A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection

Comparative Medicine - OneHealth and Comparative Medicine Poster SessionThis is a randomized, double blind, placebo controlled, parallel group multicenter study in women with biopsy confirmed Grade 2 or Grade 3 cervical intraepithelial neoplasia (CIN). Two hundred patients will be enrolled and randomized in a 2: 1 ratio of RO5217790: placebo. They will be stratified on the basis of their HPV genotyping with stratum 1 consisting of those women with HPV 16 single infection and stratum 2 consisting of those with single or multiple infections with other high risk genotypes. Three injections of RO5217790 (5 x 107pfu) will be administered subcutaneously, each one week apart. Interim colposcopy, cytology and HPV assessments will be performed at Month 3. All patients will undergo conization at Month 6. The primary endpoint is histologic response at Month 6 in HPV 16 single infected patients, as assessed by central pathology review. The secondary endpoints include histologic response in all CIN2/3 patients enrolled regardless of genotype, viral clearance, safety, and immune response (cellular and humoral). After the Month 6 conization, the study will be unblinded and patients will undergo follow-up for an additional 2 years for efficacy and safety. This includes visits at Months 12, 18, 24 and 30 to assess histologic relapse/recurrence and viral re-infection as well as reporting of any serious adverse events. An interim analysis will be conducted when a minimum of 80 patients (at least 20 of whom have single infection with HPV 16 and 20 of whom have infection with HPV 16 plus HPV 16 related genotypes) have undergone conization. NCT0102234

3q26 Amplification is Rarely Present in Women Whose LSIL Cytology does not Represent CIN 2+ Disease

Comparative Medicine - OneHealth and Comparative Medicine Poster SessionObjective: 10-17% of women with LSIL cytology truly have CIN 2+ disease at colposcopically directed biopsy and 20% of the CIN 2+ lesions derive from women with LSIL cytology. No molecular marker has yet been able to triage LSIL cytology effectively. If possible, the triage would spare women the referral to colposcopy. Irreversible chromosomal damage occurs during oncogenesis. Increasing cervical dysplastic severity occurs with increasing amplification of the 3q26 chromosomal region. The purpose of this study is to evaluate the test characteristics of 3q26 amplification in women whose routine cytology is reported as LSIL with emphasis on the negative predictive value for reassurance. Methods: We conducted a retrospective study using the available SurePath™ liquid cytology LSIL archival samples from women 17-59 years old which were linked to colposcopically directed biopsy samples taken on average 36 days after cytology sampling (3-90 day range). Nuclei from the LSIL samples were hybridized with a single-copy probe for the chromosome 3q26 region and a control probe for the centromeric alpha repeat sequence of chromosome 7, using standard FISH methods. Amplification was defined as five or more signals present in at least 2 cells. Results: Of the 68 paired cytology/biopsy samples, 3q26 amplification occurred in 40% of the women with CIN 2+ disease (sensitivity 95% CI: 12, 74). There was no amplification in 91% of women with less than CIN 2 disease (specificity 95% CI: 81, 97); and the negative predictive value was 90% (79, 96). Conclusions: The lack of 3q26 amplification in women with screening cytology LSIL results offers reassurance that CIN 2+ disease has not developed. Future prospective studies are ongoing

"I try and smile, I try and be cheery, I try not to be pushy. I try to say ‘I’m here for help’ but I leave feeling… worried’’: A qualitative study of perceptions of interactions with health professionals by community-based older adults with chronic pain

Background: Over 50% of community-dwelling older adults experience chronic pain, which threatens their quality of life. Of importance to their pain management is older people’s interaction with health professionals that, if unsatisfactory, may impair the outcome. Aims: To add to the limited research specific to older people living with chronic pain in the community, we explored how they perceive their experiences of interacting with health professionals, seeking factors that might optimise these interactions. Methods: Purposive sampling was used to recruit men and women .65 years with self-reported musculoskeletal chronic pain. Qualitative individual interviews and one group interview were undertaken with 23 participants. Data were transcribed verbatim and underwent Framework Analysis. Results: Three themes were identified. Seeking help illustrates issues around why older people in the community may or may not seek help for chronic pain, and highlights the potential involvement of social comparison. Importance of diagnosis illustrates the desire for professional validation of their condition and an aversion to vague explanations based on the person’s age. Being listened to and being heard illustrates the importance of empathic communication and understanding expectations, with due respect for the person’s age. Conclusions: In common with people of all ages, an effective partnership between an older person in pain and health professionals is essential if pain is to be reported, appropriately assessed and managed, because of the subjective nature of pain and its treatment responses. For older people with pain, perception about their age, by both parties in the partnership, is an additional factor that can unnecessarily interfere with the effectiveness of this partnership. Health professionals should engage with older adults to clarify their expectations about pain and its management, which may be influenced by perceptions about age; and to encourage expression of their concerns, which may also be affected by perceptions about age

Intent to participate in future cervical cancer screenings is lower when satisfaction with the decision to be vaccinated is neutral.

