April 23, 2026: NIH to Host Workshop on Combining RCT and Real-World Data for Studying Infant Postnatal HIV Prophylaxis

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) will host a workshop on methods for combining data from randomized controlled trials with real-world data for studying prevention of HIV vertical transmission.

NIH logoThe virtual workshop is scheduled for May 11-12, 2026.

The workshop will convene methodologists, clinical trialists, epidemiologists, data scientists, and regulators to evaluate innovative methods for combining these types of data, with the eventual goal of designing an efficacy-effectiveness trial of long-acting agents as infant postnatal prophylaxis against HIV. The organizers also have an interest in extending this methodology into pragmatic designs.

WORKSHOP INFORMATION AND REGISTRATION

Combining Randomized Controlled Trial and Real-World Data for Long-Acting Agents as Infant Postnatal Prophylaxis Against HIV

  • Dates and Times: May 11–12, 2026, 10:00 am – 2:30 pm EDT
  • Location and Format: Virtual

Objective: To evaluate novel study designs, analytical approaches, and data methods for combining RCT and RWD for an efficacy-effectiveness trial of long-acting agents as infant HIV postnatal prophylaxis against HIV.

Agenda Overview

May 11, 2026, 10:00 am – 2:30 pm EDT (Virtual)

  • Session I. Welcome and Opening Session
  • Session II. Study Design Considerations for Combining RCT and RWD

May 12, 2026, 10:00 am – 2:30 pm EDT (Virtual)

  • Session III. Novel Methods and Analytical Approaches for Combining RCT and RWD
  • Session IV. Data Standards, Management, and Harmonization

Register at https://cvent.me/Yl2RYq. All registered participants will receive the link to the virtual workshop in a reminder email approximately 1 week prior to the event.