Including Pregnant and Lactating Populations in HIV Prevention Research

Pregnancy and the post-partum period after giving birth are times of heightened HIV risk. Cisgender women are two to three times more likely to acquire HIV during pregnancy and four times more likely post-partum than otherwise. Women who acquire HIV during pregnancy have an 18 percent change of transmiting HIV to their newborn, which goes up to a 27 percent chance if they acquire HIV while breastfeeding.

Yet, HIV prevention options for pregnant and lactating populations (PLP) are limited, and their inclusion in research inadequate and hence evidence gaps can be seen across the research landscape for new prevention products. Most biomedical HIV prevention research excludes PLP, and those who become pregnant during a trial are typically stopped from further use of the study drug. PLP include cisgender women, transgender men and those who identify as gender non-binary who are able to get pregnant. For transgender and gender-diverse pregnant people, evidence gaps are even further magnified.

The exclusion of Pregnant and Lactating People (PLP) from research results in:

  • A lack of data on dosing and maternal and fetal safety
  • Limitations around prescribing potentially beneficial interventions
  • Exclusion from potential direct benefits of research participation
  • Delays and discrepancies in health policies and programs

There is growing consensus for the greater inclusion of PLP in HIV prevention research as a public health ethical imperative, but action and a paradigm shift is needed from a variety of stakeholders to promote ethical inclusion rather than presumptive exclusion of pregnant women from clinical drug trials.

“Excluding pregnant women from clinical trials doesn’t eliminate risk, it simply shifts the risk from research studies to the doctor’s office, where pregnant women receive treatments rarely supported by robust data about how they will respond and whether the drugs are effective in pregnancy.” – Dr Anne Lyerly, PHASES, Source: Undark 2020

The Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Project guidance identifies conceptual shifts for the ethical framing of research as shown here.

Ethical Shifts in the Framing of Research in PLP (PHASES, 2020)

The resources below provide background on the issue, updates on progress toward the inclusion of PLP in HIV prevention research and explore advocacy to accelerate this progress.