Quality of Life Related to the Care of Women Living With HIV During the Perinatal Period

NCT06666530 | Recruiting

• 2 other identifiers: APHP2316512023-A02061-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"The improvement of patient care by assessing the Quality of Life Related to Care (QLRC) in pregnant women living with HIV is of great importance for informing decision-making, resource allocation, and health policy formulation Prospective descriptive survey of women living with HIV followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France, between the first obstetric ultrasound and the 28th week of amenorrhea. 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 records. Three self-questionnaires, either completed independently or with assistance, will be administered at inclusion (between the first obstetric ultrasound and 28 weeks of amenorrhea), during the third trimester of pregnancy, and at 1 year postpartum."

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale

  during the Perinatal Period at 1 Year Postpartum

Secondary Outcomes (15)

• Describe the sociodemographic characteristics of the mothers

  up to 1 year postpartum

• Describe the course of pregnancy period through different parameters: HIV discovery setting, type of mother's income, administrative status, mother treatments, immunovirological control, intrapartum AZT infusion

  up to 9 month

• Describe the course of the postpartum period through different parameters: type of mother's income, administrative status, mother and child treatments, immunovirological control, delivery method, characteristics of newborns at birth

  at 1 year postpartum

• Describe the care of children born to women living with HIV : Collection of clinical and epidemiological data from children

  up to 1 year

• Describe the serological status of children born to women living with HIV (HIV+ or HIV-)

  at 1 year

Study Arms (1)

women living with HIV

women living with HIV during the perinatal period

Other: Questionary

Interventions

Questionary OTHER

Three self-questionnaires, either completed independently or with assistance, will be administered at inclusion (between the first obstetric ultrasound and 28 weeks of amenorrhea), during the third trimester of pregnancy, and at 1 year postpartum

women living with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women living with HIV followed for a pregnancy in the SMIT of Bichat-Claude Bernard Hospital, PARIS, France, between the first obstetric ultrasound and the 28th week of amenorrhea

You may qualify if:

• Woman living with HIV
• Age ≥ 18 years
• Pregnant - due date between the first obstetric ultrasound and 28 weeks of amenorrhea
• Information provided about the study and the right to refuse participation

You may not qualify if:

• Refusal to participate in the study
• Non-French speaker"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

Study Officials

• Bachelard Antoine

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bachelard Antoine

CONTACT

01 40 25 62 08; antoine.bachelard2@aphp.fr

Sylvie Lariven

CONTACT

01 40 25 68 56; sylvie.lariven@aphp.fr

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 30, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

FR (1)