Related Experiment Video
Updated: May 5, 2026
Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs
Published on: December 9, 2010
Exploring pregnant women's experiences with dapivirine vaginal ring insertion during the MTN-042/DELIVER study in
Joselyne Nansimbe1, Brenda Gati Mirembe2, Phionah Kibalama Ssemambo2
1Makerere University-John Hopkins University Research Collaboration, Upper Mulago Hill Road, P.O. Box 23491, Kampala, Central 256, Uganda.
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® once daily and the Dapivirine Vaginal Ring (DVR) every month. There is limited data on pregnant women's experiences with ring insertion, which we explored.
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 DVR or Truvada in varying ratios into three successive cohorts (based on gestational age). Ring self-insertion was required at enrolment and every 4 weeks until delivery. Pre-insertion counselling and supervised ring placement assessment were done. Enrollment data were collected to include counselling sessions, insertion tactics, ring self-insertion scores (Very difficult: 3+ attempts and/or pain, severe discomfort, Difficult: 2 attempts and/or moderate discomfort, Easy: 1 attempt with some ring repositioning and/or mild discomfort, Very easy: Smooth insertion and positioning in one attempt with no discomfort), assistance during insertion, encountered challenges and ring expulsion during use.
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.
