Exploring pregnant women's experiences with dapivirine vaginal ring insertion during the MTN-042/DELIVER study in Uganda: a description of secondary data.

Background: Involving pregnant women in HIV prevention trials is key to ensuring that they benefit from efficacious products. MTN-042/DELIVER was a phase IIIb, open-label, multi-site, randomized safety study, the first of its kind to enroll HIV-negative pregnant women into a prevention trial using oral Truvada Objectives: To explore the experiences of pregnant women with DVR insertion during the MTN-042/DELIVER study at MU-JHU Care Limited in Kampala, Uganda. Design: A description of secondary data from the MTN-042/DELIVER study. Methods: Participant randomization was to either Results: Out of 154 participants, 73% were randomized to the ring. At enrolment, all participants attempted self-insertion. Only one participant required additional counselling. The squatting position was uniformly favoured. Across all cohorts, 95% of participants had easy/very easy ring self-insertion. Five percent had difficult ring self-insertion, with some variations across cohorts. Challenges included difficulty in folding, gripping, inserting the ring far enough, requiring multiple attempts and reluctance to insert it. No expulsions during ring use were reported. Conclusion: Most pregnant women managed to insert the Ring themselves. However, participants above 36 weeks required more help with ring insertion compared to others. This suggests that it may be beneficial to encourage pregnant women to start using this HIV prevention method early in pregnancy, to minimize potential initial insertion challenges in late pregnancy. Trial registration: The primary study, MTN-042/DELIVER is registered as ID NCT03965923 at https://www.ClinicalTrials.gov.