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R01DA053325

Project Grant

Overview

Grant Description
A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs - Project Abstract

Globally, more than 3.5 million people are infected with Hepatitis C Virus (HCV). In the United States, due to the opioid epidemic, HCV cases have increased, especially among adults under 30. However, few young people who inject drugs (PWID =30 years old) – who are at the center of the HCV epidemic in the US – are benefiting from curative HCV therapy.

A potentially promising, yet untapped avenue for increasing HCV treatment among PWID is the leveraging of their injecting partners to successfully navigate the multiple obstacles between diagnosis and treatment. Our team’s extensive research with dyads identified a potential action-point within injecting partnerships that can be harnessed through behavioral intervention.

Quantitative findings identified specific injecting related interpersonal factors (i.e., trust, intimacy, cooperation) associated with increased health and safety for injecting partnerships. Followed by qualitative results that in combination with interpersonal factors, partner involvement (i.e., emotional, tangible, affectionate, and positive social support) enhances a partnership’s ability to coordinate behavior (dyadic capacity). Interpersonal factors with partner involvement was found to overcome barriers to HCV treatment.

Building on our extensive foundation of dyadic research and dyadic behavior change theories, we developed the Partner Navigation Intervention, a two-session injecting partnership intervention to enhance dyadic capacity for HCV treatment initiation for young adult PWID.

The proposed study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase HCV treatment initiation among young adult PWID. In partnership with our community-based HCV testing organizations (CBOS), we will randomize young adult PWID with recently diagnosed HCV infection (250 partnerships, N=500) and their primary injecting partner to intervention or standard of care.

Scalability was core to the design of the two-session intervention. Session 1 expands on standard-of-care HCV infection diagnosis counseling with counselor-led discussion with the HCV positive PWID to identify situational and personal barriers to HCV treatment and identify an injecting partner to aid in their HCV treatment navigation. Session 2 is a dyad session with both the young adult PWID and their injecting partner. A counselor facilitated discussion will develop strategies to respond to the identified HCV treatment initiation barriers and partnerships practice strategies and concretize a plan involving both partners for addressing barriers, including a timeline and potential alternative strategies in treatment navigation.

During both sessions, the counselor records key information discussed onto a paper handout (Partner Navigation Map) serving as the intervention tool. A community advisory board of young adult PWID will guide implementation and dissemination.

The proposed study will improve the cure rate in this highly impacted population. Our strategy of enhancing dyadic capacity may be adapted for targeted change of other health behaviors (e.g., HCV prevention) affecting young PWID.
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
San Francisco, California 94143 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 315% from $726,713 to $3,017,588.
San Francisco Regents Of The University Of California was awarded Partner Navigation Intervention for HCV Treatment Among Young PWID Project Grant R01DA053325 worth $3,017,588 from National Institute on Drug Abuse in June 2022 with work to be completed primarily in San Francisco California 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 Research Project Grant (Parent R01 Clinical Trial Required).

Status
(Ongoing)

Last Modified 4/4/25

Period of Performance
6/1/22
Start Date
3/31/27
End Date
72.0% Complete

Funding Split
$3.0M
Federal Obligation
$0.0
Non-Federal Obligation
$3.0M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01DA053325

Transaction History

Modifications to R01DA053325

Additional Detail

Award ID FAIN
R01DA053325
SAI Number
R01DA053325-2358038371
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
KMH5K9V7S518
Awardee CAGE
4B560
Performance District
CA-11
Senators
Dianne Feinstein
Alejandro Padilla

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) $1,520,651 100%
Modified: 4/4/25