Inclusion of Pregnant and Lactating People in HIV Research

What you need to know 

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 


Advocacy Resources:

Pregnant and Lactating People (PLP) in Ongoing HIV Prevention Trials

Advancing HIV Prevention Research in Pregnant and Lactating People (PLP): Think Tank Report & Action Plan

The work of the AVAC/PHASES think tank to advance HIV prevention research with pregnant and lactating people was importantly grounded in a trio of conceptual frameworks: 1. Reproductive Justice, 2. Conceptual shifts articulated in the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Ethics Guidance and 3. WHO/ IMPAACT framework for accelerated inclusion of pregnant women in pre-licensure clinical trials.

More than Vessels: Pregnant people deserve inclusion in HIV prevention clinical and implementation research

Wednesday, December 14, 2022

During this webinar, panelists explored the need for Pregnant and Lactating Populations (PLP) to be included HIV prevention clinical and implementation research

Speakers included Dr. Elaine Abrams, Raniyah Copeland, Dr. Lisa Noguchi and Dr. Lynda Stranix-Chibanda. The discussion was moderated by Dr. Dvora Joseph Davey.

Recording / Slides / Resources




RINGing the Bell for Choice: Actions and Solutions on Dapivirine Ring Access

Thursday, September 22, 2022

Hear the latest updates from African advocates leading the advocacy for access to the dapivirine ring. Plus tune in for the Population Council’s plans for moving the ring forward on multiple fronts, from roll-out of the monthly ring to research around the 3-month ring and multipurpose ring.

Recording / Slides / Resources

An Advocate’s Guide to Research in Pregnant and Lactating Populations

A resource that provides background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

Report of Community Consultation Among Young Women Living with HIV Currently Accessing PMTCT Services in Benue, Edo, Akwa-Ibom and Lagos States

A 7-page document developed by 2013 AVAC Fellow Oladayo Taiwo Oyelakin identifying challenges women face in access PMTCT services in Nigeria. This report used a community community consultation framework to identify barriers and provide recommendations.