Background: Developing effective and safe microbicides requires study procedures (e.g., technology used, abstinence requirements, and product use) that are acceptable to participants.
Methods: Thirty women completed 4 study visits including pelvic examination, colposcopy, optical coherence tomography (OCT), and semistructured, qualitative interviews. Additional requirements included abstinence (for approximately 16 days) and twice daily vaginal product use (for 5.5 days). Interviews were audio-recorded, transcribed, and analyzed using framework analysis. Themes addressing OCT experiences, acceptability of abstinence, and vaginal product use were examined.
Results: OCT was viewed favorably as an imaging technology. Some women reported feeling the fiber-optic probe "poking" them and more than one-third spontaneously reported feeling pressure or pinching upon rotation of the speculum in connection with the OCT evaluation. Compliance with vaginal gel use was high, but for many women assigned to use a product containing nonoxynol-9 (vs. placebo), the postproduct use examination was more uncomfortable, relative to the initial examination or 1 week following product discontinuation. Nearly all women experienced product leakage; acceptability of leakage varied. Two women were not abstinent and several more found abstinence challenging. Some women involved their partner in decision making regarding trial enrollment. Strategies to remain abstinent included participating when the partner was away, avoiding early intimacy, and engaging in alternative sexual activities.
Conclusions: Qualitative interviews in early-phase studies provide insights and capture information that would be missed by behavioral inference alone. Understanding participant's experiences is important in order to provide anticipatory guidance and plan future microbicide studies that facilitate adherence with trial requirements.