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Principal Investigator: Mohammed Kumail Ali
Organization: EMORY UNIVERSITY
Fiscal Year: 2024
Award: $622,558
Funding agency: National Cancer Institute
ABSTRACT
In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that
causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH)
have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the
leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign,
represented by donors such as the President’s Emergency Plan for AIDS Relief (PEPFAR), the George W.
Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an
exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is
available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to
care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate
treatment. Implementation science studies are needed to better understand and surmount barriers to
integrated care in publicly funded HIV clinics. Specifically, we need to explore and innovate strategies to
overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines,
link WLWH who require further diagnostic testing and/or treatment with effective and accessible care, and
document services for accountability and quality improvement. In this proposal, our team will apply our
extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt
and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app
[tested and scaled in Tanzania]) that address key multi-level barriers identified through a formative,
stakeholder-engaged research phase. Using the EPIS framework to guide our project, we will: Aim 1a),
Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and
prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b),
Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and
evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics
(assessing implementation [provision of CC screening with HPV self-testing] and effectiveness [proportion of
HPV-positive WLWH who receive subsequent diagnostic triage and/or treatment] over months 0-12; and Aim
3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over
months 13-18. The overall goal of this study is to employ rigorous empirical methods to adapt and test
implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC
lesions in a sustainable, scalable way. Through partnering with Kenya’s MOH, this project will have critical
institutional support and dissemination capability, and will directly inform public health practice and policy,
offering a high likelihood of sustainable cancer impact among WLWH that can be adopted across SSA.
Terms: <AIDS><AIDS Virus><Access to Care><Accountability><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Active Follow-up><Address><Administrator><Adopted><Africa South of the Sahara><African><Android App><Android Application><Assess implementation><Attitude><Awareness><Behavioral><Cancer Cause><Cancer Etiology><Cancers><Caring><Cell Phone Application><Cell phone App><Cellular Phone App><Cellular Phone Application><Cervical><Cervical Cancer><Cervical Cancer Screening><Cervix Cancer><Cessation of life><Clinic><Clinical Trials><Collaborations><Communities><Country><Data><Death><Diagnostic><Diagnostic tests><Early Diagnosis><Effectiveness><Emergencies><Emergency Situation><Ensure><Face><Female><Fracture><Funding><Goals><Government><Guidelines><HIV><HPV><HPV positive><HPV(+)><HPV+><Health><Health Policy><Health Services Accessibility><Human><Human Immunodeficiency Viruses><Human Papilloma Virus><Human Papillomavirus><Human Resources><Hybrids><Implementation assessment><Incidence><Infectious Human Wart Virus><Infrastructure><Institution><Kenya><Knowledge><LAV-HTLV-III><LMIC><Lesion><Letters><Link><Lymphadenopathy-Associated Virus><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Neoplasm of the Cervix><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Cervix><Malignant Tumor of the Cervix Uteri><Malignant Uterine Cervix Neoplasm><Malignant Uterine Cervix Tumor><Malignant neoplasm of cervix uteri><Manpower><Measures><Meta-Analysis><Methods><Mobile Health App><Mobile Health Application><Modeling><Modern Man><Morbidity><Morbidity - disease rate><Motivation><Outcome><Patients><Phase><Preparation><Preparedness><Professional Organizations><Provider><Public Health Practice><Randomized><Readiness><Research><Research Resources><Research Technics><Research Techniques><Resources><Screening for cancer><Services><Smart Phone App><Smart Phone Application><Smartphone App><Structure><Sub-Saharan Africa><Subsaharan Africa><System><Tanzania><Testing><Triage><Uterine Cervix Cancer><Virus-HIV><Woman><Women's mortality><Work><World Health Organization><access to health services><access to services><access to treatment><accessibility to health services><active followup><availability of services><barriers to implementation><behavior change wheel><bone fracture><burden of disease><burden of illness><care access><care fragmentation><care seeking><cell phone based app><cervical cancer early detection><cervical screening><clinical care><cost><cost effectiveness><cost estimate><cost estimation><death among females><death among women><death in females><death in women><death rate among women><death rate in women><design><designing><disease burden><early cancer detection><early detection><economic impact><effectiveness and implementation trial><effectiveness outcome><effectiveness-related outcomes><effectiveness/implementation hybrid trial><effectiveness/implementation trial><evaluate implementation><evaluation of implementation><evidence base><faces><facial><female death><female mortality><female treatment><follow up><follow-up><followed up><followup><health care policy><health service access><health services availability><healthcare policy><high risk><human papillomavirus +><human papillomavirus positive><iOS app><iOS application><iPhone App><iPhone Application><implementation barriers><implementation challenges><implementation cost><implementation evaluation><implementation investment><implementation outcomes><implementation research><implementation science><implementation strategy><improved><innovate><innovation><innovative><integrated care><integrated model of care><intervention design><low and middle-income countries><m-Health><m-Health app><m-Health application><mHealth><mHealth app><mHealth application><malignancy><mobile health><mobile phone app><mortality><mortality among females><mortality among women><mortality in females><mortality in women><multidisciplinary><neoplasm/cancer><patient barriers><patient-level barriers><personnel><precancer><precancer cervical detection><precancerous><premalignant><preparations><presence of HPV><presence of human papillomavirus><prevent><preventing><professional association><professional membership><professional society><provider barriers><provider-level barriers><randomisation><randomization><randomly assigned><screening><screening cancer patients><screenings><self testing><service availability><smartphone application><smartphone based app><smartphone based application><standard of care><strategies for implementation><system-level barriers><therapy design><tool><treat females><treat women><treatment access><treatment among females><treatment among women><treatment design><treatment in females><treatment in women><treatment strategy><uptake><wart virus><women's death><women's death rate><women's treatment>