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R01DA053184

Project Grant

Overview

Grant Description
Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade - Project Summary

People who inject drugs (PWID) are at exceedingly high risk of HIV compared to the general population, yet pre-exposure prophylaxis (PrEP) programs that target them in the U.S. are scarce, and accordingly, PrEP uptake in this population remains low.

In recent years, substance use services have been scaled up to address overdose among PWID. However, they remain an underutilized entry point into PrEP. Pivotal gains made in reducing HIV could be rapidly eroded by the expanding population of PWID attributed to the ongoing opioid epidemic, new HIV outbreaks among new injectors, and the emergent COVID-19 pandemic, which has disrupted key HIV prevention services including syringe services programs, treatment, and condom distribution.

The overarching aim of the RADAR (Rapid Alerts through Drug Analysis and Response) study is to design, implement, and evaluate a mobile health van that provides on-site PrEP, peer navigation, and co-located drug checking services (DCS). This study will expand the reach of PrEP services by offering a novel intervention designed to increase PrEP awareness and engagement. DCS enables PWID to understand the precise chemical contents of their drugs to inform safer drug practices and are critical in places where illicit fentanyl drives overdose mortality. The integration of peer navigation will help attend to the multiple, pressing needs of PWID and subsequently enhance their engagement in the PrEP continuum.

Our specific aims are:

1. To develop a community-level, mobile, integrated PrEP intervention aimed to increase PWID engagement in the PrEP care continuum.

2. To implement the intervention through a stepped wedge cluster randomized trial and evaluate its impact on being on PrEP or having seen a PrEP provider in the last six months among PWID (N=600) over the course of 18 months.
2A. To measure the intervention's impact on HIV risk behaviors (e.g., syringe sharing, condomless sex).

3. To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWID (N=600) over the course of 18 months.

The intervention (on-site PrEP, peer navigation, SMS reminders, DCS, and associated risk reduction counseling, standard-of-care services) will be compared to the standard-of-care only (HIV testing, PrEP referrals, fentanyl test strips, naloxone) condition.

The proposal is directly responsive to PAR-18-915's aim to leverage implementation science to improve each step of the Seek, Test, Treat, and Retain (STTR) continuum for PWUD, as well as broader NIH priorities to reduce HIV incidence and develop, test, and implement strategies to improve HIV testing and entry into prevention and care.

The study is innovative as it attends to multiple comorbidities, it is inclusive of the expertise of PWID in all components of the study, and builds on our experience in delivering outreach services during COVID-19.
Funding Goals
TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Place of Performance
Baltimore, Maryland 212051546 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 453% from $794,472 to $4,391,293.
The Johns Hopkins University was awarded RADAR Study: Mobile PrEP & Drug Checking for PWID Project Grant R01DA053184 worth $4,391,293 from National Institute on Drug Abuse in September 2021 with work to be completed primarily in Baltimore Maryland United States. The grant has a duration of 4 years 9 months and was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs. The Project Grant was awarded through grant opportunity HIV/AIDS High Priority Drug Abuse Research (R01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 7/3/25

Period of Performance
9/1/21
Start Date
6/30/26
End Date
87.0% Complete

Funding Split
$4.4M
Federal Obligation
$0.0
Non-Federal Obligation
$4.4M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01DA053184

Transaction History

Modifications to R01DA053184

Additional Detail

Award ID FAIN
R01DA053184
SAI Number
R01DA053184-3747149961
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
FTMTDMBR29C7
Awardee CAGE
5L406
Performance District
MD-07
Senators
Benjamin Cardin
Chris Van Hollen

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute on Drug Abuse, National Institutes of Health, Health and Human Services (075-0893) Health research and training Grants, subsidies, and contributions (41.0) $1,828,250 100%
Modified: 7/3/25