EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)

Study Overview
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Brief Summary
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The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. The study population will consist of female participants who are identified as becoming pregnant during their participation in a microbicide or PrEP trial, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.

Detailed Description
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The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort study of maternal exposures to investigational HIV prevention agents. Approximately 550 pregnant participants and 400 live infants will be offered enrollment. The study population will consist of current or recent female participants identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies. This study will also include infants resulting from those pregnancies. This protocol will monitor for adverse pregnancy and delivery outcomes, monitor the prevalence of major malformations, evaluate growth parameters of infants during the first year of life, and evaluate the prevalence and persistence of HIV drug resistance mutations in a cohort of infants who were either exposed to active study agents or not exposed to active study agents while in utero.

Official Title
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HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study

Conditions
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Pregnancy Related

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mother cohort Able and willing to provide written informed consent to take part in the study During participation in a parent protocol, has/had a known confirmed pregnancy, meeting at least one of the following sets of criteria in A or B: A. Two consecutive monthly study visits, at least 14 days apart, with positive pregnancy tests, in the absence of signs/symptoms of miscarriage or participant report of pregnancy termination. B. One or more of the following assessments: Auscultation of fetal heart tones Positive pregnancy test confirmed by clinic staff in the presence of clinically confirmed enlarged uterus Positive pregnancy test confirmed by clinic staff in the presence of missed menses (no menses occurring at least 60 days from the first day of the last menses) by participant report (For amenorrheic or irregularly cycling women, two consecutive positive hCG tests (criterion A) or any of the other clinical signs of pregnancy included under the criteria B listing will be used to confirm MTN-016 eligibility). Clinical assessment of fetal movement Demonstration of pregnancy by ultrasound Able and willing to provide adequate locator information, as defined in site SOPs Note: Participants do not have to be currently enrolled or engaged in follow-up in a parent protocol to participate in EMBRACE. Inclusion Criteria: Infant cohort Has written informed consent provided by parent(s)/guardian to take part in the study in a manner consistent with local standards, site Institutional Review Board (IRB) guidance and the US Code of Federal Regulations (CFR) Born to EMBRACE participant mother from pregnancy concurrent with participation in parent study Exclusion Criteria: Mother cohort Has any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives Pregnancy outcome occurred greater than one year ago Exclusion Criteria: Infant cohort Has any condition that, in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives Has reached 1 year birth date
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Pregnant women exposed to an HIV prevention study agent during pregnancy | |
| Infant<br>Infants resulting from pregnancies where there exists maternal HIV prevention agent exposure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy and delivery outcomes comparison | To compare adverse pregnancy and delivery outcomes between participant mothers assigned to an active agent with those of mothers assigned to placebo/control. Pregnancy and delivery outcomes of interest are: delivery prior to 37 completed weeks of gestation stillbirth or intrauterine fetal demise (≥ 20 weeks) spontaneous abortion (< 20 weeks) ectopic pregnancy intrapartum hemorrhage postpartum hemorrhage non-reassuring fetal status chorioamnionitis hypertensive disorders of pregnancy gestational diabetes intrauterine growth restriction | Duration of Study | 
| Major malformations comparison | To compare the prevalence of major malformations identified in the first year of life between infants of mothers assigned to an active agent with those of infants of mothers assigned to placebo/control. Major malformations are defined as structural abnormalities with surgical, medical, or cosmetic importance. | Duration of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant growth parameters comparison | To compare growth parameters in the first year of life between infants of mothers assigned to an active agent with those of mothers assigned to placebo/control. Growth parameters of interest are weight, length, and head circumference at birth, one month, six months and 12 months. | Duration of Study | 
| HIV drug resistance mutations comparison | 2. To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants. | Duration of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Chemoprophylactic Exposure, Mother, Infant, malformations, HIV