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

NCT ID: NCT06666530

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2028-05-31

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."

Detailed Description

"The latest report from the WHO shows that with 1.3 million (between 970,000 and 1.6 million) HIV-positive pregnant women worldwide in 2020, HIV continues to be a major global public health issue. In France, approximately 2 out of 1,000 pregnant women are infected with HIV, resulting in about 1,500 births per year over the past fifteen years. Although therapeutic advances have not yet led to a cure for the infection, they have increased life expectancy, improved the quality of life for people living with HIV, and reduced mother-to-child transmission during pregnancy, childbirth, and breastfeeding. Indeed, the very low transmission rate during replication has been completely eliminated.

The measurement of quality of life is increasingly used to complement the clinical or biological management of a disease, as it provides data to evaluate the quality of patient care, identify additional care needs, and assess the effectiveness of interventions. This approach enhances patient experience and satisfaction with treatment, in contrast to traditional management, which focuses on disease progression.

Generally, pregnant women report a lower health-related quality of life due to the impact of pregnancy on their physiological and mental health. In addition to limited physical activities in early pregnancy, most pregnant women are likely to experience nausea, vomiting, dizziness, depression, nervousness, and anxiety throughout their pregnancy. Compared to HIV-negative pregnant women, HIV-positive pregnant women may also have poorer physical health, a greater susceptibility to depression, and worse mental health. Factors such as education level, number of children, pregnancy symptoms, and occupation are key determinants of Health-Related Quality of Life (HRQoL) for pregnant women.

Consequently, improving patient care by assessing HRQoL in HIV-positive pregnant women is crucial for informing decision-making, resource allocation, and health policy formulation.

Through this project, we will explore the HRQoL of women living with HIV during the perinatal period under the care of the Infectious diseases department at Bichat-Claude Bernard Hospital, PARIS, FRANCE.

In 2022, the Infectious diseases department of Bichat-Claude Bernard Hospital cared for 5,242 people living with HIV, including 544 women of childbearing age (under 43 years). From January 1, 2005, to December 31, 2022, 1,158 women living with HIV were monitored for pregnancy, with 1,036 delivering at Bichat-Claude Bernard Maternity.

During the period from January 1 to December 31, 2022, 43 women living with HIV were followed at Bichat Maternity during their pregnancy, and 38 gave birth to live infants at the hospital. Among these 38 women, the median age was 36 years (range: 20-50), and 86.8% were originally from Sub-Saharan Africa.

According to the report from the Interministerial Mission on Poverty and Social Exclusion, areas with the highest prevalence of poverty and social exclusion are located in the northern part of Paris and Île-de-France, and the Bichat-Claude Bernard hospital group is at the heart of this area. The PréCARE cohort study (which monitored pregnant women from October 2010 to May 2012) highlighted specific vulnerabilities in this territory, particularly among undocumented migrants who faced a higher risk of obstetric complications compared to women born in France.

The outpatient follow-up for pregnant women living with HIV has been designed to provide comprehensive health management during pregnancy, focusing not only on complications related to the infection or pregnancy but also on ensuring ""a state of complete physical, mental, and social well-being"" (WHO definition of health).

This approach ensures:

• Adherence to and good tolerance of antiretroviral therapy, as well as effective virological control of HIV infection
• Proper management of pregnancy
• Physical and psychological well-being
• Addressing potential social issues."

Conditions

HIV

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

women living with HIV

women living with HIV during the perinatal period

Questionary

Intervention Type: 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

Interventions

Questionary

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bachelard Antoine

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat-Claude Bernard

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bachelard Antoine

Role: CONTACT

antoine.bachelard2@aphp.fr

01 40 25 62 08 ext. +33

Sylvie Lariven

Role: CONTACT

sylvie.lariven@aphp.fr

01 40 25 68 56 ext. +33

Facility Contacts

Antoine Bachelard

Role: primary

antoine.bachelard2@aphp.fr

01 40 25 62 08 ext. +33

Sylvie Lariven

Role: backup

sylvie.lariven@aphp.fr

01 40 25 68 56 ext. +33

Other Identifiers

2023-A02061-44

Identifier Type: OTHER

Identifier Source: secondary_id

APHP231651

Identifier Type: -

Identifier Source: org_study_id