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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085717
Recruitment Status : Unknown
Verified February 2022 by Raincy Montfermeil Hospital Group.
Recruitment status was:  Recruiting
First Posted : October 20, 2021
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Raincy Montfermeil Hospital Group

Study Description
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Brief 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


Condition or disease
HIV Infection

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
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Study Type : Observational
Estimated Enrollment : 960 participants
Observational Model: Cohort
Time Perspective: Prospective
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,
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. impact of male counselling on testing for HIV and other infections [ Time Frame: 6 months ]
    Assessing the impact of male counselling on testing for HIV and other infections

  2. impact of male consultation on vaccination coverage, [ Time Frame: 6 months ]
    Evaluate the impact of male consultation on other interventions: on vaccination coverage, social security coverage and on the declaration of a attending physician.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085717


Contacts
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Contact: Pauline Penot, MD +33 6 22 86 89 20 pauline.penot@chi-andre-gregoire.fr

Locations
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France
Pauline Penot Recruiting
Montreuil, France, 93100
Contact: Pauline Penot    +33622868920    pauline.penot@chi-andre-gregoire.fr   
Sponsors and Collaborators
Raincy Montfermeil Hospital Group
More Information
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Publications of Results:

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Responsible Party: Raincy Montfermeil Hospital Group
ClinicalTrials.gov Identifier: NCT05085717    
Other Study ID Numbers: 2020-A03198-31
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raincy Montfermeil Hospital Group:
HIV
prevention
pregnancy
health
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases