Why researchers should include pregnant and lactating women in HIV prevention research
- 2 min. read ▪ Published
More than 400,000 adolescent girls and women contracted Human Immunodeficiency Virus (HIV) in sub-Saharan Africa in 2023, the last year for which data is available. If untreated, HIV—spread through blood, semen, vaginal fluids, and rectal fluids most commonly through unprotected sex, shared needles, or from mother to baby—can progress to AIDS, a deadly disease which has killed more than 43.2 million people around the world, according to the United Nations.
While there are medications that cut the risk of contracting HIV to 1%, there is little uptake of these pre-exposure prophylaxis (PrEP) drugs by pregnant and lactating women in sub-Saharan Africa, even though women are at a heightened risk of contracting HIV during and immediately after pregnancy. There is also little research on how safe and effective they are for this group – which spurred the Forum for Collaborative Research, a public/private partnership at UC Berkeley School of Public Health, to convene an international panel of experts to develop strategies to increase their inclusion.
The group, which included professionals from academia, industry, and government and community groups, convened from January 2024 to February 2025, identifying key barriers that have kept pregnant and lactating women from participating in clinical PrEP trials.
Their report, published July 5, 2026 in Frontiers of Public Health, noted that these barriers included ethical concerns, limited safety data, minimal community engagement, regulatory gaps, weak incentives, and limited surveillance capacity.
Most importantly, the authors noted that pregnant and lactating women have long been viewed as too vulnerable for inclusion in many drug trials—a perspective which is changing, but slowly. They argued that ensuring pregnant and lactating women are meaningfully involved in research and decision-making is key to sustainable, equitable HIV prevention.
The authors recommend reframing pregnant and lactating women as needing protection through research, rather than from research—along with stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.
“The problem is if we don’t include those women in clinical trials then nobody will have any idea of how safe” treatments are, said Dr. Veronica Miller, director of the Forum and an adjunct professor at the School of Public Health. “If people are worried about the safety—it could be the primary care doctor, or the women themselves, they won’t use it. We have to ensure that all women have access to what is out there.”
Miller would like to see broad acceptance of the report’s recommendations, in particular an increase in community engagement and partnership with civil society.
