20-003832-SOW-DRAFT.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW)

(SERVICES)

1. GENERAL INFORMATION

1.1. Title of Project

Impact of the Collaborative Hubs for International Research in Mental Health

1.2. Statement of Need and Purpose

The National Institute of Health (NIH), National Institute of Mental Health (NIMH) is interested in evaluating the impact of the Collaborative Hubs for International Research on Mental Health (CHIRMH) launched in 2010 (RFA-MH-11-070). The objective of that RFA was to establish regional hubs in low- and middle-income countries (LMICs) that would conduct innovative public health-relevant mental health research, build research infrastructure, and develop research capacity.

This RFA aimed to expand research activities in LMICs with the goal of providing the necessary knowledge, tools, and sustainable research-based strategies for use by government agencies, non-governmental organizations, academic institutions and health care institutions to reduce the mental health treatment gap. Lessons learned from these contexts can inform mental health service delivery in other low-resource settings.

The purpose of this acquisition is to evaluate the performance outcomes and programmatic impact of an NIMH-funded global mental health research program, the CHIRMH program (RFA-MH-11- 070).

The successful completion of the overall contract will result in: (a) a synthesized summary of the outcomes for each Hub based on (1) knowledge development; (2) strength of partnerships developed and/or enhanced; (3) development of research capacity; (4) impact on policy and practices; (5) implementation or enhancement of programs; (b) a report describing barriers and facilitators impacting the success of the goals of the FOA and recommendations to guide the CGMHR’s future investments, as well to share lessons learned with the Global Mental Health research community.

1.3. Background Information and Objective

The proportion of people who need, but do not receive care—the mental health treatment gap— is exacerbated by the dearth of health care workers available to provide evidence-based mental health services that meet minimum standards. Although a growing evidence base for reducing the treatment gap exists for higher income countries like the United States, far less research has been conducted in countries identified by the World Bank as low- and middle-income (LMICs). Evidence also suggests that the majority of LMICs have limitations in a number of mental health specialties: 67% showed a shortage of psychiatrists, 95% a shortage of nurses and 79% a shortage of psychological care providers.1 2 Although human resource inadequacies for mental health worldwide have been well established, researchers, policy-makers, and international agencies have called for scale-up of mental health services3. Task shifting—that is, delegating tasks to varied cadres of health professionals with specialized training—has shown promise with certain mental health interventions.4,5,6 These studies suggest that the delivery of mental health services in primary healthcare settings through community-based and task-shifting approaches, in combination with appropriate training and increased capacity, can be used as a strategy for reducing the burden on caregivers and coordinating care of individuals with mental disorders.7 To tackle this issue, NIMH established the Collaborative Hubs for International Research on Mental Health (CHIRMH) in 2011-2012 (RFA-MH-11-070 and RFA-MH-12-110)8 to increase the evidence base for mental health interventions in World Bank designated LMICs.

Five projects grants were awarded. The CHIRMH program used an innovative model with a three-fold purpose:

Increase scientific knowledge about mental health interventions delivered by non-specialist providers under the supervision of mental health specialists (i.e., task sharing) in low- and middle-income countries (LMICs) to expand access to care.

Strengthening of partnerships among local researchers, policymakers, and health care providers to maximize the chances that resulting research findings would respond to local needs and would be applied in practice and policy once the grant ended.

Develop research capacity of LMIC investigators to increase their representation and LMIC research in the scientific literature on mental health. Each hub was to develop its own capacity- building activities and the five hubs were to network with one another to (a) facilitate cross-hub knowledge development, (b) expand individual hubs’ research development opportunities, and

(c) facilitate new research partnerships.

