UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age15-55
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:
\- Do composite adverse pregnancy events, maternal health outcomes, and/or infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?
Women who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.
In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Confirmed pregnancy by urine pregnancy test or ultrasound.
Aged 15 years or older
PrEP-eligible by Malawi local guidelines
Confirmed HIV-negative based on the local HIV testing algorithm
Disqualifiers
Known to be living with HIV
Known allergies to CAB-LA, TDF/3TC or FTC/TDF
Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.
Intention to leave the study site's catchment area of Bwaila before scheduled study exit.
Trial design
Design model
Parallel
Treatments tested in this trial
Initiating daily oral PrEP during pregnancy
DrugGroup 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.
Already using daily oral PrEP at the time of pregnancy diagnosis
DrugGroup 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.
Initiating injectable PrEP during pregnancy
DrugGroup 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.
Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis
DrugGroup 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.
Treatment groups
621 Participants
are divided into 2 treatment groupsGroup A: Oral PrEP (FTC/TDF or TDF/3TC) during pregnancyActive comparator 2 interventions
Group B: Long-acting injectable cabotegravir (CAB-LA) during pregnancyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of composite adverse pregnancy outcomes
Rate will be calculated as the number of women with an adverse pregnancy outcome, defined as the occurrence of any one of the following events: spontaneous miscarriage (pregnancy lost before 28 weeks gestation), stillbirth (fetal death at or after 28 weeks gestation), preterm birth (delivery before 37 weeks gestation), infant born small for gestational age (birth weight of less than 10th percentile for gestational age) over the accumulated person time from enrollment through birth.
Time frame
Enrollment through birthSecondary outcomes
1
Proportion of women developing grade 3 or higher clinical or laboratory events
Proportions will be calculated as the number of women developing grade three or higher clinical or laboratory events over the total number of enrollees in the cohort. Grade 3 or higher clinical or laboratory events will be assessed and graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame
Enrollment through 52 weeks postpartum2
Proportion of infants developing stage 3 or higher clinical or laboratory events
Proportions will be calculated as the number of infants developing stage three or higher clinical or laboratory events over the total number of infants in the cohort. Stage 3 or higher clinical or laboratory events will be accessed and graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame
Birth through 52 weeks of life3
Proportion of infants born with congenital anomalies
Proportions will be calculated as the number of infants born with congenital anomalies over the total number of infants in the cohort. Congenital anomalies will be diagnosed with neonatal surface exam and fetal anatomic ultrasound
Time frame
Birth through 52 weeks of life4
Number of infants who are underweight
Number of infants who are underweight, defined as weight for age z-score (WAZ) \<-2, assessed at weeks 1, 6, 12, 26 and 52 weeks after birth.
Time frame
Birth through 52 weeks of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
United States President's Emergency Plan for AIDS Relief
Collaborator
Ministry of Health, Malawi
Collaborator
Source ClinicalTrials.gov