Advancing the inclusion of pregnant and lactating populations in HIV PrEP research
Ethical, regulatory, and surveillance recommendations from a multisectoral working group
Bibliographic Data
Despite a 60% decline in new HIV infections since 1995, significant challenges persist. In 2023, 1.3 million new HIV infections occurred, with 645,500 in sub-Saharan Africa, where cisgender adolescent girls and women represent over two-thirds of new cases. Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials, despite a recent movement toward inclusion, such as in the PURPOSE 1 trials evaluating the efficacy and safety of lenacapavir. This data gap is concerning given that women face an elevated risk of HIV acquisition during pregnancy. Despite this heightened risk, access to PrEP remains restricted among these groups. This article, based on insights from a multi-regional and multi-sectoral working group convened by the Forum for Collaborative Research between January 2024 and February 2025, addresses this critical issue. The working group, comprising stakeholders from regulatory agencies, research, industry, and communities, held meetings and a scientific symposium to inform evidence-based strategies for improving the inclusion of pregnant and lactating women in PrEP trials. The working group identified key barriers, including ethical concerns, limited safety data, minimal community engagement, regulatory gaps, weak incentives, and limited surveillance capacity. They recommend reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts
Clinical trial · Cognitive reframing · Pre-exposure prophylaxis · Pregnancy · Working group · HIV Research and Treatment · HIV-related health complications and treatments · HIV/AIDS Research and Interventions
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