NCT05085717

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

September 27, 2021

Last Update Submit

March 31, 2025

Conditions

Keywords

HIVpreventionpregnancyhealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • impact of male counselling on testing for HIV and other infections

    6 months

  • impact of male consultation on vaccination coverage,

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pauline Penot

Montreuil, 93100, France

Location

Related Publications (3)

  • 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.

    PMID: 29870831BACKGROUND
  • 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):280-9. doi: 10.1097/QAI.0b013e3181ab6eab.

    PMID: 19521248BACKGROUND
  • Penot 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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 20, 2021

Study Start

March 17, 2021

Primary Completion

June 10, 2022

Study Completion

June 10, 2022

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations