Integrating human papillomavirus testing as a point-of care service using GeneXpert platforms: Findings and lessons from a Kenyan pilot study (2019–2020)

Background: Globally, cervical cancer is a major public health problem, with about 604,000 new cases and over 340,000 deaths in 2020. In Kenya, it is the leading cause of cancer deaths, with over 3,000 women dying in 2020 alone. Both the Kenyan cancer screening guidelines and the World Health Organization’s Global Cervical Cancer Elimination Strategy recommend human papillomavirus (HPV) testing as the primary screening test. However, HPV testing is not widely available in the public healthcare system in Kenya. We conducted a pilot study using a point of care (POC) HPV test to inform national roll-out. Methods: The pilot was implemented from October 2019 to December 2020, in nine health facilities across six counties. We utilized the GeneXpert platform (Cepheid, Sunnyvale, CA, USA), currently used for TB, Viral load testing and early infant diagnosis for HIV, for HPV screening. Visual inspection with acetic acid (VIA) was used for triage of HPV-positive women, as recommended in national guidelines. Quality assurance (QA) was performed by the National Oncology Reference Laboratory (NORL), using the COBAS 4800 platform (Roche Molecular System, Pleasanton, CF, USA). HPV testing was done using either self or clinician-collected samples. We assessed the following screening performance indicators: screening coverage, screen test positivity, triage compliance, triage positivity and treatment compliance. Test agreement between local GeneXpert and central comparator high-risk HPV (hrHPV) testing for a random set of specimens was calculated as overall concordance and kappa value. We conducted a final evaluation and applied the Nominal Group Technique (NGT) to identify implementation challenges and opportunities. Key findings: The screening coverage of target population was 27.0% (4500/16,666); 52.8% (2376/4500) were between 30–49 years of age. HPV positivity rate was 22.8% (1027/4500). Only 10% (105/1027) of HPV positive cases were triaged with VIA/VILI; 21% (22/105) tested VIA/VILI positive, and 73% (16/22) received treatment (15 received cryotherapy, 1 was referred for biopsy). The median HPV testing turnaround time (TAT) was 24 hours (IQR 2–48 hours). Invalid sample rate was 2.0% (91/4500). Concordance between the Cepheid and COBAS was 86.2% (kappa value = 0.71). Of 1042 healthcare workers, only 5.6% (58/1042) were trained in cervical cancer screening and treatment, and only 69% (40/58) of those trained were stationed at service provision areas. Testing capacity was identifed as the main challenge, while the community strategy was the main opportunity. Conclusion: HPV testing can be performed on GeneXpert as a near point of care platform. However, triage compliance and testing TAT were major concerns. We recommend strengthening of the screening-triage-treatment cascade and expansion of testing capacity, before adoption of a GeneXpert-based HPV screening among other near point of care platforms in Kenya

Baseline assessment of cervical cancer screening and treatment capacity in 25 counties in Kenya, 2022

Background: Cervical cancer is the leading cause of cancer deaths among women in Kenya. In the context of the Global strategy to accelerate the elimination of cervical cancer as a public health problem, Kenya is currently implementing screening and treatment scale-up. For effectively tracking the scale-up, a baseline assessment of cervical cancer screening and treatment service availability and readiness was conducted in 25 priority counties. We describe the findings of this assessment in the context of elimination efforts in Kenya. Methods: The survey was conducted from February 2021 to January 2022. All public hospitals in the target counties were included. We utilized healthcare workers trained in preparation for the scale-up as data collectors in each sub-county. Two electronic survey questionnaires (screening and treatment; and laboratory components) were used for data collection. All the health system building blocks were assessed. We used descriptive statistics to summarize the main service readiness indicators. Results: Of 3,150 hospitals surveyed, 47.6% (1,499) offered cervical cancer screening only, while 5.3% (166) offered both screening and treatment for precancer lesions. Visual inspection with acetic acid (VIA) was used in 96.0% (1,599/1,665) of the hospitals as primary screening modality and HPV testing was available in 31 (1.0%) hospitals. Among the 166 hospitals offering treatment for precancerous lesions, 79.5% (132/166) used cryotherapy, 18.7% (31/166) performed thermal ablation and 25.3% (42/166) performed large loop excision of the transformation zone (LLETZ). Pathology services were offered in only 7.1% (17/238) of the hospitals expected to have the service (level 4 and above). Only 10.8% (2,955/27,363) of healthcare workers were trained in cervical cancer screening and treatment; of these, 71.0% (2,097/2,955) were offering the services. Less than half of the hospitals had cervical cancer screening and treatment commodities at time of survey. The main health system strength was presence of multiple screening points at hospitals, but frequent commodity stock-outs was a key weakness. Conclusion: Training, commodities, and diagnostic services are major gaps in the cervical cancer program in Kenya. To meet the 2030 elimination targets, the national and county governments should ensure adequate financing, training, and service integration, especially at primary care level

Impact, cost-effectiveness, and budget implications of HPV vaccination in Kenya: A modelling study.

BACKGROUND: Sub-Saharan Africa has the highest rate of cervical cancer cases and deaths worldwide. Kenya introduced a quadrivalent HPV vaccine (GARDASIL, hereafter referred to as GARDASIL-4) for ten-year-old girls in late 2019 with donor support from Gavi, the Vaccine Alliance. As Kenya may soon graduate from Gavi support, it is important to evaluate the potential cost-effectiveness and budget impact of the current HPV vaccine, and potential alternatives. METHODS: We used a proportionate outcomes static cohort model to evaluate the annual budget impact and lifetime cost-effectiveness of vaccinating ten-year-old girls over the period 2020-2029. We included a catch-up campaign for girls aged 11-14 years in 2020. We estimated cervical cancer cases, deaths, disability adjusted life years (DALYs), and healthcare costs (government and societal perspective) expected to occur with and without vaccination over the lifetimes of each cohort of vaccinated girls. For each of the four products available globally (CECOLIN©, CERVARIX©, GARDASIL-4©, and GARDASIL-9 ©), we estimated the cost (2021 US$) per DALY averted compared to no vaccine and to each other. Model inputs were obtained from published sources, as well as local stakeholders. RESULTS: We estimated 320,000 cases and 225,000 deaths attributed to cervical cancer over the lifetimes of the 14 evaluated birth cohorts. HPV vaccination could reduce this burden by 42-60$ 100 (5 % of Kenya's national gross domestic product per capita) compared to no vaccination. Should Kenya reach its target of 90 % coverage and graduate from Gavi support, the undiscounted annual vaccine program cost could exceed US$ 10 million per year. For all three vaccines currently supported by Gavi, a single-dose strategy would be cost-saving compared to no vaccination. CONCLUSION: HPV vaccination for girls is highly cost-effective in Kenya. Compared to GARDASIL-4, alternative products could provide similar or greater health benefits at lower net costs. Substantial government funding will be required to reach and sustain coverage targets as Kenya graduates from Gavi support. A single dose strategy is likely to have similar benefits for less cost

Reframing Non-Communicable Diseases and Injuries for Equity in the Era of Universal Health Coverage: Findings and Recommendations from the Kenya NCDI Poverty Commission.

Background: Kenya has implemented a robust response to non-communicable diseases and injuries (NCDIs); however, key gaps in health services for NCDIs still exist in the attainment of Universal Health Coverage (UHC). The Kenya Non-Communicable Diseases and Injury (NCDI) Poverty Commission was established to estimate the burden of NCDIs, determine the availability and coverage of health services, prioritize an expanded set of NCDI conditions, and propose cost-effective and equity-promoting interventions to avert the health and economic consequences of NCDIs in Kenya. Methods: Burden of NCDIs in Kenya was determined using desk review of published literature, estimates from the Global Burden of Disease Study, and secondary analysis of local health surveillance data. Secondary analysis of nationally representative surveys was conducted to estimate current availability and coverage of services by socioeconomic status. The Commission then conducted a structured priority setting process to determine priority NCDI conditions and health sector interventions based on published evidence. Findings: There is a large and diverse burden of NCDIs in Kenya, with the majority of disability-adjusted life-years occurring before age of 40. The poorest wealth quintiles experience a substantially higher deaths rate from NCDIs, lower coverage of diagnosis and treatment for NCDIs, and lower availability of NCDI-related health services. The Commission prioritized 14 NCDIs and selected 34 accompanying interventions for recommendation to achieve UHC. These interventions were estimated to cost $11.76 USD per capita annually, which represents 15% of current total health expenditure. This investment could potentially avert 9,322 premature deaths per year by 2030. Conclusions and Recommendations: An expanded set of priority NCDI conditions and health sector interventions are required in Kenya to achieve UHC, particularly for disadvantaged socioeconomic groups. We provided recommendations for integration of services within existing health services platforms and financing mechanisms and coordination of whole-of-government approaches for the prevention and treatment of NCDIs

Cervical cancer programme, Kenya, 2011–2020: lessons to guide elimination as a public health problem

Background: Cervical cancer is the leading cause of cancer mortality in Kenya, with an estimated 3,200 deaths in 2020. Kenya has implemented cervical cancer interventions for more than a decade. We describe the evolution of the cervical cancer programme over the last 20 years and assess its performance. Methods: We searched the Ministry of Health’s archives and website (2000–2021) for screening policy documents and assessed them using seven items: situational analysis, objectives, key result areas, implementation framework, resource considerations, monitoring and evaluation and definition of roles/responsibilities. In addition, a trend analysis was performed targeting screening and disease burden indicators in the period 2011–2020, using data from Kenya Health Information System and the Global Burden of Disease database. Findings: Policy guidance improved over time, but the implementation of screening was poor. Before 2016, a clear leadership and accountability structure was lacking; improvement occurred after the establishment of the National Cancer Control Program. The main health system gaps included the lack of a trained healthcare workforce and poor data collection. Annual screening coverage varied between \u3c1% and 36% of the target population for the year for HIV-negative women and between \u3c1% and 7% for HIV-positive women, from 2011 to 2020. Test positivity for visual inspection with acetic acid was below 5% for most of the period. Compliance to treatment of precancerous lesions ranged between 22% and 39%. The detection rate of cervical cancer ranged between 0.5% and 1.0%. The burden of invasive cervical cancer did not change significantly: world age-standardised incidence and mortality rates of 26.3–27.4 and 16.6–18.0/100,000 women-years, respectively; disability-adjusted life years of 579–624/100,000 life years. Conclusion: The Kenyan cervical cancer control programme suffered from inadequate health system strengthening and poor quality implementation. Evidence-based policy implementation and sustained health system strengthening are necessary to move towards cervical cancer elimination as a public health problem

Cancer staging distribution by cancer center.

For 50 years, comprehensive cancer treatment services were provided at one public hospital and a few private facilities in the capital city. In 2019, the services were decentralized to new national and regional centers to increase service accessibility using an integration model. This study aimed to analyze the status of the utilization of services at regional cancer centers. We analyzed data from the district health information system, focusing on patient demographics, visit type, cancer stage, and the type of treatment provided. For comparison, a trend analysis of new cancer cases recorded at the main national referral hospital between 2011–2021 was also conducted. We conducted a descriptive analysis of the variables of interest; the median was used to summarize continuous variables and percentages were used for categorical variables. A total of 29,321 patients visited the regional centers in 2021; the median age was 57 years (IQR 44–68) and 57.3% (16,815) were female. Visits to regional centres represented 38.8% (29,321/75,501) of all visits to public cancer centers; new visits accounted for 16.4% (4814/29321), and the rest were follow-up visits. Most patients (71%) had an advanced disease. The proportion of male patients with advanced-stage cancer was significantly higher than that of female patients (74% vs. 69%, P</div

Cancer staging by gender.

For 50 years, comprehensive cancer treatment services were provided at one public hospital and a few private facilities in the capital city. In 2019, the services were decentralized to new national and regional centers to increase service accessibility using an integration model. This study aimed to analyze the status of the utilization of services at regional cancer centers. We analyzed data from the district health information system, focusing on patient demographics, visit type, cancer stage, and the type of treatment provided. For comparison, a trend analysis of new cancer cases recorded at the main national referral hospital between 2011–2021 was also conducted. We conducted a descriptive analysis of the variables of interest; the median was used to summarize continuous variables and percentages were used for categorical variables. A total of 29,321 patients visited the regional centers in 2021; the median age was 57 years (IQR 44–68) and 57.3% (16,815) were female. Visits to regional centres represented 38.8% (29,321/75,501) of all visits to public cancer centers; new visits accounted for 16.4% (4814/29321), and the rest were follow-up visits. Most patients (71%) had an advanced disease. The proportion of male patients with advanced-stage cancer was significantly higher than that of female patients (74% vs. 69%, P</div

Trends of new cancer patients at the main referral hospital (2011 to 2021) and the regional cancer centers (2020–2021).

Trends of new cancer patients at the main referral hospital (2011 to 2021) and the regional cancer centers (2020–2021).</p

Predictors of cervical cancer screening among Kenyan women: results of a nested case-control study in a nationally representative survey

Abstract Background Cervical cancer is a major public health concern in Kenya. It is the leading cause of cancer morbidity and mortality among women. Although screening is an effective prevention method, uptake is low among eligible women. Little is known about predictors of cervical cancer screening uptake. This study explored relationship between uptake of cervical cancer screening, socio-demographic, behavioral and biological risk factors. Methods Nested case-control study within STEPS survey, a population-based cross-sectional household survey conducted between April and June 2015.Cases were women who had undergone cervical cancer screening and controls were unscreened women. Study participants were women eligible for cervical cancer screening (30–49 years). Variables included socio-demographic; behavioral risk factors such as physical activity, tobacco and alcohol use diet and biological factors like diabetes and hypertension. Outcome of interest was cervical cancer screening. Data analysis was done using STATA version 14. Logistic regression model was used to assess relationship between cervical cancer screening and socio-demographic, behavioral and biological risk factors. Results Of 1180 women interviewed, 16.4% (n = 194) had been screened for cervical cancer. Of unscreened women (n = 986), 67.9% were aware of cervical cancer screening. Higher screening rates were observed in more educated women (25.2%), highest income quintile (29.6%) and living in urban areas (23%) than in women with no formal education (3.2%), poorest (3.6%) and living in rural areas (13.8%). Younger women (35–39) and those with low High-density lipoprotein (HDL) were less likely to be screened [OR = 0.56; 95% CI = (0.34, 0.93); p-value = 0.025] and [OR = 0.51; 95% CI = (0.29, 0.91); p = value 0.023] respectively. Self-employed women, those in the fourth wealth quintile, binge drinkers, high sugar consumption and insufficient physical activity were more likely to be screened [OR 2.55 (1.12, 5.81) p value 0.026], [OR 3.56 (1.37, 9.28) p value 0.009], [OR 5.94 (1.52, 23.15) p value 0.010], [OR 2.99 (1.51, 5.89) p value 0.002] and [OR 2.79 (1.37, 5.68) p value 0.005] respectively. Conclusion Uptake of cervical cancer screening is low despite high awareness. Strategies to improve cervical cancer screening in Kenya should be implemented with messages targeting persons with both risky and non-risky lifestyles especially younger women with no formal education living in rural areas

Sociodemographic characteristics of patients visiting the Regional Cancer Centres in 2021.

Sociodemographic characteristics of patients visiting the Regional Cancer Centres in 2021.</p