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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| women living with HIV | women 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.
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)
Describe the sociodemographic characteristics of the mothers
Measured: 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
Measured: 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
Measured: at 1 year postpartum
Describe the care of children born to women living with HIV : Collection of clinical and epidemiological data from children
Measured: up to 1 year
Describe the serological status of children born to women living with HIV (HIV+ or HIV-)
Measured: at 1 year
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
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
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
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
Describe the evolution of the mother's anxiety and depression
Hospital Anxiety and Depression Scale
Measured: up to 1 year postpartum
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
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
describe breastfeeding practices
Duration, difficulties encountered, adherence to follow-up, and satisfaction
Measured: up to one year
Describe maternal virological conditions associated with breastfeeding
maternal viral load during breastfeeding
Measured: up to one year
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.
- First posted30 Oct 2024
- Study start19 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bachelard Antoine, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Related to the Care of Women Living With HIV During the Perinatal Period
- ClinicalTrials.gov ID
- NCT06666530
- Acronym / sponsor ID
- QUASOVIH / APHP231651
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women living with HIV | – | Other: Questionarywomen living with HIV during the perinatal period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Non-French speaker"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionaryThree 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 | Other | women living with HIV |
Primary outcome
Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale
Time frame: during the Perinatal Period at 1 Year Postpartum
15 secondary outcomes
Describe the sociodemographic characteristics of the mothers
Time frame: 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
Time frame: 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
Time frame: at 1 year postpartum
Describe the care of children born to women living with HIV : Collection of clinical and epidemiological data from children
Time frame: up to 1 year
Describe the serological status of children born to women living with HIV (HIV+ or HIV-)
Time frame: at 1 year
Describe the sharing of HIV status with the partner during pregnancy: yes or no and the reason for not sharing
Time frame: up to 1 year postpartum
Collection of perceptions of pregnancy care
Time frame: at 1 year postpartum
Describe the mother's perception of the care of the newborn
Time frame: at 1 year postpartum
Describe the mother's perception of the possibility of breastfeeding and conditions associated with breastfeeding
Time frame: up to 1 year postpartum
Describe the evolution of the mother's anxiety and depression
Time frame: up to 1 year postpartum
Describe the perception of the management of the previous pregnancy
Time frame: 1 day
Describe the reasons for non-inclusions: Patient refusal, Doctor refusal; Term pregnancy after 28 weeks; Does not speak French; Doesn't have time; Other
Time frame: 1 day
describe breastfeeding practices
Time frame: up to one year
Describe maternal virological conditions associated with breastfeeding
Time frame: up to one year
describe pediatric conditions associated with breastfeeding
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bachelard Antoine principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.