NIH – Development and Testing of Novel Interventions to Improve HIV Prevention, Care, and Program Implementation (R34-Clinical Trial Optional)Development and Testing of Novel Interventions to Improve HIV Prevention, Care, and Program Implementation (R34-Clinical Trial Optional)

May 21, 2018 by School of Medicine Webmaster

The Centers for Disease Control & Prevention (CDC) estimates that 1.2 million people are living with HIV in the US and while declines in new HIV cases have been observed among adults and adolescents in recent years, the magnitude of decline suggest that advancements in prevention and treatment and efforts to increase the reach of effective interventions have not been sufficient, to date, in decisively ending the HIV epidemic in the US. Globally, it is estimated that 35 million people are living with HIV with 2.1 million new infections each year. Emergent HIV epidemics related to stimulant and/or opioid use have been occurring in Southeast Asia and sub-Sahara Africa and epidemics related to drug use continue in Eastern Europe and Central Asia. Domestically, outbreaks of HIV have been identified in newer opioid injector populations who are younger and less urban than HIV-positive injectors seen in the past, while stimulant drug use remains a significant contributor to HIV sexual risk.

Many people living with HIV are unaware of their diagnosis and these individuals are likely to account for a disproportionate share of new infections. There is considerable regional variation in the domestic US epidemic and variation globally in terms of the specific risk factors and populations affected by HIV; HIV incidence and prevalence often vary by age, gender, sexual orientation, race/ethnicity, geographic location and risk behavior. Disparities often exist which disadvantage populations who have been marginalized by income, resources, gender, sexuality, race/ethnicity or geography. Progress has been made in the development of efficacious HIV interventions, including seek/test/treat/retain approaches, more sensitive HIV testing technologies, new interventions for prevention and HIV treatment adherence, and development of biomedical prevention modalities and efforts are increasing to broaden the reach, intensity, and integration of these interventions.

Nonetheless, incident infections remain unacceptably high in many US and global populations, and persons affected populations still need better access to HIV testing, preventive interventions, optimal HIV care, and management of co-morbidities such as substance use disorders. A great many HIV-seropositive individuals are not adequately linked, engaged or retained in care and treatment adherence may be inconsistent or otherwise inadequate to achieve viral suppression. Attention to problematic, episodic and ongoing use of substances also needs further attention. Therefore, the development of innovative behavioral, social, and integrated behavioral/biomedical approaches remains critical in order to address the HIV pandemic.

Novel approaches are needed to ensure that interventions address the particular needs within different groups of at-risk individuals. Interventions also need to address the range of settings where at-risk individuals can be found and the different service delivery systems which may be available to them. HIV seropositive individuals have needs that differ from those who are HIV negative, and interventions for those living with HIV are needed to promote continued transmission risk reduction, HIV medication adherence, consistent linkage to HIV medical care, and the promotion of a quality of life that is free of problematic substance use, co-occurring disorders (infectious disease and psychiatric), stigma, and discrimination.

Substance use should be integrated in study aims and hypotheses in ways that reflect its roles in HIV risk and impediments to consistent participation in care. The full range of substance use will be considered including problematic episodic use and substance use disorders, as well as a complete range of relevant substances (including alcohol and tobacco) and modes of substance administration. The most important consideration is that substance use may affect transmission directly as in the case of injection drug use or may affect transmission risk behavior or treatment adherence. Domestic and overseas intervention studies will be considered with particular attention to populations with disproportionate burden of HIV infection. Adaptation of interventions with known efficacy or effectiveness to novel populations, settings, or systems of delivery should represent significant potential contributions to the understanding of how to appropriately adapt and tailor interventions to new circumstances.

This FOA does not support the projects that focus only on development of intervention protocols, manuals, or the standardization of protocols as interventions. Instead, this FOA provides resources to support (a) pilot or feasibility studies of new or adapted interventions to prevent HIV infection among populations where substance use is a contributing factor; (b) pilot or feasibility studies of new interventions to improve the care of HIV infection among populations where substance use is prevalent, including interventions that integrate treatment for substance use disorders and HIV infection; or (c)  pilot or feasibility studies to increase the scale, uptake, delivery, and/or quality of HIV prevention or care interventions with established evidence of efficacy. Both primary and secondary prevention as well as HIV care interventions will be supported. If successful, these investigations should lead to applications using the R01 or similar mechanisms for evaluating large scale efficacy or effectiveness.

Applications to this FOA are not required to present pilot data in support of the proposed hypotheses and aims, but rather should provide a strong scientific premise that includes a well-supported theory of change or logic model and associated hypotheses. Applications will not be penalized for a lack of preliminary data supporting the proposed hypotheses and aims. Applicants are encouraged to provide strong evidence of their capability to conduct the proposed study by documenting the availability of needed resources, the training and experience of the investigator team, and/or the conduct of related studies.

HIV prevention and care are recognized to be long-term objectives that are not likely to be ameliorated by one-time interventions. This makes it important to consider ways to improve intervention durability and the integration of efficacious interventions into existing systems of public health, health care, and other systems of human service delivery. Disparities in HIV morbidity are evident in the US and in many other nations; hence, novel interventions which address the root causes of these disparities is of particular importance. Attention to social/environmental and structural factors that affect individual and population health, as well as developmental considerations may enhance the uptake and effect of existing interventions, as well as address root causes of disparity.  Innovative research is encouraged that engages multidisciplinary teams, including researchers from fields related to public health, primary care, epidemiology, public policy, behavioral and social science, systems science, organizational behavior, demography, and decision sciences.

Specific Areas of Research Interest

Exploratory or pilot research studies for purposes other than collecting pilot or feasibility data for use in later, larger-scale intervention studies should not be submitted under this FOA. However, they may be appropriate for submission to R03 or R21 FOAs supported by NIDA which include AIDS submission dates.

Examples of research questions that may help move the HIV intervention field forward, under this FOA, include (but are not limited to) the following:

Studies to advance HIV prevention:

  • Studies to develop and test approaches to enhance the long term maintenance of risk reduction, including biomedical modalities.
  • Interventions which make use of innovative approaches for seeking and/or engaging high risk populations through venues, networks, service delivery systems, etc. and utilize new testing modalities to identify recent infection, or other co-factors for HIV transmission.
  • Studies that test ways to combine prevention interventions of known efficacy, including those which test different sequences of intervention implementation to optimize implementation.
  • Interventions that incorporate a syndemic approach to HIV prevention with consideration of substance use and comorbidities such as psychiatric disorder or infectious disease, along with contributory conditions such as intimate partner violence, childhood sexual abuse, stigma, or discrimination based on race/ethnicity, sexual minority membership or drug injection.
  • Studies using novel technological approaches to recruit, enroll, and retain high risk groups (e.g., young men and women, MSM) who are difficult to reach by other means, particularly where technology directly enables access to prevention and/or screening services.
  • Studies to identify and test interventions that integrate HIV prevention into primary care settings or other settings where these interventions traditionally have not not offered (e.g., criminal justice, drug treatment, youth-serving organizations).
  • Pilot feasibility evaluations of biological and combination biological/behavioral prevention modalities among substance using populations.
  • Prevention intervention research that addresses drug use among MSM, particularly young ethnic/racial minority MSM in the US and applicable MSM populations in international locations, particularly in countries with emergent HIV epidemics among substance using MSM.
  • Development and testing of HIV/AIDS prevention interventions that incorporate reduction in stigma toward persons at elevated risk for HIV/AIDS acquisition.
  • Develop and test interventions that meet prevention needs of persons whose risk persists despite previous engagement in typical prevention interventions (e.g., testing, behavioral risk reduction, PrEP).
  • Studies that take advantage of opportunities to evaluate the implementation and short-term effects of new policies, settings, or health care financing systems that are designed to prevent HIV and related consequences of substance use.
  • Pilot or feasibility studies that take initial steps toward implementation of structural or community-level prevention interventions.

Studies to Advance Treatment and Adherence Research:

  • Studies to optimize the provision of brief, evidence-based interventions to treat or reduce substance use in HIV at-risk populations.
  • Studies which increase the likelihood of achieving and/or maintaining viral suppression of HIV infection.
  • Studies to develop novel approaches for augmenting the impact of interventions of known efficacy to promote HIV treatment adherence and persistence.
  • Feasibility and acceptability studies that incorporate technological tool(s) to promote patient engagement in HIV care (including early and efficient linkage to care; treatment adherence behaviors; and long-term retention in care) among drug using populations living with HIV.
  • Early stage trials of integrated drug abuse treatment (behavioral or pharmacological) and HIV prevention interventions that address risky sexual behavior, risky injection practices, and overall risk reduction behaviors for adolescent and adult vulnerable populations (e.g., minorities, criminal justice populations, MSM, dually diagnosed individuals, etc.).
  • Feasibility and acceptability studies of HIV risk reduction interventions for use during treatment, including those that target stress responses or other mental health variables likely to affect HIV risk behavior and which examine the mechanism of action of the intervention.
  • Feasibility testing of new treatments for drugs of abuse which directly affect motivational systems related to risky sexual behavior (e.g., hyperarousal associated with stimulant use).

Studies to Advance Program Implementation and Health Services Research:

  • Improving access and quality of HIV prevention or treatment services for HIV+ drug users from vulnerable populations including women, adolescents, racial/ethnic minorities, sexual minorities, and those with co-occurring disorders (e.g., psychiatric disorder, viral hepatitis).
  • Pilot testing of interventions to improve the delivery of substance use treatment services for HIV at-risk populations in non-traditional settings such as schools, criminal justice, settings, primary care practices, and AIDS service organizations.
  • Develop and pilot test interventions that provide integrated, holistic approaches to service delivery to HIV+ persons with comorbid substance abuse and/or mental health disorders (e.g., depression, PTSD, schizophrenia, and other disorders).
  • Developing and evaluating innovative implementation strategies and novel service delivery strategies for the treatment and care for vulnerable HIV+ persons.
  • Interventions that that target and address structural, organizational or policy interventions to address barriers to and facilitators of, the implementation of science-based HIV/AIDS treatment and/or prevention.
  • Developing interventions that influence organizational structure, climate, and culture in order to promote organizational readiness and capacity for dissemination and adoption of evidence based practices.
  • Evaluations of the adaptation process, and subsequent effectiveness of evidence-based interventions when implemented in real-world community and clinical settings.
  • Pilot or feasibility studies that take initial steps toward implementation of structural approaches to improving the quality and appropriateness of services and/or access and utilization of services.
  • Investigators are encouraged, when appropriate, to utilize the NIDA Clinical Trials Network (CTN) ( infrastructure as a platform for their studies.

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.

Deadlines:  standard AIDS dates apply


Filed Under: Funding Opportunities