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Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity

NCT06419491 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-05-23

No results posted yet for this study

Summary

The context of HIV has changed dramatically this last two decades with the availability of highly active and well tolerated antiretroviral therapies, and the extension of prevention methods to include treatment as prevention of onward transmissions. It is time to test and treat as many HIV infected people as possible. HIV testing that target people known to have been exposed to HIV is an interesting option to explore to curb the spread of the epidemic. Notifying HIV exposed sexual partner for them to get an HIV test and treatment contribute to reduce HIV transmissions. The partner notification (PN) gives the opportunity to HIV positive partners to access to care and negative partners, access to prevention services.

Several tools have been developed worldwide, in particular in the United Kingdom and the US, to help HIV or index patients to notify their sexual partner or needle-sharing people. This approach is new in France and PN intervention has to be assessed.

The present study aimed to assess the effectiveness of a digital PN tool or a counselling interview to help men having sex with men (MSM) newly diagnosed for HIV to notify their exposed partners. The study also aimed to evaluate the acceptability of these PN intervention in index patients and their notified partners in the French context.

To meet the objectives, an interventional study was developed in index patients (described above) coupled with :

* an observational study in notified partners to assess their PN acceptability and their HIV testing uptake after being notified
* a qualitative study in a sample of index patients and notified partner to assess more in depth their PN acceptability.

Expected results and perspectives Feasible and effective, assisted PN services may complete HIV testing offer (and by extension sexually transmitted infections screening) as well as the prevention offer Pre-Exposure Prophylaxis (PrEP) for MSM.

The study will provide information enabling the best practice guides. In a next step, PN interventions adapted to other key populations will be studied.

Conditions

  • HIV Infections

Interventions

OTHER

Partner notification by a trained counsellor

One (or more if needed) interview with a partner notification trained counsellor is offered to index patients. During the interview, the counsellor gives information on partner notification, helps the index patients to remember their partners, to assess their HIV/sexually transmitted infection exposure and explains options to notify them. During the interview, the index patient can choose to entrust the notification of some of their partners to the counsellor. However, according to French law, provider referral is permitted only when it is anonymous. Therefore, this option is reserved to partners with a lot of partners in order to limit the risk of identifying the index patient

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Jade Ghosn, MD PhD · AP-HP Hôpital Bichat Claude-Bernard, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419491 on ClinicalTrials.gov