STINot'ISTNCT04921618
Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers
An observational study of STI and Hiv, run by ANRS, Emerging Infectious Diseases at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 2 online self-administered questionnaires on
- How many people
- 2,200 participants
- Where
- 9 sitesFrance
- Study dates
- 12 Jul 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CeGIDD d'Aix-en-Provence
Aix-en-Provence
Dominique AYMAR-MOULENE, Dr, 04 13 31 84 69, dominique.aymarmoulene@departement13.fr
- Recruiting
CeGIDD de Caen
Caen
Caroline GALIMARD, Dr, 02 31 38 51 58, cpmi@fondation-misericorde.fr
- Recruiting
CeGIDD de Lille
Lille
Laetitia RANDOUX, Dr, 03 59 73 69 80, laetitia.randoux@lenord.fr
- Recruiting
CeGIDD - La Joliette
Marseille
Julie SAULE, Dr, 04 13 31 69 14, julie.saule@departement13.fr
- Recruiting
CeGIDD - Saint Adrien
Marseille
Jean-Luc ROBERT, Dr, 04 13 31 56 78, jeanluc.robert@departement13.fr
- Recruiting
CeGIDD de Bichât
Paris
Jade GHOSN, Pr, 01 40 25 84 34, jade.ghosn@aphp.fr
- Recruiting
CeGIDD de La Pitié Salpêtrière
Paris
Gentiane MONSEL, Dr, 01 42 17 70 12, gentiane.monsel@aphp.fr
- Recruiting
Centre de santé sexuelle - LE 190
Paris
Michel OHAYON, Dr, 01 55 25 32 72, mohayon@le190.fr
- Recruiting
Institut Alfred Fournier
Paris
William TOSINI, Dr, 01 40 78 26 00, william.tosini@institutfournier.org
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- 2 online self-administered questionnaires on
- Keywords
- partner notification, STI, HIV, testing center, intervention design
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 online self-administered questionnaires onOther
- Participant profile
- Spontaneous partner notification practices collected one month after STIs diagnosis
2 online self-administered questionnaires onOther
- Participant profile
- Experiences with partner notification and use of STI testing following notification
| Study group | Role | What they receive |
|---|---|---|
| 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)] Receives: Other: 2 online self-administered questionnaires on | |
| 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] Receives: Other: 2 online self-administered questionnaires on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partner notification by index patients
Proportion of index patients who notified at least one sexual partner one month after their STI diagnosis
Measured: One month after STI diagnosis
Secondary outcomes (2)
Partners notified by index patients
Mean proportion of notified partners among partners reported by index patients
Measured: One month after STI diagnosis
Notified partners tested positive
Proportion of notified partners tested positive among notified partners attending STI testing
Measured: At notified partners inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start12 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STIStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jade Ghosn, Pr, Principal investigator, IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, ParisKaren Champenois, Principal investigator, IAME, Inserm UMR1137, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921618
- Sponsor's protocol ID
- ANRS MIE Not'IST
- Acronym
- Not'IST
- Status last verified
- Jul 2022
- First submitted
- 27 Apr 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04921618
- Acronym / sponsor ID
- Not'IST / ANRS MIE Not'IST
- Keywords
- partner notification, STI, HIV, testing center, intervention design
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index patients | – | Other: 2 online self-administered questionnaires onPeople aged 18 or more diagnosed with >= 1 STI in testing centers. [STI = bacterial STIs and/or HIV and/or acute hepatitis C virus (HCV)] |
| Notified partners | – | Other: 2 online self-administered questionnaires onPeople 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] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 online self-administered questionnaires on1. Participant profile 2. Spontaneous partner notification practices collected one month after STIs diagnosis | Other | Index patients |
| 2 online self-administered questionnaires on1. Participant profile 2. Experiences with partner notification and use of STI testing following notification | Other | Notified partners |
Primary outcome
Partner notification by index patients
Time frame: One month after STI diagnosis
Proportion of index patients who notified at least one sexual partner one month after their STI diagnosis
2 secondary outcomes
Partners notified by index patients
Time frame: One month after STI diagnosis
Notified partners tested positive
Time frame: At notified partners inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CeGIDD d'Aix-en-Provence
Aix-en-Provence, France
Jade Ghosn, Pr principal investigator
IAME, Inserm UMR1137, Paris and Infectious diseases department, Bichat Hospital, Paris
Karen Champenois principal investigator
IAME, Inserm UMR1137, Paris
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STI and Hiv, run by ANRS, Emerging Infectious Diseases at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partner notification by index patients (time frame: One month after STI diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.