PrEP research: Why pregnant, lactating women shouldn’t be excluded – Expert

The Executive Director of New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Mrs Florita Durueke, has called for the inclusion of pregnant and lactating women in the HIV clinical trial intervention for pre-exposure prophylaxis (PrEP) saying their involvement would help in the reduction of HIV as they face substantial risk of HIV infection. 

Speaking in one of the just concluded five-day webinar series by the organisation, Durueke recalled that  there is a growing consensus globally around the ethical and public health imperative for the responsible inclusion of pregnant women and lactating mothers in clinical research.

She said: “there is a need to develop ethics guidelines for the inclusion of pregnant women and lactating mothers in HIV/co-infections research.

“World Health Organisation, WHO, in partnership with MPACT has identified these gaps and they have developed a framework that stipulates that pregnant women and breastfeeding mothers can participate in research, especially at the face two. They design a situation that if a woman is faced with two trials, at the cost of the trial becoming pregnant she discontinues.

“When we did the trial in Lagos, one of the criteria is that you are not going to get pregnant for that period, so if the person gets pregnant she will discontinue.

“But the WHO framework is saying when a person gets pregnant in an HIV prevention trial, they should offer the person the opportunity to decide if she is willing to continue in the research and if the person says yes, then they should allow the person and then collect the data,” Durueke said.

While calling for advanced responsible HIV prevention research in pregnant and lactating populations, PLP, using a Reproductive Justice, she said that there is a need to engage stakeholders in an early, sustained, and meaningful way in designing and conduct a biomedical HIV prevention trials tailored to the distinctive complexities of research with PLP.

She also advocated sound ethics review processes that promote the responsible inclusion of PLP, including adolescent girls and young women, in biomedical HIV prevention research.