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

NCT06419491 | Not Yet Recruiting

• 1 other identifier: ANRS95048
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HIV; Partner notification tools

Outcome Measures

Primary Outcomes (1)

• The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients

  An emailed invitation to complete an online self-administered questionnaire will be send to index patients to carry out an assessment of the notification process (number of partners exposed, contacted, notified, etc). Up to 3 reminders will be sent if no response.

  One month after the intervention

Secondary Outcomes (2)

• Percentage of acceptability of partner notification by index patients

  One month after the intervention

• Percentage of adverse events of partner notification reported by index patients

  One month after the intervention

Study Arms (2)

Digital notification tool

NO INTERVENTION

A partner notification digital tool allowing the sending of anonymous or personalised standardised text messages to partners and an information leaflet are provided to index patients

Digital notification tool and counseling

EXPERIMENTAL

In addition to the provision of the partner notification digital tool and the leaflet, a partner notification approach assisted by a trained counsellor during a specific counselling interview is offered to index patient.

Other: Partner notification by a trained counsellor

Interventions

Partner notification by a trained counsellor OTHER

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

Digital notification tool and counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men
• aged ≥18
• having sex with ≥2 men in the last 12 months

You may not qualify if:

• Persons who do not provide an email address, needed to receive the study questionnaires
• Persons who do not speak or read French
• Persons subject to a legal protection measure (guardianship, safeguard of justice)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jade Ghosn, MD PhD

  AP-HP Hôpital Bichat Claude-Bernard, Paris, France

  STUDY DIRECTOR

Central Study Contacts

01 40 25 78 03 Ghosn, MD PhD

CONTACT

01 40 25 78 03; jade.ghosn@aphp.fr

Karen Champenois, PhD

CONTACT

01 40 25 78 03; karen.champenois@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05