Clinical trial NCT04921618: Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers
Official title: Towards Improving Information, Testing and Treatment for Partners of People Diagnosed With STIs in Testing Centres and Sexual Health Clinics, the Not'IST Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STI
Hiv
Keywords: partner notification
STI
HIV
testing center
intervention design
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2021-06-10
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Partner notification by index patients
timeFrame: One month after STI diagnosis
Secondary outcomes:
measure: Partners notified by index patients
timeFrame: One month after STI diagnosis
measure: Notified partners tested positive
timeFrame: At notified partners inclusion
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CeGIDD d'Aix-en-Provence
city: Caen
country: France
facility: CeGIDD de Caen
city: Lille
country: France
facility: CeGIDD de Lille
city: Marseille
country: France
facility: CeGIDD - La Joliette
city: Marseille
country: France
facility: CeGIDD - Saint Adrien
city: Paris
country: France
facility: CeGIDD de Bichât
city: Paris
country: France
facility: CeGIDD de La Pitié Salpêtrière
city: Paris
country: France
facility: Centre de santé sexuelle - LE 190
city: Paris
country: France
facility: Institut Alfred Fournier
Study officials:
affiliation: IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris
name: Jade Ghosn, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: IAME, Inserm UMR1137, Paris
name: Karen Champenois
role: PRINCIPAL_INVESTIGATOR
References: