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.
Qualitative interviews of 30 women revealed acceptability of a novel imaging tool for the genital tract, challenges and strategies regarding abstinence as a trial requirement, and vaginal product use toxicities.
From the *Department of Health Sciences Research, Division of Health Care Policy & Research, Mayo Clinic, Rochester, MN; †Department of Pediatrics, University of Texas Medical Branch, Galveston, TX; ‡Department of Obstetrics & Gynecology, University of Texas Medical Branch, Galveston, TX; §ReProtect Inc, Baltimore, MD; and the Departments of ¶Pediatrics and ∥Psychiatry, Columbia University Medical Center, College of Physicians and Surgeons and New York Presbyterian Morgan Stanley Children's Hospital, New York, NY
The authors acknowledge Massoud Motamedi, PhD, and the UTMB Center for Biomedical Engineering for contributions related to the imaging aspects of the project. The authors also thank Jeremy Paull, PhD, Brent Bell, BS, Lora Black, MA, Katie Johnston, AAS, and Jingna Wei, MD, for their scientific contributions to the project.
Supported by U19 AI060598 from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and 1UL1RR029876-01 from the National Center for Research Resources.
Correspondence: Carmen Radecki Breitkopf, PhD, Mayo Clinic Rochester, Health Sciences Research, Charlton 6-235, 200 First St. SW, Rochester, MN 55905. E-mail: email@example.com.
Received for publication April 5, 2011, and accepted August 4, 2011.