Integrated Model for the Prevention of Anal Cancer using screen and Treat for HSIL (IMPACT)
Project Number5U01CA275053-03
Contact PI/Project LeaderNOWAK, REBECCA G. Other PIs
Awardee OrganizationUNIVERSITY OF MARYLAND BALTIMORE
Description
Abstract Text
Project Abstract
Anal cancer risk is 80-fold higher among men who have sex with men (MSM) living with HIV compared to the
general population, making MSM a critical population for implementing evidence-based anal cancer prevention
interventions. A randomized controlled trial at 21 clinical sites in the United States of people living with HIV,
recently established treatment of high-grade squamous intraepithelial lesions (HSIL) as an evidence-based
intervention (EBI) for anal cancer prevention. Given its established efficacy, HSIL screening and treatment
should be implemented as prophylactic care to prevent anal cancer in low- and middle-income country (LMIC)
settings where HIV is highly prevalent. To accelerate adoption of HSIL screening and treatment in LMIC settings,
we will leverage an existing HIV infrastructure, the TRUST clinic, an MSM-friendly facility in Nigeria that has
been providing HIV care to a cohort of MSM since 2012. We conducted a proof-of-concept anal cancer screening
and treatment study at the TRUST clinic and found high uptake in the MSM community; representativeness, as
those screened had similar prevalence of HIV and high-risk human papillomavirus as our overall cohort; and
overall patient satisfaction. Despite high screening volumes, we under-detected and under-treated HSIL.
Knowledge gaps in HSIL screening and treatment among both the care team and the participants were identified
as major barriers that impeded implementation of the EBI with fidelity. The objective of the proposed Integrated
Model for the Prevention of Anal Cancer using screen and Treat for HSIL (IMPACT) study is to address these
barriers while capitalizing on facilitators within the existing TRUST clinic infrastructure to create an enhanced
training on Screening and Treatment of HSIL (e-STH) intervention. To achieve this goal, in AIM 1, we will use
the Consolidated Framework for Implementation Research (CFIR) and mixed methods to identify barriers and
facilitators to usual training on the EBI at the TRUST clinic. In AIM 2, we will engage an implementation team to
co-design the e-STH intervention by matching the barriers identified with CFIR with specific strategies in the
Expert Recommendations for Implementing Change (ERIC) framework. We will then take an iterative
improvement approach to test and refine the implementation of the e-STH intervention based on specific
outcomes. In AIM 3, we will conduct a prospective study to evaluate the reach, efficacy, and implementation and
explore the sustainability of e-STH compared to usual training using the RE-AIM framework. The proposed
IMPACT study will provide insight into implementation of an HSIL screening and treatment EBI adapted for
existing community-based HIV clinics in Nigeria and generate essential evidence for scalability across LMICs.
Public Health Relevance Statement
Project Narrative
Men who have sex with men and are living with HIV bear the greatest burden of anal cancer. Treatment of the
anal cancer precursor, high-grade squamous intraepithelial lesions (HSIL), has proven effective for preventing
cancer, and research on how to best implement screening and treatment of HSIL is key to mitigating the risk of
anal cancer in low- and middle-income countries (LMIC) such as Nigeria where HIV is highly prevalent. This
work will yield a systematic strategy for evaluating HSIL screening and treatment implementation in an HIV
care setting and provide generalizable knowledge on context-specific adaptation of a complicated evidence-
based intervention in a challenging LMIC environment that will benefit the broader field of implementation
science.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AccelerationAddressAdherenceAdoptionAnusCancer ControlCancer Prevention InterventionCaringClientClient satisfactionClinicCommunitiesConsolidated Framework for Implementation ResearchDataDevelopmentEligibility DeterminationEnrollmentEnsureEnvironmentEvidence based interventionEvidence based treatmentFeasibility StudiesFriendsGeneral PopulationGoalsGroup InterviewsHIVHIV riskHPV-High RiskInfrastructureInternationalInterruptionInterventionInterviewKnowledgeLanguageLearningMaintenanceMalignant NeoplasmsMalignant neoplasm of anusMethodsModelingNeoplasmsNigeriaOutcomeParticipantPatientsPersonsPhysiciansPolicy MakerPopulationPrevalencePreventionProspective StudiesRandomized, Controlled TrialsReach, Effectiveness, Adoption, Implementation, and MaintenanceRecommendationResearchRisk FactorsScreening ResultScreening for cancerSeriesSiteSocietiesSquamous intraepithelial lesionStructureTestingTimeTrainingUnited StatesVirusWorkcancer preventioncancer riskclinical research sitecohortcost effectivedesigneducational atmosphereevidence baseevidence based guidelinesexperiencefollow-uphybrid type 2 trialimplementation barriersimplementation interventionimplementation scienceimplementation strategyimprovedinsightlow and middle-income countriesmen who have sex with menmultidisciplinarypreventprimary outcomeprophylacticrisk mitigationscale upscreeningscreening guidelinessecondary outcometooluptake
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