PATC3H-IN Frequently Asked Questions (FAQs)

The following information applies to the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) Implementation Science Network (IN) notices of funding opportunities.

Requests for Applications (RFAs)

  • RFA-HD-23-013: PATC3H-IN: Clinical Research Centers (UG1 Clinical Trial Optional)
  • RFA-HD-23-014: PATC3H-IN: Coordination, Translation, and Advanced Methods and Analytics Center (UM2 Clinical Trial Optional)

Technical Assistance (TA) Webinar Materials

If you have additional question that are not addressed in the webinar presentation or on this page, please email NICHD-PATC3H-IN-FOA@mail.nih.gov.

FAQs

  • What are the essential features of the overall structure of PATC3H-IN?
    • PATC3H-IN will consist of the following interdependent functional parts:
      • Clinical Research Centers (CRCs)
        Four to five CRCs will conduct clinical research and clinical trials, including implementation, effectiveness, and hybrid implementation-effectiveness studies at their participating clinical research performance sites (CRPS). Additional information about this component is available at RFA-HD-23-013.
      • Coordination, Translation, and Advanced Methods and Analytics Center (CTAMAC)
        A single CTAMAC will manage logistics, stakeholder engagement, and dissemination of findings and products from PATC3H-IN. It will also support the work of the clinical sites by conducting foundational research and by managing research education, training and capacity building, and emerging research pilots (ERPs). Additional information about this component is available at RFA-HD-23-014.
      • Scientific Leadership Committee (SLC)
        The SLC will be responsible for PATC3H-IN governance, oversight, and coordination, and will develop and implement the network research agenda.
    • A chart of the network structure appears on Slide 49 of the PATC3H-IN TA webinar presentation (PDF 1 MB).
  • What are the critical features of a UG1 CRC?
    • A theoretically grounded, hypothesis-driven research project designed to address gaps along the HIV prevention and/or HIV care continuum among adolescents and young adults in low- and middle-income countries (LMICs)
    • Five or more CRPS that will implement the research project. Each CRPS must submit letters of support from:
      • The targeted national and/or regional health ministry or other local health authority(ies)
      • The community-based HIV-related service provider entity(ies)
    • Collaboration capacity to implement required programs such as HIV implementation science capacity building, emerging research pilots, and community engagement activities in partnership with the CTAMAC and its cores
  • What kinds of studies should a UG1 CRC propose as a research project?
    • Implementation science (IS) research guided by IS frameworks/theories to improve the adoption, implementation, and sustainment of evidence-based HIV prevention and care interventions for at-risk adolescents and young adults and those living with HIV within one or more LMICs. Effectiveness-implementation hybrid study designs are encouraged.
    • Proposed studies in new geographic settings with limited IS research capacity (e.g., outside of South Africa) and/or risk populations who are poorly represented in international adolescent HIV research (e.g., sexual and gender minorities; commercial sex workers; drug users) will receive additional program priority
    • Interventions that utilize evidence-based efficacious innovations such as long-acting injectable, implantable, or other sustained release platforms of antiretrovirals for prevention and treatment of HIV will receive additional program priority.
  • What are the critical features of the UM2 CTAMAC?
    • The CTAMAC is expected to provide coordination, infrastructure, statistical and data management leadership, and other supports for the PATC3H-IN.
    • The CTAMAC will accomplish its objectives through four cores:
      • Administrative Core (AC): Will provide overarching administrative resources and organizational structure and management
      • Data and Analytics Core (DAC): Will facilitate the collection, archiving, storage, analysis of, and access to network data
      • Advanced Methodology and Emerging Science Core (AMES): Will conduct novel modeling research using existing data and data acquired through the network, and support implementation science capacity building and an emerging scientific agenda for the network
      • Dissemination and Community Engagement Core (DCEC): Will translate network findings into resources of interest to external stakeholders and will engage them in the PATC3H-IN research agenda
  • What are special budget instructions and limits for the cores of the UM2 CTAMAC?
    • AC
      • SLC Meetings: Budgets should include funds for travel to Bethesda, Maryland, for three SLC meetings in the first year for the program director(s)/principal investigator(s) (PDs/PIs), including each core lead, and support staff. In subsequent years, budgets should include funds for travel to two annual SLC meetings in Rockville, Maryland. SLC meetings are generally expected to last 2 days.
      • SLC Chair Support: Budgets should include a line item for travel and salary support for an SLC chair, who will lead all SLC meetings. For budgeting purposes, assume the equivalent of 2 months effort annually at a senior investigator-level salary. Budget for the SLC chair should also include reimbursement for travel expenses to all in-person SLC meetings. Budget does not need to consider indirect costs specific to the SLC chair’s institution.
      • External Scientific Advisory Board (ESAB) meetings: Budgets should include placeholders for payment of members (do not name individuals) of external advisory groups. Use the instructions in the announcement in conjunction with the application guide to prepare your application. If instructions conflict, follow the funding opportunity.
    • AMES
      • ERPs: ERP awards may be issued through the AMES as fixed price subawards, will not exceed $110,000 in total costs, and will not be longer than 24 months in duration. No more than $375,000 in total costs will be made available annually for ERP awards.
      • Research Education, Training, and Capacity Building: Budgets are limited to $500,000 in direct costs annually plus applicable facilities and administrative costs.
  • Can a foreign institution receive an award without a collaborating U.S. institution?
    • Applications may be for collaborations between institutions in the United States and an eligible LMIC or may involve just LMIC institutions if there is a previous track record of externally funded research and/or research training programs by the lead LMIC institution.
  • Can multiple PIs apply for a UG1 CRC?
  • In planning budget requests, are there any centralized resources or infrastructure that UM2 CTAMAC will provide for the UG1 CRC?
    • Applications for each RFA are expected to be reviewed independently and stand on their own scientific merits.
    • While the CTAMAC will provide resources for the CRC (as noted in RFA HD-23-014), the extent of overlap in some activities is intentionally not defined as there is expected variability in areas supported and over time as progress in the network matures.
      • For example, in provision of data management and analytic support, it would be expected that the CRC plan to provide its own support for these activities in their research project in accordance with RFA HD-23-013. However, when considering how future research activities will be developed and implemented as in the ERPs, it is expected that the CTAMAC plan to provide support for data management and analysis for these projects in accordance with RFA HD-23-014.
    • NIH reserves discretion with application selection to ensure optimal collaboration and range of topics among the network’s CTAMAC and multiple CRCs to maximize the success of PATC3H-IN

