grant

Optimizing implementation of long-acting, injectable Cabotegravir for HIV prevention among adolescents and young adults in Zambia

Organization JOHNS HOPKINS UNIVERSITYLocation BALTIMORE, UNITED STATESPosted 1 Aug 2022Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY2025AIDS VirusAIDS preventionAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAdherenceAdolescent and Young AdultAffectiveAfrica South of the SaharaAreaAssess implementationCharacteristicsClinical TrialsCognitiveCompetenceContraceptionContraceptive methodsCountryDataData CollectionDevelopmentDevelopment and ResearchDiseaseDisorderEastern AfricaEducational AchievementEducational StatusEducational workshopEffectivenessEnsureExploration, Preparation, Implementation, and SustainabilityExploration, Preparation, Implementation, and SustainmentFertility ControlFood and Drug AdministrationFormulationFutureGoalsGrantGuidelinesHIVHIV PreventionHIV/AIDS preventionHealthHealth Care FacilityHealth Care ProvidersHealth FacilitiesHealth PersonnelHealth systemHeterogeneityHigh PrevalenceHuman Immunodeficiency VirusesImplementation assessmentImprove AccessIncidenceIndividualInfectionInfection preventionInhibition of FertilizationInjectableInternationalInternetInterventionInvestigatorsK01 AwardK01 MechanismK01 ProgramKnowledgeLAV-HTLV-IIILow incomeLow-resource areaLow-resource communityLow-resource environmentLow-resource regionLow-resource settingLymphadenopathy-Associated VirusMapsMeasuresMentored Research Scientist Development AwardMentored Training AwardMentorsNational Institutes of HealthNorthern RhodesiaOralOutcomeParticipantPerceptionPersonsPoliciesPopulationPrEPPredispositionPrevent infectionPreventative interventionPreventionPrincipal InvestigatorProcessProductivityR & DR&DRecommendationRegimenRegulatory approvalReportingResearchResearch MethodologyResearch MethodsResearch PersonnelResearch Scientist Development AwardResearchersResource-constrained areaResource-constrained communityResource-constrained environmentResource-constrained regionResource-constrained settingResource-limited areaResource-limited communityResource-limited environmentResource-limited regionResource-limited settingResource-poor areaResource-poor communityResource-poor environmentResource-poor regionResource-poor settingRisk AssessmentSamplingSouthern AfricaSpecific qualifier valueSpecifiedStratificationSub-Saharan AfricaSubgroupSubsaharan AfricaSusceptibilityTechnologyTestingTimeTrainingTreatment EfficacyUSFDAUnited StatesUnited States Food and Drug AdministrationUnited States National Institutes of HealthVirus-HIVWWWWorkshopYouthYouth 10-21Zambiaagedcare facilitiescareercareer developmentdevelopmentaleducational levelevaluate implementationevaluation of implementationevidence baseexperienceexperimentexperimental researchexperimental studyexperimentshealth and care deliveryhealth care deliveryhealth care personnelhealth care workerhealth delivery systemshealth providerhealth services deliveryhealth workforceimplementation evaluationimplementation facilitationimplementation scienceimplementation strategyimprovedinfection riskinnovateinnovationinnovativeintervention efficacyintervention for preventionmedical personnelnovelpre-exposure prophylaxispreferenceprevention interventionpreventional intervention strategypreventive interventionprogramsrecruitregulatory authorizationregulatory certificationregulatory clearanceresearch and developmentresearch and methodsskillsstrategies for implementationsuccesstherapeutic efficacytherapy efficacytooltraining achievementtraining leveltraining statustreatment provideruptakewebworld wide webyouth age
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Full Description

This K01 Mentored Research Scientist Development Award application will facilitate the Principal Investigator’s career development as a leading, productive, independent researcher conducting innovative implementation science to maximize the real-world impact of human immunodeficiency virus prevention interventions in low-resource settings. The proposed training plan and research implementation in Zambia will allow her to meet her training objectives, developing the critical knowledge, skills, and competencies required to transition into an independent researcher. She will: 1. Gain expertise in pre-exposure prophylaxis (PrEP) and prevention interventions, 2.

Develop skills in evidence-based, stakeholder-informed implementation strategy specification to optimize population-level impact of novel interventions, 3. Develop statistical expertise in discrete choice experiments and latent class analysis, 4. Establish capacity in internet-based recruitment and data collection in a low-resource setting, 5. Understand and measure developmental differences, including cognitive and affective development, among adolescents and young adults and their associations with HIV prevention.

Her well-established mentoring team will support her successful achievement of her training, research, and career development goals. Her primary mentor is an international expert in HIV prevention. She has five co-mentors offering expertise in Cabotegravir long-acting injectable prevention; implementation science with latent class analysis expertise; development, execution, and analysis of discrete choice experiments; adolescent and young adult development; and human immunodeficiency virus research in Zambia. Her Scientific Advisor is an expert in internet-based research in low-income settings.

Cabotegravir long-acting injectable prevention was found superior to daily oral PrEP in clinical trials and received United States Food and Drug Administration approval in December 2021 with international regulatory approvals following. Cabotegravir long-acting injectable prevention has the potential to be effective among people who have found oral PrEP ineffective, including adolescents and young adults in sub-Saharan Africa who remain susceptible to new infections. The proposed research utilizes implementation science to establish evidence needed to optimize Cabotegravir long-acting injectable prevention implementation among adolescents and young adults in Zambia, minimizing the time from proven intervention efficacy to population impact: Aim 1. Assess the fidelity and sustainability of implementation strategies for two related interventions: oral PrEP and injectable contraception, to inform Cabotegravir long-acting injectable prevention implementation using participatory process mapping; Aim 2.

Identify preferences for Cabotegravir long-acting injectable prevention implementation and heterogeneity among adolescents and young adults and healthcare workers using discrete choice experiments and latent class analysis with internet-based recruitment; Aim 3. Specify Cabotegravir long-acting injectable prevention implementation strategies to support use and persistence. A future National Institutes of Health grant will evaluate implementation.

Grant Number: 3K01MH130244-04S1
NIH Institute/Center: NIH

Principal Investigator: Laura Beres

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