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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04921618
Other study ID # ANRS MIE Not'IST
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date December 2022

Study information

Verified date July 2022
Source ANRS, Emerging Infectious Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 2200
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
2 online self-administered questionnaires on
Participant profile Spontaneous partner notification practices collected one month after STIs diagnosis
2 online self-administered questionnaires on
Participant profile Experiences with partner notification and use of STI testing following notification

Locations

Country Name City State
France CeGIDD d'Aix-en-Provence Aix-en-Provence
France CeGIDD de Caen Caen
France CeGIDD de Lille Lille
France CeGIDD - La Joliette Marseille
France CeGIDD - Saint Adrien Marseille
France CeGIDD de Bichât Paris
France CeGIDD de La Pitié Salpêtrière Paris
France Centre de santé sexuelle - LE 190 Paris
France Institut Alfred Fournier Paris

Sponsors (1)

Lead Sponsor Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Partners notified by index patients Mean proportion of notified partners among partners reported by index patients One month after STI diagnosis
Secondary Notified partners tested positive Proportion of notified partners tested positive among notified partners attending STI testing At notified partners inclusion
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