  • Are there any specific requirements for senior/key personnel of the UG1 CRC?
    • The following are important highlights relevant to senior/key personnel that must be included in accordance with the detailed and additional instructions of the RFA (Senior/Key Person Profile and Budget):
      • The CRC PD(s)/PI(s) should be established investigator(s) with a record of leading multidisciplinary research projects that include multisite clinical trials, a record of scholarly publications, and a record of proactive community engagement in development of research activities.
      • Biosketches should describe senior/key personnel recent experience and participation in multisite randomized clinical trials.
      • Biosketches should also be included for representative senior leaders from a relevant national and/or regional health ministry or other local health authority(ies); and a relevant community-based HIV-related service provider entity(ies) relevant to the proposed study.
      • PD(s)/PI(s) must expend at least two person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI must commit a minimum of two person-months annually over the life of the grant award.
      • One or more representative senior leaders from a relevant national and/or regional health ministry or other local health authority(ies) and a relevant community-based HIV-related service provider entity(ies) should be named as key personnel and should each expend a minimum of 0.6 person-months effort annually on the award over the entire period of support.
  • Can new CRPS join after the award has been made?
    • In general, it is expected that applicants will be able to pre-specify all expected CRPS. If there is a compelling reason why this cannot or should not be done, applicants should provide similar detail regarding potential sites, including their collaboration capacity as requested in the RFA (Research Plan, Section C) and what approach will be used in ultimately selecting sites.
  • Must I ensure community relationship-establishment and engagement?
    • Yes, this is a requirement in your application and should be done before work is planned and should be an integral part of ongoing network research activities.
  • How will solicitations for ERPs be developed in coordination with the CTAMAC and the SLC?
    • The PATC3H-IN research agenda will ensure capacity for rapid response to evolving scientific priorities through recurring competitive open solicitations for ERPs. These solicitations will be developed and published by the CTAMAC in collaboration with NIH project scientists and supported by the coordination and operational infrastructure of the CTAMAC. The CTAMAC will 1) receive and convene reviews for applications; 2) coordinate and support application prioritization by the SLC; and 3) implement funded meritorious research through CRC-supported CRPS after approval by the NICHD Director or her designee. Finally, the ERPs will be conducted through the site consortia’s multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment venues in their communities (e.g., academic, clinic, health department, community-based organizations, online, social media and other virtual health platforms, etc.).
  • Will external projects (e.g., R01s) be considered after the PATC3H-IN cycle begins?
    • Yes, the SLC will develop policies and procedures for such collaborations.
  • During the 5-year PATC3H-IN project cycle, can any of the research projects be defunded, changed, or not allowed to continue forward?
    • Yes. The PATC3H-IN ESAB and NIH are responsible for ongoing monitoring and evaluation of the progress of all research conducted in the network. Based on performance, the ESAB can make recommendations to NIH to best align resources that maximize and ensure appropriate and expeditious completion of project objectives.
  • What does the $2,500,000 in direct costs for the UM2 CTAMAC cover?
    • The PATC3H-IN UM2 Scope of Work, as described in the FOA, is covered in these direct costs. This scope of work encompasses infrastructure for: 1) rapid response and ERPs, including management and distribution of protocol-restricted funds through performance-based subawards; and 2) research education and capacity building for PATC3H-IN.
  • Can researchers from the United States interested in obtaining training for implementation science in LMICs participate in the UM2 CTAMAC’s Research Education, Training, and Capacity Building program?
    • No. This AMES program will only support training and capacity building activities that are focused exclusively on researchers from LMICs.

  • How will the review of the UG1 and UM2 applications be conducted?
    • A special emphasis panel with the relevant content expertise will be convened by NICHD/NIH.
  • What are the foci of review for a CTAMAC Cooperative Agreement (UM2)?
    • The UM2 CTAMAC is a single program infrastructure that will support an integrated and interdependent network. The focus of the review will be on three areas:
      • An integrated collection of cores and research projects, and the overall scientific and technical merit of the program
      • Individual cores
      • Individual research projects
  • What are the review criteria for these FOAs?
    • Standard NIH peer review system criteria plus RFA-specific criteria will be used. There are additional criteria for the UM2 on the program project as an integrated effort.

  • What is a UG1?
    • UG1 is a Clinical Research Cooperative Agreement – Single Project.
    • A UG1 aims to support single-project applications conducting clinical evaluation of various methods of therapy and/or prevention (in specific disease areas).
    • A cooperative agreement research program generally involves the organized efforts of large groups, members of which are conducting research projects designed to elucidate the various aspects of a specific objective.
    • Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award.
    • The investigators have primary authorities and responsibilities to define research objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.
    • Each research project is usually under the leadership of an established investigator in an area representing their special interest and competencies.
    • Each project supported through this mechanism should contribute to or be directly related to the common theme of the total research effort.
    • The award can provide support for certain basic shared resources, including clinical components, which facilitate the total research effort.
    • These scientifically meritorious projects should demonstrate an essential element of unity and interdependence.
  • What is a UM2?
    • A UM2 is Program Project or Center with Complex Structure Cooperative Agreement.
    • A UM2 aims to support cooperative agreements involving program projects or centers with complicated structures that cannot be appropriately categorized into an available multicomponent activity code, e.g., clinical networks, research programs or consortiums.
    • At least one component must be UM1-like, supporting a variety of functions that are dependent on each other and cannot be separated into distinct components
    • Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of the award.
  • Will PATC3H-IN participate in protocols supported by other networks or individual grants?
    • Yes. The PATC3H-IN SLC will establish policies and procedures for co-endorsement of protocols from other NIH-funded networks and those from individual grants.
  • Will data generated by the PATC3H-IN be available to interested researchers outside the network, and if so, what is the process for accessing these?
  • Will sites and their investigators be able to contribute and shape the science of the PATC3H-IN?
    • Yes, all applicants are encouraged to forge close partnerships with candidate sites as they consider participating in each UG1. Relationships that meaningfully and substantively contribute (e.g., protocol conceptualization, development, leadership, analysis, and data dissemination through publications, etc.) to the scientific agenda of the PATC3H-IN are also encouraged.
  • How will a network of individual but interdependent UG1s operate efficiently and communicate with each other and with other components of the network (like the CTAMAC and its cores) to achieve desired results in a timely fashion?
    • Communication and collaboration between all network components are encouraged and expected. Communication and collaboration between UG1s are also encouraged. However, please note the following:
      • Any investigators from separate, established institutions proposing a priori collaboration as CRCs must apply as multiple PIs on an application for a single CRC.
      • After the network is established, multi-PI collaborations between CRCs can occur best by leveraging the resources and support of the CTAMAC. The CTAMAC and its cores are defined in its respective RFA.
  • Can an institution apply to both RFAs for a UG1 CRC and the UM2 CTAMAC?
    • If these are distinct applications and none of the senior or key personnel who might overlap play senior roles in more than one of the applications, then yes, an institution may apply to both.

