'Some parts of the consent form are written using complex scientific language': community perspectives on informed consent for research with pregnant and lactating mothers in Uganda.

Background: Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research.

Methods: A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members.

Recruitment of pregnant and breastfeeding women in pharmacokinetic studies: strategies, opportunities, barriers, and recommendations.

Pregnant and breastfeeding women are often under-represented in clinical research, including pharmacokinetic studies, due to ethical and logistical challenges. This paper examines strategies to improve the recruitment and retention of this demographic in pharmacokinetic research, drawing on experiences from five studies conducted at the Infectious Diseases Institute, Makerere University, Uganda. Key strategies implemented include Community Advisory Board meetings, the involvement of Peer Mothers as Co-Investigators, established recruitment sites, the use of safety protocols, and the utilization of diverse communication platforms, including social media and stakeholder meetings.

Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother-infant pairs.

Pharmacokinetic studies are important for understanding drug disposition in the human body. However, pregnant and lactating women are often excluded from primary pharmacokinetic studies and as such there is often limited dosing information regarding drug use in pregnant and/or lactating women. The objectives of this interim analysis were to define the transfer of rifampicin to a breastfed infant and to determine the area under the concentration-time curve of rifampicin in maternal plasma, breastmilk and infant plasma.

Pharmacokinetics of drugs used to treat drug sensitive-tuberculosis in breastfeeding mother-infant pairs: An observational pharmacokinetic study.

Background: Globally, more than half of women take medicines whilst breastfeeding. Data concerning the exposure of the breastfed infant to drugs and any related risks are sparce. Lactation studies are only rarely performed close to licensing for medicines anticipated to be widely used in women of childbearing age.

Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024.

Everybody deserves access to evidence-based information to make decisions about their health. However, in many situations, clinical trial eligibility criteria mean that specific data do not exist for certain groups of individuals. These include pregnant and breastfeeding women, children, older people, those with hepatic and renal dysfunction, those with acute severe illness, and those with multiple co-morbidities and interacting medications.

It Takes A Village; Involvement of Village Health Teams to Develop Tools and Resources to Communicate about Antiretroviral Use in Pregnancy and Breastfeeding at Community Level in Uganda.

Background: Research findings must be communicated to the populations who will benefit from them, in a manner that is accessible and understandable.

Aims: We recently generated novel data on medication use in breastfeeding. A Faculty of Health and Life Sciences (Liverpool) grant enabled work with a team of Village Health Teams (VHTs) in Hoima, rural Uganda, to co-create related communication materials for use in their house-to-house visitation and health education.

-Pharmacokinetics of antimalarial drugs used to treat uncomplicated malaria in breastfeeding mother-infant pairs: An observational pharmacokinetic study.

Data surrounding the exposure of the breastfed infant to drugs and any associated risks are sparse. Drugs usually are transferred to milk in small quantities, and many have been used without obviously noticeable infant toxicity for many years - this lack of a 'safety signal' has further reduced the interest in studying mother-to-infant transfer of the drugs. In sub-Saharan Africa, pregnant women are at risk of   infection, and one in four women have evidence of placental infection at the time of delivery.