Better survival is observed in cervical cancer patients positive for specific anti-glycan antibodies and receiving brachytherapy.

OBJECTIVE: To measure anti-glycan antibodies (AGA) in cervical cancer (CC) patient sera and assess their effect on therapeutic outcome. PATIENTS AND METHODS: Serum AGA was measured in 276 stage II and 292 stage III Peruvian CC patients using a high content and throughput Luminex multiplex glycan array (LMGA) containing 177 glycans. Association with disease-specific survival (DSS) and progression free survival (PFS) were analyzed using Cox regression. RESULTS: AGAs were detected against 50 (28.3%) of the 177 glycans assayed. Of the 568 patients, 84.5% received external beam radiation therapy (EBRT) plus brachytherapy (BT), while 15.5% only received EBRT. For stage-matched patients (Stage III), receiving EBRT alone was significantly associated with worse survival (HR 6.4, p < 0.001). Stage III patients have significantly worse survival than Stage II patients after matching for treatment (HR = 2.8 in EBRT+BT treatment group). Furthermore, better PFS and DSS were observed in patients positive for AGA against multiple glycans belonging to the blood group H, Lewis, Ganglio, Isoglobo, lacto and sialylated tetrarose antigens (best HR = 0.49, best p = 0.0008). CONCLUSIONS: Better PFS and DSS are observed in cervical cancer patients that are positive for specific antiglycan antibodies and received brachytherapy.

A Phase 2, Randomized, Control Trial of Group B Streptococcus (GBS) Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Colonization With GBS III.

BACKGROUND: Group B Streptococcus (GBS) frequently colonizes pregnant women and can cause sepsis and meningitis in young infants. If colonization was prevented through maternal immunization, a reduction in perinatal GBS disease might be possible. A GBS type III capsular polysaccharide (CPS)-tetanus toxoid conjugate (III-TT) vaccine was evaluated for safety and efficacy in preventing acquisition of GBS colonization. METHODS: Healthy, nonpregnant women aged 18-40 years and screened to be GBS III vaginal and rectal culture negative were randomized to receive III-TT conjugate or tetanus diphtheria toxoid vaccine in a multicenter, observer-blinded trial. GBS vaginal and rectal cultures and blood were obtained bimonthly over 18 months. Serum concentrations of GBS III CPS-specific antibodies were determined using enzyme-linked immunosorbent assay. RESULTS: Among 1525 women screened, 650 were eligible for the intent-to-treat analysis. For time to first acquisition of vaginal GBS III, vaccine efficacy was 36% (95% confidence interval [CI], 1%-58%; P = .044), and for first rectal acquisition efficacy was 43% (95% CI, 11% to 63%; P = .014). Two months post-immunization, geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G were 12.6 µg/mL (95% CI, 9.95 to 15.81) in GBS III-TT recipients, representing a 4-fold increase from baseline in 95% of women, which persisted. Both vaccines were well tolerated. CONCLUSIONS: GBS CPS III-TT conjugate vaccine significantly delayed acquisition of vaginal and rectal GBS III colonization. In addition to its use for maternal immunization to passively protect infants with maternally derived antibodies, a multivalent vaccine might also serve to reduce fetal and neonatal exposure to GBS. CLINICAL TRIALS REGISTRATION: NCT00128219.

Improved anal Cytology Sampling: Tush Brush Compared With Dacron Swab.

OBJECTIVE: The objective of this study was to determine the performance characteristics of the Tush brush (TB) compared with a saline moistened Dacron swab (DS) as anal cytology sampling devices. MATERIALS AND METHODS: TB and DS anal cytology tests were randomly collected from 146 patients presenting for anal cytology. High-resolution anoscopy and biopsies were obtained as indicated. Sensitivity and specificity as well as rates of satisfactory specimens were determined for each method using the areas under the receiver operating characteristic curve (AUCROC) and McNemar's test, respectively. Perceived discomfort of each device was determined using a visual analog scale and compared using a paired t test. RESULTS: The adjudicated AUCROC, sensitivity, and specificity were greater, but not significantly different, for the brush (0.63, 85.5, and 40.0, respectively) compared with the swab (0.50, 79.6, and 33.3, respectively) when the anal biopsy results were considered the criterion standard. In the 1 subject diagnosed with anal cancer, the swab cytology result was normal, but the brush result was abnormal. Specimen adequacy was 95.2% for the brush and 93.2% for the swab. Mean discomfort (visual analog scale) scores were swab 28.5 mm versus brush 35.6 mm (p = .0003) with both scores within the minimal to moderate discomfort range. CONCLUSIONS: Anal cytology AUCROC, sensitivity, and specificity in detecting anal neoplasia were greater using the TB when compared with the DS. A novel anal cytology sampling device designed specifically to increase the detection of anal neoplasia would be clinically beneficial.

