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IntroductionDespite the increased risk of cervical cancer among HIV-positive women, many HIV-care programs do not offer integrated cervical cancer screening. Incorporating self-collected Human Papillomavirus (HPV) testing into HIV programs is a potential strategy to identify women at higher risk for cervical cancer while leveraging the staffing, infrastructure and referral systems for existing services. Community-based HIV and HPV testing has been effective and efficient when offered in single-disease settings.MethodsThis cross-sectional study was conducted within a community outreach and multi-disease screening campaigns organized by the Family AIDS Care and Education Services in Kisumu County, Kenya. In addition to HIV testing, the campaigns provided screening for TB, malaria, hypertension, diabetes, and referrals for voluntary medical male circumcision. After these services, women aged 25-65 were offered self-collected HPV testing. Rates and predictors of cervical cancer screening uptake and of HPV positivity were analyzed using tabular analysis and Fisher's Exact Test. Logistic regression was performed to explore multivariate associations with screening uptake.ResultsAmong the 2016 women of screening age who attended the outreach campaigns, 749 women (35.6%) were screened, and 134 women (18.7%) were HPV-positive. In bivariate analysis, women who had no children (p

BackgroundThe 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.MethodsIn 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.ResultsDoor-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.ConclusionNearly 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 registrationNCT02124252 , Registered 25 April 2014.

BACKGROUND:Cervical cancer is the most frequent neoplasm among Kenyan women, with 4800 diagnoses and 2400 deaths per year. One reason is an extremely low rate of screening through pap smears, at 13.8% in 2014. Knowing the costs of screening will help planners and policymakers design, implement, and scale programs. METHODS:We conducted HPV-based cervical cancer screening via self-collection in 12 communities in rural Migori County, Kenya. Six communities were randomized to community health campaigns (CHCs), and six to screening at government clinics. All HPV-positive women were referred for cryotherapy at Migori County Hospital. We prospectively estimated direct costs from the health system perspective, using micro-costing methods. Cost data were extracted from expenditure records, staff interviews, and time and motion logs. Total costs per woman screening included three activities: outreach, HPV-based screening, and notification. Types of inputs include personnel, recurrent goods, capital goods, and services. We costed potential changes to implementation for scaling. RESULTS:From January to September 2016, 2899 women were screened in CHCs and 2042 in clinics. Each CHC lasted for 30 working days, 10 days each for outreach, screening, and notification. The mean cost per woman screened was $25.00 for CHCs [median: $25.09; Range: $22.06-30.21] and $29.56 for clinics [$28.90; $25.27-37.08]. Clinics had higher costs than CHCs for personnel ($14.27 vs. $11.26) and capital ($5.55 vs. $2.80). Screening costs were higher for clinics at $21.84, compared to $17.48 for CHCs. In contrast, CHCs had higher outreach costs ($3.34 vs. $0.17). After modeling a reduction in staffing, clinic per-screening costs ($25.69) were approximately equivalent to CHCs. CONCLUSIONS:HPV-based cervical cancer screening through community health campaigns achieved lower costs per woman screened, compared to screening at clinics. Periodic high-volume CHCs appear to be a viable low-cost strategy for implementing cervical cancer screening.

ObjectiveTo determine the effectiveness of community health campaigns (CHCs) as a strategy for human papillomavirus (HPV)-based cervical cancer screening in rural western Kenya.MethodsBetween January and November 2016, a cluster-randomized trial was carried out in 12 communities in western Kenya to investigate high-risk HPV testing offered via self-collection to women aged 25-65 years in CHCs versus government health facilities. Outcome measures were the total number of women accessing cervical cancer screening and the proportion of HPV-positive women accessing treatment.ResultsIn total, 4944 women underwent HPV-based cervical cancer screening in CHCs (n=2898) or health facilities (n=2046). Screening uptake as a proportion of total eligible women in the population was greater in communities assigned to CHCs (60.0% vs 37.0%, P

BackgroundImproving patient flow and reducing over-crowding can improve quality, promptness of care, and patient satisfaction. Given low utilization of preventive care in low-resource countries, improved patient flows are especially important in these settings.ObjectiveCompare patient flow and provider efficiency between two cervical cancer screening strategies via self-collected human papillomavirus (HPV).MethodsWe collected time and motion data for patients screened for cervical cancer in 12 communities in rural Migori County, Kenya as part of a larger cluster randomized trial. Six communities were randomized to screening in community health campaigns (CHCs) and six to screening at government clinics. We quantified patient flow: duration spent on each active stage of screening and wait times, and the number of patients arriving at CHCs and clinics each hour of the day. In addition, for four CHCs, we collected time and motion data for providers, and measured provider efficiency as a ratio of active (service delivery) time to total time spent at the clinic.ResultsTotal duration of screening visits, at CHCs and clinics was 42 and 87 minutes, respectively (p

BACKGROUND:Despite guidelines for cervical cancer prevention in low-resource countries, a very small proportion of women in these settings undergo screening, and even fewer women are successfully treated. Using pilot data from western Kenya and World Health Organization recommendations, we developed a protocol to implement evidence-based cervical cancer screening and linkage to treatment strategies to the rural communities. We describe the protocol for a cluster-randomized trial to compare two implementation strategies for human-papillomavirus (HPV)-based cervical cancer screening program using metrics described in the RE-AIM (reach, efficacy, adaption, implementation and maintenance) framework. METHODS:The study is a three-year, two-phase cluster-randomized trial in 18 communities in western Kenya. During Phase 1, six control communities were offered screening in health facilities; and six intervention communities were offered screening in community health campaigns. Screening was done with human-papillomavirus testing through self-collected specimens. Phase 1 ended and we are working in partnership with communities to further contextualize the implementation strategy for screening, and develop an enhanced linkage to treatment plan. This plan will be tested in an additional six communities in Phase 2 (enhanced intervention). We will compare the reach, efficacy, cost-effectiveness and adaptability of the implementation strategies. DISCUSSION:Effective low-cost cervical cancer prevention technologies are becoming more widely available in low- and middle-income countries. Despite increasing government support for cervical cancer prevention, there remains a sizeable gap in service availability. We will use implementation science to identify the most effective strategies to fill this gap through development of context-specific evidence-based solutions. This protocol design and results can help guide implementation of cervical cancer screening in similar settings, where women are most underserved and at highest risk for disease. TRIAL REGISTRATION:This trial is registered at ClinicalTrials.gov , NCT02124252 .

ObjectiveA biomarker with increased specificity for cervical dysplasia compared with human papillomavirus (HPV) testing would be an attractive option for cervical cancer screening among HIV-infected women in resource-limited settings. p16(INK4a) has been explored as a biomarker for screening in general populations.DesignA 2-year cross-sectional study.Setting2 large HIV primary care clinics in western Kenya.Participants1054 HIV-infected women in western Kenya undergoing cervical cancer screening as part of routine HIV care from October 2010 to November 2012.InterventionsParticipants underwent p16(INK4a) specimen collection and colposcopy. Lesions with unsatisfactory colposcopy or suspicious for cervical intraepithelial neoplasia 2+ (CIN2+; including CIN2/3 or invasive cervical cancer) were biopsied. Following biopsy, disease status was determined by histopathological diagnosis.Primary and secondary outcome measuresWe measured the sensitivity, specificity and predictive values of p16(INK4a) ELISA for CIN2+ detection among HIV-infected women and compared them to the test characteristics of current screening methods used in general as well as HIV-infected populations.ResultsAverage p16(INK4a) concentration in cervical samples was 37.4 U/mL. After colposcopically directed biopsy, 127 (12%) women were determined to have CIN2+. Receiver operating characteristic analysis showed an area under the curve of 0.664 for p16(INK4a) to detect biopsy-proven CIN2+. At a p16(INK4a) cut-off level of 9 U/mL, sensitivity, specificity, positive and negative predictive values were 89.0%, 22.9%, 13.6% and 93.8%, respectively. The overall p16(INK4a) positivity at a cut-off level of 9 U/mL was 828 (78.6%) women. There were 325 (30.8%) cases of correct p16(INK4a) prediction to detect or rule out CIN2+, and 729 (69.2%) cases of incorrect p16(INK4a) prediction.Conclusionsp16(INK4a) ELISA did not perform well as a screening test for CIN2+ detection among HIV-infected women due to low specificity. Our study contributes to the ongoing search for a more specific alternative to HPV testing for CIN2+ detection.

IntroductionHIV-infected women may have higher rates of recurrent cervical precancer after treatment. Knowledge about rates and predictors of recurrence could impact guidelines and program planning, especially in low-resource settings.MethodsIn this prospective cohort study in Western Kenya, we followed HIV-infected women at 6 and 12 months after treatment for cervical intraepithelial neoplasia 2 or greater (CIN2+) after treatment with loop electrosurgical excision procedure (LEEP). All women underwent follow-up colposcopy with biopsy as indicated for the diagnosis of CIN2+. We calculated the incidence and predictors of primary disease recurrence after treatment.ResultsAmong the 284 women who underwent LEEP and had at least 1 follow-up visit, there were 37 (13%) cases of CIN2+ detected by 12-month follow-up. Four (10.8%) of the recurrences were invasive cancer, all stage IA1. The 6- and 12-month rates of recurrence were 13.7 and 12.8 cases per 100 person-years of follow-up, respectively. Antiretroviral therapy use did not significantly impact the rate of recurrence (hazard ratio: 1.24, 95% confidence interval: 0.59 to 2.79). The only significant predictor of recurrence in the multivariate analysis was CD4(+) nadir

Visual inspection with acetic acid (VIA) is becoming a more widely recommended and implemented screening tool for cervical cancer prevention programs in low-resource settings. Many of these settings have a high prevalence of HIV-infected women. We carried out a cross-sectional validation study to define the sensitivity, specificity and predictive values of VIA among HIV-infected women. Women enrolled in HIV care at the Family AIDS Care and Education Services clinic in Kisumu, Kenya, were recruited for participation. All participants underwent VIA followed by colposcopy performed by a second blinded clinician. At colposcopy, lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Disease status was determined by final histopathologic diagnosis in women who underwent biopsies. A satisfactory colposcopy with no lesions was considered a negative result. From October 2010 to June 2012, 1,432 women underwent VIA and colposcopy. A total of 514 (35.7%) women had a positive VIA, and 179 (12.2%) had CIN2+ confirmed by colposcopically directed biopsy. Sensitivity, specificity, positive and negative predictive values of VIA for CIN2+ were 86.6, 71.6, 30.3 and 97.4%, respectively. Specificity, but not sensitivity, increased with older age. Among older women, sensitivity was affected by CD4+ count and use of antiretroviral therapy. Although they are impacted by age and immune status, test characteristics for VIA among HIV-infected women are similar to what has been reported for general populations. Recommendations to use VIA as a screening tool should not vary by HIV status.

HIV-infected women are at increased risk for recurrence of cervical dysplasia after treatment. Short-term recurrence rates may reflect treatment efficacy and therefore impact screening protocols and follow-up planning. We conducted a prospective study of 297 HIV-infected women undergoing loop electrosurgical excision procedure for cervical intraepithelial neoplasia 2+ (CIN2+) in an HIV clinic in Kisumu, Kenya. By 6 months after the procedure, 20 (7.1%) of women had recurrent CIN2+. Recurrence was significantly associated with CD4 nadir but not with highly active antiretroviral therapy use. Longer-term follow-up of this cohort will illustrate the potential impact of highly active antiretroviral therapy and immune status on CIN2/3 disease recurrence.

ObjectiveTo determine the optimal strategy for cervical cancer screening in women with human immunodeficiency virus (HIV) infection by comparing two strategies: visual inspection of the cervix with acetic acid (VIA) and VIA followed immediately by visual inspection with Lugol's iodine (VIA/VILI) in women with a positive VIA result.MethodsData from a cervical cancer screening programme embedded in two HIV clinic sites in western Kenya were evaluated. Women at a central site underwent VIA, while women at a peripheral site underwent VIA/VILI. All women positive for cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) on VIA and/or VILI had a confirmatory colposcopy, with a biopsy if necessary. Overall test positivity, positive predictive value (PPV) and the CIN 2+ detection rate were calculated for the two screening methods, with biopsy being the gold standard.FindingsBetween October 2007 and October 2010, 2338 women were screened with VIA and 1124 with VIA/VILI. In the VIA group, 26.4% of the women tested positive for CIN 2+; in the VIA/VILI group, 21.7% tested positive (P

HIV and cervical cancer are intersecting epidemics in many low-resource settings, yet there are few accurate estimates of the scope of this public health challenge. To understand disease prevalence and risk factors for cervical intraepithelial neoplasia 2 or greater (CIN2+), we conducted a cross-sectional study of women undergoing cervical cancer screening as part of routine HIV care in Kisumu, Kenya. Women were offered screening with visual inspection with acetic acid, followed by confirmation with colposcopy and biopsy as needed. Univariable and multivariable analyses were carried out to determine clinical and demographic predictors of prevalent CIN2+. Among 3,241 women screened, 287 (9%) had an initial diagnosis of biopsy-confirmed CIN2+. On multivariable analysis, combined oral contraceptives remained significantly associated with detection of CIN2+ among women on HAART (AOR 1.84, CI 1.20-2.82), and not on HAART (AOR 1.72, 95% CI 1.08-2.73), while use of a progesterone implant was associated with increased detection of CIN2+ (AOR 9.43, 95% CI 2.85-31.20) only among women not on HAART. CD4+ nadir over 500 cells/mm(3) was associated with reduced detection of CIN2+ (AOR 0.61, CI 0.38, 0.97) in the overall group, but current CD4+ was only associated with reduced detection of CIN2+ among women not on HAART (AOR 0.42, CI 0.22, 0.80). In conclusion, a history of less severe immunosuppression appeared to reduce the risk of CIN2+ detection, but current CD4+ count was significant only in non-HAART users. The association of CIN2+ with hormonal contraception should be explored more in prospective studies designed to better control for confounding factors.

ObjectiveTo 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.MethodsWe 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.ResultsOf 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.ConclusionMost 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.

In resource-limited settings, detection of sexually transmitted infections (STIs) often relies on self-reported symptoms to initiate management. We found self-report demonstrated poor sensitivity for STI detection. Adding clinician-initiated questions about symptoms improved detection rates. Vaginal examination further increased sensitivity. Including clinician-initiated screening in resource-limited settings would improve management of treatable STIs.

HIV testing has been promoted as a key HIV prevention strategy in low-resource settings, despite studies showing variable impact on risk behavior. We sought to examine rates of HIV testing and the association between testing and sexual risk behaviors in Kisumu, Kenya. Participants were interviewed about HIV testing and sexual risk behaviors. They then underwent HIV serologic testing. We found that 47% of women and 36% of men reported prior testing. Two-thirds of participants who tested HIV-positive in this study reported no prior HIV test. Women who had undergone recent testing were less likely to report high-risk behaviors than women who had never been tested; this was not seen among men. Although rates of HIV testing were higher than seen in previous studies, the majority of HIV-infected people were unaware of their status. Efforts should be made to increase HIV testing among this population.

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. [ABSTRACT FROM AUTHOR]