criteria, will, after obtaining his consent, answer a series of questions through a self-administrated questionnaire that will take approximately 40 minutes.

Recently infected with HIV

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Understanding and speaking French
  • Affiliated in or beneficiary of a Social Security (excluding State Medical Aid or AME that aren't considered as Social Security coverage)
  • Men and women with a diagnosis of HIV infection known for less than three months and with recent HIV infection established on:
  • a diagnostic confirmation test by Western Blot (WB) or Immuno Blot showing incomplete pattern.
  • OR Previous HIV negative screening test performed within 6 months of diagnosis.

You may not qualify if:

  • Less than 18 years old
  • Unable to understand French
  • Not affiliated to a social security coverage
  • Under guardianship or under curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

Marseille, 13009, France

Location

Related Publications (1)

  • Lions C, Laroche H, Mora M, Pialoux G, Cotte L, Cua E, Piroth L, Molina JM, Salnikova M, Maradan G, Poizot-Martin I, Spire B. Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study. HIV Med. 2023 Feb;24(2):191-201. doi: 10.1111/hiv.13367. Epub 2022 Aug 9.

    PMID: 35943165RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Isabelle Poizot-Martin, Dr

    Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 14, 2018

Study Start

April 3, 2019

Primary Completion

October 3, 2020

Study Completion

October 3, 2021

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

FR(1)