HIV InfectionsNCT07011017
Sexual Health of Sub-Saharan African Migrant Women Recently Diagnosed With HIV in Île-de-France: Missed Opportunities for Prevention
An observational study of HIV Infections and Sexual Health, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Sexual Health, Migrants
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- Sub-Saharan African migrant women recently diagnosed with HIV (from 2021 onward)
- HIV diagnosis made on French territory
- Aged 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
France
Saint-Denis, France
Johanna ANTON PULENDRARASA, +33142356140, coordination.rechercheclinique@ghtpdfr.fr
About this study
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.
- Conditions
- HIV Infections, Sexual Health, Migrants, Women's Health, Health Services Accessibility, Sub-Saharan Africa
- Medical subject headings
- HIV Infections, Risk-Taking
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: enrollment - 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011017
- Sponsor's protocol ID
- 0078.1_SMIT_FASVIH
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health of Sub-Saharan African Migrant Women Recently Diagnosed With HIV in Île-de-France: Missed Opportunities for Prevention
- ClinicalTrials.gov ID
- NCT07011017
- Acronym / sponsor ID
- 0078.1_SMIT_FASVIH
- Conditions
- HIV Infections, Sexual Health, Migrants, Women's Health, Health Services Accessibility, Sub-Saharan Africa
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 8 Jun 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Sub-Saharan African migrant women recently diagnosed with HIV (from 2021 onward)
- HIV diagnosis made on French territory
- Aged 18 years or older
Key exclusion criteria (4 listed)
- 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
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
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
Time frame: enrollment - 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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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.
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 Infections and Sexual Health, run by Centre Hospitalier de Saint-Denis 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: enrollment - 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2025.