Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers (Not'IST)

July 22, 2022 updated by: ANRS, Emerging Infectious Diseases

Towards Improving Information, Testing and Treatment for Partners of People Diagnosed With STIs in Testing Centres and Sexual Health Clinics, the Not'IST Study

Since the 2000s, the incidence of bacterial STIs increases, mainly among men who have sex with men but also among heterosexual men and women with multiple sexual partners. A partner notification (PN) approach could break transmission chains and curb STI epidemics. PN brings together a set of interventions to help people diagnosed with STIs to inform their partners, encourage them to get tested, so that they can access treatment or prevention. A PN approach, systematically offered at STI diagnosis, has not yet been implemented in France and needs to be evaluated. In 2018, the Conseil National du Sida (French National AIDS Council) stated in favor of a formalized PN approach, particularly in testing centers, which carry out a large part of STI diagnoses.

The aim of our research project is to build interventions facilitating information, testing and treatment of partners of people diagnosed with STIs in testing centers and sexual health clinics.

Step 1: A cross-sectional study

Primary objective

To describe the PN practices of people diagnosed with an STI in testing centers and sexual health clinics without any intervention

Secondary objectives

  • To describe the profiles of people diagnosed with an STI in testing centers or sexual health clinics and therefore likely to receive an intervention to help them notify their partners;
  • To describe the profiles of people notified by their partners and who attend testing centers or sexual health clinics for STI testing;
  • To describe the notification received by these notified partners and identify the facilitators of testing use following notification.

Step 2: A qualitative study

Objectives

  • To evaluate the acceptability of testing center staff for an STI notification program in general and discuss the feasibility of interventions pre-identified by a literature review;
  • In a collaborative (researchers and staffs) approach, to adapt these interventions to (1) the testing centers working and (2) the needs of their users identified in the cross-sectional study.

Expected results

This study is the first step in implementation of a PN program as part of a comprehensive management of STI diagnoses in France.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods

Step 1: A cross-sectional study

Cross-sectional study conducted in testing centers and sexual health clinics (6 centers, 6 months of enrollment), targeting two populations:

  • People aged 18 years or more diagnosed for at least one STI: the index patients;
  • People aged 18 years or more attending the same centers for STI testing after being notified by a sexual partner: the notified partners.

This study is based on 3 online self-administered questionnaires:

  • A questionnaire, the same for index patients and notified partners, collecting socio-demographic profile, health care and testing use, STI history and sexual behavior;
  • A questionnaire for index patient on spontaneous PN practices of index patients one month after STI diagnosis, including types of partners notified, methods used to notify, and reasons for not notifying partners (this questionnaire will be sent one month after STI diagnosis to give participants the time to inform their partners);
  • A questionnaire for notified partner on their experience of PN, such as the type of notifying partner, the methods and information transmitted during notification, their feelings and what led them to get testing after being notified.

A notified partner diagnosed with an STI will receive also the questionnaire on spontaneous practices of index patients at M1. This will allow us to observe whether people who had already been notified for an STI are more likely to notify their partners.

Step 2: A qualitative study

Focus-groups of 6-8 volunteers involved in STI testing in testing centers and sexual health clinics will be conducted based on an interview guide. Doctors and other staffs will be interviewed separately.

Thematic analysis

Study Type

Observational

Enrollment (Anticipated)

2200

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
      • Aix-en-Provence, France
      • Caen, France
      • Lille, France
      • Marseille, France
      • Marseille, France
      • Paris, France
        • Recruiting
        • CeGIDD de Bichât
        • Contact:
      • Paris, France
        • Recruiting
        • CeGIDD de La Pitié Salpêtrière
        • Contact:
      • Paris, France
        • Recruiting
        • Centre de santé sexuelle - LE 190
        • Contact:
      • Paris, France

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Two distinct populations will be studied

  • People diagnosed with >= 1 STI in testing centers or sexual health clinics: index patients,
  • People attenting testing centers or sexual health clinics for STI testing and/or access to treatment following notification of possible exposure to an STI by one of their partners: notified partners.

Index patients and notified partners will be included on a voluntary basis. The study will be offered to all eligible individuals during the study period.

Description

Inclusion Criteria:

For index patients

  • Diagnosed with at least one bacterial STI, and/or HIV and/or acute HCV at one of the participating centers during the study period,
  • Aged >= 18,
  • Agree to participate in the study after oral and written information.

For notified partners

  • Attend one of the participating centers during the study period, within 6 months of being notified of their exposure to an STI (bacterial STI, and/or HIV and/or acute HCV) by one of their partners, who is infected with one or more of these STIs,
  • Aged >= 18,
  • Agree to participate in the study after oral and written information.

Non-Inclusion Criteria:

For index patients and notified partners

  • People who do not read or speak French,
  • Wardship or curatorship adults.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Index patients

People aged 18 or more diagnosed with >= 1 STI in testing centers.

[STI = bacterial STIs and/or HIV and/or acute hepatitis C virus (HCV)]
Other: 2 online self-administered questionnaires on
  1. Participant profile
  2. Spontaneous partner notification practices collected one month after STIs diagnosis
Other: 2 online self-administered questionnaires on
  1. Participant profile
  2. Experiences with partner notification and use of STI testing following notification
Notified partners

People aged 18 or more getting STI testing in testing centers after being notified by a sexual partner.

[STI = bacterial STIs and/or HIV and/or acute HCV]
Other: 2 online self-administered questionnaires on
  1. Participant profile
  2. Spontaneous partner notification practices collected one month after STIs diagnosis
Other: 2 online self-administered questionnaires on
  1. Participant profile
  2. Experiences with partner notification and use of STI testing following notification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partner notification by index patients
Time Frame: One month after STI diagnosis
Proportion of index patients who notified at least one sexual partner one month after their STI diagnosis
One month after STI diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partners notified by index patients
Time Frame: One month after STI diagnosis
Mean proportion of notified partners among partners reported by index patients
One month after STI diagnosis
Notified partners tested positive
Time Frame: At notified partners inclusion
Proportion of notified partners tested positive among notified partners attending STI testing
At notified partners inclusion

Collaborators and Investigators

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

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Jade Ghosn, Pr, IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris
  • Principal Investigator: Karen Champenois, IAME, Inserm UMR1137, Paris

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)

July 12, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANRS MIE Not'IST

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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