Abstract:
Purpose Pharmacovigilance (PV) systems to assess the
safety of antiretroviral treatment used periconception
and during pregnancy are lacking in low- resource
settings with high HIV burdens, and strategies to guide
their implementation are limited. We implemented the
Measuring Adverse Pregnancy and Newborn Congenital
Outcomes (MANGO) study in Kenya to address these gaps.
Participants In MANGO, we ascertained delivery
outcomes for pregnant women living with HIV (WLH) and
not living with HIV (WNLH) enrolled in care at Moi Teaching
and Referral Hospital (MTRH) through two cohorts: C1,
a prospective cohort of 1:1 matched WLH and WNLH
attending antenatal clinic; and C2, a cross- sectional cohort
of all deliveries, including among those who did not attend
antenatal clinic at MTRH.
Findings to date 24 205 deliveries were recorded from
October 2020 to September 2023 (853 in C1 and 23 352
in C2). Median maternal age was 32 years, 4.5% were
WLH and 2.6% of deliveries were stillbirths. Among
liveborn infants, 17.2% were preterm (<37 weeks), and
15.1% were low birth weight (<2.5 kg). Prevalence of
≥1 major congenital abnormality was 73.9/10 000 births
(47.7 in C1 and 76.1 in C2). Assessing implementation
barriers/facilitators, lack of national PV policy was a
barrier overcome through establishing partnerships
with the Kenya Ministry of Health. The facility’s size
and complexity were barriers to newborn surface exam
coverage overcome through staff training and cocreation
of a standardised form for newborn surface exam
documentation. High staff turnover was addressed by
involving head nurses to champion implementation and
incentivising staff participation with medical education
credits. Use of audit/feedback cycles and focusing
on PV as a way to improve care quality facilitated PV
institutionalisation at MTRH.
Future plans The MANGO model is a multifaceted
strategy with replicative potential in other settings.
Research is needed to understand the model’s
opportunities for implementation in other settings.
