Opportunity Information: Apply for PA 13 078

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Behavioral Integrative Treatment Development Program (R34)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs.
  • This funding opportunity was created on Jan 9, 2013 and posted on Jan 9, 2013.
  • Applicants must submit their applications by Jan 7, 2016. (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: Private institutions of higher education Small businesses State governments County governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Independent school districts Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Special district governments.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Behavioral Integrative Treatment Development Program (R34) (Funding Opportunity Number PA-13-078) is a National Institutes of Health (NIH) discretionary grant opportunity designed to support early-stage, tightly scoped research projects that can be fully completed within a three-year period. The central aim is to help investigators develop, generate, refine, and preliminarily test behavioral interventions or integrated interventions that combine behavioral and pharmacological components. This program is positioned as a “Stage I” intervention development mechanism, meaning it is geared toward building and strengthening the foundation for later, larger-scale efficacy or effectiveness trials rather than funding full definitive trials at this stage.

The FOA emphasizes intervention research in several priority areas. First, it targets substance abuse, including substance use disorders and relevant comorbidities, recognizing that co-occurring mental health conditions and other medical or psychosocial issues often influence treatment outcomes. Second, it supports work focused on preventing the acquisition or transmission of HIV among individuals who are in substance abuse treatment, reflecting the ongoing overlap between substance use risk environments and HIV vulnerability. Third, it prioritizes projects that promote adherence, including adherence to substance abuse treatment itself as well as adherence to HIV and addiction medications. This includes improving consistent engagement with care and medication-taking behaviors where lapses can undermine outcomes. Fourth, it includes chronic pain as a key target area, which is especially relevant given the intersections between pain, opioid exposure, misuse risk, and the need for interventions that address pain management without worsening substance-related harms.

In terms of the kinds of studies NIH is seeking, the announcement highlights several examples of responsive projects. One is Stage I intervention generation, which can include designing new interventions, adapting existing approaches for new populations or settings, and building the core components and procedures of an intervention. Another is Stage I pilot or feasibility testing, where investigators conduct small-scale studies to determine whether an approach is workable, acceptable, and deliverable, and whether study methods (recruitment, retention, randomization, measurement, and fidelity procedures) function as intended. Importantly, the FOA expects both intervention generation and pilot/feasibility projects to incorporate development and examination of putative moderators, mediators, and change mechanisms. In practice, this means applicants should think beyond whether an intervention can be delivered and begin identifying how it may work (mechanisms), for whom it works best (moderators), and which intermediate processes explain outcomes (mediators), even if the project is not powered for definitive mediation analyses.

The FOA also calls out primary care as an important context for Stage I work, encouraging studies that generate or refine substance abuse treatment or adherence interventions specifically for use in primary care settings. This reflects the broader shift toward integrating addiction-related services into routine healthcare, where interventions often need to be brief, scalable, and compatible with real-world workflows. In addition, the announcement encourages creative uses of technology to boost intervention effects and improve implementability. This can include digital tools that enhance reach and engagement, support adherence and monitoring, or make delivery more efficient for providers and systems, as long as the work remains focused on early-stage development and testing rather than large confirmatory trials.

From an administrative and funding standpoint, this is a grant mechanism (Funding Instrument Type: Grant) within NIH’s health and education-related research activity categories. It does not require cost sharing or matching. The award ceiling listed is $225,000, indicating a cap on the maximum award amount under this FOA as presented in the source information. The opportunity was posted on January 9, 2013, with an original and final closing date of January 7, 2016, and an archive date of February 7, 2016. While those dates indicate this particular announcement is no longer open, the summary remains useful as a model for the scope and expectations of NIH R34 Stage I behavioral/integrated intervention development opportunities.

Eligibility is broad and includes many types of domestic and non-domestic applicants. Eligible organizations listed include public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses and other for-profit organizations (other than small businesses), and various government entities (state, county, city/township, special district governments, and independent school districts), as well as public housing authorities/Indian housing authorities. The FOA also explicitly includes a range of mission-focused and community-linked institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations. Foreign organizations and foreign institutions are eligible to apply, and non-U.S. components of U.S. organizations may participate; foreign components are allowed consistent with the NIH Grants Policy Statement. The relevant CFDA program areas referenced are 93.273 (Alcohol Research Programs) and 93.279 (Drug Abuse and Addiction Research Programs), aligning the FOA with NIH’s alcohol and drug abuse research portfolios.

Overall, PA-13-078 frames the R34 as a practical, time-limited mechanism meant to move promising behavioral and integrated intervention ideas through early development steps: defining and refining the intervention, testing feasibility, strengthening measurement and implementation strategies, and beginning to map the processes that drive change. Applicants are essentially being asked to produce a well-defined, three-year package of work that de-risks a future larger trial by showing that the intervention can be delivered, is acceptable, and has a plausible, measurable pathway to improving outcomes in substance abuse, HIV-related prevention and adherence, addiction medication adherence, and chronic pain contexts.

FAQs: Behavioral Integrative Treatment Development Program (R34) - PA-13-078

What is the Behavioral Integrative Treatment Development Program (R34) (PA-13-078)?

PA-13-078 describes an NIH discretionary grant opportunity using the R34 mechanism to support early-stage, tightly scoped research focused on developing, refining, and preliminarily testing behavioral interventions or integrated interventions that combine behavioral and pharmacological components.

What is the main purpose of this R34 funding opportunity?

The central purpose is to move promising intervention ideas through Stage I development activities so investigators can build a solid foundation for later, larger-scale efficacy or effectiveness trials. It is meant to help de-risk a future definitive trial, not to fund that definitive trial at this stage.

What does it mean that this program is a "Stage I" intervention development mechanism?

