Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419491
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-14
Brief Title:
Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NotiVIH
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
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
Detailed 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 11
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 003 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 HIVsexually 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
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 11
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 003 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 HIVsexually 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None