Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers

NCT04921618 | Unknown

• 1 other identifier: ANRS MIE Not'IST
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

STI; Hiv

Keywords

partner notification; STI; HIV; testing center; intervention design

Outcome Measures

Primary Outcomes (1)

• Partner notification by index patients

  Proportion of index patients who notified at least one sexual partner one month after their STI diagnosis

  One month after STI diagnosis

Secondary Outcomes (2)

• Partners notified by index patients

  One month after STI diagnosis

• Notified partners tested positive

  At notified partners inclusion

Study Arms (2)

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

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

Interventions

2 online self-administered questionnaires on OTHER

1. Participant profile 2. Spontaneous partner notification practices collected one month after STIs diagnosis

Index patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• For index patients and notified partners
• People who do not read or speak French,
• Wardship or curatorship adults.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (9)

CeGIDD d'Aix-en-Provence

Aix-en-Provence, France

RECRUITING

CeGIDD de Caen

Caen, France

RECRUITING

CeGIDD de Lille

Lille, France

RECRUITING

CeGIDD - La Joliette

Marseille, France

RECRUITING

CeGIDD - Saint Adrien

Marseille, France

RECRUITING

CeGIDD de Bichât

Paris, France

RECRUITING

CeGIDD de La Pitié Salpêtrière

Paris, France

RECRUITING

Centre de santé sexuelle - LE 190

Paris, France

RECRUITING

Institut Alfred Fournier

Paris, France

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jade Ghosn, Pr

  IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris

  PRINCIPAL INVESTIGATOR

• Karen Champenois

  IAME, Inserm UMR1137, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 10, 2021
• Study Start: July 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

FR (9)