CompletedNot Applicable

Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital

France172 participantsStarted 2024-03-20

Plain-language summary

"The strategies for the Prevention of Mother-to-Child Transmission of the Human Immunodeficiency Virus (HIV) are very effective and have become common practices in many contexts. Some studies have identified clinical and biological anomalies in a small proportion of infants exposed to antiretrovirals. Beyond 2 years of age, there are few studies with low power describing the long-term consequences of perinatal exposure to antiretrovirals. It is necessary to understand the impact of antiretroviral treatment during the perinatal period in order to improve the management of children born to HIV-positive mothers. Retrospective cohort study with interviews of women living with HIV who were followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France. After recruitment during a follow-up consultation: * Information regarding the prenatal and perinatal management of HIV and the infant's outcomes up to 12 months will be collected retrospectively through the medical record * Information regarding the child's development and follow-up from the age of 1 to a maximum of 15 years will be gathered retrospectively through a self-administered questionnaire or a questionnaire filled out with assistance during a single 1-hour interview with the mother."

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

"Inclusion Criteria * Woman living with HIV followed for HIV infection at Bichat-Claude Bernard Hospital * Age ≥ 18 years * Having given birth at the maternity ward of Bichat-Claude Bernard Hospital between 01/01/2007 and 31/12/2022 to at least one child who is HIV-uninfected * Information provided about the study and the right to refuse participation Exclusion Criteria * Refusal to participate in the study * Not speaking French"

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years)

Timeframe: 1 day

Trial details

NCT IDNCT06666543

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-20

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