Stage I indicates the work is focused on generating or refining an intervention and conducting pilot/feasibility testing. The emphasis is on whether the intervention can be delivered, is acceptable, and can be studied with workable methods, rather than proving definitive effectiveness.

How long can an R34 project under this program last?

The program is designed for projects that can be fully completed within a three-year period.

What types of interventions does this FOA support?

The FOA supports (1) behavioral interventions and (2) integrated interventions that combine behavioral and pharmacological components.

What topic areas are prioritized in this FOA?

The FOA emphasizes intervention research in these priority areas: substance abuse (including substance use disorders and relevant comorbidities), HIV acquisition or transmission prevention among people in substance abuse treatment, adherence (including adherence to substance abuse treatment and adherence to HIV and addiction medications), and chronic pain.

Does the FOA address co-occurring conditions (comorbidities)?

Yes. The substance abuse priority area explicitly includes relevant comorbidities, noting that co-occurring mental health conditions and other medical or psychosocial issues often influence treatment outcomes.

What HIV-related work is considered responsive under this FOA?

Responsive work includes interventions aimed at preventing the acquisition or transmission of HIV among individuals who are in substance abuse treatment, reflecting the overlap between substance use risk environments and HIV vulnerability.

What does the FOA mean by "adherence" as a priority area?

Adherence includes adherence to substance abuse treatment and adherence to HIV and addiction medications. It also includes improving consistent engagement with care and medication-taking behaviors where lapses can undermine outcomes.

Why is chronic pain included as a target area?

Chronic pain is highlighted due to intersections between pain, opioid exposure, misuse risk, and the need for interventions that address pain management without worsening substance-related harms.

What kinds of studies are encouraged under this FOA?

The FOA highlights examples including Stage I intervention generation and Stage I pilot/feasibility testing. Both categories are expected to go beyond basic deliverability and incorporate attention to moderators, mediators, and mechanisms of change.

What is "Stage I intervention generation" in the context of this program?

Stage I intervention generation can include designing new interventions, adapting existing approaches for new populations or settings, and building the core components and procedures needed for a well-defined intervention.

What is "Stage I pilot or feasibility testing" in the context of this program?

Stage I pilot/feasibility testing involves small-scale studies to determine whether an intervention is workable, acceptable, and deliverable, and whether key study methods function as intended.

Which study methods does the FOA specifically call out for feasibility assessment?

The FOA specifically mentions recruitment, retention, randomization, measurement, and fidelity procedures as methods that may be examined to ensure they function as intended in small-scale studies.

Does the FOA expect applicants to study how an intervention works, not just whether it can be delivered?

Yes. The FOA expects intervention generation and pilot/feasibility projects to incorporate development and examination of putative moderators, mediators, and change mechanisms.

What are "moderators, mediators, and change mechanisms" as referenced in the FOA?

As described, mechanisms address how the intervention may work, moderators address for whom it works best, and mediators describe intermediate processes that help explain outcomes. The FOA signals that applicants should begin identifying these elements even if the project is not powered for definitive mediation analyses.

Is primary care an encouraged setting for projects under this FOA?

Yes. The FOA calls out primary care as an important context for Stage I work and encourages generating or refining substance abuse treatment or adherence interventions for use in primary care settings.

Why does the FOA emphasize primary care?

The FOA frames this emphasis as part of a shift toward integrating addiction-related services into routine healthcare, where interventions often need to be brief, scalable, and compatible with real-world workflows.

Does the FOA encourage the use of technology?

Yes. The FOA encourages creative uses of technology to boost intervention effects and improve implementability, such as digital tools that enhance reach and engagement, support adherence and monitoring, or make delivery more efficient.

Are large confirmatory trials supported under this FOA?

No. The FOA positions the R34 as early-stage development and testing rather than funding full definitive trials or large confirmatory trials.

What is the funding instrument type for this opportunity?

The funding instrument type is a Grant.

Is cost sharing or matching required?

No. The opportunity states that cost sharing or matching is not required.

What is the award ceiling listed for this FOA?

The award ceiling listed is $225,000, described as a cap on the maximum award amount under this FOA as presented in the source information.

When was this funding opportunity posted, and what were the closing dates?

It was posted on January 9, 2013. The original and final closing date was January 7, 2016. The archive date was February 7, 2016.

Is this specific FOA still open?

No. Based on the provided dates (final closing date January 7, 2016 and archive date February 7, 2016), this particular announcement is no longer open.

Who is eligible to apply for this FOA?

Eligibility is broad and includes many types of domestic and non-domestic applicants. Eligible organizations listed include public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses; other for-profit organizations (other than small businesses); and government entities such as state, county, city/township, special district governments, and independent school districts, as well as public housing authorities/Indian housing authorities.

Are community-based and mission-focused institutions included in the eligible applicant types?

Yes. The FOA explicitly includes organizations such as HBCUs, Hispanic Serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.

Are foreign organizations eligible to apply?

Yes. Foreign organizations and foreign institutions are eligible to apply, and non-U.S. components of U.S. organizations may participate. Foreign components are allowed consistent with the NIH Grants Policy Statement.

Which CFDA program areas are referenced for this FOA?

The CFDA program areas referenced are 93.273 (Alcohol Research Programs) and 93.279 (Drug Abuse and Addiction Research Programs).

What overall outputs is NIH looking for from an R34 project under PA-13-078?

The FOA frames the R34 as a practical, time-limited mechanism to define and refine the intervention, test feasibility, strengthen measurement and implementation strategies, and begin mapping processes that drive change. The intent is to produce a well-defined three-year package of work that supports a future larger trial by showing the intervention can be delivered, is acceptable, and has a plausible, measurable pathway to improving outcomes in the priority areas.

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