Inclusion of Pregnant and Lactating People in HIV Research

Produced and hosted by Jeanne Baron

People who are pregnant or lactating (PLP) have historically been excluded from research because of concerns for the developing fetus. But this has led to a dearth of data on new interventions against health threats for this population. In the case of HIV, pregnancy raises the risk of acquiring HIV by up to three times, but providers often do not have the data to know whether a new intervention is safe or how it will work for pregnant patients. As a result, PLP and their physicians are left to make difficult decisions around the use of proven HIV prevention products as they await more data specific to pregnancy and lactation. 

But change is in the air. Champions for the inclusion of PLP in research are paving the way for a paradigm shift—one that will redefine this population from needing protection from research to being better protected through research. In this episode of Px Pulse, AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policymakers and donors to understand why this population gets excluded, the impact it has and what to do about it.   

Tune it to hear:

• Dr. Anne Drapkin Lyerly, Principal Investigator of the PHASES Project to advance equitable inclusion of pregnant women in HIV research and its follow-on project, PREPARE, focused on ethical HIV research in adolescents who are pregnant. 
• Elisia Madende, trial participant in the HPTN 084 trial in Zimbabwe 
• Dr. Ashley Lima, Health Science Specialist and Lead Technical Advisor for Socio-behavioral Research — USAID Office of HIV/AIDS Research Division 
• Dr. Takunda Sola, HIV Prevention and Key Populations Medical Officer — Zimbabwe MoH AIDS/TB Unit 

Links:

• Listen to the episode (34:28)
• Read the transcript

Advocacy Resources:

• Report: Advancing HIV Prevention Research in PLP: Think Tank Report & Action Plan
• Advocates’ Guide: An Advocate’s Guide to Research in Pregnant and Lactating Population
• Factsheet: Including Pregnant and Lactating Populations in HIV Prevention Research
• Infographic: Pregnant and Lactating People (PLP) in Ongoing HIV Prevention Trials
• Webinar: More than Vessels: Pregnant people deserve inclusion in HIV prevention research
• Guidance: PHASES Guidance: Ending the evidence gap for pregnant women around HIV & co-infections 
• Meeting Report: Call to accelerate the study of new drugs for HIV in pregnant and breastfeeding women
• JIAS Special Issue: ‘Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy’