Prevention, Access to Rights, Catch-up Vaccination, Treatment of Conditions During Pregnancy and for Children

HIV Infection Clinical Trial

— PARTAGE  

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,

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085717
• Other study ID #: 2020-A03198-31
• Status: Recruiting
• Start date: March 17, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2022
• Source: Raincy Montfermeil Hospital Group
• Contact: Pauline Penot, MD
• Phone: +33 6 22 86 89 20
• Email: pauline.penot[@]chi-andre-gregoire.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Persons who are unable to give their non-opposition due to a poor understanding of the French language

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
France	Pauline Penot	Montreuil

Sponsors (1)

Lead Sponsor	Collaborator
Raincy Montfermeil Hospital Group

Country where clinical trial is conducted

France, 

References & Publications (2)

Kigozi 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):2 — View Citation

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	impact of male counselling on testing for HIV and other infections	Assessing the impact of male counselling on testing for HIV and other infections	6 months
Secondary	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.	6 months