HIV InfectionPARTAGENCT05085717
Prevention, Access to Rights, Catch-up Vaccination, Treatment of Conditions During Pregnancy and for Children
An observational study of HIV Infection, run by Raincy Montfermeil Hospital Group at 1 site in France.
Trial summary
Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France. Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 1,347 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2021to 10 Jun 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population targeted by the data collection is the same as the population targeted by the intervention. Are eligible for a prenatal consultation all men living in Ile de France including the companion is followed at the intercommunal hospital of Montreuil for a progressive pregnancy. Women are also targeted by data collection. All women are eligible newly enrolled in the maternity ward of the Montreuil intercommunal hospital centre for a progressive pregnancy declaring a partner involved in the pregnancy and residing in Ile de France.
Who may be able to join
- For future fathers
- are eligible for a prenatal consultation all adult men living in Ile de France whose companion is followed at the intercommunal hospital of Montreuil for a pregnancy Evolutionary.
- having expressed no opposition to participation in the research
- For future mothers
- all adult women newly enrolled in the maternity ward of the Montreuil intercommunal hospital centre for a progressive pregnancy declaring a partner involved in pregnancy and residing in Ile de France.
- having expressed no opposition to participation in the research
Who cannot join
- Persons who are unable to give their non-opposition due to a poor understanding of the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention, Access to Rights, Catch-up Vaccination, Treatment of Conditions During Pregnancy and for Children, Acceptability and Determinants of a Male Prenatal Consultation, Including Screening, Catch-up Vaccination and Access to Social Rights, for Fathers Unborn Children at Montreuil Hospital,
Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France.
Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015 the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious The male prenatal consultation exists but it is not organized: it is possible to implement it, provided that the constraints exerted on men are taken into account.
the projet study the feasibility and the implementation processes place of prenatal consultation of future fathers
Read the detailed description
Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France. No significant decline is recorded in heterosexual, whether born in France or abroad. Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015. The arrival of a child could be an opportunity to screening for the future father as well. However, well that a consultation and a biological assessment intended for future fathers are provided for and fully reimbursed by the social security, the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious. She puts in contact with the care of pregnant women who were sometimes distant, but not their companions: beyond the issue of reduction of the hidden HIV epidemic, increased needs for prevention and access to health appeared to us for the pilot phase of this project.
- Conditions
- HIV Infection
- Keywords
- HIV, prevention, pregnancy, health
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the proportion of fathers-to-be who fathers who accepted prenatal consultation among
Study the feasibility and processes of setting up the prenatal consultation of future fathers, through the different modalities proposed (in the maternity ward, elsewhere in the hospital, in the heart of city; during the day or in the evening; with or without an appointment) over a period of 26 months at the hospital intercommunal of Montreuil.
Measured: 6 months
Secondary outcomes (2)
impact of male counselling on testing for HIV and other infections
Assessing the impact of male counselling on testing for HIV and other infections
Measured: 6 months
impact of male consultation on vaccination coverage,
Evaluate the impact of male consultation on other interventions: on vaccination coverage, social security coverage and on the declaration of a attending physician.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start17 Mar 2021
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085717
- Sponsor's protocol ID
- 2020-A03198-31
- Acronym
- PARTAGE
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Piffaretti C, Looten V, Rey S, Fresson J, Fagot-Campagna A, Tuppin P. Management of pregnancy based on healthcare consumption of women who delivered in France in 2015: Contribution of the national health data system (SNDS). J Gynecol Obstet Hum Reprod. 2018 Sep;47(7):299-307. doi: 10.1016/j.jogoh.2018.05.014. Epub 2018 Jun 2.
PubMed 29870831Kigozi IM, Dobkin LM, Martin JN, Geng EH, Muyindike W, Emenyonu NI, Bangsberg DR, Hahn JA. Late-disease stage at presentation to an HIV clinic in the era of free antiretroviral therapy in Sub-Saharan Africa. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):280-9. doi: 10.1097/QAI.0b013e3181ab6eab.
PubMed 19521248Penot P, Jacob G, Guerizec A, Trevisson C, Letembet VA, Harich R, Phuong T, Renevier B, Manuellan PE, du Lou AD; Partage Study Group. Implementing a prenatal health screening intervention for future fathers in Montreuil, France: most users are immigrants facing hardship. BMC Public Health. 2024 Oct 28;24(1):2982. doi: 10.1186/s12889-024-20388-x.
PubMed 39468472
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention, Access to Rights, Catch-up Vaccination, Treatment of Conditions During Pregnancy and for Children, Acceptability and Determinants of a Male Prenatal Consultation, Including Screening, Catch-up Vaccination and Access to Social Rights, for Fathers Unborn Children at Montreuil Hospital,
- ClinicalTrials.gov ID
- NCT05085717
- Acronym / sponsor ID
- PARTAGE / 2020-A03198-31
- Conditions
- HIV Infection
- Keywords
- HIV, prevention, pregnancy, health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,347 participants (actual)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 20 Oct 2021 (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.
Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France.
Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015 the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious The male prenatal consultation exists but it is not organized: it is possible to implement it, provided that the constraints exerted on men are taken into account.
the projet study the feasibility and the implementation processes place of prenatal consultation of future fathers
Detailed description
Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France. No significant decline is recorded in heterosexual, whether born in France or abroad. Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015. The arrival of a child could be an opportunity to screening for the future father as well. However, well that a consultation and a biological assessment intended for future fathers are provided for and fully reimbursed by the social security, the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious. She puts in contact with the care of pregnant women who were sometimes distant, but not their companions: beyond the issue of reduction of the hidden HIV epidemic, increased needs for prevention and access to health appeared to us for the pilot phase of this project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population targeted by the data collection is the same as the population targeted by the intervention. Are eligible for a prenatal consultation all men living in Ile de France including the companion is followed at the intercommunal hospital of Montreuil for a progressive pregnancy. Women are also targeted by data collection. All women are eligible newly enrolled in the maternity ward of the Montreuil intercommunal hospital centre for a progressive pregnancy declaring a partner involved in the pregnancy and residing in Ile de France.
Key inclusion criteria (6 listed)
- For future fathers
- For future mothers
- all adult women newly enrolled in the maternity ward of the Montreuil intercommunal hospital centre for a progressive pregnancy declaring a partner involved in pregnancy and residing in Ile de France.
- having expressed no opposition to participation in the research
Key exclusion criteria (1 listed)
- Persons who are unable to give their non-opposition due to a poor understanding of the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of the proportion of fathers-to-be who fathers who accepted prenatal consultation among
Time frame: 6 months
Study the feasibility and processes of setting up the prenatal consultation of future fathers, through the different modalities proposed (in the maternity ward, elsewhere in the hospital, in the heart of city; during the day or in the evening; with or without an appointment) over a period of 26 months at the hospital intercommunal of Montreuil.
2 secondary outcomes
impact of male counselling on testing for HIV and other infections
Time frame: 6 months
impact of male consultation on vaccination coverage,
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 29870831Piffaretti C, Looten V, Rey S, Fresson J, Fagot-Campagna A, Tuppin P. Management of pregnancy based on healthcare consumption of women who delivered in France in 2015: Contribution of the national health data system (SNDS). J Gynecol Obstet Hum Reprod. 2018 Sep;47(7):299-307. doi: 10.1016/j.jogoh.2018.05.014. Epub 2018 Jun 2.
- Background: PubMed 19521248Kigozi IM, Dobkin LM, Martin JN, Geng EH, Muyindike W, Emenyonu NI, Bangsberg DR, Hahn JA. Late-disease stage at presentation to an HIV clinic in the era of free antiretroviral therapy in Sub-Saharan Africa. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):280-9. doi: 10.1097/QAI.0b013e3181ab6eab.
- Derived from this study: PubMed 39468472Penot P, Jacob G, Guerizec A, Trevisson C, Letembet VA, Harich R, Phuong T, Renevier B, Manuellan PE, du Lou AD; Partage Study Group. Implementing a prenatal health screening intervention for future fathers in Montreuil, France: most users are immigrants facing hardship. BMC Public Health. 2024 Oct 28;24(1):2982. doi: 10.1186/s12889-024-20388-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Raincy Montfermeil Hospital Group at 1 site in France.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the proportion of fathers-to-be who fathers who accepted prenatal consultation among (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05085717, which also lists 3 linked publications.
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 3 Apr 2025.