- 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.
- 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).
- 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.