NCT07011017

Brief Summary

This study looks at the sexual health of women from Sub-Saharan Africa who recently found out they have HIV after arriving in Île-de-France. It aims to understand their risk factors and identify missed chances for HIV testing and prevention. The goal is to improve care and support for these women by learning more about their experiences and the challenges they face.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 30, 2025

Last Update Submit

May 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of sexual health characteristics (e.g., history of sexually transmitted infections, contraceptive use, number and type of sexual partners, presence of transactional sex, and access to sexual health services) in Sub-Saharan African migrant wom

    enrollment - 5 months

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of Sub-Saharan African migrant women living in Île-de-France who were newly diagnosed with HIV on French territory from 2021 onward. Participants will be selected from two infectious disease departments: the SMIT at the Centre Hospitalier Sud Francilien (CHSF) and the SMIT at the hospital in Melun. Eligible participants must be at least 18 years old and meet the inclusion criteria. This population is particularly vulnerable due to social, economic, and structural barriers that may limit access to sexual health services and HIV prevention.

You may qualify if:

  • Sub-Saharan African migrant women recently diagnosed with HIV (from 2021 onward)
  • HIV diagnosis made on French territory
  • Aged 18 years or older

You may not qualify if:

  • Inability to inform the patient about the study due to a language barrier or other obstacle
  • HIV diagnosis made before 2021
  • HIV diagnosis made in the country of origin
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

HIV InfectionsRisk-Taking

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

June 15, 2025

Primary Completion

November 15, 2025

Study Completion

November 15, 2025

Last Updated

June 8, 2025

Record last verified: 2025-05

Locations