Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04921618
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2021-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Not'IST
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: