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Objectives and Priorities

Purpose

The purpose of the PEER-supported CCS&PT activities is to strengthen capacity in Malawi and Mozambique to more efficiently and effectively implement CCS&PT interventions at scale that are effectively integrated and linked with voluntary family planning programs. The activities will generate evidence that will inform efforts to introduce and scale-up CCS&PT interventions nationally and in other LMICs.


Objectives

The CCS&PT program has two interrelated objectives, which are described below:

1. To accelerate the scale up of more efficient implementation models of integrating CCS&PT with voluntary family planning programs that optimize the uptake and health impact of both.

Other organizations have previously supported and implemented activities integrating CCS&PT with voluntary family planning, while measuring the potential of integration to increase the health impact of both services. For example, The Bill and Melinda Gates Foundation (BMGF) supported integration of quality CCS&PT into voluntary family planning programs. This initiative, which was called the Cervical Cancer Screening and Preventive Therapy Initiative, worked in Uganda, Nigeria, Tanzania, and Kenya, generating preliminary evidence to indicate that the integration of CCS&PT with voluntary family planning programs could increase uptake of both health care services. In addition to this work, other organizations have implemented pilot projects around integration of cervical cancer with family planning; however, gaps remain in the evidence.

Therefore, it is expected that all potential funding recipients clearly establish how proposed activities can leverage the existing evidence base, as well as establish innovative approaches to fill evidence gaps. Examples of evidence generated might include: (1) quantifying demand for and uptake of CCS&PT and voluntary family planning offered in tandem vs. separately; (2) determining the cost per client of adding CCS&PT to voluntary family planning programming; (3) documenting additional voluntary family planning acceptors disaggregated by method; (4) estimating increased client load per provider; (5) documenting the number of women coming in for voluntary family planning and accepting CCS&PT; and (6) determining whether or not integration efforts could increase provider/client experience, quality, and satisfaction. It is expected that projects implemented under PEER Program awards will build on this existing evidence and establish a clear learning agenda that will define common challenges of integrating these services, while documenting innovative solutions to overcoming those challenges. Other potential indicators can be found in sub-Section 5 of Section VI: Outline of Requested Partner Program Concepts/ Descriptions.

2. To accelerate the introduction and scale-up of new technologies that will increase the health impact and efficiency of CCS&PT programs

Examples of these technologies include:

HPV-DNA Testing
The past few decades have seen a dramatic decline in cervical cancer deaths in higher-income countries. This can be attributed initially, in part, to increased availability of Pap smears, which enable precancerous lesions to be detected and treated before they spread. To overcome concerns with infrastructure and cost, screening in developing countries is most commonly done by visual inspection of the cervix with acetic acid (VIA). VIA is not only cheaper and easier to implement than Pap smears, but also allows women to receive immediate treatment after a positive screen, which can help avoid treatment delays and loss to follow-up. Cervical cancer screening and treatment of precancerous lesions has been described by the WHO as a “best buy.”1 However, there are considerable concerns with VIA that make it a less-preferred method of screening moving into the future. As VIA has been implemented outside of clinical trial settings, a high inter-provider variability has become apparent, leading to low sensitivity in many cases. Moreover, even in clinical trial settings, VIA only prevents a minority of deaths from cervical cancer. New and emerging technologies like HPV-DNA testing have the potential to increase the quality of cervical cancer screening services.

HPV-DNA testing is more sensitive and specific than VIA and Pap tests2, can be provided by a lower cadre of health worker, requires less training, and has the potential for sample self-collection, which is less invasive and could decrease stigma and other barriers that keep women from screening3. Furthermore, self-collection of HPV-DNA test samples can potentially be integrated into mobile outreach and community health worker programs. This approach could increase the reach of cervical cancer prevention services while providing avenues to increase efficiencies, and decrease the loss to follow-up seen with technologies that are not as conducive to single-visit “screen and treat.” While activities performed under this program should work closely with partner governments to implement programs that can best inform national-level implementation plans and policies (which given cost constraints, may include a focus on VIA), partners will be encouraged to consider innovative pilot programs to decrease costs and increase access to new technologies like HPV-DNA testing. Where national guidelines or policies do not exist, partners will be expected to work with Ministries of Health to ensure appropriate development of guidelines and resource packages for the introduction of new technologies. As mentioned above, activities might include feasibility studies around integration into mobile or static clinics, but could also include innovative approaches towards leveraging equipment that may already be available in LMIC settings, such as platforms used for HIV viral load testing and/or tuberculosis testing; using iterative user research methodologies like human-centered design to understand patient values and preferences that hinder/drive uptake of different types of HPV-DNA tests; or employing market shaping interventions that aim to reduce long-term demand and supply imbalances.

New Ablation Technologies
While providing quality screening for precancerous lesions is a critical step for decreasing cervical cancer incidence and mortality, access to early and cost-effective treatment of pre-cancerous lesions including ablation is of equal importance. Recently, innovative new approaches to the ablation of precancerous lesions have been developed and introduced. For example, thermocoagulation has been shown to be effective and in many cases, simpler to implement than traditional cryotherapy interventions. Recently, with the help of the Global Fund, Malawi has procured 300 portable thermocoagulation devices. Additionally, new portable technologies, including portable gas-less cryotherapy devices as well as enhanced ethanol ablation, may be able to overcome the challenges with existing ablation technologies, like the need for large medical-grade gas tanks. As is the case with the introduction of screening technologies, implementing partners should work with countries to ensure protocols used in these programs are in line with national guidelines and policies for ablation of precancerous lesions in partner countries. Where national guidelines or policies do not exist, partners will be expected to work with Ministries of Health to ensure appropriate development of clinical guidelines and resource packages for the introduction of new technologies. There is a clear value in increasing women’s access to existing high-quality commodities, including through the strengthening of country supply chains and service delivery points in an effort to lay a foundation for the introduction of new technologies that will overcome barriers to making a significant global impact on cervical cancer incidence and mortality. Therefore, applicants are encouraged to consider innovative approaches towards the integration of new, proven technologies into country-level programs, including coordinated strategic planning in partnership with manufacturers, health care providers, policymakers, and market shaping interventions.

New Visualization Approaches/Technologies that Improve the Accuracy of Visual Assessment of the Cervix for Precancerous Lesions
Imaging plays a central role across the comprehensive cancer care spectrum from screening, to early detection and diagnosis, through treatment and follow-up. The ability to non- or minimally-invasively visualize anatomy and physiology empowers healthcare teams in providing optimal care to patients. It reduces unnecessary treatment and further testing, especially in already overburdened medical systems. Particularly relevant to cancer care, optical imaging tools are safe, fast, and versatile: useful for repeated procedures to evaluate disease progression and monitor treatment. Rapid, point-of care (POC) imaging, coupled with image-analysis software and proper training programs, can change the landscape of cancer staging and diagnosis in settings where a lack of pathology services has created a bottleneck in clinical work-flows or can enhance capacity for traditional pathology services, offer new avenues for digital telepathology, or task-shift roles to primary care providers to improve the early detection of cancer.

Colposcopy, an examination of the cervix performed using a magnifying device called a colposcope, allows providers to identify abnormal cervical cells for biopsy and further evaluation. Traditional colposcopy requires a trained provider; adequate equipment (including a functioning colposcope), space, and time for a pelvic exam. Innovative approaches to colposcopy in resource-limited settings, however, have the potential to redefine these requirements. In particular, low-cost, portable approaches to performing colposcopy at the point-of-need have been developed that allow for image capture and analysis while simplifying workflow. By reducing the training level required for use, these tools allow for task-shifting models that empower community-level providers to enhance early detection of cervical abnormalities at the point-of-need.

Low-cost, portable optical microscopy may also allow for high-quality, real-time imaging at the cellular level in vivo. Real-time evaluation, diagnosis, and staging of cervical neoplasia can assist providers in determining the necessity of immediate cryotherapy, improving the efficiency of both mobile and in-clinic see-and-treat approaches and ultimately reducing over-treatment.

An integrative approach using a first-line self-sampled molecular test that provides a high level of reassurance when negative, such as POC HPV-DNA testing, followed by triage, employing these emerging imaging strategies, could achieve high program efficiency. It would rule out disease risk in the majority of women and reduce the need for gynecologic examinations. HPV-DNA tests that are faster and less expensive than current options would be welcomed.


mHealth/eHealth Strategies
The enormous potential for mobile technology to transform health care has led to the rapid development of new health-related phone applications and device attachments. The potential of mHealth is especially relevant to LMICs, where cell phone ownership is rising rapidly, but access to health care and providers is often limited. mHealth strategies may be employed to support early detection, facilitate accurate diagnosis and effective treatment planning; support reliable communications between all members of the care team, including the patient, during treatment; and offer an unbroken system of support during follow-up, survivorship, and at end-of-life.

In particular, mHealth can be used to enhance screen-and-treat program efficiency through behavioral interventions focused on patient follow-up, referral, or abandonment of care, improving patient education, and by creating a communication safety net for cancer survivors that will allow them to thrive after treatment, while adhering to the evolving guidance of a proactive survivorship care plan.

mHealth tools can also be used in conjunction with a screening program to translate data from the visit into e-Health records and cancer surveillance systems.

Liquid cytology4
In higher-income countries evidence suggests that liquid cytology may have advantages over conventional cytology. Similar to HPV-DNA testing, this may result in an increase in overall cost–effectiveness for the process, even though the test itself is more expensive. The advantages of liquid-based cytology are that it produces a uniform layer of cells and removes cellular and other debris. Liquid cytology has the potential to offer improved sensitivity and specificity as well as increased laboratory efficiency. However, its implementation requires health professional and technician training, as well as the provision, storage and transport of media, new equipment, and ongoing quality assurance review. Evidence suggests, however, that health professionals and technicians learn the needed new skills rapidly and reliably.

Implementing or expanding cervical cytology screening on a subset of patients is important to assure the quality of screening and increase program efficiency by reducing under-treatment or over-treatment (see Section VI, Subsection 3 below for further details). Private sector engagement as well as innovative ways to leverage existing resources could help expand the use of liquid cytology.


Research Priorities

The PEER activities will utilize implementation research to generate evidence that can be applied to programs in real-time. This will be done by providing support to build capacity of country partners to expand implementation of CCS&PT integrated with voluntary family planning while at the same time embedding research within this implementation.

Research activities should generate evidence that is relevant to the following two broad questions:
  1. How can CCS&PT and voluntary family planning be integrated and linked with one another in different types of service delivery settings to increase the health impact of both services, as measured by increased numbers of precancerous lesions ablated and increased availability of voluntary family planning counseling, uptake, and client satisfaction?
  2. How can new technologies for cervical cancer screening be most effectively utilized within programs in low-income countries to increase the impact of CCS&PT, while also potentially decreasing the burden on health systems and health providers in terms of the overall resources required (as measured by the fully-loaded costs of screening, including time spent by providers for screening and reduction of client costs)?
As they seek to increase uptake of cervical cancer screening by women age 30 and older in voluntary family planning programs, the projects should also seek to identify efficient approaches to leverage these efforts to also improve screening among women who are beyond their childbearing years. (Please see Section VI, Subsection 2 for further discussion of this important issue.)

A key priority of the CCS&PT program will be to generate evidence with a potential to be used to inform global and national guidelines and policies. In May of 2018, the WHO Director General made a call to eliminate cervical cancer as a public health threat. In the months since, WHO has convened a number of technical expert group meetings and is working to galvanize a global group of stakeholders towards elimination. While significant advancement in reducing incidence and mortality can be achieved in the near-term, it’s clear that the horizon for global elimination is much longer. Achievement of these goals will require sustained investments in HPV vaccination, identification and ablation of precancerous lesions, identification of and linkage to care for invasive cervical cancer, and palliative care. As WHO and other international stakeholders work to increase attention and focus on elimination of cervical cancer, it is important for governments and global donors to provide support that not only will catalyze global investment, but also lead to increased efficiencies among programs. With USAID’s long history in implementing voluntary family planning and reproductive health programs, and NCI’s expertise in cutting-edge cervical cancer interventions, the PEER partnership represents an excellent opportunity to leverage each organization’s comparative advantage to generate evidence that can support partner countries and the global community to implement innovative and cost-effective programs.

1http://www.who.int/nmh/publications/best_buys_summary.pdf
2https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0013711
3https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0013711
4http://www.who.int/cancer/media/en/cancer_cervical_37321.pdf
 
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