title: Acceptability of optical coherence tomography and abstinence requirements among women participating in microbicide safety trials.
abstract: 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.
authors.affiliation: Department of Health Sciences Research, Division of Health Care Policy & Research, Mayo Clinic, Rochester, MN 55905, USA. radeckibreitkopf.carmen@mayo.edu
authors.forename: Carmen
authors.initials: C
authors.lastname: Radecki Breitkopf
authors.forename: Melissa
authors.initials: M
authors.lastname: Loza
authors.forename: Kathleen
authors.initials: K
authors.lastname: Vincent
authors.forename: Thomas
authors.initials: T
authors.lastname: Moench
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Stanberry
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenthal
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D017137:Nonoxynol / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D017060:Patient Satisfaction; D012449:Safety; D012746:Sexual Abstinence / Q000523:psychology*; D012725:Sexual Behavior; D013501:Surface-Active Agents / Q000008:administration & dosage / Q000009:adverse effects; D041623:Tomography, Optical Coherence / Q000379:methods*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D013501:Surface-Active Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol