Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group

E-mail Print

The article, Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group, a perspective from the Forum for Collaborative Research/HIV Forum is now available in Frontiers in Public Health.

In 2024 and 2025 the HIV Forum convened a multisectoral working group across academia, industry, community, government organizations, and regulatory agencies to formulate evidence-based, representative recommendations to advance the inclusion of pregnant and lactating people in HIV PrEP Research. The group identified several major barriers to inclusion, including ethical complexities, limited pre-clinical and clinical safety data, minimal community engagement, regulatory gaps, and weak surveillance capacity. To achieve equitable inclusion the working group highlighted specific recommendations such as establishing standardized digital data systems, implementing regulatory incentives modeled after pediatric research acts, and utilizing regional bodies like the African Medicines Agency to harmonize global regulatory standards. These topics, among others, are further explored in the article.

Thank you to the authors, collaborators, and members of the HIV Forum - Long-acting PrEP during pregnancy and lactation working group, whose active contribution and expertise enable this work.

Read the article in Frontiers in Public Health: https://doi.org/10.3389/fpubh.2026.1811039