Reimbursement Incentives to Improve Adherence to Follow-Up of Cervical Cancer Cytology Screening Results in Peru.

OBJECTIVE: The purpose of this study was to determine Peruvian women's attitudes toward novel reimbursement incentives used to improve adherence to obtaining cervical cytology test results. MATERIALS AND METHODS: Women presenting for cervical cancer screening in Peru completed a 34-item Investigational Review Board-approved questionnaire. The questionnaire determined their attitudes toward various reimbursement incentives to improve adherence to obtaining cervical cytology results. Descriptive statistics, generalized linear models, and Kruskal-Wallis tests were used in the analyses. RESULTS: Completed questionnaires were available for 997 women. Most women (51%) would be more likely to return for their Pap result if an incentive was provided, 79% (759/956) agreed that they would pay for the Pap test, and 51% (402/859) would be willing to pay 10 Soles or less. Quechua-speaking women considered follow-up more difficult (p < .0001) but were less likely to return for their Pap results (p < .0001), pay for the Pap test (p < .0001), and afford paying more than 5 Soles (p < .0001) than women who spoke Spanish or both languages. More women who earn 1000 Soles/year or less would likely return if incentivized (p < .0001), felt the incentive would help them remember to return (p = .0047), and would be willing to pay whether there was a rebate (p = .010) as compared with women earning more money. CONCLUSIONS: A reimbursement incentive program designed to improve follow-up of cervical cytology test results was acceptable to most Peruvian women. Such a behavioral-modifying program may improve patient follow-up after cervical cytology testing. Implementation may reduce the morbidity and mortality of cervical cancer in remote regions of the country.

Salud es Vida: a Cervical Cancer Screening Intervention for Rural Latina Immigrant Women.

This study examined the feasibility and efficacy of Salud es Vida-a promotora-led, Spanish language educational group session on cervical cancer screening (Pap tests)-self-efficacy (belief in ability to schedule and complete a Pap test), and knowledge among immigrant Hispanic/Latina women from farmworker backgrounds. These women are disproportionately burdened with cervical cancer, with mortality rates significantly higher than non-Hispanic whites. The two-arm, quasi-experimental study was conducted in four rural counties of Southeast Georgia in 2014-2015. Hispanic/Latina immigrant women aged 21-65 years and overdue for a Pap test were included as intervention (N = 38) and control (N = 52) group participants. The intervention was developed in partnership with a group of promotoras to create the toolkit of materials which includes a curriculum guide, a brochure, a flipchart, a short animated video, and in-class activities. Twelve (32 %) intervention group participants received the Pap test compared to 10 (19 %) control group participants (p = 0.178). The intervention group scored significantly higher on both cervical cancer knowledge recall and retention than the control group (p < 0.001). While there was no statistically significant difference in cervical cancer screening self-efficacy scores between the group participants, both groups scored higher at follow-up, adjusting for the baseline scores. The group intervention approach was associated with increased cervical cancer knowledge but not uptake of Pap test. More intensive interventions using patient navigation approaches or promotoras who actively follow participants or conducting one-on-one rather than group sessions may be needed to achieve improved screening outcomes with this population.

Social network characteristics and cervical cancer screening among Quechua women in Andean Peru.

