Other: HIV/AIDS & STBBI Clinical Trials Research Network - Phase 1

Eligibility

Applicants:

For an application to be eligible, all the requirements stated below must be met:

1. The Nominated Principal Applicant (NPA) must be:
   1. an independent researcher or a knowledge user affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge translation) at the time of funding.
      1. If the Nominated Principal Applicant is a knowledge user, there must be at least one Principal Applicant who is an independent researcher.
      OR
   2. an individual affiliated with an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate.
      OR
   3. an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate.
2. The NPA must have their substantive role in Canada for the duration of the requested grant term.
3. The Institution Paid must be authorized to administer CIHR funds before the funding can be released (see Administration of Funds).

Governance

1. The Governance structure must be composed of at least five individuals who are listed on the application as the NPA, Principal Applicants (PAs), Principal Knowledge Users (PKUs), Co-Applicants (Co-Apps) and/or Knowledge Users (KUs), each fulfilling at least one of the following roles:
   1. A Knowledge Mobilization (KM) Lead.
   2. An EDI Champion with expertise in sound EDI practices and principles.
   3. At least one person with lived/living experience (PWLLE) of HIV/AIDS.
   4. At least one PWLLE of Hepatitis C.
   5. At least one PWLLE of other STBBIs.

Research Teams

1. The application must include a minimum of 5 Teams, each functioning as a regional node. Each regional node may represent one or more provinces or territories; however, each region should be distinct (i.e., any one province or territory should only be represented by one Team).
2. Each Team must include a minimum of four members. A member may fulfill multiple roles, but the team must include the following:
   1. Two Co-Leads listed as PAs and/or PKUs based in the provinces/territories represented by their regional node for a total of ten individuals across all five Research Teams. The NPA may be listed as a Co-Lead for one of the Teams.
      1. At least one Co-Lead from each team must be either an early career researcher (ECR) or mid career researcher (MCR).
      2. At least one Co-Lead from each team must hold a leadership role in governance of the Network.
   2. In addition to the ECR/MCR Co-Lead, Research Teams must include at least one early career researcher or mid career researcher listed as PA, PKU, Co-App or KU. If only one co-lead is an ECR or MCR, the team must also include either an MCR if the co-lead is an ECR or an ECR if the co-lead is an MCR. If the co-leads are an ECR and an MCR, an additional ECR or MCR is not required.
   3. At least one applicant listed as the NPA, PA, PKU, Co-App or KU who is one of the following (see the How to Apply section for more details):
      1. self-identifies as Indigenous (First Nations, Inuit or Métis) and/or
      2. demonstrates a track record of meaningful and culturally safe involvement with Indigenous Peoples and/or
      3. is an Indigenous Elder and/or an Indigenous Knowledge Keeper and/or
      4. is an Indigenous non-governmental organization.
   4. At least one person with lived/living experience (PWLLE) from a key population listed as PAs, PKUs, Co-Apps and/or KUs. Additional PWLLE or community members from key populations are encouraged and may be listed as PAs, PKUs, Co-Apps, KUs and/or collaborators.
   5. At least one KM Liaison as PA, PKU, Co-Applicant or KU.
   Additional participants fulfilling criteria 6.b.–e. are encouraged to support diverse perspectives.
3. The NPA*, Team Co-Leads, KM Lead and EDI Champion must have successfully completed one of the sex- and gender-based analysis training modules available online through the CIHR Institute of Gender and Health and submit a Certificate of Completion. Applicants are encouraged to review the page "How to integrate sex and gender in research" on the CIHR website. See How to Apply section for more details.
   *Organizations as NPAs: For organizations applying as the NPA, a representative of the organization must complete the training module on the organization's behalf.

Notes:

• Individuals may fulfill multiple roles within and across the different components of the Network (Research Teams, Governance, KM Hub).

Summary

In alignment with the priorities of the CIHR HIV/AIDS and STBBI Research Initiative Strategic Plan: 2022-2027, and the Government of Canada's Pan-Canadian STBBI Framework for Action, the purpose of the CIHR Pan-Canadian Network for HIV/AIDS and STBBI Clinical Trials Research funding opportunity is to support a single, nationally-coordinated, interdisciplinary clinical trials research network (the Network) for addressing STBBI, including but not limited to HIV/AIDS, hepatitis B (HBV) and C (HCV), chlamydia, gonorrhea, syphilis and human papilloma virus (HPV). The Network is expected to establish research infrastructure (including resources and expertise) that facilitates the advancement of innovative, community-centred clinical trials research, including research to address STBBI in the context of co-morbidities, co-infections, and disparities in the health and well-being of key populations disproportionately affected by STBBI in Canada.

The Network should be positioned to collaborate with other leading clinical trials networks in Canada and abroad to advance equitable, inclusive, innovative, robust and efficient clinical trials. These partnerships should enable leveraging of resources and mobilization of knowledge that can pivot for combatting emerging infectious disease outbreaks and other related public health crises with a focus on key populations.

Note: This funding opportunity does not include funding for the actual conduct of Phase 1-3 clinical trials.

Network Structure and Required Key Components

The current funding opportunity represents Phase 1 of the CIHR Pan-Canadian Network for HIV/AIDS and STBBI Clinical Trials Research program. Phase 2 will provide funding to develop multiple platforms for interdisciplinary training and mentoring that will foster the approaches and skills necessary to address the emerging needs of clinical trials research for STBBI and related conditions. Phase 2 is anticipated to be launched pending internal approvals after the funding for the Network is awarded. See the schema for the funding opportunity for more information.

Phase 1 proposals for the Network will include the 3 required key components to address the objectives of the funding opportunity as follows:

1. Interdisciplinary Clinical Trials Research Teams,
2. Community-Centred Knowledge Mobilization Hub, and
3. Governance

Demonstrating the Network's capacity to advance equity, diversity and inclusion (EDI) and uphold Indigenous Rights is required when establishing the composition of each of the key components (see the Equity, diversity and inclusion resources). Additionally, the Network should strive for a balance of research expertise in HIV and other STBBI beyond HIV, and ensure inclusion of researchers with strong track records for STBBI research in leadership positions within the teams and in governance.

Objectives

The specific objectives of this funding opportunity are to:

• Strengthen capacity for clinical trials research in STBBI by establishing a network with pan-Canadian governance that advances a diverse and inclusive leadership model and by leveraging partnerships with other Canadian and international clinical trial networks;
• Advance a community-centred approach to clinical trials research by ensuring meaningful engagement of community members and People with Lived and Living Experience (PWLLE) throughout the entire research process, including in research priority-setting, leading to more relevant, applicable and timely solutions for populations at greatest risk of STBBI in Canada and abroad;
• Mobilize knowledge amongst decision makers, health practitioners, PWLLE, communities, industry, Indigenous communities and HIV/AIDS and STBBI researchers in Canada and abroad in both official languages to enhance, share and foster equitable benefit of evidence-based interventions;
• Develop skills and methodology for the future of clinical trials research by establishing the framework for an interdisciplinary training and mentoring network, baseline activities for training across the Teams and a vision and appropriate capacity to support expanded activities through the anticipated Phase 2 training and mentoring platforms;
• Improve Health Equity by advancing equitable access to participation in clinical trials with a focus on key populations, and by supporting clinical trials research and interventions that address and reduce the impact of stigma, racism, homophobia, transphobia, sexism and other forms of discrimination and systemically entrenched oppression;
• Advance commitments towards Truth and Reconciliation by upholding the rights and priorities of Indigenous Peoples, including through Indigenous-led research, respecting self-determination, and supporting distinction-based approaches.