Acceptability of optical coherence tomography and abstinence requirements among women participating in microbicide safety trials.

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.

Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial.

OBJECTIVE: Colposcopy has been used to detect epithelial damage with vaginal microbicides. In animal models, optical coherence tomography provided increased sensitivity over colposcopy in detecting epithelial injury. This randomized, double-blinded, clinical study compared optical coherence tomography to colposcopy for the evaluation of epithelial injury in women using placebo or nonoxynol-9. METHODS: Thirty women aged 18-45 were randomized to use hydroxyethyl cellulose placebo or nonoxynol-9 vaginal gel twice daily for 5.5 days. Imaging with colposcopy and optical coherence tomography was performed before product use, after the last dose, and 1 week later. Colposcopy was graded using standard criteria. Optical coherence tomography images were scored for epithelial integrity based on a published scoring system and were measured for epithelial thickness. RESULTS: Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02). CONCLUSION: Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage. CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry, www.umin.ac.jp/ctr/index.htm, R000006186. LEVEL OF EVIDENCE: I.

Perceptions of reimbursement for clinical trial participation.

A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22-45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.

Adult women's attitudes toward the HPV vaccine.

AIMS: Two human papillomavirus (HPV) vaccines have demonstrated efficacy in preventing HPV infection and are currently being administered to adolescent girls in several countries. Although the most efficient HPV prevention strategy is immunizing adolescents before there is any risk of exposure, adult women also may benefit from vaccination. This study aimed to explore the attitudes of women aged 27-55 years toward the HPV vaccine. METHODS: Thirty-eight women were recruited from a university-based gynecological practice, completed a demographic questionnaire, and then were interviewed. RESULTS: Most participants had heard about the vaccine and were positive about the HPV vaccine for adult women. Women advocated universal access to this vaccine, indicating that all women should have the option. They assessed their risk level in several ways, including level of monogamy, relationship status, previous sexual risk behaviors, history of an abnormal Pap smear, and family history. All but 2 woman described barriers to vaccination, including cost, side effects, and hassle factors. Most women did not believe the vaccine would change risk behaviors. CONCLUSIONS: The women from this convenience sample knew the HPV vaccine existed and in general found it acceptable. If an HPV vaccine becomes available to adult women, healthcare professionals will be faced with the challenge of providing accurate information, being sensitive and willing to help each individual woman make a decision, and being creative when developing new ways to eliminate barriers to getting the vaccine.

Uptake of HPV vaccine: demographics, sexual history and values, parenting style, and vaccine attitudes.

PURPOSE: To examine the relationships of demographics, parenting, and vaccine attitudes with the acceptance of the human papillomavirus (HPV) vaccine or to the intent to vaccinate in the next 12 months. METHODS: Mothers (n = 153) with daughters ages 11 to 17 years were recruited through the pediatric clinic waiting room/announcements to complete a questionnaire. RESULTS: Eighteen percent of the daughters had not received the vaccine, although it had been offered; 34% had not been offered the vaccine and did not intend to get it in the next 12 months; 22% had not been offered the vaccine but intended to get it in the next 12 months; 26% had started vaccination or completed the series. In a multinomial, multivariable logistic regression model, those mothers who had less than a high school degree, had a history of a sexually transmitted infection, supervised their daughter more when she was with peers, and whose daughter would not mind three shots were more likely to be favorable about their daughter being vaccinated. The following variables were not related to their attitudes about getting the vaccine: mothers' and daughters' ages, race/ethnicity, mothers' self-reported history of HPV disease and age of sexual initiation, daughters' dating status and anticipated age of sexual initiation, the number of sexual topics discussed and level of comfort, mother's sexual values, and the family environment. CONCLUSIONS: Mothers' decisions about the HPV vaccine were not related to their sexual values or their daughters' sexual behavior, but rather their parenting, sense of vulnerability, and vaccine attitudes. Mothers who were not planning to vaccinate did not appear to not feel an urgency given the newness of the vaccine, and many planned to vaccinate eventually.