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.

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.

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.

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.

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.