ABSTRACT
In the United States (US), transgender and gender diverse (TGD) youth have high rates of new HIV diagnoses,
with Black, Latinx, and other TGD youth of color representing the majority of these cases. The HIV prevention
and care continua emphasize the need to reduce HIV transmission risk via regular HIV testing, consistent
condom use, and linkages to HIV prevention and care, such as pre-exposure prophylaxis (PrEP) among HIV-
negative individuals and antiretroviral therapy (ART) and viral suppression among people living with HIV.
However, there are inequities at each step of these continua among TGD youth of color. TGD youth of color
experience intersectional oppression that results in unmet gender affirmation, legal, and economic needs,
which have been linked to inequities in HIV prevention and continua outcomes. Building on formative work, this
project seeks to test the effectiveness of the LEAP intervention, a HIV status-neutral intervention designed to
address social determinants of health to reduce sexual risk behaviors, increase HIV prevention uptake (PrEP
use), and treatment outcomes (viral suppression). LEAP will harness the resources, geographic diversity, and
multidisciplinary expertise of the Adolescent Trials Network for HIV/AIDS Interventions (ATN) to provide
gender-affirming individualized HIV prevention and treatment peer support, address health-harming legal
needs, and improve educational and employment outcomes for translation into real-world practice. We propose
a hybrid type 1 effectiveness-implementation study focused on testing the effectiveness of LEAP and
secondarily conducting a prospective implementation process evaluation. HIV risk will be assessed using a
composite indicator of risk, which is a binary HIV risk indicator of validated measures of sexual risk behavior,
as well as self-reported and biomarkers of HIV status, PrEP use, and viral suppression. We will recruit and
randomize 250 TGD youth of color from five different ATN Site Consortiums (stratified by site, HIV status, and
gender), following participants for 12 months and collecting biological (i.e., HIV status, PrEP use, or viral load)
and behavioral data. Findings will provide critical insights into the effectiveness of an urgently needed
multicomponent intervention designed to address unmet gender affirmation, legal, and economic needs to
reduce HIV inequities among TGD youth of color.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAcquired Immunodeficiency SyndromeAddressAdherenceAdolescent Medicine Trials NetworkAdolescent and Young AdultAgeBehavioralBiologicalBiological MarkersBlack raceCaringClinicConsultationsContinuity of Patient CareCost Effectiveness AnalysisDataDevelopmentDiscriminationDropsEconomicsEducationEffectivenessEmploymentEnvironmentEpidemicGenderGeographyGoalsGrantHIVHIV InfectionsHIV SeronegativityHIV diagnosisHIV disparitiesHIV riskHIV/AIDSHealthHealth CareHeterogeneityHomelessnessHousingHuman immunodeficiency virus testHybridsImprisonmentIncomeIndividualInequityInterventionLatinxLawyersLeadershipLegalLegal systemLinkMeasuresMediatorMentorsModelingNamesOutcomeParticipantPatient Self-ReportPersonal SatisfactionPersonsPopulationRaceRandomizedRecording of previous eventsResearchResourcesRiskSchoolsServicesSex BehaviorSiteSystemTranslationsTreatment outcomeTrustUnited StatesViralViral Load resultWorkYouthantiretroviral therapyarmcare outcomescare systemschildren of colorcommunity partnershipconsistent condom usecosteconomic needeffectiveness testingeffectiveness/implementation designeffectiveness/implementation studyethnic disparityevidence baseexperiencefood insecuritygender affirmationgender diversehealth equityimplementation frameworkimplementation processimprovedinsightmulti-component interventionmultidisciplinarypeerpeer supportperceived discriminationpre-exposure prophylaxisprevention serviceprocess evaluationprogramsprospectiveracismrecruitscale upsexual risk behaviorsexual risk reductionsocial determinantssocial health determinantstheoriestherapy designtransgendertransmission processtreatment effectuptake
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
DUNS Number
790877419
UEI
JF2BLNN4PJC3
EXTRKMMCVKS7
WEUJG9RND395
Project Start Date
25-January-2023
Project End Date
21-March-2025
Budget Start Date
01-December-2024
Budget End Date
30-November-2025
Project Funding Information for 2025
Total Funding
$895,147
Direct Costs
$892,989
Indirect Costs
$2,158
Year
Funding IC
FY Total Cost by IC
2025
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$895,147
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 5UM2HD111102-03 6975
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