  • Is an organization permitted to be on more than one application?
    • Yes. For example, a UG1 applicant’s CRC may have a component such as a CRPS that is also included in a study proposed by another UG1 application for a separate and distinct CRC. However, each application is expected to be distinct, reviewed independently, and stand on its own scientific merits.
  • Is prior approval from NIH necessary for a proposed budget of more than $500,000 in direct costs for either the UG1 or the UM2 RFA?
    • No. The policy regarding obtaining prior approval for applications that request more than $500,000 in direct costs does not apply to applications submitted in response to RFAs. Each RFA has its own Award Budget (See RFAs, Part 2, section II.)
  • In the UG1 RFA, what types of geographic constraints are there for CRPS locations?
    • Each of the five proposed CRPS must be non-overlapping in terms of patient populations engaging with services, and also must have collaborative relationships with participant recruitment venues in their communities. However, they do not necessarily need to be restricted along national borders, as long as multiple national regulatory mechanisms and/or policies or other logistical barriers do not threaten feasibility in carrying out the proposed study design according to the requirements of the RFA. These include but are not limited to the expeditious establishment of the necessary collaborative relationships between a national or other local health authority and one or more community-based HIV-related service providers that are required for successful implementation of the proposed study.
  • Can a CRPS be named in an application for the purpose of accessing a key population in a future study within PATC3H-IN (e.g., as infrastructure for ERPs), but not for the purpose of the initially proposed study?
    • No, each of the five or more proposed CRPS must be justified in accordance with the UG1 RFA (Part 2, Section IV).
  • Would pregnant adolescents be considered a population of interest?
    • Yes.
  • Would young male sexual partners of sex workers be considered a population of interest?
    • Yes. A study must focus on adolescents and young adults, as per the RFA. The proposed study may include sexual partners of the AYA being studied.
  • Must a trial proposing to study a biomedical innovation only include biomedical interventions approved in-country, or can products with demonstrated effectiveness but without in-country approval be included (e.g., long-acting cabotegravir has demonstrated efficacy at preventing HIV but is not approved in all countries)?
    • Biomedical interventions with demonstrated safety and efficacy may be included provided that their use is consistent with local and jurisdictional laws and regulations for clinical practice among AYA at risk for or living with HIV.
  • Must the intervention in a proposed CRC research study be one that has been previously implemented in NIH funded work (e.g., PATC3H, the Adolescent HIV Prevention and Treatment Implementation Science Alliance [AHISA], or other independent grants)?
    • Proposals that include an adolescent HIV research partnership with AHISA, where it is feasible based on geography, are desirable. Proposals including efficacious interventions from other NIH-funded activities are also welcomed.
  • Are proposed CRC studies expected to cover both HIV treatment and prevention outcomes in the same study?
    • Proposed studies may cover outcomes in either the HIV prevention continuum or the HIV care continuum, or both.
  • Can one CRC propose multiple interventions?
    • A proposal that includes more than one intervention must be feasible and scientifically justifiable in a single research project as described in the RFA (Part 2, Section IV).
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