BACKGROUND: Peru has high cervical cancer incidence and mortality rates compared to other Andean countries. Therefore, partnerships between governmental and international organizations have targeted rural areas of Peru to receive cervical cancer screening via outreach campaigns. Previous studies have found a relationship between a person's social networks and cancer screening behaviors. Screening outreach campaigns conducted by the nonprofit organization CerviCusco created an opportunity for a social network study to examine cervical cancer screening history and social network characteristics in a rural indigenous community that participated in these campaigns in 2012 and 2013. The aim of this study was to explore social network characteristics in this community related to receipt of cervical cancer screening following the campaigns. METHODS: An egocentric social network questionnaire was used to collect cross-sectional network data on community participants. Each survey participant (ego) was asked to name six other women they knew (alters) and identify the nature of their relationship or tie (family, friend, neighbor, other), residential closeness (within 5 km), length of time known, frequency of communication, topics of conversation, and whether they lent money to the person, provided childcare or helped with transportation. In addition, each participant was asked to report the nature of the relationship between all alters identified (e.g., friend, family, or neighbor). Bivariate and multivariate analyses were used to explore the relationship between Pap test receipt at the CerviCusco outreach screening campaigns and social network characteristics. RESULTS: Bivariate results found significant differences in percentage of alter composition for neighbors and family, and for mean number of years known, mean density, and mean degree centrality between women who had received a Pap test (n = 19) compared to those who had not (n = 50) (p's < 0.05). The final logistic regression model was statistically significant (χ2 (2) = 20.911, p < .001). The model included the variables for percentage of family alter composition and mean density, and it explained 37.8% (Nagelkerke R(2)) of the variance in Pap test receipt, correctly classifying 78.3% of cases. Those women with higher percentages of family alter composition and higher mean density in their ego networks were less likely to have received a Pap test at the CerviCusco campaigns. CONCLUSIONS: According to this exploratory study, female neighbors more than family members may have provided an important source of social support for healthcare related decisions related to receipt of a Pap test. Future studies should collect longitudinal social network data on participants to measure the network effects of screening interventions in rural indigenous communities in Latin American countries experiencing the highest burden of cervical cancer.

Impact of a Video Intervention for Rural Peruvian Women With Cervical Neoplasia Before Loop Excisional Procedures.

OBJECTIVE: Indigenous Peruvian women have very high rates of cervical cancer. This study assessed the impact of an educational video on impoverished rural Peruvian women seeking loop excision surgery. MATERIALS AND METHODS: Women completed baseline, postvideo and postsurgery questionnaires that assessed knowledge and attitudes about the procedure. Differences between groups were examined using repeated measures analysis of variance. RESULTS: Women who watched the video were significantly more calm (2.6, 2.6, and 2.3, respectively; P = 0.04), relaxed (2.5, 2.5, and 2.1, respectively; P = 0.02), and content (3.4, 3.4, and 2.4, respectively, P < 0.01) at postvideo and postsurgery assessments compared with mean results at the baseline assessment. The same women were also significantly more tense (2.5, 2.0, and 2.0, respectively; P = 0.01), upset (1.6, 1.1, and 1.1, respectively; P = 0.01), and worried (3.0, 2.0, and 2.0, respectively; P = 0.01) at baseline compared with postvideo and postsurgery results. Approximately 93% of women believed that other women scheduled to have loop excision surgery should also watch the video. CONCLUSIONS: Dissemination of culturally sensitive video information minimizes adverse emotional responses associated with loop excision procedures before surgery. Such an intervention quickly improves the psychological well-being of women eventually subjected to surgical management of cervical neoplasia.

The Impact of Accessible Cervical Cancer Screening in Peru-The Día del Mercado Project.

OBJECTIVE: The purpose of this study was to determine the potential impact of accessible secondary cervical cancer prevention efforts in indigenous Peruvian women living in the rural Andes Mountain region of Peru. METHODS: Peruvian women presenting for a Pap test or visiting a local marketplace, clinic, or public facility were asked to complete a questionnaire that assessed their response to the rural Pap screening program. We identified the following: 1) barriers to care, 2) patient knowledge of cervical cancer and Pap tests, and 3) perceptions of and reactions to the market clinic model. Chi-square or Fisher exact tests, t tests and 1-way ANOVA were used to examine differences between locations. RESULTS: Of 4,560 women enrolled, those examined in tents indicated it was easier to get a Pap test (98.7%, P = 0.001) compared with women seen in buildings (96.8%) or CerviCusco (98.0%), and they felt it was more important to have a Pap test close to their home more often (99.3%) than those seen at CerviCusco (97.8%) or buildings (98.8%). Women examined in tents felt the market was a good place to have a Pap test more often (67.0%, P < 0.001) than women who went to buildings (46.0%) or CerviCusco (29.2%). CONCLUSIONS: Many poor indigenous women living in isolated regions are unable to travel to distant health-care facilities. Using a novel mobile clinic model, the "Dia del Mercado Project" successfully reduced barriers to cervical cancer screening by using local marketplaces.

