Participant experiences with a multipurpose vaginal ring for HIV and pregnancy prevention during a phase 1 clinical trial: learning from users to improve acceptability

• DOI: 10.3389/frph.2023.1147628
• Publication Date: 2023-07-06T18:11:16Z
• Authors: Mary Kate Shapley...; Mei Song; Beatrice A. Chen; Brid Devlin; Ellen Luecke; Jill Brown; Diana L. Blithe; Sharon L. Achilles; Ariane van der St...
• Keywords: Vaginal ring

With high concurrent global rates of HIV incidence and unintended pregnancy, there is a need to provide options beyond condoms enable users simultaneously prevent acquisition pregnancy. Multiple vaginal rings are in development as "MPTs" (multipurpose prevention technologies) they shown several co-occurring benefits such discretion, convenience, reversibility user control.In this Phase 1 trial 3-month MPT ring the U.S., 25 participants (low-risk for pregnancy) were randomized use study 90 days continuously or 28-day cycles with 2-day removal periods between. All completed in-depth interviews at end their participation.Overall, was well tolerated. Participants resoundingly endorsed concept an extended-use, dual-purpose ring, but reported too many functional challenges side effects endorse particular ring. assigned continuous regimen more positive experiences than those cyclic group. A minority who experienced minimal did not experience retention found it appealing. However, majority (ring slippage, expulsions, effects, bleeding changes) product that outweighed potential led them report - future would be interested using specific version its current form. subset expressed interest under certain conditions (e.g., if fewer less bleeding, higher risk HIV/pregnancy).User feedback regarding participant shared developer, underscoring value early-stage end-user development.