The purpose of this Notice is to communicate the National Institute on Drug Abuse's (NIDA) interest in advancing the development of pharmacological and non-pharmacological interventions for the HIV /HCV/ Substance Use Disorders (SUD) syndemic. The ultimate goal of this endeavor is to reduce the burden of HIV/HCV/SUD by discovering safe and effective therapeutic approaches for these health conditions.

Background:

Syndemic (synergistic epidemic) is the aggregation of two or more, concurrent or sequential epidemics or disease clusters, interacting synergistically in a population, contributing to excess burden of disease and prognosis. People who inject drugs (PWID) are at high risk of developing chronic bloodborne infectious disorders, among them HIV and HCV, with notorious morbidity and mortality rates. In spite of major advances in the treatment of HIV, HCV and SUD, a substantial number of PWID perpetuates HIV and HCV epidemics, particularly in the most vulnerable populations. Therefore, the syndemic of HIV/HCV/SUD is a significant public health concern.

Although research to date has focused on the treatment of each individual condition, a growing body of knowledge indicates that the concurrent syndromic presence is difficult to treat and has worse prognosis. Thus, the development of safe and effective treatments for this syndemic condition is a high public health priority.

Research Objectives:

NIDA is interested in receiving research applications focusing on studying the safety and efficacy of medications to treat the triple comorbidity of HIV/HCV/SUD.

This NOSI encourages, but is not limited to, research applications in the following areas:

1. Development of safe and effective pharmacotherapies (oral combinations or long-acting injectable combinations) to treat this triple comorbidity. It includes chemistry and formulations using existing medications or exploring new molecular entities (NMEs), non-clinical safety pharmacology and toxicology testing, IND submission, clinical safety, PK-PD evaluations and efficacy in phase I, II and III trials, as well as FDA approval submission.

2. Development of non-pharmacological therapies in combination with pharmacotherapies to improve treatment outcome. It will include improvement in cognitive behavioral therapies and counselling techniques, development of therapeutic devices both invasive and non-invasive types for brain stimulation, and integrative health approaches such as mindfulness meditation, yoga and acupuncture.

3. Development or improvement in adherence strategies using innovative approaches (e.g., telehealth, mobile health) for treatment outreach, counselling, monitoring treatment adherence and long- term follow-up care in order to achieve optimal measures of drug reduction, abstinence and viral suppression.

Application and Submission Information

This notice applies to due dates on or after June 5, 2020 and subsequent receipt dates through September 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-19-055 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-091 NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DA-20-032” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.

Scientific/Research Contact(s)

Raul Mandler, MD; FAAN; FANA
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2541
Email: mandlerr@nih.gov