Access to essential cancer medicines for children: a comparative mixed-methods analysis of availability, price, and health-system determinants in east Africa.

BACKGROUND: Access to essential childhood cancer medicines is a core determinant of childhood cancer outcomes. Available evidence, although scarce, suggests that access to these medicines is highly variable across countries, particularly in low-income and middle-income countries, where the burden of childhood cancer is greatest. To support evidence-informed national and regional policies for improved childhood cancer outcomes, we aimed to analyse access to essential childhood cancer medicines in four east African countries-Kenya, Rwanda, Tanzania, and Uganda-by determining the availability and price of these medicines and the health system determinants of access. METHODS: In this comparative analysis, we used prospective mixed-method analyses to track and analyse the availability and price of essential childhood cancer medicines, investigate contextual determinants of access to childhood cancer medicines within and across included countries, and assess the potential effects of medicine stockouts on treatment. Eight tertiary care hospitals were included, seven were public sites (Kenyatta National Hospital [KNH; Nairobi, Kenya], Jaramogi Oginga Odinga Referral and Teaching Hospital [JOORTH; Kisumu, Kenya], Moi University Teaching and Referral Hospital [MTRH; Eldoret, Kenya], Bugando Medical Centre [BMC; Mwanza, Tanzania], Muhimbili National Hospital [MNH; Dar es Salaam, Tanzania], Butaro Cancer Centre of Excellence [BCCE; Butaro Sector, Rwanda], and Uganda Cancer Institute [UCI; Kampala, Uganda]) and one was a private site (Aga Khan University Hospital [AKU; Nairobi, Kenya]). We catalogued prices and stockouts for 37 essential drugs from each of the eight study siteson the basis of 52 weeks of prospective data that was collected across sites from May 1, 2020, to Jan 31, 2022. We analysed determinants of medicine access using thematic analysis of academic literature, policy documents, and semi-structured interviews from a purposive sample of health system stakeholders. FINDINGS: Recurrent stockouts of a wide range of cytotoxic and supportive care medicines were observed across sites, with highest mean unavailability in Kenya (JOORTH; 48·5%), Rwanda (BCCE; 39·0%), and Tanzania (BMC; 32·2%). Drugs that had frequent stockouts across at least four sites included methotrexate, bleomycin, etoposide, ifosfamide, oral morphine, and allopurinol. Average median price ratio of medicines at each site was within WHO's internationally accepted threshold for efficient procurement (median price ratio ≤1·5). The effect of stockouts on treatment was noted across most sites, with the greatest potential for treatment interruptions in patients with Hodgkin lymphoma, retinoblastoma, and acute lymphocytic leukaemia. Policy prioritisation of childhood cancers, health financing and coverage, medicine procurement and supply chain management, and health system infrastructure emerged as four prominent determinants of access when the stratified purposive sample of key informants (n=64) across all four countries (Kenya n=19, Rwanda n=15, Tanzania n=13, and Uganda n=17) was interviewed. INTERPRETATION: Access to childhood cancer medicines across east Africa is marked by gaps in availability that have implications for effective treatment delivery for a range of childhood cancers. Our findings provide detailed evidence of barriers to access to childhood cancer medicine at multiple points in the pharmaceutical value chain. These data could inform national and regional policy makers to optimise cancer medicine availability and affordability as part of efforts to improve childhood cancer outcomes specific regions and internationally. FUNDING: American Childhood Cancer Organization, Childhood Cancer International, and the Friends of Cancer Patients Ameera Fund.

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

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.

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.

Decentralizing cancer care in sub-Saharan Africa through an integrated regional cancer centre model: The case of Kenya.

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<0.001). Of the 15,275 patients who received treatment at regional centers, 69.1% (10,550) received chemotherapy.The increased patient visits show good service uptake at the regional centers, implying improved access. These findings can inform policies that will guide future expansion and service improvement. We recommend optimizing cancer service delivery at regional centers across the care continuum to improve patient outcomes.

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.

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$) per DALY averted compared to no vaccine and to each other. Model inputs were obtained from published sources, as well as local stakeholders. RESULTS: We estimated 320,000 cases and 225,000 deaths attributed to cervical cancer over the lifetimes of the 14 evaluated birth cohorts. HPV vaccination could reduce this burden by 42-60 %. Without cross-protection, CECOLIN had the lowest net cost and most attractive cost-effectiveness. With cross-protection, CERVARIX was the most cost-effective. Under either scenario the most cost-effective vaccine had a 100 % probability of being cost-effective at a willingness-to-pay threshold of US$ 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.

Cervical Cancer Screening Positivity Among Women Living With HIV in CDC-PEPFAR Programs 2018-2022.

BACKGROUND: The US President's Emergency Plan for AIDS Relief aims to address the higher risk of cervical cancer among women living with HIV by offering high-quality screening services in the highest burden regions of the world. METHODS: We analyzed the US President's Emergency Plan for AIDS Relief Monitoring, Evaluation, and Reporting data from Centers for Disease Control and Prevention-supported sites in 13 countries in sub-Saharan Africa for women living with HIV aged older than 15 years who accessed cervical cancer screening services (mostly visual inspection, with ablative or excisional treatment offered for precancerous lesions), April 2018-March 2022. We calculated the positivity by age, country, and clinical visit type (first lifetime screen or routine rescreening). We fitted negative binomial random coefficient models of log-linear trends in time to estimate the probabilities of testing positive and any temporal trends in positivity. RESULTS: Among the 2.8 million completed cancer screens, 5.4% identified precancerous lesions, and 0.8% were positive for suspected invasive cervical cancers (6.1% overall). The positivity rates declined over the study period among those women screening for cervical cancer for the first time and among those women presenting to antiretroviral therapy clinics for routine rescreening. CONCLUSIONS: These positivity rates are lower than expectations set by the published literature. Further research is needed to determine whether these lower rates are attributable to the high level of consistent antiretroviral therapy use among these populations, and systematic program monitoring and quality assurance activities are essential to ensure women living with HIV have access to the highest possible quality prevention services.

Mobilizing stakeholders to drive the cervical cancer elimination agenda in Kenya: The national cervical cancer stakeholders' forum 2022.

Background: Kenya is among the nineteen countries in Sub-Saharan Africa with the highest burden of cervical cancer globally. The high burden of cervical cancer in developing countries reflects the absence of effective cervical cancer prevention programs with limited resources invested to provide comprehensive services. Objective: We aimed to engage stakeholders in a structured consultative forum, to gain insights and forge effective partnerships to drive the cervical cancer elimination agenda in Kenya. Methods: The National Cervical Cancer Stakeholders Consultative Forum was organized as a part of activities to commemorate the National Cervical Cancer Awareness Month on 19th January 2022 in Nairobi, Kenya. The overall goal of the meeting was to provide a forum to sensitize stakeholders on the National Cervical Cancer Prevention and Control Program (NCCP) with a view to strengthen partnerships, increase coordination for improved service delivery and to provide a forum for resource mobilisation and alignment of key stakeholders towards elimination of cervical cancer in Kenya. Nominal group technique was adopted for structured discussions, and the findings analysed to derive key themes. Findings: Key challenges to primary and secondary prevention of cervical cancer were identified as low awareness, stigma and misinformation, high unmet need for treatment of early lesions, few health care providers with capacity to screen and treat, inadequate supplies, inefficient health information systems and poor referral pathways. Championing integration of cervical cancer screening and treatment services into routine health programs, strengthening policy implementation and robust monitoring and evaluation were identified as critical interventions. Conclusion: The National Cervical Cancer Stakeholders Forum 2022 provided insights for enabling Kenya to progress on the 2030 elimination targets. Such forums can be useful in bringing all actors together to evaluate achievements and identify opportunities for more effective national cervical cancer prevention and control programs.

Breast health awareness campaign and screening pilot in a Kenyan County: Findings and lessons.

BACKGROUND AND AIM: Breast cancer is the leading cancer in terms of incidence in Kenya. We conducted a breast cancer awareness and screening pilot to assess feasibility of rolling out a national screening program in Kenya. METHODS: Conducted in Nyeri County during October-November 2019, the pilot had three phases; awareness creation, screening (clinical breast examination and/or imaging) and final evaluation (post-screening exit interviews and retrospective screening data review). Descriptive statistics on awareness, screening process and outputs were derived. RESULTS: During the pilot, 1813 CBE, 217 breast ultrasounds and 600 mammograms were performed. Mammography equipment utilization increased from 11% to 83%. Of 49 women with suspicious lesions on mammography, only 22 (44.9%) had been linked to care 4 months after the campaign. Of 532 exit interview respondents; 95% (505/532) were ≥35 years of age; 80% (426/532) had been reached by the awareness campaign. Majority (75% [399/532]) had received information from community health volunteers; 68% through social groups. Majority (79% [420/532]) felt the campaign had changed their behavior on breast health. Although 77% (407/532) had knowledge on self breast examination (SBE); only 13% practiced monthly SBE. More than half (58% [306/532]) had previously undertaken a CBE. Approximately 70% (375/528) were unaware of mammography before the pilot; 86% (459/532) had never previously undertaken a mammogram. Fifty-five percent (293/532) of respondents had screening waiting times of >120 min. CONCLUSION: Community health workers can create breast cancer screening demand sustainably. Adequate personnel and effective follow-up are crucial before national roll-out of a breast cancer screening program.

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 <1% and 36% of the target population for the year for HIV-negative women and between <1% 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.

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.