Polarized Light Colposcopy Compared With Standard Colposcopy.

OBJECTIVE: The objective of this study was to determine the potential benefits of polarized light colposcopy compared with standard colposcopy examinations in the evaluation of women with abnormal cervical cytology. MATERIALS AND METHODS: Polarized and standard colposcopy examinations were performed on 330 subjects. Respective images and biopsy annotations were obtained. Sensitivity and specificity; differences in the severity of cervical neoplasia; agreement of colposcopy impression, biopsy intent, and biopsy site; and differences in the number of biopsies were determined using the ROC, Bowker's test of symmetry, kappa statistic, and paired t test, respectively. RESULTS: The sensitivity and specificity for a lesion being seen with nonpolarized light and polarized light colposcopy were 96.8% and 64.5%, and 96.8% and 64.9%, respectively. There was no statistically significant difference in the ROC of the lesion being seen between nonpolarized (80.7) and polarized (80.9) colposcopy. Likewise, there was no statistically significant difference in the ROC of intent to biopsy between nonpolarized (80.2) and polarized colposcopy (78.8). The agreement of cervical histopathology and colposcopy impression for nonpolarized and polarized colposcopy were 0.986 and 0.952, respectively. There was no significant difference between nonpolarized and polarized colposcopy in the mean number of lesions seen or number of sites intended to biopsy. CONCLUSIONS: Polarized light colposcopy was not useful as an adjunct to conventional colposcopy in this study. Further research needs to be performed to determine the overall utility of polarized light colposcopy in clinical practice.

Incidence, clearance, and disease progression of genital human papillomavirus infection in heterosexual men.

BACKGROUND: In this analysis, we examine the incidence and clearance of external genital human papillomavirus (HPV) infection among heterosexual males aged 16-24 years. METHODS: A total of 1732 males aged 16-24 years old in the placebo arm of a quadrivalent HPV vaccine trial were included in this analysis. Participants were enrolled from 18 countries in Africa, the Asia-Pacific region, Europe, Latin America, and North America. Subjects underwent anogenital examinations and sampling of the penis, scrotum, and perineal/perianal regions. RESULTS: The incidence rate of any HPV DNA genotype 6, 11, 16, and/or 18 detection was 9.0 cases per 100 person-years. Rates of HPV DNA detection were highest in men from Africa. Median time to clearance of HPV genotypes 6, 11, 16, and 18 DNA was 6.1, 6.1, 7.7, and 6.2 months, respectively. Median time to clearance of persistently detected HPV 6, 11, 16, and 18 DNA was 6.7, 3.2, 9.2, and 4.7 months, respectively. CONCLUSION: The study results suggest that the acquisition of HPV 6, 11, 16, and/or 18 in males is common and that many of these so-called infections are subsequently cleared, similar to findings for women. Nevertheless, given the high rate of HPV detection among young men, HPV vaccination of males may reduce infection in men and reduce the overall burden of HPV-associated disease in the community.

HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.

