Study Objectives

  1. Describe the prevalence and timing (in-utero versus peripartum) of MTCT in HIV exposed infants delivered preterm vs those delivered at term in the setting of ART.
  2. Assess the hematologic safety of ARV prophylaxis among HIV-exposed infants born preterm in the first month of life, evaluating for anaemia and/or neutropenia

Study Design: This study was a secondary analysis of existing data and thus would not require participant contact. Information from participants who consented and agreed for re-use of their data/information in future related studies while participating in the Mpepu study was evaluated.

Study Population and Size: HIV exposed infants and their mothers co-enrolled in the Mpepu Study (575 delivered preterm, 2299 delivered at term).

Study Duration: 18 months.

Sponsor: European and Developing Countries Clinical Trials Partnership (EDCTP – TMA2017CDF-1906).

Study Findings
  • Low MTCT rate.
  • High ART coverage in pregnant WLHIV. 
  • High preterm delivery rate of 19% in WLHIV in a setting of high ART coverage.
  • No difference in HIV acquisition rate in HIV exposed infants delivered preterm vs term overall (0.8% vs 0.6%), at birth (0.2% vs 0.3%) and at 14-34 days post-delivery (0.6% vs 0.3%).
  • Trend towards higher rates of peripartum HIV acquisition among infants delivered preterm as against no increase at all in those delivered term (0.2% – 0.6%).
  • Nonuse of antiretroviral by women during pregnancy being the only measured covariate in our cohort that was independently predictive of HIV acquisition in children born to WLHIV.
  • Significant increase in odds of severe anemia in infants born preterm when compared with those born full term. 
  • Significant increase in odds of severe neutropenia in infants born preterm when compared with those born at term.
  • No difference in proportions of infants with severe anemia and neutropenia amongst those who took AZT vs NVP for prophylaxis.
  • No significant independent predictor of severe anemia identified.
  • Younger age at randomization (< 28 days), enrolled in an urban site. (Gaborone) versus peri-urban site and formula feeding from birth remained. Significant independent predictors of severe (grade 3/4) neutropenia.