A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
1. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report.
1. Known or suspected allergy to silicone or EVA, as reported by participant. 2. Positive pregnancy test at screening or enrollment based on urine hCG test. 3. Positive for HIV at screening based on rapid test per site SOPs. 4. Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) at screening.
Single group
Pro-type IVR
DeviceWomen will test three non-medicated IVRs on two one-day clinic visits (two on the first day, one on the second day) by manipulating them, vaginally inserting each ring and then performing a controlled set of tasks simulating routine daily activities with the ring in the vagina.
Mean Acceptability Score per IVR
For the primary outcome we will compute the mean acceptability score per IVR, for each of three IVRs of different compression strengths. The scores women give each of the three rings will be compared using a mixed-effects model with orthogonal contrasts, with all 3 pairwise comparisons using the Bonferroni method to adjust for multiple comparisons.
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Population Council
Lead sponsor
Emory University
Collaborator
