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U01DA063078

Cooperative Agreement

Overview

Grant Description
A binational cohort of the intersection between substance use, HIV, and associated comorbidities among people who inject drugs in San Diego, CA - our goal is to prospectively study the intersection between substance use, HIV and related co-morbidities in a binational cohort of people who inject drugs (PWID) in San Diego County (SD).

For >25 years, Strathdee has studied the epidemiology of HIV and related co-infections among PWID across North America, with N=500-1000 and annual retention rates ≥90%.

Since 2020, our most recent NIDA-funded cohort, La Frontera I, has documented HIV and HCV incidence on the Mexico-U.S. border which appears to be the highest among PWID in North America (i.e., cumulative incidence: 3.89% and 23.1%, respectively).

Skaathun and Strathdee (MPIs) et al conducted phylodynamic analysis of HIV sequences revealing cross-border HIV transmission clusters of PWID that continue to grow.

Due to our location on a major drug trafficking corridor, we observe a wide range of substances (e.g., heroin, fentanyl, methamphetamine, xylazine, benzodiazepines).

We previously leveraged La Frontera I to evaluate initiatives to improve uptake of PrEP, COVID-19 testing and vaccination.

U01 funding would allow us to track emerging substance use trends and evaluate the impact of nascent harm reduction services on HIV incidence such as vending machines (VM) dispensing naloxone and drug testing strips, spectrometry-based drug checking services (DCS) and California’s new policies to reduce homelessness.

Our main hypotheses are:

H1: Predictors of HIV and HCV incidence among PWID

H1.A. PWID who inject synthetic drugs with shorter half-lives (e.g., fentanyl, nitazenes) will have higher HIV incidence than PWID who inject other drugs.

H1A.I. Lower self-efficacy for safer injection will mediate the relationship between injecting these drugs and syringe sharing will mediate the relationship between injection of synthetic drugs and HIV incidence.

H1.B. Those who use opioids through non-injection will have lower HIV and HCV incidence than those who use opioids more frequently via injection.

H2: Comorbidities, clustering, and engagement in prevention

H2.A. PWID who receive treatment for active HCV infection (i.e., HCV RNA+) will subsequently be more likely to initiate PrEP than HCV RNA+ PWID not accessing HCV treatment.

H2.C. Newly diagnosed PWID living with HIV (LWH) belonging to existing or new molecular clusters will be more likely to have prevalent STIs with an effective reproductive number indicative of cluster growth (i.e., Re >1).

H2.D. PWID with neurobehavioral dysfunction (e.g., neurocognitive impairment, depression, anxiety) will be less likely to utilize interventions (e.g., syringe service programs, VM, DCS), MOUD, PrEP and ART.

H3: Impact of structural interventions

H3.A. Among unhoused PWID, utilization of PrEP, ART and MOUD will be greatest among those residing in sanctioned homeless encampments and lowest among those experiencing evictions and homelessness sweeps and will be higher post-implementation of new housing programs compared to pre-implementation.

H3.B. PWID using DCS will have lower HIV and HCV incidence than PWID not accessing DCS, with this effect mediated by changes in drug use behaviors.
Funding Goals
TO SUPPORT BASIC, CLINICAL, TRANSLATIONAL, AND IMPLEMENTATION RESEARCH IN THE FIELD OF SUBSTANCE USE. TO DEVELOP NEW KNOWLEDGE AND APPROACHES FOR THE PREVENTION, DIAGNOSIS, AND TREATMENT OF DRUG USE, MISUSE, AND ADDICTION, DRUG OVERDOSE, AND RELATED HEALTH OUTCOME, 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 SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) LEGISTLATION IS INTENDED TO 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; 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
La Jolla, California 920930507 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 101% from $2,437,310 to $4,892,099.
San Diego University Of California was awarded Binational Study on Substance Use, HIV & Comorbidities in PWID Cooperative Agreement U01DA063078 worth $4,892,099 from National Institute on Drug Abuse in July 2025 with work to be completed primarily in La Jolla California United States. The grant has a duration of 4 years 10 months and was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs. The Cooperative Agreement was awarded through grant opportunity Cohort Studies of HIV/AIDS and Substance Use (U01 Clinical Trial Not Allowed).

Status
(Ongoing)

Last Modified 5/5/26

Period of Performance
7/15/25
Start Date
5/31/30
End Date
17.0% Complete

Funding Split
$4.9M
Federal Obligation
$0.0
Non-Federal Obligation
$4.9M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to U01DA063078

Transaction History

Modifications to U01DA063078

Additional Detail

Award ID FAIN
U01DA063078
SAI Number
U01DA063078-1907739127
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
UYTTZT6G9DT1
Awardee CAGE
50854
Performance District
CA-50
Senators
Dianne Feinstein
Alejandro Padilla
Modified: 5/5/26