BACKGROUND: The rate of anal cancer is increasing among both women and men, particularly men who have sex with men. Caused by infection with human papillomavirus (HPV), primarily HPV type 16 or 18, anal cancer is preceded by high-grade anal intraepithelial neoplasia (grade 2 or 3). We studied the safety and efficacy of quadrivalent HPV vaccine (qHPV) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 infection in men who have sex with men. METHODS: In a substudy of a larger double-blind study, we randomly assigned 602 healthy men who have sex with men, 16 to 26 years of age, to receive either qHPV or placebo. The primary efficacy objective was prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18. Efficacy analyses were performed in intention-to-treat and per-protocol efficacy populations. The rates of adverse events were documented. RESULTS: Efficacy of the qHPV vaccine against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 was 50.3% (95% confidence interval [CI], 25.7 to 67.2) in the intention-to-treat population and 77.5% (95% CI, 39.6 to 93.3) in the per-protocol efficacy population; the corresponding efficacies against anal intraepithelial neoplasia associated with HPV of any type were 25.7% (95% CI, -1.1 to 45.6) and 54.9% (95% CI, 8.4 to 79.1), respectively. Rates of anal intraepithelial neoplasia per 100 person-years were 17.5 in the placebo group and 13.0 in the vaccine group in the intention-to-treat population and 8.9 in the placebo group and 4.0 in the vaccine group in the per-protocol efficacy population. The rate of grade 2 or 3 anal intraepithelial neoplasia related to infection with HPV-6, 11, 16, or 18 was reduced by 54.2% (95% CI, 18.0 to 75.3) in the intention-to-treat population and by 74.9% (95% CI, 8.8 to 95.4) in the per-protocol efficacy population. The corresponding risks of persistent anal infection with HPV-6, 11, 16, or 18 were reduced by 59.4% (95% CI, 43.0 to 71.4) and 94.9% (95% CI, 80.4 to 99.4), respectively. No vaccine-related serious adverse events were reported. CONCLUSIONS: Use of the qHPV vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer. (Funded by Merck and the National Institutes of Health; ClinicalTrials.gov number, NCT00090285.).

Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.

BACKGROUND: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. METHODS: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. RESULTS: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). CONCLUSIONS: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).

Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy.

High-risk human papillomavirus (hrHPV) testing is now being introduced as a potential primary screening test for improved detection of cervical precancer and cancer. Current U.S. Food and Drug Administration-approved tests are batch tests that take several hours to complete. A rapid, non-batch test might permit point-of-care (POC) testing, which can facilitate same-day screen and management strategies. For a non-batch, random-access platform (GeneXpert; Cepheid, Sunnyvale, CA), a prototype hrHPV assay (Xpert) has been developed where testing for 14 hrHPV types can be completed in 1 h. In the first clinical evaluation, Xpert was compared to two validated hrHPV tests, the cobas HPV test (cobas, Roche Molecular Systems) and Hybrid Capture 2 (hc2, Qiagen), and to histologic outcomes using specimens from colposcopy referral populations at 7 clinical sites in the United States (n = 697). The sensitivity of Xpert for cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) (n = 141) was equal to that of cobas (90.8% versus 90.8%, P = 1) and greater than that of hc2 (90.8% versus 81.6%, P = 0.004). Xpert was more specific than cobas (42.6% versus 39.6%, P = 0.02) and less specific than hc2 (42.6% versus 47.7%, P < 0.001). Similar results were observed for cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (n = 91). HPV16 detection by Xpert identified 41.8% of the CIN2+ specimens with a positive predictive value (PPV) of 54.6%. By comparison, HPV16 detection by cobas identified 42.6% of the CIN2+ specimens with a PPV of 55.0%. hrHPV detection by the Xpert demonstrated excellent clinical performance for identifying women with CIN2+ and CIN3+ that was comparable to that of currently available clinically validated tests.

Twelve serum proteins progressively increase with disease stage in squamous cell cervical cancer patients.

OBJECTIVE: This study aimed to reliably identify serum protein profile alterations that may be useful for elucidation of the disease mechanism and/or finding new targets for treatment and intervention. MATERIALS AND METHODS: A total of 1057 women at 4 different squamous cell cervical cancer stages (noninvasive, invasive International Federation of Gynecology and Obstetrics stages I, II, and III) were included in this cross-sectional study. Forty-seven serum proteins were profiled using multiplex Luminex immunoassays. RESULTS: Serum concentration of serum amyloid A (SAA), C-reactive protein (CRP), soluble tumor necrosis factor receptor I and II (sTNFRI and sTNFRII), soluble interleukin 2 receptor α (sIL2Rα), CXCL1, CXCL9, hepatocyte growth factor, squamous cell carcinoma antigen (SCCA), insulin-like growth factor binding protein 2, CA125, and carcinoembryonic antigen (CEA) were elevated significantly as disease progressed in cervical cancer patients. Serum levels are significantly different at early stage (I) for SAA, CRP, sIL2Rα, sTNFRII, SCCA, and CEA (P values ranged from 0.02 for CEA to 0.0001 for CRP and SCCA) and at late stages (II and III) for all 12 proteins (P values ranged from 8.78E-5 for CA125 to 3.49E-47 for SAA), as compared to the noninvasive stage. The areas under the curves of these proteins for disease state separation also improved with the advancement of the disease. The correlations between serum concentrations of these proteins also show different patterns at different clinical stages. These proteins are involved in multiple mechanisms including inflammation and immunity, angiogenesis, growth promotion, and metastasis. CONCLUSIONS: A number of serum proteins are significantly different between patients at different stages of cervical cancer.

Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results.

OBJECTIVE: To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. METHODS: A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. RESULTS: Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. CONCLUSIONS: MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.

Women's knowledge and attitudes toward anal Pap testing.

OBJECTIVE: The objectives of this study were to determine women's knowledge of human papillomavirus (HPV) and anal cancer and knowledge and attitudes toward the anal Pap test. MATERIALS AND METHODS: A convenience sample of 370 women from the general population 21 years or older completed a 48-question preintervention survey; read an informational pamphlet about anal cancer, HPV, and anal Pap tests; and then completed a 21-question postintervention survey in Augusta, Atlanta, and Savannah, GA. The survey assessed their knowledge about anal cancer, HPV, and the anal Pap test and determined their attitudes toward the anal Pap test. Only preintervention results were considered in this article. Descriptive statistics were determined for all variables. RESULTS: Only 17.6% of women had previously heard of anal Pap tests, and the majority knew nothing (48.9%) or only a little (38.5%) about anal cancer. Yet, most women (78.6%) knew that anal Pap tests help to prevent anal cancer, and 86.2% knew that anal Pap tests are not only for people who have anal sex. Only a minority of women recognized known risk factors for anal cancer. Lack of knowledge about anal Pap tests (43.8%), pain or discomfort (41.3%), cost (24.0%), and embarrassment (21.2%) were the main reasons cited for not wanting an anal Pap test. CONCLUSIONS: Although most women had limited knowledge about anal cancer and anal Pap tests and few recognized known risk factors for anal cancer, women were receptive to screening. Further implementation of anal Pap testing for women may be improved by understanding women's limited knowledge and concerns.

Impact of pap test compliance and cervical cancer screening intervals on human papillomavirus vaccine acceptance.

OBJECTIVES: The objective of this study was to determine the impact of Pap test compliance and cervical cancer screening intervals on human papillomavirus (HPV) vaccination acceptance. MATERIALS AND METHODS: A convenience sample of 499 women 21 to 65 years old completed a 37-question survey in Augusta and Savannah, GA. The survey assessed their knowledge about HPV, cervical cancer, and the HPV vaccine. The questionnaire also determined their Pap test compliance and how longer Pap test intervals would influence their willingness to receive the HPV vaccine. Differences between categorical variables and knowledge scores were examined using χ test and unequal-variance t tests, respectively. RESULTS: Pap test-noncompliant women were more likely to get the HPV vaccine if they only needed a Pap test every 10 years compared with Pap test-compliant women (27.6% vs 14.6%, p = .02). A greater number (83.5%) of Pap test-noncompliant women preferred the HPV vaccine plus every 10-year Pap test option compared with Pap test-compliant women (31.3%, p < .0001). Most women (87%) responded that they would likely get the HPV vaccine if it would safely reduce the frequency of Pap testing. CONCLUSIONS: Women are receptive to getting the HPV vaccine in exchange for longer cervical cancer screening intervals. Moreover, Pap test-noncompliant women are more likely to get the HPV vaccine if Pap testing was needed less frequently. Increasing the Pap testing interval may be an excellent method to improving HPV vaccine acceptance in women at highest risk for cervical cancer.

Comparison of knowledge and attitudes toward human papillomavirus, HPV vaccine, pap tests, and cervical cancer between US and Peruvian women.

