Involvement of Stakeholders in Planning and Implementing HIV Clinical Research Trials among Pregnant and Breastfeeding Women in Uganda.



Phase IIb and III trials on the safety and efficacy of the dapivirine vaginal ring (DVR) involved women of reproductive age, yet pregnant and breastfeeding women were excluded from enrolling. Those who became pregnant during study participation were required to discontinue study product immediately. As such, limited information is known about the safety of the DVR in pregnant and breastfeeding women, despite high vulnerability to HIV in these populations. For this reason, the Microbicide Trials Network (MTN) designed the MTN042/DELIVER and MTN-043/B-PROTECTED studies to better understand safety of the DVR, as well emtricitabine/tenofovir disoproxil fumarate (Truvada) as oral PrEP, among these groups of women.


MTN, AVAC, MU-JHU and civil society partners identified a range of stakeholders from both the HIV prevention and maternal health arenas to attend a two day meeting to provide their input in preparation for and implementation of the two protocols. This was followed by two smaller group engagement meetings, one for the Kampala Capital City Authority (KCCA) health workers and the other for community-based private health practitioners and local leaders. Agendas were developed that allowed open discussion and the provision of key issue feedback to the research team.


Three meetings were held and 214 (97%) of the 220 invited stakeholders attended, including policy makers, regulators, civil society, religious leaders, private midwives, political leaders, former participants in DVR studies, PrEP and Prevention to Mother To Child Transmission (PMTCT) beneficiaries, mentor mothers, KCCA health workers, community based-private health practitioners, local leaders, and other community stakeholders. Attendees were supportive of the studies proposed and made suggestions to improve implementation that included: joint protocol reviews by regulating bodies to minimize delays in obtaining approvals, substantial male involvement to minimize social harm, development of information and education materials to promote better understanding of the studies, and continuous community sensitization about oral PrEP, pregnancy-related complications, birth defects and the known study product side effects to help minimize the potential of communities apportioning blame to study products.


Careful selection of stakeholders and interactive agendas enabled meaningful engagement and solicitation of input to support the planning, preparation, and implementation of the two protocols.