ABSTRACT
Monitoring treatment response for Kaposi sarcoma (KS) using present clinical judgement is inadequate. While
objective monitoring of KS lesions can be performed, the measurements required are tedious and time-
consuming, making them impractical for use in routine clinical care in busy low- and middle-income country
(LMIC) clinics. This leads clinicians in LMIC to rely on subjective monitoring strategies, which may unnecessarily
prolong treatment and incur unnecessary chemotherapy toxicities. KS remains a major public health threat: it is
the most common cancer and a leading cause of cancer-related death among men in Malawi, Mozambique,
Uganda, and Kenya.1-4 Current standard of care for monitoring KS treatment response is also imprecise. These
methods are based on clinical assessment of lesion area and height and are subject to human variation. They
perform particularly poorly in persons with dark skin, leading to racial inequities in adverse effects including
alopecia, cardiac toxicity, neuropathy, bone marrow suppression, financial toxicity, decreased quality of life, and
premature treatment discontinuation, undermining effectiveness.7,8 To address these challenges, we propose to
test a new technology — SkinScan3D (SS3D) — to elucidate its contribution in clinical practice, optimize
performance, and integrate into workflows in Africa where need is greatest. SS3D is a simple, low-cost, and
user-friendly technology that combines liquid lens technology and artificial intelligence (AI), providing high-
resolution 3D images/maps of KS skin lesions that incorporate lesion height and volume. We will formally refine
the technology to make it user-friendly and easy to integrate into workflows in Uganda and Kenya, determine its
measurement improvements in real-world clinical practice, and assess its contribution to improved clinical
outcomes. Our specific aims are: Aim 1: Refine SkinScan3D Technology and Usage Protocols for Routine
KS Imaging in East Africa. We will engage end-users (clinicians, nurses), and patients to refine SS3D through:
a) focus group discussions; b) discrete choice experiments to identify and quantify preferences for re-design of
hardware, software, and standard operating procedures; and c) iterative Human-Centered Design workshops.
Aim 2: Compare Reproducibility and Accuracy of KS Lesion Size Measurements Between SkinScan3D
and Current Standard of Care Measurement. We will compare the concordance correlation coefficients
(quantitative measure of reproducibility) and coefficients of determination (quantitative measure of accuracy)
between SkinScan3D and the manual method (ruler-based). Aim 3: Validate and Optimize SkinScan3D
Clinical Workflow in Real-World Settings. We will roll out the refined SS3D package to a variety of practice
locations in East Africa to determine whether the device will perform robustly and efficiently in different settings.
Specifically, we will measure: device usability with the System Usability Scale; device acceptability,
appropriateness and feasibility with validated quantitative instruments; clinic workflows and time burden with
time-and-motion studies; and implementation costs with activity-based micro-costing.
Public Health Relevance Statement
PROGRAM NARRATIVE
The Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS) study addresses the urgent need for precision
in Kaposi Sarcoma monitoring among people living with HIV in Low and Middle Income Countries. SkinScan3D
offers an efficient, low-cost, and accessible solution to make monitoring less burdensome and more accurate for
patients and providers. This transformative technology will advance health equity globally.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS clinical trial groupAddressAdverse effectsAffectAfricaAfricanAfrican American populationAgreementAlopeciaAreaArtificial IntelligenceBlack raceBone Marrow SuppressionCalibrationCancer EtiologyCardiotoxicityCessation of lifeClinicClinicalClinical TrialsClinical assessmentsColorComputer softwareConsumptionCountryDarknessDevicesDiscover, Design, Build, and Test FrameworkEducational workshopEffectivenessElectricityEnsureFocus GroupsHIVHIV therapyHealth care facilityHeightHumanImageInternetJudgmentKaposi SarcomaKenyaLaboratoriesLesionLiquid substanceLocationMalawiMalignant NeoplasmsManualsMapsMeasurementMeasuresMethodsMonitorMozambiqueNeuropathyNursesOutcomeParticipantPatientsPerformancePersonsPhaseProceduresProtocols documentationProviderPublic HealthQuality of lifeRandomizedReproducibilityResolutionSiteSkinSkin Kaposi's SarcomaSystemTechnologyTestingThree-Dimensional ImageTimeTime and Motion StudiesToxicity due to chemotherapyTranslatingUgandaVariantclinical careclinical practicecostcost effectivedesignexperimental studyfinancial toxicityhealth equityhuman centered designimplementation costimprovedinnovationinstrumentlenslow and middle-income countriesmanufacturemenmicrocostingnew technologyopen sourceoperationpreferenceprematureprototyperacial disparityrecruitroutine caresecondary analysisskin lesionstandard of caretreatment responseusabilityuser-friendly
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