NotiHIV study : effectiveness of assisted partner notification after HIV discovery

Presentation of the NotiHIV study

What is the main objective of the study?

Among men who have sex with men (MSM) who discover their HIV-positive status (known as index patients), to assess the effectiveness of assisted partner notification procedures and, more specifically, to compare the effectiveness of two interventions: the provision of a digital tool and the provision of the same tool accompanied by an interview with a specialist counsellor.

Who can take part?

• Men, ≥18 years of age, having sex with at least two men in the preceding 12 months, discovering their HIV-positive status ≤3 months prior to inclusion (index patients)
• Partners notified ≥18 years old

Index patients and their notified partners are not linked in the study.

How does the study work?

NotiVIH is an interventional study for index patients and an observational study for notified partners. In both cases, online self-administered questionnaires will be used to collect the participants’ profiles, their experiences of notification and other information needed to assess the effectiveness of the tools in increasing the number of partners (i) informed of the risk of HIV infection, and (ii) having recourse to screening.

Inclusions

Inclusions for 12 months from September 2024

Important information for participants

Data collected through online self-administered questionnaires

From index patients

• Participant profile (available on inclusion): socio-demographic characteristics, previous HIV screening (lifetime and last 12 months) and STI screening (12 months) and sexual practices over the last 6 months (number, type, status of partners, use of condoms and other prevention techniques to assess the sexual network and risks of transmission).
• Effectiveness of notification by index patients (available one month after inclusion): total number of partners reachable during the period of probable infection and number of partners notified one month after the NP-assisted approach/inclusion. For each partner notified, the questionnaire will collect the type of partner (main, regular, occasional) and the means of notification. More details will be requested for the first three partners notified: gender, age and HIV status if known by the partner, time since last sexual relationship with this partner, sexual practices with this partner in order to assess exposure to HIV. The same type of questions will be asked about partners who have not been notified and the reasons why. This will make it possible to identify barriers to notification.
• Acceptability of notification (available one month after inclusion): experience of the passive or assisted notification process, obstacles to notification, events that may have occurred after notification (meeting a notified partner, violence suffered at the hands of a notified partner, break-up of the couple, etc.), general opinion questions on the NP process, etc.

From notified partners

• Participant profile (available on inclusion): socio-demographic characteristics, previous HIV screening (lifetime and last 12 months) and STI screening (12 months) and sexual practices over the last 6 months (number, type, status of partners, use of condoms and other prevention techniques to assess the sexual network and risks of transmission).
• Use of HIV screening in the month following notification (available one month after inclusion). If the person has been tested in the last 4 weeks: details of the facility attended / type of test, the test result and the link to care or PrEP depending on the result. If the person has not been screened for HIV: reasons for not taking up the test.
• Acceptability of NP (available one month after inclusion): experience of receiving and understanding the notification message, and intention to use it to notify STIs/HIV in the future, general questions of opinion on the NP approach.

Reuse of study data

• No reuse of the study data is planned.
• No biological samples were taken as part of this study.

Processing of personal data

The personal data of participants and persons concerned by the study is processed to enable the questions asked in the study to be answered. This data processing is part of the public interest mission of the promoter, Inserm – ANRS | Emerging Infectious Diseases, which justifies the processing of specific categories of data for scientific research purposes. The data (see above) is collected via the online questionnaires by the service provider Epiconcept, a company governed by French law, on behalf of the data controller and then sent to the research teams for statistical analysis. In order to guarantee the confidentiality of the data, participants in this research are identified by an encrypted code. The data is thus pseudonymised. This means that no information that could identify the participants by name is directly associated with them.

There are no plans to transfer data to other national or international research teams.

Data retention

Identifying data (email address) is kept in the active database for 21 months and then deleted. Pseudonymised data is kept in the active database (for analysis) for 5 years, after which it is archived by Inserm for 15 years in accordance with current regulations on archiving in clinical research.

Rights of participants and persons affected by the study

In accordance with the provisions of Law no. 78-17 of 6 January 1978 on Data Processing, Data Files and Individual Liberties, as amended, and the General Data Protection Regulation (Regulation (EU) 2016/679), you have the right to access, the right to rectify the data collected from you, the right to object to the processing of your data, the right to restrict the processing (restriction of the use of data) and the right to have your data deleted. You have the right to withdraw your consent to the study at any time without giving any reason.

Please note, however, that in accordance with the provisions of Article 17 of the General Data Protection Regulation (GDPR) and to ensure compliance with Article L.1122-1-1 of the French Public Health Code, insofar as the deletion of data may make it impossible or seriously compromise the achievement of the objectives of the study, data collected prior to the withdrawal of your consent, the exercise of your right to deletion or the exercise of your right to object may not be deleted and may continue to be processed under conditions that guarantee their minimisation and confidentiality.

You may also access all your medical data directly or through a doctor of your choice, in accordance with the provisions of article L 1111-7 of the French Public Health Code. To exercise your rights, you should contact the investigator coordinating the study. If you have any difficulty in exercising your rights, you can contact Inserm’s Data Protection Delegation by e-mail (dpo@inserm.fr) or by post (Data Protection Delegate, 101 rue de Tolbiac, 75013 Paris).

Finally, you have the right to lodge a complaint with the French supervisory authority, the CNIL: https://www.cnil.fr/fr/cnil-direct/question/adresser-une-reclamation-plainte-la-cnil-quelles-conditions-et-comment