Stimulant drug (e.g., crystal methamphetamine, cocaine, ecstasy, MDMA) use is a substantial public
health problem among young gay, bisexual and other men who have sex with men (YGBMSM) in the United
States (US). Stimulant use is associated with increased engagement in sexual risk behaviors and decreased
use of HIV prevention and treatment services, and as such leads to increased HIV acquisition/transmission.
There are currently no evidence-based interventions to reduce stimulant use and concurrent HIV risk among
YGBMSM; in response to this urgent need and building of over a decade of NIH-funded formative and pilot
research, the proposed hybrid type 2 effectiveness-implementation trial is designed to assess the
effectiveness and implementation strategies of Project IMPACT—a HIV status neutral, modular behavioral
intervention to reduce HIV risk in YGBMSM who use stimulants in the context of high-risk sex. The
intervention incorporates HIV risk reduction counseling (including supporting PrEP and ART use) with
behavioral activation (BA)—an evidence-based, easy to administer, cognitive behavioral approach to treat
depression that focuses on helping individuals re-engage in activities that generate feelings of enjoyment.
Our conceptual model posits that BA will re-engage YGBMSM in pleasurable non-drug use activities
that will serve as a natural reinforcement for functional behavior, improve depressed mood when not on
stimulants by experiencing increases in pleasure, and decrease overall distress so that YGBMSM who use
stimulants can better benefit from HIV risk reduction counseling. The initial pilot trials of Project IMPACT
resulted in significant reductions in sexual risk, stimulant use and depressive symptoms.
Research Plan Overview: By harnessing the resources, geographic and site diversity, and
multidisciplinary expertise of the AdolescentTrialsNetwork (ATN), the current proposal aims to efficiently and
rigorously prepare Project IMPACT for rapid translation into real-world practice. Following the RE-AIM
Framework, we will test the reach and effectiveness of Project IMPACT (compared to an enhanced Standard
of Care condition) in a two-arm, multi-site and multi-format (i.e., in-person and virtual) randomized controlled
trial of 360 cisgender YGBMSM who use stimulants in the context of high-risk sex. Participants will be
followed for 12 months, and primary outcomes include number of condomless anal sex acts while not
protected by PrEP (HIV- YGBMSM) or while not virally suppressed (HIV+ YGBMSM) and stimulant use (via
urinalysis). We will also test our multi-faceted implementation strategy by assessing adoption/ accessibility
and implementation using mixed-methods assessments that describe and examine characteristics of
successful implementation (including differences by intervention delivery format). Finally, we will assess the
feasibility of maintenance and sustainment of Project IMPACT by using the well-established CEPAC-AYA
model to project its cost effectiveness on HIV transmissions, QALYs, and per person lifetime costs.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AIDS preventionAddressAdherenceAdministratorAdolescent Medicine TrialsNetworkAdolescent and Young AdultAdoptionAgeBehaviorBehavior TherapyBehavioralBiological MarkersBisexualCaringCharacteristicsClinicClinicalCocaineCognitiveCognitive TherapyCommunitiesCompetenceConsultationsCounselingDepressed moodDevelopmentDistressEducational workshopEffectivenessEvidence based interventionFeedbackFeelingFundingGaysGeographyHIVHIV riskHIV/AIDSHIV/STDHealthHeterosexualsHybridsIndividualInterventionInterviewLeadershipMaintenanceManualsMeasuresMediatingMediatorMental DepressionMethamphetamineMethodsModelingMotivationOutcomeParticipantPatient Self-ReportPersonsPharmaceutical PreparationsPrevalencePrimary CareProfessional counselorPsychological reinforcementPublic HealthQuality-Adjusted Life YearsRandom AllocationRandomizedRandomized, Controlled TrialsReach, Effectiveness, Adoption, Implementation, and MaintenanceReportingResearchResourcesRiskRisk ReductionSecureSex BehaviorSexual TransmissionSiteStimulantStructureTestingTrainingTraining ActivityTranslationsUnited StatesUnited States National Institutes of HealthUnsafe SexUrinalysisViralViral Load resultantiretroviral therapyarmbehavioral disinhibitioncisgendercondomless anal sexcost effectivenesscost estimatedepressive symptomsdesigneconomic impactecstasyeffectiveness evaluationeffectiveness outcomeeffectiveness/implementation trialevidence baseexperiencefield studyimplementation evaluationimplementation strategyimprovedintervention deliveryintervention effectlife time costmen who have sex with menmultidisciplinarynon-drugpilot trialpleasurepre-exposure prophylaxisprevention serviceprimary outcomepsychosocialrelapse preventionresponsesatisfactionsecondary outcomesexsexual risk behaviorsexual risk reductionsexually activeskillsstandard of carestimulant usesubstance usesubstance use treatmenttherapy adherencetranslational impacttransmission processtreatment as preventiontreatment servicesuptakevirtual
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
$1,989,068
Direct Costs
$1,681,274
Indirect Costs
$307,794
Year
Funding IC
FY Total Cost by IC
2025
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$1,989,068
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 5UM2HD111102-03 6978
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5UM2HD111102-03 6978
Patents
No Patents information available for 5UM2HD111102-03 6978
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5UM2HD111102-03 6978
Clinical Studies
No Clinical Studies information available for 5UM2HD111102-03 6978
News and More
Related News Releases
No news release information available for 5UM2HD111102-03 6978
History
No Historical information available for 5UM2HD111102-03 6978
Similar Projects
No Similar Projects information available for 5UM2HD111102-03 6978