OBJECTIVES: The purpose of this study was to determine and compare the knowledge and attitudes toward human papillomavirus (HPV), HPV vaccine, Pap tests, and cervical cancer among US and Peruvian women. MATERIALS AND METHODS: A convenience sample of 275 US women in Augusta, GA, and 702 Peruvian women living in or near Cusco, Peru, completed 22- or 21-item questionnaires, respectively. These questionnaires determined their knowledge about HPV, the HPV vaccine, Pap tests, and cervical cancer. Simple logistic regression was used to determine the relationship between location and language on the correct responses. Odds ratios (ORs) and 95% confidence intervals were calculated. RESULTS: US Spanish- (OR = 0.02), Quechua- (OR = 0.05), and Peru Spanish-speaking women (OR = 0.03) were significantly less likely to know that HPV causes cervical cancer compared with US non-Spanish-speaking women. US Spanish- (OR = 10.61, OR = 5.74), Quechua- (OR = 11.08, OR = 9.89), and Peru Spanish-speaking women (OR = 17.25, 14.43) were significantly more likely to be embarrassed and afraid, respectively, to get a Pap test compared with US non-Spanish-speaking women. US Spanish- (OR = 0.11), Quechua- (OR = 0.14), and Peru Spanish-speaking women (OR = 0.11) women were significantly less likely to know the HPV vaccine is safe and effective compared with US non-Spanish-speaking women. CONCLUSIONS: Education must be implemented to address serious misconceptions and worrisome attitudes toward Pap tests and the HPV vaccine to decrease the rate of cervical cancer in Peru and US Spanish-speaking women.

External genital human papillomavirus prevalence and associated factors among heterosexual men on 5 continents.

BACKGROUND: We examined the baseline prevalence of penile, scrotal, and perineal/perianal human papillomavirus (HPV) in heterosexual men (HM). We also evaluated baseline characteristics of HM to assess factors associated with prevalent HPV detection. METHODS: We tested serum samples from 3463 HM aged 16-24 years with 1-5 lifetime female sexual partners for antibodies to HPV 6, 11, 16, and 18. We collected baseline swab specimens for the detection of DNA of HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59 from 3 areas: penile, scrotal, and perineal/perianal. Risk factors for prevalent HPV DNA detection were evaluated. RESULTS: The prevalence of any tested HPV type was 18.7% at the penis, 13.1% at the scrotum, 7.9% at the perineal/perianal region, and 21.0% at any site. Having >3 lifetime female sexual partners had the greatest impact on HPV prevalence: odds ratio (OR) 3.2 (95% confidence interval (CI) 2.1-4.9) for HPV 6, 11, 16, and 18; and OR 4.5 (95% CI 3.3-6.1) for all HPV types tested. HPV DNA detection was highest in Africa. Neither condom usage nor circumcision was associated with HPV DNA prevalence. CONCLUSION: Genital-HPV DNA detection is common in young, sexually active HM. We found HPV to be most prevalent in African men and least prevalent in men from the Asia-Pacific region. Increased numbers of sexual partners was an important risk factor for HPV DNA prevalence.

Prevalence of and risk factors for human papillomavirus (HPV) infection among HIV-seronegative men who have sex with men.

BACKGROUND: We examined the baseline prevalence of penile, scrotal, perineal/perianal, and intra-anal human papillomavirus (HPV) infection in human immunodeficiency virus (HIV)-seronegative men who have sex with men (MSM). METHODS: Data were analyzed from 602 MSM aged 16-27 years with ≤ 5 lifetime sexual partners. Serum samples were tested for antibodies to HPV6/11/16/18. Swab samples were collected separately from several anogenital areas for detection of HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59 DNA. RESULTS: The prevalence of any tested HPV type was 18.5% at the penis, 17.1% at the scrotum, 33.0% at the perineal/perianal region, 42.4% in the anal canal, and 48.0% at any site. Overall, 415 MSM (69.7%) were negative to HPV 6, 11, 16, and 18 at enrollment by both serology and DNA detection. Men residing in Europe and Latin America had significantly increased risk of HPV infection at external genital sites and the anal canal compared to men from Australia. Tobacco use and greater number of lifetime sexual partners was associated with higher HPV infection prevalence. CONCLUSIONS: The prevalence of HPV infection is high among young sexually active MSM, with the anal canal being the most common site of infection. Lifetime number of sexual partners was the most important modifiable risk factor for anogenital HPV infection.