Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers
NCT ID: NCT04921618
Last Updated: 2022-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2200 participants
OBSERVATIONAL
2021-07-12
2022-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Index patients
People aged 18 or more diagnosed with \>= 1 STI in testing centers.
\[STI = bacterial STIs and/or HIV and/or acute hepatitis C virus (HCV)\]
2 online self-administered questionnaires on
1. Participant profile
2. Spontaneous partner notification practices collected one month after STIs diagnosis
Notified partners
People aged 18 or more getting STI testing in testing centers after being notified by a sexual partner.
\[STI = bacterial STIs and/or HIV and/or acute HCV\]
2 online self-administered questionnaires on
1. Participant profile
2. Experiences with partner notification and use of STI testing following notification
Interventions
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2 online self-administered questionnaires on
1. Participant profile
2. Spontaneous partner notification practices collected one month after STIs diagnosis
2 online self-administered questionnaires on
1. Participant profile
2. Experiences with partner notification and use of STI testing following notification
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Jade Ghosn, Pr
Role: PRINCIPAL_INVESTIGATOR
IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris
Karen Champenois
Role: PRINCIPAL_INVESTIGATOR
IAME, Inserm UMR1137, Paris
Locations
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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, , France
Countries
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Facility Contacts
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Other Identifiers
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ANRS MIE Not'IST
Identifier Type: -
Identifier Source: org_study_id
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