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Objective: To identify health systems-level barriers to treatment for women who screened positive for high-risk human papillomavirus (hrHPV) in a cervical cancer prevention program in Kenya., Methods: In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy. The current analysis draws on treatment data from this trial, as well as two observational studies that were conducted: 1) periodic assessments of the treatment sites to ascertain availability of resources for treatment and 2) surveys with treatment providers to elicit their views on barriers to care. Bivariate analyses were performed for the site assessment data, and the provider survey data were analyzed descriptively., Results: Seventeen site assessments were performed across three treatment sites. All three sites reported instances of supply stockouts, two sites reported treatment delays due to lack of supplies, and two sites reported treatment delays due to provider factors. Of the 16 providers surveyed, ten (67%) perceived lack of knowledge of HPV and cervical cancer as the main barrier in women's decision to get treated, and seven (47%) perceived financial barriers for transportation and childcare as the main barrier to accessing treatment. Eight (50%) endorsed that providing treatment free of cost was the greatest facilitator of treatment., Conclusion: Patient education and financial support to reach treatment are potential areas for intervention to increase rates of hrHPV+ women presenting for treatment. It is also essential to eliminate barriers that prevent treatment of women who present, including ensuring adequate supplies and staff for treatment., Competing Interests: The authors have declared that no competing interests exist.

Objective: To characterize the efficiency of screening through high-volume community health campaigns (CHCs) by comparing the costs and population reach and identify factors associated with gains in efficiency. Access to effective cervical cancer screening remains limited in low-resource settings, especially in rural areas. Periodic CHCs are a novel method of offering screening for HPV at lower costs and higher population coverage than health facilities., Methods: A micro-costing study was conducted within a cervical cancer screening trial to measure efficiency (cost per woman screened) and population uptake of HPV-based screening offered through CHCs in Migori County, Kenya between January and September 2016. Regression analysis assessed relationships between population size and efficiency. Structured observations and qualitative interviews identified implementation factors that affected efficiency in individual campaigns., Results: Communities screening through CHCs had costs per woman screened ranging from US $22.06 to $30.21. Efficiency was directly correlated to overall numbers of women screened, but not to proportion of population screened. Modifiable factors that acted as context-specific facilitators and barriers with a potential impact on efficiency were identified., Conclusion: There was substantial variation in efficiency among CHCs. Cultural factors, health beliefs, and poor coordination among implementation partners as potential key barriers to screening uptake were identified., (© 2019 International Federation of Gynecology and Obstetrics.)

Importance: Many cervical cancer screening strategies are now recommended in the United States, but the benefits, harms, and costs of each option are unclear., Objective: To estimate the cost-effectiveness of 12 cervical cancer screening strategies., Design, Setting, and Participants: The cross-sectional portion of this study enrolled a convenience sample of 451 English-speaking or Spanish-speaking women aged 21 to 65 years from September 22, 2014, to June 16, 2016, identified at women's health clinics in San Francisco. In this group, utilities (preferences) were measured for 23 cervical cancer screening-associated health states and were applied to a decision model of type-specific high-risk human papillomavirus (hrHPV)-induced cervical carcinogenesis. Test accuracy estimates were abstracted from systematic reviews. The evaluated strategies were cytologic testing every 3 years for women aged 21 to 65 years with either repeat cytologic testing in 1 year or immediate hrHPV triage for atypical squamous cells of undetermined significance (ASC-US), cytologic testing every 3 years for women age 21 to 29 years followed by cytologic testing plus hrHPV testing (cotesting), or primary hrHPV testing alone for women aged 30 to 65 years. Screening frequency, abnormal test result management, and the age to switch from cytologic testing to hrHPV testing (25 or 30 years) were varied. Analyses were conducted from both the societal and health care sector perspectives., Main Outcomes and Measures: Utilities for 23 cervical cancer screening-associated health states (cross-sectional study) and quality-adjusted life-years (QALYs) and total costs for each strategy., Results: Utilities were measured in a sociodemographically diverse group of 451 women (mean [SD] age, 38.2 [10.7] years; 258 nonwhite [57.2%]). Cytologic testing every 3 years with repeat cytologic testing for ASC-US yielded the most lifetime QALYs and conferred more QALYs at higher costs ($2166 per QALY) than the lowest-cost strategy (cytologic testing every 3 years with hrHPV triage of ASC-US). All cytologic testing plus hrHPV testing (cotesting) and primary hrHPV testing strategies provided fewer QALYs at higher costs. Adding indirect costs did not change the conclusions. In sensitivity analyses, hrHPV testing every 5 years with genotyping triage beginning at age 30 years was the lowest-cost strategy when hrHPV test sensitivity was markedly higher than cytologic test sensitivity or when hrHPV test cost was equated to the lowest reported cytologic test cost ($14)., Conclusions and Relevance: Cytologic testing every 3 years for women aged 21 to 29 years with either continued cytologic testing every 3 years or switching to a low-cost hrHPV test every 5 years confers a reasonable balance of benefits, harms, and costs. Comparative modeling is needed to confirm the association of these novel utilities with cost-effectiveness.

