UH3HL165839
Cooperative Agreement
Overview
Grant Description
Peer support for adolescents and emerging adults with sickle cell pain: Promoting engagement in cognitive behavioral therapy - Abstract.
Pain is the clinical hallmark of sickle cell disease (SCD), yet pain management remains inadequate for many in this population due to lack of evidence-based pain treatment approaches for SCD, and due to stigma and implicit bias in the healthcare system.
Black adolescents and young adults (AYAs, ages 16-30) with SCD are particularly vulnerable as they endure repeat hospitalizations due to pain crises while coping with stigma and related stressors, as well as the other challenges of transitioning to adulthood.
Opioids are the primary agent used in chronic SCD pain management, despite evidence that they provide poor long-term relief and lead to negative physical and psychological consequences.
Psychosocial interventions that teach cognitive and behavioral strategies can simultaneously reduce pain and stigma and enhance mood in patients with SCD.
Cognitive behavioral therapy (CBT) is the primary behavioral health approach to managing pain in the general population, and digital CBT has expanded its accessibility.
In SCD and other minority populations, we have demonstrated that a low-cost, scalable, technology-delivered version of CBT is feasible and can be effective for addressing stress and pain.
We have learned that personalized support can improve engagement with digital CBT.
We will now test a personalized approach customized for AYAs with SCD using peer support delivered through community-based organizations (CBOs).
We will conduct a multisite, randomized controlled trial of digital CBT to understand the level of support needed to achieve benefits for reducing pain and stigma.
Our Peer Support for Adolescents and Emerging Adults with Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy (PRESENCE) study aims to reduce pain, opioid use, and healthcare utilization among AYAs with SCD.
During the UG3 phase, we will leverage an established infrastructure for delivering virtual peer support interventions, existing digital CBT programs tailored by and for people with SCD, and partnerships with CBOs to jointly refine the study design, digital CBT content, and peer support component and work with the HEAL ERN CCC and DCC to prepare for the UH3 trial.
After meeting UG3 milestones and transitioning to the UH3 phase, we will randomize 470 AYAs with frequent pain (≥4 days/week) over the past ≥3 months to one of 3 treatment groups:
1) A digital CBT program with weekly one-on-one peer support provided via text and/or telephone based on participant preference (CBT+PEER),
2) The same digital CBT program without peer support (self-guided CBT), or
3) Usual care (UC).
We first hypothesize that AYAs receiving either digital CBT treatment (CBT+PEER or self-guided CBT) will have better pain and mental health outcomes than AYAs receiving UC at 6 months.
Second, we hypothesize that CBT+PEER will be associated with improved program engagement and pain and mental health outcomes at 6 months compared with self-guided CBT.
The PRESENCE trial will determine effectiveness of digital CBT for pain management among AYAs with SCD, a critical step toward future wide-scale deployment as part of routine SCD care.
Pain is the clinical hallmark of sickle cell disease (SCD), yet pain management remains inadequate for many in this population due to lack of evidence-based pain treatment approaches for SCD, and due to stigma and implicit bias in the healthcare system.
Black adolescents and young adults (AYAs, ages 16-30) with SCD are particularly vulnerable as they endure repeat hospitalizations due to pain crises while coping with stigma and related stressors, as well as the other challenges of transitioning to adulthood.
Opioids are the primary agent used in chronic SCD pain management, despite evidence that they provide poor long-term relief and lead to negative physical and psychological consequences.
Psychosocial interventions that teach cognitive and behavioral strategies can simultaneously reduce pain and stigma and enhance mood in patients with SCD.
Cognitive behavioral therapy (CBT) is the primary behavioral health approach to managing pain in the general population, and digital CBT has expanded its accessibility.
In SCD and other minority populations, we have demonstrated that a low-cost, scalable, technology-delivered version of CBT is feasible and can be effective for addressing stress and pain.
We have learned that personalized support can improve engagement with digital CBT.
We will now test a personalized approach customized for AYAs with SCD using peer support delivered through community-based organizations (CBOs).
We will conduct a multisite, randomized controlled trial of digital CBT to understand the level of support needed to achieve benefits for reducing pain and stigma.
