Study on improving prevention of postnatal HIV transmission in Zambia and Burkina Faso called PROMISE-EPI: a phase 3, open-label, randomized controlled trial.
The study titled "Optimised prevention of postnatal HIV transmission in Zambia and Burkina Faso (PROMISE-EPI): a phase 3, open-label, randomised controlled trial" focuses on reducing postnatal HIV transmission through extended postnatal prophylaxis with lamivudine guided by point-of-care maternal viral load testing. The research was conducted at health-care facilities in Zambia and Burkina Faso, with mothers and infants randomly assigned to intervention or control groups. The intervention group had maternal viral load measured at EPI-2 and 6 months, with infants of high viral load mothers receiving lamivudine prophylaxis. The primary outcome was infant HIV infection at 12 months.
The study enrolled 1506 mother-infant pairs, with most mothers already on ART. Maternal viral load of ≥1000 copies/mL was observed in 11.5% of mothers. The results showed one HIV transmission in the intervention group versus six in the control group, with no statistical significance. However, the intervention group had a lower transmission rate. The study also noted similar HIV-free survival and serious adverse events in both groups.
The intervention aimed to enhance prevention of mother-to-child transmission by targeting infants at high risk with extended postnatal prophylaxis while using point-of-care viral load testing for rapid decision-making. The analysis revealed a ten-fold reduction in the high-risk period for infants in the intervention group, supporting the effectiveness of the intervention. The study highlighted the importance of addressing maternal viral load control and extending infant postnatal prophylaxis to reduce postnatal HIV transmission.
Although the study faced challenges like COVID-19 disruptions and incomplete sample size, the results demonstrated the near-zero postnatal vertical transmission potential of the intervention. The strategy combining extended infant prophylaxis and point-of-care viral load testing showcased promise in reducing postnatal HIV transmission. The research underscores the value of scaling up such interventions and point-of-care technologies for early infant diagnosis and maternal viral load testing to achieve near-zero postnatal transmission rates.
The study's findings suggest that a simple yet effective strategy can significantly reduce postnatal HIV transmission rates, emphasizing the importance of extending postnatal prophylaxis for infants at high risk and utilizing point-of-care viral load testing for timely interventions. The research contributes valuable insights into optimizing prevention strategies for mother-to-child HIV transmission.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02464-9/fulltext
The study enrolled 1506 mother-infant pairs, with most mothers already on ART. Maternal viral load of ≥1000 copies/mL was observed in 11.5% of mothers. The results showed one HIV transmission in the intervention group versus six in the control group, with no statistical significance. However, the intervention group had a lower transmission rate. The study also noted similar HIV-free survival and serious adverse events in both groups.
The intervention aimed to enhance prevention of mother-to-child transmission by targeting infants at high risk with extended postnatal prophylaxis while using point-of-care viral load testing for rapid decision-making. The analysis revealed a ten-fold reduction in the high-risk period for infants in the intervention group, supporting the effectiveness of the intervention. The study highlighted the importance of addressing maternal viral load control and extending infant postnatal prophylaxis to reduce postnatal HIV transmission.
Although the study faced challenges like COVID-19 disruptions and incomplete sample size, the results demonstrated the near-zero postnatal vertical transmission potential of the intervention. The strategy combining extended infant prophylaxis and point-of-care viral load testing showcased promise in reducing postnatal HIV transmission. The research underscores the value of scaling up such interventions and point-of-care technologies for early infant diagnosis and maternal viral load testing to achieve near-zero postnatal transmission rates.
The study's findings suggest that a simple yet effective strategy can significantly reduce postnatal HIV transmission rates, emphasizing the importance of extending postnatal prophylaxis for infants at high risk and utilizing point-of-care viral load testing for timely interventions. The research contributes valuable insights into optimizing prevention strategies for mother-to-child HIV transmission.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02464-9/fulltext
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