HIV InfectionsNotiVIHNCT06419491
Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity
A study testing Partner notification by a trained counsellor in people with HIV Infections, run by ANRS, Emerging Infectious Diseases.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Partner notification by a trained counsellor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men
- aged ≥18
- having sex with ≥2 men in the last 12 months
- diagnosed for HIV since ≤3 months at the time of inclusion
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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 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.
- Conditions
- HIV Infections
- Being tested
- Partner notification by a trained counsellor
- Keywords
- HIV, Partner notification tools
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner notification by a trained counsellorOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Partner notification by a trained counsellor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month after the intervention
Secondary outcomes (2)
Percentage of acceptability of partner notification by index patients
Percentage of index patients who notified at least one exposed partner
Measured: One month after the intervention
Percentage of adverse events of partner notification reported by index patients
Percentage of index patients who reported violence, social harm, feeling left out from sexual partners.
Measured: One month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jade Ghosn, MD PhD, Study director, AP-HP Hôpital Bichat Claude-Bernard, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419491
- Sponsor's protocol ID
- ANRS95048
- Acronym
- NotiVIH
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity
- ClinicalTrials.gov ID
- NCT06419491
- Acronym / sponsor ID
- NotiVIH / ANRS95048
- Conditions
- HIV Infections
- Keywords
- HIV, Partner notification tools
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Partner notification by a trained counsellorIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men
- aged ≥18
- having sex with ≥2 men in the last 12 months
- diagnosed for HIV since ≤3 months at the time of inclusion
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner notification by a trained counsellorOne (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 | Other | Digital notification tool and counseling |
Primary outcome
The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients
Time frame: One month after the intervention
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.
2 secondary outcomes
Percentage of acceptability of partner notification by index patients
Time frame: One month after the intervention
Percentage of adverse events of partner notification reported by index patients
Time frame: One month after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jade Ghosn, MD PhD study director
AP-HP Hôpital Bichat Claude-Bernard, Paris, France
Questions about this trial
What is this clinical trial studying?
A study testing Partner notification by a trained counsellor in people with HIV Infections, run by ANRS, Emerging Infectious Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 01 40 25 78 03 Ghosn, MD PhD (01 40 25 78 03, jade.ghosn@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients (time frame: One month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.