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HHS/NIH/National Institute on Drug Abuse (NIDA)

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Abstract Text:
Abstract The opioid crisis in North America comes with a multitude of health consequences, including HIV and Hepatitis C (HCV) outbreaks. HIV and HCV are major contributors to morbidity and mortality among persons who inject drugs (PWID). These infections also bear significant medical costs. While HIV treatment scale-up remains essential, significant improvements in HIV and HCV prevention and care are required to reduce substantially the HIV and HCV burden among PWID. Pre-exposure prophylaxis (PrEP) and the HCV cure regimens have transformative potential to reduce these two co-occurring epidemics. A key question for implementation research is how to best integrate these pharmacological advances in prevention and care strategies for PWID. Given the relative dearth of prior research on PrEP among PWID, we critically need to expand our understanding of the potential role of PrEP for PWID engaged in HCV assessment and treatment. Within this context, we propose a randomized hybrid effectiveness-implementation trial (n=500) to evaluate two implementation strategies for PrEP and HCV care integration among PWID: on-site integrated care (PrEP initiation and HCV treatment) vs. off-site referral with patient navigation to specialized care. HIV-negative PWID will be recruited from two venues—opioid substitution therapy (OST) venues and syringe exchange programs (SEPs)—within two North American cities—Miami and Montréal. The cities provide variability in background health access (Montreal-High Services/Low Barriers versus Miami-Low Services/High Barriers); venues provide variability in overhead/resources (OTPs-High Resources versus SEPs-Low Resource). There are two overall aims: 1) To determine if integrated PrEP and HCV treatment offered on-site in treatment and harm reduction settings results in higher rates of a) sustained PrEP adherence and/or b) HCV cure (primary outcomes), compared to an off-site referral with patient navigation, and to c) test the contributions of local environment and venue on primary outcomes, and 2) To evaluate a) the health care utilization impact and the relative resource use of the on-site integrated care approach compared to the referral with patient navigator approach and b) the health care resources required to scale up these intervention approaches in the local environments and settings. Secondary outcomes will include PrEP initiation, use, long-term sustained PrEP adherence, HCV treatment initiation, risk behavior changes, HCV infection/reinfection, and STD/HIV incidence. For these secondary outcomes, we also will include a qualitative study to understand the interplay of the personal, interpersonal, and social contextual factors that may be associated with PrEP adherence and issues of behavioral compensation over time for PWID. Additional qualitative study will examine facilitators and barriers to implementation. This two-city by two-venue design will provide crucial information to understand implementation/dissemination issues in both high and low resource geographic contexts and high and low overhead venues.
Project Terms:
Address; Adherence; AIDS prevention; AIDS/HIV problem; American; Anti-Retroviral Agents; base; Behavior; behavior change; Behavioral; Caring; Cities; Comorbidity; Comparative Study; contextual factors; Continuity of Patient Care; cost; cost effectiveness; Country; design; Disease Outbreaks; Effectiveness; Eligibility Determination; Environment; Epidemic; Financial compensation; Florida; Geography; Harm Reduction; Health; Health Care Costs; health care service utilization; Healthcare; Healthcare Systems; Hepatitis C; Hepatitis C Transmission; high risk; HIV; HIV/HCV; Human immunodeficiency virus test; Human Resources; Hybrids; implementation research; implementation trial; improved; Incidence; Individual; Infection; Injecting drug user; injection drug use; Intervention; Investments; Medical; Modeling; Morbidity - disease rate; mortality; Needle-Exchange Programs; North America; Opioid; Opioid Rotation; Outcome; Patients; Pharmaceutical Preparations; Pharmacology; Positioning Attribute; pre-exposure prophylaxis; prevent; Prevention; Primary Health Care; primary outcome; public health relevance; Quebec; Randomized; Randomized Controlled Trials; Recruitment Activity; Regimen; Research; Resources; Risk; Risk Behaviors; Role; scale up; screening; secondary outcome; Services; Sexually Transmitted Diseases; Site; social; Testing; Time; transmission process; United States; uptake; Ursidae Family; Viral; Virus


Contact PI / Project Leader Information:
Other PI Information:
Awardee Organization:
City:  NEW YORK    
Congressional District:
State Code:  NY
District:  13
Other Information:
Fiscal Year: 2017
Award Notice Date: 23-Sep-2017
DUNS Number: 621889815
Project Start Date: 30-Sep-2017
Budget Start Date: 30-Sep-2017
CFDA Code: 279
Project End Date: 31-Jul-2022
Budget End Date: 31-Jul-2018
Agency: ?

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

HHS/NIH/National Institute on Drug Abuse (NIDA)
Project Funding Information for 2017:
Year Agency

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

FY Total Cost
2017 NIDA

HHS/NIH/National Institute on Drug Abuse (NIDA)




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