The Role of Peer Mothers in the Recruitment of Pregnant and Breastfeeding Women in Pharmacokinetic Studies

For years, the suggested approach to clinical research was to exclude pregnant and breastfeeding women. The rationale was to protect and avoid any risk to the baby. This has created a vast evidence gap, leaving clinicians and families making unknown medical decisions in the dark. Including pregnant and breastfeeding populations in research is not only scientifically necessary, but it is also an ethical imperative for health equity.

In most cases, pregnancy and breastfeeding change the mother's body functions, which affect how the medicine works, making it important to understand whether the known doses remain safe and effective for the mother and baby, and whether the medicine can safely pass into breast milk. In addition, recruiting mothers into these studies was to provide firsthand evidence that could help improve healthcare for future mothers and babies.

For over ten years, the Infectious Diseases Institute (IDI) has conducted several groundbreaking pharmacokinetic studies among pregnant and breastfeeding women in Uganda. Pharmacokinetic studies help researchers understand how medicines move through the body, how it is absorbed, distributed, metabolized, and eliminated. These processes change dramatically in pregnant and breastfeeding populations.

Peer mothers are critical to pharmacokinetic studies in pregnant and breastfeeding populations because they bridge the trust gap between researchers and participants during a vulnerable period of life. As women with lived experiences of pregnancy, birth, and breastfeeding from the same community, they translate complex PK concepts like “blood draws to measure drug levels” into relatable language, address fears about baby safety and normalize participation.

Jacqueline participating in a session during the 2nd African Workshop on Women and HIV in Nairobi, Kenya

This credibility improves recruitment, reduces dropout, and ensures more accurate self-reported adherence, all of which directly strengthen PK results. Peer mothers provide practical support by reminding participants of sampling visits, navigating stigma around research or medication use, and feeding community concerns back to the study team so that protocols can be easily adapted. In short, they make studies more ethical, feasible, and scientifically valid.

For PK studies, peer mothers are women from the same community who have personal lived experiences with pregnancy, childbirth, and breastfeeding, among others. They are trained to support research health programs. Unlike study staff or clinicians, they are seen as “one of us,” which makes a difference in sensitive studies like pharmacokinetics in lactation. 

My name is Jacqueline Kyeyune, a mother to many, and I have worked as a peer mother for over 6 years at IDI, supporting pharmacokinetic studies involving pregnant and breastfeeding mothers such as Dolutegravir in Pregnant HIV Mothers (DolPHIN-2) and Maternal and Infant Lactation Pharmacokinetics (MILK) studies.

In a pharmacokinetic study with pregnant or breastfeeding mothers, a peer mother’s role is hands-on, community-based, and driven by trust. A typical day mixes logistics, counseling, and data support, and today I would love to share my experience about my involvement in the recruitment of pregnant and breastfeeding women into pharmacokinetic studies.

Jacqueline Kyeyune leads a session on providing psychosocial support in the community. Photo by Simon Peter Asiimwe

My roles in recruitment

As a mothers’ representative, successful recruitment requires me to work hand in hand with the research study team. I make sure that all informed consent forms are reviewed to my understanding before the study commences. This helps mothers to easily understand the informed consent forms in simplified and relatable language.

I serve as a bridge between the research team and the mothers since I personally experienced pregnancy, breastfeeding, and participation in clinical trial research studies. This allows me to easily relate to women’s concerns with understanding, empathy, and compassion. On many occasions, mothers openly tell me that they missed taking their drug doses because of pill burden, yet on the other hand they tell the researchers otherwise.  I step in to inform and educate the mothers with understanding about the consequences of poor adherence for the mother and baby. In addition, I inform the research team about these incidents without the mothers’ knowledge to find possible solutions to the problem at hand. Mothers feel more comfortable discussing their concerns with someone who has shared similar experiences.

Recruiting mothers requires me to build trust with them. Many women fear research participation because they have anxiety about taking medicine, worry about the safety of their unborn babies, blood sample collection, and misconceptions surrounding research. I first listen to their concerns and acknowledge their fears then I share my experience with them “I also had the same fears and anxiety on my fourth pregnancy when I was approached to participate in a research study but all the fears were erased when I gave birth to a healthy bouncing baby boy”. 

My experiences encourage and show mothers that other mothers have safely participated in pharmacokinetic studies before. I continuously remind mothers that decision-making about participation is entirely voluntary.

My role involves identifying eligible participants. I make visits to the various government (KCCA) facilities where mothers receive maternal and child healthcare services (Kiswa, Komamboga, Kitebi, Kawaala and Kisenyi) and communities (Katanga, Kalerwe and Bwaise). I work hand in hand with the facility focal persons who refer potential participants, and together with the research nurses, I identify those who are eligible.

This requires patience because women often prefer talking privately about their personal situations before discussing research participation. Some decline to participate, and I respectfully thank them for their time and remind them that their decision not to participate cannot in any way affect the care they receive at the facility. Mothers who accept participation are referred to researchers for consenting, and this enables mothers to have enough time to understand the study before deciding. I constantly remind mothers that participation is entirely voluntary.

 I carefully discuss all study procedures (risks and benefits) with mothers using simple, relatable, and understandable language. This helps mothers know the purpose of the study and have confidence to ask questions. I simplify some scientific terms that might create confusion. For example, instead of saying: "Researchers are studying drug metabolism." I explain: "We are trying to understand how pregnancy changes the way medicines move through your body so doctors can know the safe medicine and the correct dose for mothers and babies."

Jacqueline Kyeyune discussing participant informed consent form in simple and relatable language. Photo by Simon Peter Asiimwe.

One of the everyday lessons I learn is that listening is more important than speaking. Women openly share their fears and concerns such as fear of repeated blood draws, anxiety about taking medicines during pregnancy and breastfeeding, worries about breastfeeding safely, among others. They only need someone to listen to their concerns and fears before they are ready to discuss research participation.

For the mothers who are recruited, a simple act of remembering their name or the baby’s name makes them feel valued and happy. One day I asked a participant why she was happy whenever I called her name or the baby’s name, and she said, “Researchers are always very busy with various participants, and for any of them to remember my name or the baby’s name means I am important and offering a valuable contribution to the research and healthcare services.” This always reminds me that the little things matter.

Research recruitment brings together people with different beliefs and cultural backgrounds.  It is critically important to acknowledge and respect participants’ cultural values and norms. This helps me and the research team gain trust amongst the communities we work with.

It is very important to disseminate research findings to participants. Some mothers who declined participation have had a history of previous research studies that did not disseminate research findings. During recruitment, mothers thought our studies would not disseminate results.

Challenges encountered

Some mothers have misconceptions about research. They believe blood samples can be misused. One common rumour suggests that “blood collected during studies is used to manufacture lipstick”. Addressing these misconceptions requires patience, honesty, and respectful conversations.

Some mothers experience emotional and social challenges such as anxiety, physical exhaustion, financial difficulties, relationship challenges, fear of stigma, and lack of family support. These challenges often influence their decisions about research participation.

Recruitment and consenting require mothers to stay in hospital for longer hours. This causes them to be anxious since some of them don’t inform their spouses about study participation.

Rewarding moments

One of the most rewarding parts of my work is seeing women become advocates for research. Some mothers who were initially hesitant later encourage others to participate. They share their own positive experiences, reassure friends, and feel proud in contributing to research that can improve healthcare. Watching this transformation evidences the power of trust, empathy and community engagement.

Working with healthcare workers and researchers has widened my understanding of clinical research. I have gained a greater appreciation for research ethics, participant protection, informed consent, confidentiality and good Clinical Practice.

Research team during one of the community Engagement activity in Mbarara. Photo by Simon Peter Asiimwe.

At the same time, I recognise how important community voices are in shaping research. Peer mothers help researchers understand local beliefs, community concerns, cultural practices, preferred communication styles and barriers to participation. In many ways, we serve as a bridge between science and communities.

I am honored to contribute to research that aims to improve healthcare for pregnant and breastfeeding women and their babies. Through Pharmacokinetic Studies, I have witnessed the strength of women who decide to participate despite the uncertainty, the commitment of researchers working to get useful evidence, and the resilience of communities navigating complicated healthcare challenges.