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
