Clinical trial NCT06666530: Quality of Life Related to the Care of Women Living with HIV During the Perinatal Period
Official title: Quality of Life Related to the Care of Women Living with HIV During the Perinatal Period
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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

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.

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"

Primary outcomes:
measure: Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale
timeFrame: during the Perinatal Period at 1 Year Postpartum
Secondary outcomes:
measure: Describe the sociodemographic characteristics of the mothers
timeFrame: up to 1 year postpartum
measure: 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
timeFrame: up to 9 month
measure: 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
timeFrame: at 1 year postpartum
measure: Describe the care of children born to women living with HIV : Collection of clinical and epidemiological data from children
timeFrame: up to 1 year
measure: Describe the serological status of children born to women living with HIV (HIV+ or HIV-)
timeFrame: at 1 year
measure: Describe the sharing of HIV status with the partner during pregnancy: yes or no and the reason for not sharing
timeFrame: up to 1 year postpartum
measure: Collection of perceptions of pregnancy care
timeFrame: at 1 year postpartum
measure: Describe the mother's perception of the care of the newborn
timeFrame: at 1 year postpartum
measure: Describe the mother's perception of the contraindication to breastfeeding
timeFrame: up to 1 year postpartum
measure: Describe the evolution of the mother's anxiety and depression
timeFrame: up to 1 year postpartum
measure: Describe the perception of the management of the previous pregnancy
timeFrame: 1 day
measure: Describe the reasons for non-inclusions: Patient refusal, Doctor refusal; Term pregnancy after 28 weeks; Does not speak French; Doesn't have time; Other
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bachelard Antoine
role: PRINCIPAL_INVESTIGATOR
References: