grant

A self-administered PrEP Decisional Aid for dissemination with HIV self-test kits (DASH)

Organization UNIVERSITY OF MICHIGAN AT ANN ARBORLocation ANN ARBOR, UNITED STATESPosted 15 May 2024Deadline 28 Feb 2027
NIHUS FederalResearch GrantFY2025AIDS VirusAIDS preventionAIDS testAIDS/HIV testAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusActive Follow-upAddressAdoptionAdvisory CommitteesAgeAwarenessCOVID crisisCOVID epidemicCOVID pandemicCOVID-19 crisisCOVID-19 epidemicCOVID-19 eraCOVID-19 global health crisisCOVID-19 global pandemicCOVID-19 health crisisCOVID-19 pandemicCOVID-19 periodCOVID-19 public health crisisCOVID-19 yearsCaringCollaborationsCommunitiesConflictConflict (Psychology)DataDecision AidDecision MakingDevelopmentDiagnostic Reagent KitsEducationEducational MaterialsEducational aspectsEpidemicEquityEvaluationExerciseFrequenciesFriendsGeneralized GrowthGoalsGrowthGuidelinesHIVHIV PreventionHIV SeronegativitiesHIV SeronegativityHIV negativeHIV testHIV-1 testHIV-2 testHIV/AIDS preventionHTLV-III SeronegativitiesHTLV-III SeronegativityHealthHealth CareHomeHuman Immunodeficiency VirusesHuman immunodeficiency virus testHybridsIndividualInternationalInterviewKnowledgeLAV-HTLV-IIILinkLogistic RegressionsLymphadenopathy-Associated VirusMeasuresMedicalMetadataMethodsModelingOn-Line SystemsOnline SystemsParticipantPatient Self-ReportPatientsPatternPersonal SatisfactionPersonsPilot ProjectsPopulation HeterogeneityPrEPPreventionProcessProgram AcceptabilityProtocolProtocols documentationPsyche structureRandomizedRecommendationReportingResearchResearch ResourcesResourcesRoleSARS-CoV-2 epidemicSARS-CoV-2 global health crisisSARS-CoV-2 global pandemicSARS-CoV-2 pandemicSARS-coronavirus-2 epidemicSARS-coronavirus-2 pandemicSelf AdministeredSelf AdministrationSelf DirectionSelf-ReportServicesSevere Acute Respiratory Syndrome CoV 2 epidemicSevere Acute Respiratory Syndrome CoV 2 pandemicSevere acute respiratory syndrome coronavirus 2 epidemicSevere acute respiratory syndrome coronavirus 2 pandemicSiteSurvey InstrumentSurveysTask ForcesTaxesTechnologyTest ResultTestingTimeTissue GrowthVirus-HIVWorkacceptability and feasibilityactive followupadvisory teamagesarmcommunity consultationcommunity marginalizationcoronavirus disease 2019 crisiscoronavirus disease 2019 epidemiccoronavirus disease 2019 global health crisiscoronavirus disease 2019 global pandemiccoronavirus disease 2019 health crisiscoronavirus disease 2019 pandemiccoronavirus disease 2019 public health crisiscoronavirus disease crisiscoronavirus disease epidemiccoronavirus disease pandemiccoronavirus disease-19 global pandemiccoronavirus disease-19 pandemiccostdesigndesigningdevelop therapydevelopmentaldiagnostic kitdirected attentiondirects attentiondisparity in healthdiverse populationsearly experienceefficacy trialexperienceexpirationfollow upfollow-upfollowed upfollowuphealth disparityheterogeneous populationhomesimprovedinnovateinnovationinnovativeintervention developmentmarginalized communitymembermentalmeta datanovelonline computerontogenypilot studypopulation diversitypost-COVIDpost-COVID-19post-coronavirus disease 2019post-pandemicpre-exposure prophylaxispreventpreventingprevention serviceprimary outcomeprogramsrandomisationrandomizationrandomly assignedrecruitsatisfactionsecondary outcomeself testingsevere acute respiratory syndrome coronavirus 2 global health crisissevere acute respiratory syndrome coronavirus 2 global pandemicsocial rolesocial stigmastigmasuccesstest kittesting servicestherapy developmenttime usetooltreatment developmentunder served communityunderserved communityuptakevirtualweb basedweb sitewebsitewell-beingwellbeing
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Full Description

Project Summary
Our mixed-methods implementation hybrid (type I) pilot RCT will develop a self-administered PrEP Decisional Aid for

dissemination with Self-administered HIV test kits (DASH), and pilot it with 120 users of the Together Take Me Home

(TTMH) National free HIVST kit distribution program to characterize the potential impact of the DASH on increasing PrEP

awareness, accurate PrEP knowledge, and PrEP starts, with 30 qualitative in-depth interviews to expand understanding,

and characterization of meta-data for users of the DASH to advise refinements in the decision aid tool. Our team, in

collaboration with our expert advisory committee and community review panel of TTMH HIV self-test users, will work

with Radiant Technologies to develop the decisional aid with up-to-date content on PrEP choices, values clarification

exercises to promote decisional clarity in considering PrEP, and active links to local and remote (online) PrEP prescribing

resources. Among individuals requesting a HIVST through TTMH (ages 17-30 per TTMH protocol), we will recruit HIVST

requesters and randomly assign individuals to the DASH or standard condition (1:1), collecting baseline, 1- and 3-month

survey data. DASH participants receive a unique, time-sensitive link to the mobile friendly decision aid website, and

reminders to use the link prior to expiration (2 weeks from baseline). Standard condition arm participants receive the

standard HIVST kit and information about PrEP on the TTMH HIVST request website. All participants with negative HIV-

test results continue in the study for month 1 and 3 surveys. PrEP starts at 3-months will be characterized between

arms. Changes in accurate PrEP information and intentions to use PrEP from baseline to 1- and 3-month follow-up will

be compared between study arms using longitudinal growth modeling; feasibility/acceptability of the program (DASH or

standard KIT contents) will be assessed using mixed methods with survey data and 30 qualitative interviews with

participants in each arm (20 in DASH and 10 in standard condition), and meta-data from DASH (use, time in components,

links to resources) will be characterized. The goal of our work is to develop a feasible and acceptable PrEP resource to

accompany national dissemination of HIVST kits. The objective of the study is to produce the DASH and estimates

needed to conduct a powered, large-scale efficacy RCT.

Grant Number: 5R34MH135799-02
NIH Institute/Center: NIH

Principal Investigator: Kathy Rivet Amico

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