Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06419491 |
| Other study ID # |
ANRS95048 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
May 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
ANRS, Emerging Infectious Diseases |
| Contact |
01 40 25 78 03 Ghosn, MD PhD |
| Phone |
01 40 25 78 03 |
| Email |
jade.ghosn[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Interventional study (supplementary information)
This is a cluster-randomised interventional study that will compare two interventional arms:
- The provision of a partner notification (PN) digital tool allowing the sending of
anonymous or personalised standardised text messages to partners (Tool arm).
- In addition to the provision of the PN digital tool, a PN approach assisted by a
counsellor during a specific counselling interview and the option for the index patient
to entrust the notification of some of their partners to the counsellor (Tool +
Counselling arm). Notification of partners by the counsellor should be anonymous and
reserved for partners for whom the risk of re-identification of the index case is very
low.
Randomisation of the centres 1:1.
The PN intervention will be offered to index patients at the time of HIV diagnosis or
antiretroviral treatment initiation. They will have the option to use the available tools and
to notify all or some of their partners.
Data on participant profile, PN assessment, acceptability, and consequences are collected by
online self-administered questionnaires on a secure website. The one on participants' profile
is available at enrollment and the another that collect the PN experience, one month later.
The participant is invited by email to connect on the website and fill in the questionnaires.
The calculation of the number of index patients was based on the main outcome: increase the
number of notified partners.
Considering a difference between the two arms of 34%, statistical power of 80%, risk of 5%
and intra-cluster coefficient correlation of 0,03 with one-way test, 1104 exposed partners
have to be stated in each arm. In median, MSM had 7 sexual partners within the 6 months
before HIV diagnosis, ie. 157 index patients per arm.
This number was rounded to 200 index patients per arm to take into account uncertainty about
de the correlation coefficient and enable analysis adjusted for 6 confusion factors.
Observational study in notified partners The PN message, delivered either through the digital
tool or paper cards, informs the partners about their HIV/sexually transmitted infection
(STI) exposure and invites them to get tested. It also contains a link to a website with
information on PN, HIV testing and an invitation to participate in this study as a notified
partner.
The objectives of this part are to:
- assess the HIV testing uptake after notification
- estimate the HIV positivity rate among notified partners
- describe the PN experience
- evaluate the acceptability of notified partners, whatever they get or not HIV testing
Notified partner register themselves on the study website. Like index patients, data on
participant profile, PN acceptability, HIV testing and according to the test result, the
linkage to care or to Pre-Exposure Prophylaxis (PrEP) are collected by online
self-administered questionnaires on a secure website. The one on participants' profile is
available at enrollment and the another that collect the PN experience and HIV testing, one
month later. The participant is invited by email to connect on the website and fill in the
questionnaires.
Qualitative study A qualitative study based on individual interviews will be conducted with a
sample of participants (index patients and notified partners) to assess more in depth the
acceptability of HIV PN, identify the barriers and levers of PN, as well as the components of
intervention in the PN process that need to be adapt. Around 30 interviews will be conducted
according to the principle of data saturation.
