By Tina George, Minna
The Executive Director of the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Mrs. Florita Durueke has advocated for the inclusion of pregnant women and breastfeeding mothers in clinical trials, especially in the HIV prevention clinical research and trials.
Speaking during a recent virtual webinar training for female journalists across Nigeria, she noted that pregnant women and breastfeeding mothers remain profoundly underrepresented in clinical trials of new prevention interventions like pre-exposure prophylaxis (PrEP).
According to Durueke, without evidence specific to pregnant women and breastfeeding mothers, these individuals may be inadvertently under or overdosed and exposed to drugs that carry unacceptable risks to the pregnant person and/or fetus, while in other cases, they may be denied access to needed products and medication.
The HIV advocate noted that the World Health Organisation (WHO) in partnership with MPACT has identified these gaps, and has developed a framework that stipulates that pregnant women and breastfeeding mothers can participate in phase two of clinical trials.
She further observed that this comes with developing ethics guidelines for the inclusion of pregnant and lactating mothers in HIV/co-infections research.
“Women face a substantial risk of HIV infection during pregnancy and breastfeeding. The risk of infection is more than doubles per unprotected sex act during pregnancy and the postpartum period.
“Acute maternal infection is associated with a significantly elevated risk of perinatal transmission of HIV. Globally, there is a growing consensus around the ethical and public health imperative for the responsible inclusion of pregnant and lactating mothers in clinical research.”
She emphasized the need for an existing conceptual framework for the responsible inclusion of pregnant women and breastfeeding mothers in clinical trials.