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HIVQUASOVIHNCT06666530

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

An observational study of HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV
What is being tested?
Questionary
How many people
100 participants
Where
1 siteFrance
Study dates
19 Jun 2024to May 2028
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
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

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

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, 1 recruiting
  • Hôpital Bichat-Claude Bernard

    Paris, 75018

    Antoine Bachelard, 01 40 25 62 08 ext. +33, antoine.bachelard2@aphp.fr

    Sylvie Lariven, 01 40 25 68 56 ext. +33, sylvie.lariven@aphp.fr

    Recruiting

Other trials in France

About this study

"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:

Read more

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."

Read the 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
Being tested
Questionary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionaryOther

    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

Study groups in NCT06666530
Study groupRoleWhat they receive
women living with HIVwomen living with HIV during the perinatal period
Receives: Other: Questionary

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: during the Perinatal Period at 1 Year Postpartum

Secondary outcomes (15)
  1. Describe the sociodemographic characteristics of the mothers

    Measured: up to 1 year postpartum

  2. 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

    Measured: up to 9 month

  3. 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

    Measured: at 1 year postpartum

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

    Measured: up to 1 year

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

    Measured: at 1 year

  6. Describe the sharing of HIV status with the partner during pregnancy: yes or no and the reason for not sharing

    Measured: up to 1 year postpartum

  7. Collection of perceptions of pregnancy care

    personnal scale: feel good, feel "overwhelmed", feel reassured by the team that takes care of you, find this PEC too medicalized, which does not allow to fully enjoy pregnancy, find this PEC time-consuming and heavy and the reason

    Measured: at 1 year postpartum

  8. Describe the mother's perception of the care of the newborn

    personnal scale: reassures you, Worries you, Weighs you, You find it difficult to perform

    Measured: at 1 year postpartum

  9. Describe the mother's perception of the possibility of breastfeeding and conditions associated with breastfeeding

    personnal scale: How do you feel about the contraindication to breastfeeding?

    I am happy; I am reassured; I am sad; I am angry; Others, specify:

    Measured: up to 1 year postpartum

  10. Describe the evolution of the mother's anxiety and depression

    Hospital Anxiety and Depression Scale

    Measured: up to 1 year postpartum

  11. Describe the perception of the management of the previous pregnancy

    personnal scale: You felt good; You felt "overwhelmed"; You felt reassured by the team taking care of you; You found this PEC too medicalized, which did not allow you to fully enjoy your pregnancy; You found this PEC time-consuming and heavy, specify why; You could not follow up properly, specify

    Measured: 1 day

  12. Describe the reasons for non-inclusions: Patient refusal, Doctor refusal; Term pregnancy after 28 weeks; Does not speak French; Doesn't have time; Other

    Measured: 1 day

  13. describe breastfeeding practices

    Duration, difficulties encountered, adherence to follow-up, and satisfaction

    Measured: up to one year

  14. Describe maternal virological conditions associated with breastfeeding

    maternal viral load during breastfeeding

    Measured: up to one year

  15. describe pediatric conditions associated with breastfeeding

    childhood prophylaxis

    Measured: up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start19 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
Family based
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666530
Sponsor's protocol ID
APHP231651
Other IDs
2023-A02061-44
Acronym
QUASOVIH
Status last verified
Jan 2026
First submitted
21 Oct 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Assistance Publique - Hôpitaux de Paris 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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?

Contact Bachelard Antoine (01 40 25 62 08 ext. +33, antoine.bachelard2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale (time frame: during the Perinatal Period at 1 Year Postpartum). 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 Jan 2026.

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