P19.05
Background: When recruiting female participants for a microbicide vaginal ring trial it is important to note that they are not only individuals, but also members of a community - women who are part of complex relationships and interactions.
At Madibeng Centre for Research (MCR) it was noted that participants raised various concerns during their counselling sessions, which differed from partner-related issues to issues related to community members, who may have caused anxiety or discouraged ring use.
Methods: With participants' assistance, research nurses and the MCR investigators explored during counselling sessions concerns raised that could lead to possible trial non-compliance. Concerns identified were addressed in adherence counselling sessions to empower participants to comply with the protocol. These sessions targeted trial awareness, general knowledge about HIV and HIV risk to address personal risk awareness and were done on a one-to-one basis, during community events or, if consent was given, directly with male partners. Additional efforts were required for targeted males to intensify the support and assistance given to particular participants e.g. in cases where a partner did not understand the purpose of the trial or had safety concerns around the use of the vaginal microbicide ring.
Results: With additional knowledge, the participants are more open to share their experiences with the community, male partners and also the site staff. It has been observed that the community and male partners support the work done by the study and the trial participants.
Conclusions: Community awareness and male involvement are important to support women who are participating in a trial and encourage them to adhere to ring use, but community engagement efforts begin with the participants.