Executive Summary: The risk of cervical cancer (CC) among women immunosuppressed for a variety of reasons is well documented in the literature. Although there is improved organ function, quality of life and life expectancy gained through use of immunosuppressant therapy, there may be increased long-term risk of cervical neoplasia and cancer and the need for more intense screening, surveillance, and management. Although guidance for CC screening among HIV-infected women (see Table 1) has been supported by evidence from retrospective and prospective studies, recommendations for CC screening among non-HIV immunosuppressed women remains limited because quality evidence is lacking. Moreover, CC screening guidelines for HIV-infected women have changed because better treatments evolved and resulted in longer life expectancy.The objective of this report was to summarize current knowledge of CC, squamous intraepithelial lesions, and human papillomavirus (HPV) infection in non-HIV immunocompromised women to determine best practices for CC surveillance in this population and provide recommendations for screening. We evaluated those with solid organ transplant, hematopoietic stem cell transplant, and a number of autoimmune diseases.A panel of health care professionals involved in CC research and care was assembled to review and discuss existing literature on the subject and come to conclusions about screening based on available evidence and expert opinion. Literature searches were performed using key words such as CC, cervical dysplasia/squamous intraepithelial lesion, HPV, and type of immunosuppression resulting in an initial group of 346 articles. Additional publications were identified from review of citations in these articles. All generated abstracts were reviewed to identify relevant articles. Articles published within 10 years were considered priority for review. Reviews of the literature were summarized with relevant statistical comparisons. Recommendations for screening generated from each group were largely based on expert opinion. Adherence to screening, health benefits and risks, and available clinical expertise were all considered in formulating the recommendations to the degree that information was available., Results: Solid Organ Transplant: Evidence specific for renal, heart/lung, liver, and pancreas transplants show a consistent increase in risk of cervical neoplasia and invasive CC, demonstrating the importance of long-term surveillance and treatment. Reports demonstrate continued risk long after transplantation, emphasizing the need for screening throughout a woman's lifetime.Hematopoietic Stem Cell Transplant: Although there is some evidence for an increase in CC in large cohort studies of these patients, conflicting results may reflect that many patients did not survive long enough to evaluate the incidence of slow-growing or delayed-onset cancers. Furthermore, history of cervical screening or previous hysterectomy was not included in registry study analysis, possibly leading to underestimation of CC incidence rates.Genital or chronic graft versus host disease is associated with an increase in high-grade cervical neoplasia and posttransplant HPV positivity.Inflammatory Bowel Disease: There is no strong evidence to support that inflammatory bowel disease alone increases cervical neoplasia or cancer risk. In contrast, immunosuppressant therapy does seem to increase the risk, although results of observational studies are conflicting regarding which type of immunosuppressant medication increases risk. Moreover, misclassification of cases may underestimate CC risk in this population. Recently published preventive care guidelines for women with inflammatory bowel disease taking immunosuppressive therapy recommend a need for continued long-term CC screening.Systemic Lupus Erythematosus and Rheumatoid Arthritis: The risk of cervical high-grade neoplasia and cancer was higher among women with systemic lupus erythematosus than those with rheumatoid arthritis (RA), although studies were limited by size, inclusion of women with low-grade neoplasia in main outcomes, and variability of disease severity or exposure to immunosuppressants. In studies designed to look specifically at immunosuppressant use, however, there did seem to be an increase in risk, identified mostly in women with RA. Although the strength of the evidence is limited, the increase in risk is consistent across studies.Type 1 DM: There is a paucity of evidence-based reports associating type 1 DM with an increased risk of cervical neoplasia and cancer., Recommendations: The panel proposed that CC screening guidelines for non-HIV immunocompromised women follow either the (1) guidelines for the general population or (2) current center for disease control guidelines for HIV-infected women. The following are the summaries for each group reviewed, and more details are noted in accompanying table:Solid Organ Transplant: The transplant population reflects a greater risk of CC than the general population and guidelines for HIV-infected women are a reasonable approach for screening and surveillance.Hematopoietic Stem Cell Transplant: These women have a greater risk of CC than the general population and guidelines for HIV-infected women are a reasonable approach for screening. A new diagnosis of genital or chronic graft versus host disease in a woman post-stem cell transplant results in a greater risk of CC than in the general population and should result in more intensive screening and surveillance.Inflammatory Bowel Disease: Women with inflammatory bowel disease being treated with immunosuppressive drugs are at greater risk of cervical neoplasia and cancer than the general population and guidelines for HIV-infected women are a reasonable approach for screening and surveillance. Those women with inflammatory bowel disease not on immunosuppressive therapy are not at an increased risk and should follow screening guidelines for the general population.Systemic Lupus Erythematosus and Rheumatoid Arthritis: All women with systemic lupus erythematosus, whether on immunosuppressant therapy or not and those women with RA on immunosuppressant therapy have a greater risk of cervical neoplasia and cancer than the general population and should follow CC screening guidelines for HIV-infected women. Women with RA not on immunosuppressant therapy should follow CC screening guidelines for the general population.Type 1 Diabetes Mellitus: Because of a lack of evidence of increased risk of cervical neoplasia and cancer among women with type 1 DM, these women should follow the screening guidelines for the general population.

Background: The incidence of cervical cancer in Kenya is among the highest in the world. Few Kenyan women are able to access screening, thus fueling the high cervical cancer burden. Self-collected human papilloma Virus (HPV) tests, administered during community-health campaigns in rural areas may be a way to expand access to screening., Methods: In December 2015, we carried out a four-day community health campaign (CHC) to educate participants about cervical cancer prevention and offer self-administered HPV screening. Community enumeration, outreach and mobilization preceded the CHC. Samples were sent to Migori County Hospital for HPV DNA testing using careHPV Test Kits. Women were notified of results through their choice of short message service (SMS), phone call, home visit or clinic visit. HPV positive women were referred for cryotherapy following a screen-and-treat strategy., Results: Door-to-door enumeration identified approximately 870 eligible women in Ngodhe Community in Migori County. Among the 267 women attending the campaign, 255 women enrolled and collected samples: 243 tests were successfully resulted and 12 were indeterminate. Of the 243 resulted tests, 47 (19%) were positive for HPV, with young age being the only significant predictor of positivity. In multivariate analysis, each additional year of age conferred about a 4% decrease in the odds of testing positive (95% CI 0.1 to 7%, p = 0.046). Just over three-quarters of all women (195/255), were notified of their results. Those who were unable to be reached were more likely to prefer receiving results from clinic (54/60, 90%) and were less likely to have mobile phones (24/60, 73%). Although 76% of HPV positive women were notified of their results, just half (51%) of those testing positive presented for treatment. HPV positive women who successfully accessed the treatment facility did not differ from their non-presenting counterparts by demographics, health history, desired route of notification or access to a mobile phone., Conclusion: Nearly a third of eligible women in Ngodhe Community attended the CHC and were screened for cervical cancer. Nearly all women who attended the CHC underwent cervical cancer screening by self-collected HPV tests. Three-quarters of all participants received results, but just half of HPV positive participants presented for treatment in a timely fashion, suggesting that linkage to treatment remains a major challenge., Trial Registration: NCT02124252 , Registered 25 April 2014.

Background: HIV increases women's risk for high-risk human papillomavirus (hrHPV) infection and invasive cervical cancer. South Africa has a high HIV prevalence but low cervical cancer screening coverage. Self-collection of cervical specimens and hrHPV testing, including hrHPV messenger-RNA (mRNA) testing, are methods aimed at increasing screening rates. However, data are limited on the acceptability and accuracy of tampon-based self-collection for hrHPV mRNA testing in HIV-infected women., Methods: We recruited 325 HIV-infected women seeking care at a government HIV clinic in Pretoria, South Africa. A clinician performed a pelvic examination and obtained an endocervical specimen. Study participants performed self-collection using a tampon. Both clinician- and self-collected specimens were tested for hrHPV mRNA. Acceptability of both collection methods was assessed, the prevalence of hrHPV mRNA in our study population was estimated, test positivity of the two collection methods were compared, and test agreement was assessed by calculating the κ-statistic, sensitivity, and specificity., Results: Over 90% of women reported no difficulties self-collecting specimens and 82% were willing to perform the tampon-collection at home. Based on clinician-collection specimens, the prevalence of hrHPV mRNA in our study population was 36.7% (95% CI: 31.4%- 42.0%). There was no difference in test positivity between clinician-collection, 36.7%, and tampon-collection, 43.5% (p-value = 0.08). Using clinician-collection as the reference test, the sensitivity and specificity for hrHPV mRNA of tampon-collection were 77.4% (95% CI: 69.8-85.0%) and 77.8% (95% CI: 71.9-83.6%), respectively., Conclusions: Tampon-based self-collection is acceptable to women and has similar hrHPV mRNA positivity rates as clinician-collection, but has reduced sensitivity and specificity compared to clinician-collection. The hrHPV mRNA prevalence in our study population is high, but similar to other high-risk populations, and highlights the need for improved cervical cancer screening. Further research into the optimal use of tampon-based collection as a cervical cancer screening tool is warranted.

