CROI 2023: Reporting from Margarita Breakfast Club Session 3

The Data Gap: Filling in the Missing Perspectives on Women and Children in HIV Research

Speakers:

Professor Lee Fairlie, Wits RHI

Jane Kabami, Infectious Diseases Research Collaboration Uganda

Imelda Mahaka, Pangaea Zimbabwe AIDS Trust

Moderator:

Dawn Averitt, The Well Project, Women’s Research Initiative on HIV/AIDS

Wednesday 22 February 2023

In the third and final MBC session of the year, we received updates from key studies filling in the gaps on women and children in HIV prevention and treatment research.

Women need options for HIV prevention methods that they can use and change throughout their lives, including during pregnancy and breastfeeding. Indeed, the risk of HIV acquisition is 4 times higher during breastfeeding and 2 to 3 times higher than other times in their lives.

Professor Lee Fairlee, Wits RHI, talked us through the results of two Phase IIIb studies presented at CROI 2023. The first, B-PROTECTED, is the first prevention study in women who are actively breastfeeding. The participants were randomised on a 3:1 ratio (dapivirine vaginal ring to oral PrEP), with the objective of obtaining further data on the ring. The study confirmed its efficacy and did not produce any safety concerns for the woman or the infant.

The sister study DELIVER, looking at pregnant women, enrolled 3 groups of women at different stages of pregnancy, in accordance with the decrease in gestational age:

• Group 1: Enrolled from 36 weeks upwards (end point of pregnancy, within third trimester)
• Group 2: Enrolled at 30-35 weeks (late pregnancy, within third trimester)
• Group 3: Enrolled and being followed up during 12-29 weeks (earliest phase of pregnancy)

The rationale behind the phased study design was based on the fact that, when introduced to a new product, risks are more likely to occur to the infant at the very early stages of pregnancy. For this reason, the study began the trials with women at the latest and least risky stage first. For groups 1 and 2, no risk for the ring (or oral PrEP) was detected in any stage of the third trimester. Results from the third group will be available by May 2023.

Additionally, we heard from Jane Kabimi, Infectious Diseases Research Collaboration Uganda, who presented a study focusing on improving viral suppression in pregnant and breastfeeding women in Uganda. The key element was to ensure that pregnant women were involved as stakeholders and decision makers in the process. The study provided viral load counseling, information and support for women via a trained peer-led model. The study followed participants for one year and found an improvement in viral load suppression by around 25%, particularly in young women (15-24 years old).

In this study, 88% of participants achieved suppression, of whom 98% maintained the suppression. A key takeaway is that once a woman takes responsibility of their own health as an informed decision maker, the chances of viral suppression are very high.

Imelda Mahaka, Pangaea Zimbabwe AIDS Trust, added the community voice to the discussion reminding us of the need for communities to amplify women’s voices, push for more relaxed trial requirements for contraception and for members of community advisory boards to ask the right questions for responsible inclusion.

We must rethink the perspective and include women as a complex population, rather than a vulnerable one, and move away from the idea that we are protecting women from research to the idea that we are protecting women through research. There are many actions/ calls for society and communities for women to be engaged as partners in each phase of the R&D process. If the effort is made, we could start closing the data gap.

Click here to watch the recording of the session!

More about the MBCs: https://www.eatg.org/events/margarita-breakfast-clubs-at-croi-2023/