Integrating Mental Health Care into Health Care Systems and Non-Health Settings in Low- and Middle-Income Countries (R01 Clinical Trial Optional) | PAR 25 201

Frequently Asked Questions (FAQs)

What is the title and number of this funding opportunity?

This opportunity is PAR-25-201, titled "Integrating Mental Health Care into Health Care Systems and Non-Health Settings in Low- and Middle-Income Countries (R01 Clinical Trial Optional)."

Which NIH institute is sponsoring this opportunity?

The National Institutes of Health (NIH) is offering this opportunity through the National Institute of Mental Health (NIMH).

What type of grant mechanism is being used?

The funding instrument is an NIH R01 research project grant (a discretionary grant mechanism).

What is the overall purpose of this NOFO?

The purpose is to support implementation research that develops, refines, and rigorously tests theory-based strategies to integrate mental health care into routine practice at scale in low- and middle-income countries (LMICs). The emphasis is on making integration workable in real systems, not on inventing brand-new clinical treatments.

What does "implementation research" mean in the context of this NOFO?

Implementation research here focuses on how to successfully put proven or promising mental health care approaches into real-world settings and sustain them over time. It prioritizes practical questions like workflow integration, supervision, referrals, quality improvement, and organizational readiness rather than discovery of new treatments.

Where can the integrated mental health services be delivered?

Services may be integrated into routine health care systems and also into non-health settings that are connected to health systems, such as schools, community centers, and other community venues.

Is integration limited to mental health-only services, or does it include mental and physical health connections?

The opportunity explicitly includes stronger links between mental and physical health care as part of integrated care models.

What kinds of problems or barriers is NIMH expecting applicants to address?

NIMH highlights real-world barriers that can prevent integration from working day to day, including limited workforce capacity, weak referral pathways, fragmented service delivery, stigma, inconsistent quality, and low demand or low utilization even where services exist.

What outcomes or types of evidence are projects expected to generate?

Projects are expected to produce practical evidence on how to increase access and availability of mental health care, improve quality, and increase demand and actual service use. The intent is to generate implementation knowledge that can inform broader rollout and long-term maintenance in LMIC contexts.

Is this NOFO focused on pilot projects?

No. The intent is to move beyond small pilot projects by producing evidence that supports broader rollout, scale-up, and sustained integrated care within LMIC systems and community platforms.

What is meant by "scalable and financially sustainable" integrated care models?

The NOFO emphasizes models that can expand beyond a single site or small demonstration and that have credible pathways to continue after research funding ends, including attention to financing and governance so services can be maintained long-term.

Are applicants expected to use implementation science theories or frameworks?

Yes. The NOFO explicitly invites innovative, theory-driven implementation strategies, which implies grounding projects in established implementation science frameworks and testing strategies based on those theories.

What types of implementation strategies are encouraged?

Examples referenced in the opportunity include strategies to change provider behavior, improve organizational readiness, strengthen supervision and quality improvement, make task-sharing workable, integrate screening and referral into routine workflows, and align financing and governance to support sustainability.

What does "Clinical Trial Optional" mean?

"Clinical Trial Optional" means applicants may propose a clinical trial if it fits the research question, but a clinical trial is not required to apply under this announcement.

What study designs does this NOFO appear to allow for implementation research?

The description indicates that a range of rigorous designs may be appropriate depending on the research question, including cluster randomized designs, stepped-wedge trials, pragmatic trials, hybrid effectiveness-implementation approaches, or robust quasi-experimental and mixed-method designs that address implementation questions.

Does the opportunity emphasize capacity strengthening in LMICs?

Yes. A key objective is long-term capacity strengthening in LMIC institutions, including strengthening local expertise, infrastructure, and leadership in mental health implementation research.

What is "multidirectional knowledge exchange" in this NOFO?

It refers to two-way learning: LMIC settings generate innovations and insights that can inform global mental health practice, and high-income country (HIC) partners can contribute complementary expertise, methods, or resources.

Are partnerships between LMIC and HIC institutions encouraged?

Yes. The NOFO encourages partnerships between LMIC and HIC institutions and suggests that collaborative, equitable teams with meaningful LMIC leadership align with the program's intent.

Who is eligible to apply?

Eligibility is broad and includes U.S. and non-U.S. organizations across many categories, including various levels of government, higher education institutions (public and private), tribal governments and tribal organizations (federally recognized and not federally recognized), public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

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

Yes. The eligibility list explicitly includes non-domestic (non-U.S.) entities/foreign organizations.

Are faith-based or community-based organizations eligible?

Yes. The NOFO explicitly calls out faith-based or community-based organizations as eligible applicant types.

Are minority-serving institutions and similar organizations included in the eligible applicant types?

Yes. The eligibility list includes, among others, HBCUs, Hispanic-serving Institutions, TCCUs, AANAPISIs, Alaska Native and Native Hawaiian Serving Institutions, and other similar categories.

Are U.S. territories or possessions included in the eligibility list?

Yes. U.S. territories or possessions are included among the eligible applicant types.

What are the CFDA/Assistance Listing numbers for this opportunity?

The CFDA/Assistance Listing numbers provided are 93.242 and 93.393.

When was this funding opportunity created?

The opportunity was created on 2024-11-12.

What is the listed closing date, and what does it suggest?

The original closing date is listed as 2028-01-07, suggesting a multi-year window during which applications may be accepted on applicable receipt dates.

Is the award ceiling provided?

No. The award ceiling is not specified in the provided information.

Is the expected number of awards provided?

No. The expected number of awards is not specified in the provided information.

What activity categories are associated with this opportunity?

The activity categories listed are education and health.

What kinds of settings and partners does this NOFO seem designed to support?

The broad eligibility and focus on integrated care suggest cross-sector collaboration, including health systems, education systems (such as schools), and community-based organizations and venues connected to health systems.

What would a competitive application generally need to demonstrate based on the NOFO summary provided?

Based on the description, competitive applications would typically show a clear plan for real-world uptake, measurable improvements in access and quality, strategies to increase demand and service use, and a credible approach to scale-up and sustainability, while also contributing to LMIC research capacity and supporting meaningful LMIC-HIC collaboration.