Pregnancy in Women With HIV Infection

Pregnancy in Women With HIV Infection: a Multicenter Cohort in Spain

Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy.

Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes.

There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study.

The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020.

Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Pregnancy Related
• Intervention / Treatment: Other: Pregnancy; Other: Pregnancy

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Inma Jarrin, PhD; Phone Number: 0034918222863; Email: ijarrin@isciii.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The Cohort of the Spanish AIDS Research Network (CoRIS) is a prospective multicentre cohort of HIV-positive treatment-naïve patients aged >13 years, recruited from 46 centres from 13 Autonomous Regions in the Spanish public healthcare system. Recruitment and follow-up started in 2004 and are still ongoing. From 2004 to the last update in November 2018, 15,509 patients have been included in the cohort. This study will be performed using the update of November 2019, that will be available in June 2020.

Description

Inclusion Criteria:

• HIV-positive women recruited in CoRIS
• Became pregnant from January 2004 to November 2019
• or become pregnant during the year 2020 and agree to participate in a telephone survey

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective pregnancies; Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period.	Other: Pregnancy; To measure and characterize pregnancies and describe the clinical course during pregnancy; Other: Pregnancy; To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020
Prospective pregnancies; Women recruited in CoRIS from January 2004 to November 2019 who will become pregnant during the year 2020 and who agree to participate in a telephone survey.	Other: Pregnancy; To measure and characterize pregnancies and describe the clinical course during pregnancy; Other: Pregnancy; To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pregnancies		From 2004 to 2019
Epidemiological characteristics of women who become pregnant	Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant	2004 to 2019
Clinical course during pregnancy	Proportion of women with undetectable viral load at week 36 of pregnancy	2004 to 2019
Opportunistic infections during pregnancy	Incidence of opportunistic infections throughout pregnancy	2004 to 2019
Persistence of Antiretroviral treatment (ART) during pregnancy	Time from ART initition to treatment change during pregnancy	2004 to 2019
Antiretroviral treatment (ART) administered to pregnant women	Distribution of ART regimens administered to women at pregnancy	2004 to 2019
Follow-up after pregnancy	Rate of lost-to-follow-up during the first year after pregnancy termination	2004 to 2019
Clinical outcomes after pregnancy	Proportion of women with undetectable viral load 6 months after pregnancy termination	2004 to 2019
Outcome of the conception	Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies	2004 to 2019
Term pregnancies	Proportion of term pregnancies	2004 to 2019
Type of delivery	Proportion of vaginal deliveries	2004 to 2019
HIV infection of the newborn	Proportion of newborns with HIV infections	2004 to 2019
Attitudes towards pregnancy	Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)	Pregnancies during the year 2020

Collaborators and Investigators

• Sponsor: Carlos III Health Institute
• Collaborators: Merck Sharp & Dohme LLC; Red Temática de Investigación Cooperativa en Sida

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Pregnancy; Adverse pregnancy outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: RIS_EPICLIN_04_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Data cannot be made publicly available because they are owned by a third party, the AIDs Research Network (RIS), and because participants agreed that data would only be used for research projects by RIS or those projects approved by its

Executive and Scientific Committee. Interested readers may send requests for the data to proyectoscoris@gmail.com. Requests will be assessed by the Executive and Scientific Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No