Opportunity Information: Apply for PA 18 073

The Behavioral and Integrative Treatment Development Program (R34 Clinical Trial Optional), Funding Opportunity Number PA-18-073, is a National Institutes of Health discretionary grant program designed to support early-stage, tightly scoped treatment-development research that can be finished within a three-year project period. The central aim is to move promising behavioral and integrative interventions forward through well-defined Stage I work, including the creation, refinement, and preliminary testing of interventions that address substance use and closely related public health needs. The announcement also makes clear that a clinical trial may be included, but it is not required, which gives applicants flexibility to propose either non-trial developmental research or small early clinical studies when appropriate.

The program prioritizes research on behavioral interventions and integrated approaches that combine behavioral components with other modalities such as pharmacological treatment. The target problem areas include (a) substance abuse, (b) prevention of acquiring or transmitting HIV among people receiving substance abuse treatment, (c) improving adherence to substance abuse treatment as well as HIV and addiction medications, and (d) chronic pain. In practice, this means proposals can focus on developing or improving interventions that reduce substance use, reduce HIV risk behaviors in treatment populations, help patients take medications correctly and stay engaged in care, or address chronic pain in ways that are relevant to addiction risk and treatment outcomes.

A major emphasis is on Stage I intervention development activities. The FOA highlights several example project types: first, Stage I intervention generation, where the goal is to create a new intervention or substantially rework an existing one using theory, empirical findings, and stakeholder input. Second, Stage I pilot or feasibility studies, which are smaller, early tests intended to show that the intervention can be delivered as designed, is acceptable to the target population, and produces signals that justify later, larger-stage efficacy or effectiveness trials. Importantly, these Stage I efforts are expected to go beyond simple feasibility and incorporate the development and measurement of putative targets and change processes. That includes specifying and evaluating moderators (for whom or under what conditions the intervention works), mediators (how the intervention produces change), and mechanisms of change (the underlying processes the intervention is designed to affect). This expectation pushes applicants to build a clear conceptual model and a measurement plan that can inform optimization and later-stage testing.

The FOA also calls out Stage I studies that generate or refine substance abuse treatment or adherence interventions for primary care settings, reflecting an interest in making interventions workable in real-world, front-line healthcare environments. In addition, it encourages Stage I research aimed at boosting intervention effects and improving implementability, including creative use of technology or other strategies. That can include digital tools, telehealth formats, mobile support, automated adherence supports, or workflow-friendly designs that reduce burden for clinics and patients while preserving or strengthening outcomes.

From an eligibility standpoint, the opportunity is broad and open to many organization types, including state, county, city, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA explicitly notes additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). The listing signals an intent to support diverse institutional applicants and encourage participation from community-based, tribal, minority-serving, and international organizations where relevant to the research.

In terms of award parameters included in the provided source data, the opportunity is administered by NIH and associated with CFDA numbers 93.273 and 93.279. The award ceiling is listed as $225,000. The original closing date shown is 2019-01-07, and the opportunity record creation date is 2017-11-02. Overall, this FOA is best understood as a time-limited, development-focused grant mechanism for teams who can propose a clearly bounded set of aims that produce a more mature intervention package, stronger evidence of feasibility and promise, and a clearer understanding of targets and mechanisms that can support subsequent larger clinical research or implementation-oriented studies.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Behavioral and Integrative Treatment Development Program (R34 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.279.
  • This funding opportunity was created on 2017-11-02.
  • Applicants must submit their applications by 2019-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $225,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PA 18 073

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Frequently Asked Questions (FAQs)

What is the Behavioral and Integrative Treatment Development Program (R34 Clinical Trial Optional)?

It is a National Institutes of Health (NIH) discretionary grant program (Funding Opportunity Number PA-18-073) that supports early-stage, tightly scoped treatment-development research. The intent is to move promising behavioral and integrative interventions forward through well-defined Stage I work such as creating, refining, and preliminarily testing interventions that address substance use and closely related public health needs.

Is a clinical trial required under this FOA?

No. The FOA is labeled "Clinical Trial Optional," meaning an applicant may include a clinical trial when appropriate, but it is not required. Applicants can propose either non-trial developmental research or small early clinical studies consistent with Stage I treatment development.

How long is the project period for this opportunity?

The project period is limited to three years, and the FOA emphasizes that supported projects should be designed to be completed within that three-year period.

What is the central aim of the program?

The central aim is to advance promising behavioral and integrative interventions through Stage I intervention development activities, including the creation, refinement, and preliminary testing of interventions focused on substance use and related public health needs.

What types of interventions does the program prioritize?

The program prioritizes behavioral interventions and integrated approaches that combine behavioral components with other modalities, such as pharmacological treatment.

What public health problem areas are specifically targeted?

The FOA identifies the following target areas:

  • Substance abuse
  • Prevention of acquiring or transmitting HIV among people receiving substance abuse treatment
  • Improving adherence to substance abuse treatment as well as HIV and addiction medications
  • Chronic pain

Can a project focus on HIV prevention in substance use treatment settings?

Yes. One of the explicitly stated target areas is preventing the acquisition or transmission of HIV among people receiving substance abuse treatment.

Are medication adherence interventions within scope?

Yes. The FOA includes improving adherence to substance abuse treatment and adherence to HIV and addiction medications as a target problem area.

Is chronic pain an allowable focus area?

Yes. Chronic pain is listed as a target area, particularly in ways relevant to addiction risk and treatment outcomes.

What does the FOA mean by "Stage I" intervention development?

Stage I work is early intervention development. In this FOA, it includes activities like generating new interventions, refining existing interventions, and conducting pilot or feasibility studies to assess whether the intervention can be delivered as intended, is acceptable to the target population, and shows early signals that justify later, larger trials.

What is meant by "Stage I intervention generation"?

Stage I intervention generation refers to creating a new intervention or substantially reworking an existing one. The FOA describes using theory, empirical findings, and stakeholder input to guide this intervention development.

What is meant by "Stage I pilot or feasibility studies" under this program?

These are smaller, early tests of an intervention intended to demonstrate deliverability (can it be delivered as designed), acceptability (is it acceptable to the target population), and preliminary signals of promise that support moving toward later-stage efficacy or effectiveness trials.

Does the FOA expect more than basic feasibility testing?

Yes. The FOA emphasizes that Stage I efforts should go beyond simple feasibility and include development and measurement of putative targets and change processes, with attention to moderators, mediators, and mechanisms of change.

What are "moderators" in the context of this FOA?

Moderators refer to for whom or under what conditions an intervention works. The FOA expects applicants to specify and evaluate moderators as part of a clear conceptual model and measurement plan.

What are "mediators" and "mechanisms of change" in the context of this FOA?

Mediators are factors that help explain how an intervention produces change, while mechanisms of change refer to the underlying processes the intervention is designed to affect. The FOA encourages applicants to specify and evaluate these processes as part of Stage I development.

Does the FOA encourage research designed for primary care settings?

Yes. The FOA calls out Stage I studies that generate or refine substance abuse treatment or adherence interventions for primary care settings, signaling an interest in front-line, real-world healthcare environments.

Does the opportunity encourage technology-enabled or implementation-friendly approaches?

Yes. The FOA encourages Stage I research aimed at boosting intervention effects and improving implementability, including creative use of technology or other strategies such as digital tools, telehealth formats, mobile support, automated adherence supports, or workflow-friendly designs.

What types of applicants are eligible to apply?

Eligibility is broad and includes many organization types, such as government entities, higher education institutions, tribal governments and organizations, nonprofit and for-profit organizations, small businesses, public housing authorities, and other entities. The FOA also explicitly includes U.S. territories or possessions and non-U.S. entities (foreign organizations).

Are state, county, city, or special district governments eligible?

Yes. The FOA lists state, county, city, and special district governments as eligible applicant types.

Are institutions of higher education eligible?

Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are included as eligible applicants, and the FOA also highlights multiple minority-serving institution categories.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, and the FOA also lists tribal organizations that are not federally recognized as eligible.

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. The FOA lists nonprofit organizations with or without 501(c)(3) status as eligible.

Are for-profit organizations eligible?

Yes. The FOA includes for-profit organizations (other than small businesses) and also includes small businesses.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly notes faith-based or community-based organizations among eligible applicant categories.

Are minority-serving institutions specifically identified as eligible?

Yes. The FOA explicitly includes categories such as HBCUs, Hispanic-serving Institutions, AANAPISIs, TCCUs, and Alaska Native and Native Hawaiian Serving Institutions.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are listed as eligible.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) as eligible applicants.

Who administers this grant opportunity?

The opportunity is administered by the National Institutes of Health (NIH).

What are the associated CFDA numbers?

The FOA is associated with CFDA numbers 93.273 and 93.279.

What is the listed award ceiling?

The award ceiling in the provided information is $225,000.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is PA-18-073.

What is the original closing date shown for this opportunity?

The original closing date shown is 2019-01-07.

What is the opportunity record creation date?

The opportunity record creation date is 2017-11-02.

What kinds of outcomes is this FOA designed to produce by the end of the project?

Based on the FOA description, projects should produce a more mature intervention package, stronger evidence of feasibility and promise, and a clearer understanding of targets and mechanisms to support subsequent larger clinical research or implementation-oriented studies.

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