HPV vaccination programs have adversely affected participation in future cervical cancer screening. The purpose of this study is to determine the influence of decision satisfaction with accepting/rejecting the HPV vaccine, as well as traditional clinical factors, on the intent to participate in future screening.From January 2011 through August 2012 women 18-26 years old presenting for health care in an urban college student health and wellness clinic in the US Midwest were asked to complete a descriptive and medical history survey including a six element decisional satisfaction survey scored on 5-point Likert scales, where the intent to participate in future cervical cancer screening was measured. Of the 568 women who completed the decisional satisfaction survey, 17% of those <21 years and 7% ≥ 21 years indicated no intent to participate in future cervical cancer screenings. Among women of current screening age, the univariate risk factors of race/ethnicity, contraceptive use, number of lifetime sexual partners, and receipt of HPV vaccine were not predictors of intent for future cervical cancer screening. Instead, only a history of a prior Pap test was a significant positive predictor and only a decisional satisfaction of 'neutral' (Likert score = 3) for any of the four decisional satisfaction elements was a significant negative predictor. For the decisional satisfaction element "best for me personally", there was a 78% decreased likelihood of intending to participate in future screening if the satisfaction was neutral rather than firm (aOR = 0.22, 95% CI: 0.05-0.91) and a 26 fold increased likelihood if she had had a prior Pap test (aOR = 26, 95% CI: 5-133).HPV vaccination implementation programs must help women be the owner of their decision around HPV vaccination and understand the importance of future participation in cervical cancer screening

Women have a preference for their male partner to be HPV vaccinated.

BACKGROUND:Peer influence and social networking can change female adolescent and young adult behavior. Peer influence on preferences for male human papillomavirus (HPV) vaccination has not been documented. The primary aim of this study was to determine if women had preferences about male sexual partner HPV vaccination receipt. METHODS AND FINDINGS:A prospective survey of women 18-26 years of age was conducted at an urban university student health clinic. Education about the two HPV vaccines, cervical cancer and genital warts was provided. Women self-reported their demographic and medical history data, as well as their own preferences for HPV vaccine and their preferences for their male partner HPV vaccine using a 5 point Likert scale. 601 women, mean age of 21.5 years (SD 2.4), participated between 2011 and 2012. Nearly 95% of respondents were heterosexual; condoms and contraceptives were used in over half of the population. Regardless of the woman's vaccination status, women had significantly higher (strongly agree/agree) preferences for the male partner being vaccinated with HPV4 than not caring if he was vaccinated (63.6% vs. 13.1%, p<0.001). This preference was repeated for sexual risk factors and past reproductive medical history. Women who received HPV4 compared to those choosing HPV2 had a significantly lower proportion of preferences for not caring if the male partner was vaccinated (13% vs. 22%, p = 0.015). CONCLUSIONS:Women preferred a HPV vaccinated male partner. Peer messaging might change the male HPV vaccination uptake

Predictors of intent to participate in cervical cancer screening.

<p>Bold numbers indicate statistical significance.</p><p>*Firm decision means the satisfaction score for the category was strongly agree/agree/disagree/strongly disagree.</p>†<p>The summary score was created from the sum of four dichotomous satisfaction categories (“personally”, “my personal values”, “mine to make” and “satisfied”) where the category was a 0 if neutral or a 1 if firm (strongly agree/agree/disagree/strongly disagree). Decisional satisfaction summary scores ranged from 0–4; 0 means that all four elements were ranked as neutral and 4 means that none of the four elements were ranked as neutral.</p

Subject descriptors by age group and intent to participate in cervical cancer screening.

<p>Percentages are within intent to Pap grouping.</p>†<p>excluded from analyses.</p><p>Bold indicates statistical significance.</p

Women's preference rankings for her male partner's vaccination status by her reproductive medical history.

<p>*Women not already vaccinated and choosing HPV2 for herself had a significantly higher proportion of high rankings regarding not caring if her male partner is vaccinated with HPV4 than do vaccinated women (31% vs. 17%, p = 0.007).</p

Univariate predictors of positive intent to participate in cervical cancer screening by age group by demographics.

<p>*all women with at least one pregnancy intended to continue cervical cancer screening.</p><p>Bold font indicates statistical significance.</p