NIH – HIV/AIDS High Priority Drug Abuse Research (R01 Clinical Trial Optional)

September 21, 2018 by School of Medicine Webmaster

The National Institutes of Health (NIH) has recently announced the high priority research topics for HIV/AIDS research for the next three to five years  This Funding Opportunity Announcement) is being issued to stimulate high priority research relevant to drug misuse and/or use disorders and HIV/AIDS.

Central to the NIH high priority areas of research are principles such as engaging people at risk into screening and preventive services as well as linking and re-linking people living with HIV (PLWH) into care with the goal of achieving durable viral suppression and addressing HIV comorbidities.  Basic and clinical research that moves the field toward a cure and development of vaccines are high priority areas of research.

NIDA’s Seek, Test, Treat and Retain (STTR) paradigm provides a framework for engagement and linkage among drug using populations. Because people who misuse drugs frequently are vulnerable, stigmatized and marginalized, optimization the STTR paradigm requires attention to engaging high-risk, hard-to-reach individuals and finding effective ways to link and retain them in care. Populations of interest for this work include urban, suburban and rural drug users, including injection and non-injection drug use. Populations at elevated sexual risk for HIV such as men who have sex with men (MSM) often have elevated levels of substance use and this should be considered, along with emergent drug use epidemics such as opioid use and injection drug use in the rural US.

Innovative strategies are encouraged to improve each step of the STTR continuum. Examples of novel approaches to STTR might include the use of phylogenetic testing and social network analysis to identify people and geographic areas at highest risk and deploy resources; the use of technology to engage hard-to-reach populations and provide care; and psychosocial and systems-level interventions to support the use of medication to treat HIV and substance use disorders. Adapting STTR to novel contexts such as resource limited international settings and low density rural settings in the US is needed. In these settings, infrastructure is limited and variety of barriers, including stigma are present which may benefit from systems-level approaches to integrate substance use treatment with HIV screening, prevention and care that incorporate technology and other modalities to extend the reach of scarce professional resources. The often syndemic nature of drug use, with co-occurrence of psychiatric disorder and trauma as well as HIV and infectious disease comorbidities presents contexts where STTR approaches need to encompass linkage among a variety of different settings and intervention components.

Implementation science approaches as well as novel clinical trial designs are needed to facilitate the uptake and sustainability of evidence based interventions for substance misuse, substance use disorders, and HIV, which optimize entry into services and retention in care.  Complementary research is needed regarding social, economic, and policy environments affect the choice of interventions, their implementation and their eventual effectiveness and public health impact. Research to understand how to combine data from different settings to understand unique population needs, available resources and infrastructure within a given area and design community-based approaches to effectively address HIV and substance misuse prevention and treatment are important.

Criminal justice populations have high rates of HIV infection and substance use disorders and are an important population for STTR studies. In the U.S., minorities are disproportionately represented in criminal justice populations leading to adverse effects on the individual, family, and community that may contribute to the spread of HIV. Studies are needed on how best to implement screening and linkage in prisons and jails, as well as linkage to care after release and in community corrections.

Comorbidities and co-infections are prevalent in substance using Persons Living with HIV (PLWH). An important related aspect of NIDA research on comorbidities and co-infections are studies to improve therapeutics for HIV infected individuals through research on drug-drug interactions between current or potential new HIV/AIDS antiretrovirals and drugs of abuse, medications to treat drug addiction and other co-morbid conditions, hepatitis C (HCV) antiviral medications. HIV and drugs of abuse can influence a number of organ systems and disease outcomes such as cardiovascular, renal, and neurologic effects as wells metabolic disorders and premature aging. For example, cocaine accelerates HIV disease progression and enhances comorbidities such as cardiovascular effects, and premature aging and neurocognitive deficits are seen in methamphetamine users. It is important to understand how drugs of abuse interact with HIV infection to produce adverse health effects, especially brain and central nervous system (CNS) impact, to develop therapies to mitigate these effects.

HCV is the most common co-infection among substance users. HCV progression is enhanced by HIV co-infection, and liver disease caused by HCV infection has emerged as a major threat to the survival of co-infected HCV/HIV individuals. Studies are needed to improve HCV/HIV testing through encouraging use of rapid HCV/HIV point-of-care testing among populations at increased risk. Models of care that integrate HCV/HIV treatment with primary care, substance abuse treatment and other services must be explored to assure good treatment outcomes in PLWH.

Drugs of abuse have diverse effects on the immune system and immune function and have been shown to affect pathogenesis. Studies are needed to determine how exposure to drugs of abuse and cycles of drug abuse and withdrawal affect latency and reservoir size and persistence. While the CNS is the major focus of NIDA research on latency and reservoirs, studies of the effects of drugs of abuse on reservoirs throughout the body, e.g, lymph nodes, tonsils, gut associated lymphoid tissue, spleen, and lung are also of interest. Understanding the mechanisms underlying CNS HIV infection is important to understanding the brain as a potential reservoir of HIV infection. HIV enters the brain early in infection and replicates and evolves within the CNS. In the CNS, HIV may actively, persistently, or latently infect perivascular and meningeal macrophages, microglia, and astrocytes. HIV is not uniformly distributed throughout the brain; highest viral loads are found in basal ganglia, where drugs of abuse act through dopaminergic transmission. The brain may serve as an important reservoir and potential barrier to cure strategies because many therapeutic agents do not readily penetrate the blood brain barrier. To understand the brain as an HIV reservoir, it will be important to establish which cell types harbor replication competent virus and to quantify this in different brain regions including the impact of repeated exposure to drugs of abuse.

Special Considerations:

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA’s Web site at

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA’s credibility and reputation within the scientific community.  Please see for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (  Please see NOT-DA-12-008 ( for further details.

NIDA strongly encourages investigators to share data with other investigators.  In addition to a strong data sharing plan, one resource to facilitate data sharing is National Addiction & HIV Data Archive Program were data are currently available from NIDA-supported NIH activities such as IeDEA, MACS and WIHS, as well as other federally funded datasets that may be relevant to HIV and drug use and/or use disorders.  Investigators are encouraged to contact the NAHDAP and use this data sharing platform as part of their data sharing plan.

Deadlines:  standard AIDS dates apply


Filed Under: Funding Opportunities