Top

Wits RHI

UBOMI BUHLE

Infectious Diseases
Vaccine Preventable Diseases

UBOMI BUHLE: Understanding Birth Outcomes for Mothers and Infants, Building Healthcare by Linking Exposures. A South African Pregnancy Exposure Registry focused on improving maternal and newborn healthcare.

Rationale

As South Africa rolls out new adult and Prevention of Mother-to-Child Transmission (PMTCT) treatment guidelines incorporating dolutegravir (DTG)-based antiretroviral therapy (ART) as the first-line HIV treatment, the South African National Department of Health has initiated the establishment of a pregnancy exposure registry. Concerns about the potential risk of neural tube defects (NTDs) linked to DTG use during early pregnancy—first highlighted in Botswana in 2018—have diminished over time, with reported rates decreasing from 0.9% in 2018 to 0.2% in 2020, compared to 0.1% for women on efavirenz (EFV)-based ART at conception. However, the risk remains, approximating one NTD per 500 pregnancies exposed to DTG in early stages.

Emerging data suggest that initiating DTG later in pregnancy is relatively safe and offers better outcomes than EFV, particularly regarding maternal adverse effects, viral load reduction, and a lower likelihood of developing drug resistance. It is vital to evaluate the risks of other adverse pregnancy outcomes, such as stillbirth, preterm delivery (PTD), neonatal deaths (NNDs), and low birth weight (LBW) among infants exposed to HIV and ART. These factors are particularly relevant given the known impact of DTG-based ART on weight gain, although recent studies have not identified any short-term safety issues for pregnant women using DTG. This registry will provide valuable data to enhance the safety and quality of HIV and ART-related care for pregnant women and their babies throughout South Africa.

Primary Objectives

  • Establish capacity at key sentinel sites across three provinces to reliably collect maternal and neonatal data.
  • Create a Pregnancy Exposure Registry (PER) by enrolling and monitoring a cohort of pregnant women to evaluate the effects of ART and other therapeutic interventions on health outcomes.

Secondary Objectives

  • Enhance clinical care and record-keeping for mothers and infants at registry sites.
  • Implement a secure and accessible data management plan for the UBOMI BUHLE registry.
  • Enroll a target of 18,000 women annually across contributing sites with an 85% follow-up goal over three years.
  • Develop research outputs aligned with the national health research strategy.
  • Engage stakeholders for sustainable program implementation and government integration.

Investigators

  • Prof Lee Fairlie, Principal Investigator
  • Dr Ushma C. Mehta, Principal Investigator
  • Dr Myint Aung, Co-Investigator
  • Dr Emma Kalk, Co-Investigator
  • Ottancia B. Mhlongo, Co-Investigator
  • Dr Dhayendre Moodley, Co-Investigator
  • Dr Diane Morof, Co-Investigator
  • Dr Diane Lavies, Co-Investigator
  • Dr Faeezah Patel, Co-Investigator
  • Shobna Sawry, Co-Investigator
  • Dr Karl Technau, Co-Investigator
  • Dr Michelle Groome, Co-Investigator

Latest Update

April 2024

For more about UBOMI BUHLE project please email rhicomms@wrhi.ac.za

Click here for further details regarding the UBOMI BUHLE project.

Project Brief

UBOMI BUHLE