Objective: Cervical cancer screening uptake may be influenced by inadequate knowledge in resource-limited settings. This randomized trial evaluated a health talk's impact on cervical cancer knowledge, attitudes, and screening rates in rural Kenya., Methods: 419 women attending government clinics were randomized to an intervention (N=207) or control (N=212) group. The intervention was a brief health talk on cervical cancer. Participants completed surveys at enrollment (all), immediately after the talk (intervention arm), and at three-months follow-up (all). The primary outcomes were the change in knowledge scores and the final screening rates at three-months follow-up. Secondary outcomes were changes in awareness about cervical cancer screening, perception of personal cervical cancer risk, cervical cancer and HIV stigma, and screening acceptability., Results: Mean Knowledge Scores increased by 26.4% (8.7 points increased to 11.0 points) in the intervention arm compared to only 17.6% (8.5 points increased to 10.0 points) in the control arm (p<0.01). Screening uptake was moderate in both the intervention (58.9%; N=122) and control (60.9%; N=129) arms, with no difference between the groups (p=0.60)., Conclusion: A brief health talk increased cervical cancer knowledge, although it did not increase screening over simply informing women about free screening., Practical Implications: Screening programs can increase patient understanding with just a brief educational intervention., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate cervical cancer knowledge, risk perception, and screening intention among women attending outpatient clinics in rural Kenya., Methods: A cross-sectional oral survey was conducted among non-pregnant women aged 23-64 years who attended one of 11 western Kenyan health facilities for any reason between March 25 and April 26, 2013. Demographic and clinical predictors were identified using bivariate and multivariate regression analyses., Results: Among 419 participants, 327 (78.0%) had heard of cervical cancer screening. Nevertheless, their specific knowledge was low (mean score 8.6±2.4 [out of 15.0]). Overall, 288 (68.7%) women felt at risk for cervical cancer, and 333 (79.5%) stated that they would undergo screening if offered. Women who intended to undergo screening were less likely to attend a district hospital (adjusted odds ratio [AOR] 0.4; 95% confidence interval [CI] 0.2-0.6) and more likely to have been diagnosed with HIV more than 4 years previously (AOR 0.4; 95% CI 0.2-0.6). Additionally, increased screening acceptance was associated with high knowledge scores (P=0.004)., Conclusion: Educational interventions to increase knowledge about cervical cancer might increase screening uptake in low-income settings. Additionally, improvements in services at local health facilities could have a large effect., (Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: To determine the prevalence of invasive cervical cancer (ICC) and assess access to, and outcomes of, treatment for ICC among HIV-infected women in Kisumu, Kenya., Methods: We performed a retrospective chart review to identify women diagnosed with ICC between October 2007 and June 2012, and to examine the impact of a change in the referral protocol. Prior to June 2009, all women with ICC were referred to a regional hospital. After this date, women with stage IA1 disease were offered treatment with loop electrosurgical excision procedure (LEEP) in-clinic., Results: Of 4308 women screened, 58 (1.3%) were diagnosed with ICC. The mean age at diagnosis was 34years (range, 22-50years). Fifty-four (93.1%) women had stage IA1 disease, of whom 36 (66.7%) underwent LEEP, 7 (12.9%) had a total abdominal hysterectomy, and 11 (20.4%) had unknown or no treatment. At 6, 12, and 24months after LEEP, 8.0% (2/25), 25.0% (6/24), and 41.2% (7/17) of women had a recurrence of cervical intraepithelial neoplasia 2 or worse, respectively., Conclusion: Most HIV-positive women diagnosed with ICC through screening had early-stage disease. The introduction of LEEP in-clinic increased access to treatment; however, recurrence was high, indicating the need for continued surveillance., (© 2013.)