Our Peer Support for Adolescents and Emerging Adults with Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy (PRESENCE) study aims to reduce pain, opioid use, and healthcare utilization among AYAs with SCD.
During the UG3 phase, we will leverage an established infrastructure for delivering virtual peer support interventions, existing digital CBT programs tailored by and for people with SCD, and partnerships with CBOs to jointly refine the study design, digital CBT content, and peer support component and work with the HEAL ERN CCC and DCC to prepare for the UH3 trial.
After meeting UG3 milestones and transitioning to the UH3 phase, we will randomize 470 AYAs with frequent pain (≥4 days/week) over the past ≥3 months to one of 3 treatment groups:
1) A digital CBT program with weekly one-on-one peer support provided via text and/or telephone based on participant preference (CBT+PEER),
2) The same digital CBT program without peer support (self-guided CBT), or
3) Usual care (UC).
We first hypothesize that AYAs receiving either digital CBT treatment (CBT+PEER or self-guided CBT) will have better pain and mental health outcomes than AYAs receiving UC at 6 months.
Second, we hypothesize that CBT+PEER will be associated with improved program engagement and pain and mental health outcomes at 6 months compared with self-guided CBT.
The PRESENCE trial will determine effectiveness of digital CBT for pain management among AYAs with SCD, a critical step toward future wide-scale deployment as part of routine SCD care.
Funding Goals
THE DIVISION OF BLOOD DISEASES AND RESOURCES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE PATHOPHYSIOLOGY, DIAGNOSIS, TREATMENT, AND PREVENTION OF NON-MALIGNANT BLOOD DISEASES, INCLUDING ANEMIAS, SICKLE CELL DISEASE, THALASSEMIA, LEUKOCYTE BIOLOGY, PRE-MALIGNANT PROCESSES SUCH AS MYELODYSPLASIA AND MYELOPROLIFERATIVE DISORDERS, HEMOPHILIA AND OTHER ABNORMALITIES OF HEMOSTASIS AND THROMBOSIS, AND IMMUNE DYSFUNCTION. FUNDING ENCOMPASSES A BROAD SPECTRUM OF HEMATOLOGIC INQUIRY, RANGING FROM STEM CELL BIOLOGY TO MEDICAL MANAGEMENT OF BLOOD DISEASES AND TO ASSURING THE ADEQUACY AND SAFETY OF THE NATION'S BLOOD SUPPLY. PROGRAMS ALSO SUPPORT THE DEVELOPMENT OF NOVEL CELL-BASED THERAPIES TO BRING THE EXPERTISE OF TRANSFUSION MEDICINE AND STEM CELL TECHNOLOGY TO THE REPAIR AND REGENERATION OF HUMAN TISSUES AND ORGANS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.
Grant Program (CFDA)
Awarding Agency
Place of Performance
Pittsburgh,
Pennsylvania
152221808
United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 121% from $1,531,103 to $3,384,439.
University Of Pittsburgh - Of The Commonwealth System Of Higher Education was awarded
PRESENCE Study: Peer Support for SCD Pain in AYAs
Cooperative Agreement UH3HL165839
worth $3,384,439
from the National Institute of Neurological Disorders and Stroke in August 2023 with work to be completed primarily in Pittsburgh Pennsylvania United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs.
The Cooperative Agreement was awarded through grant opportunity HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required).
Status
(Ongoing)
Last Modified 9/24/25
Period of Performance
8/10/23
Start Date
7/31/28
End Date
Funding Split
$3.4M
Federal Obligation
$0.0
Non-Federal Obligation
$3.4M
Total Obligated
Activity Timeline
Transaction History
Modifications to UH3HL165839
Additional Detail
Award ID FAIN
UH3HL165839
SAI Number
UH3HL165839-2955791243
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Other
Awarding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Funding Office
75NQ00 NIH National Institute of Neurological Disorders and Stroke
Awardee UEI
MKAGLD59JRL1
Awardee CAGE
1DQV3
Performance District
PA-12
Senators
Robert Casey
John Fetterman
John Fetterman
Modified: 9/24/25