Each hub was to conduct research and provide capacity-building opportunities in one of six geographical regions (i.e., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean;

Middle East and North Africa; South Asia; Sub-Saharan Africa). As a group, awardees were to constitute a collaborative network of regional hubs for mental health research in LMICs with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children.

https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-11-070.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-12-110.html http://data.worldbank.org/about/country-classifications

Five Cooperative agreements were awarded: 1) Africa Focus on Intervention Research for Mental Health – AFFIRM (Ethiopia, Ghana, Malawi, South Africa, Uganda, Zimbabwe);

2) Latin America Treatment & Innovation Network in Mental Health – LATIN-MH (Brazil, Colombia, Ecuador, Guatemala, Peru, United States); 3) Partnership for Mental Health Development in Sub- Saharan Africa — PaM-D (Ghana, Kenya, Liberia, Nigeria, South Africa);

4) Regional Network for Mental Health Research in Latin America — RedeAmerica (Argentina, Brazil, Chile, Colombia, USA); and 5) South Asian Hub for Advocacy, Research & Education on Mental Health

— SHARE (Afghanistan, Bangladesh, India, Nepal, Pakistan, Sri Lanka)9. Each hub supported research on task-shifting/task-sharing for the delivery of mental health services and provides research capacity-building opportunities.

Rationale: An independent, objective assessment of the CHIRMH program will be useful for a large range of stakeholders including, but not limited to funding agencies, governmental and non-governmental organizations, academic institutions and health care institutions for several reasons. First, CHIRMH used an innovative program model to develop new scientific knowledge and build in-country research capacity through stakeholder partnerships and international networking. The standard metric of scientific publications is insufficient for capturing the intended impact of this program model. Second, two NIMH initiatives currently underway are based on the CHIRMH model; they are Research Partnerships for Scaling Up Mental Health Interventions in LMICs, and Collaborative Hubs to Reduce the Burden of Suicide among American Indian and Alaska Native Youth. A better understanding the CHIRMH model’s productivity several years post grant period will help in guiding these two follow-on initiatives and in maximizing their output. Third, the CHIRMH model required substantial amounts of NIMH staff time compared with more typical NIMH project models (e.g., R01, U19 without research capacity building). This was appropriate in 2011 given the nascent status of mental health research across most LMICs; eight years on, it will be useful to consider program accomplishments in relation to NIMH staff effort under the CHIRMH model.

1.4. Period of Performance

The Period of Performance is one (1) 12-month base period, and one (1) 3-month period option period.

2. SCOPE OF WORK

2.1. General Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-350.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-350.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-350.html

2.2. Specific Requirements

The Contractor shall provide services and materials necessary to complete the following tasks:

2.2.1. Framework

Present a multi-level framework by which different aspects of the Hubs goals will be evaluated.

Those aspects should include, but are not limited to:

Knowledge development. Outcomes/Metrics may include intervention impact on mental health outcomes; development of novel mental health interventions; numbers of intra- and inter-hub publications; impact factors of journals in which publications appear; numbers of citations; numbers of intra- and inter-hub presentations at conferences and meetings; identification of research gaps and/or development of new research directions.

Strength of partnerships developed and/or enhanced. Outcomes/ Metrics may include numbers of implementing partners where research studies were conducted and/or where capacity building research components were conducted; other resources leveraged by individual hubs such as subsequent research studies by PIs or senior key personnel that stem from the Collaborative Hubs research; the CHIRMH program and other partners (e.g., WHO expertise in economic analysis); lessons learned about hub and partnership management, including facilitators and hindrances; partnerships relevance to sustainability of the interventions.

Development of research capacity. Outcomes/Metrics may include numbers of research trainees/fellows engaged; numbers of trainee/fellow-initiated publications; numbers of trainee/fellow grant applications submitted and grants awarded; numbers of intra- and inter-hub courses and workshops given, with attendance and completion rates, evaluations and skills addressed; institutionalization of new research courses and career pathways in LMIC institutions of higher education; trainee/fellow career trajectories and involvement in further degree training; new intra- and inter-hub research partnerships; impact on the capacity of mental health services in the countries; successes and challenges with mental health research methodology and study designs.

Impact on policy or practices. Outcomes/ Metrics may include uptake and application of research findings in LMICs post or during grant period into evidence-based policy recommendations and/or adoption by government agencies, NGOs, and health care institutions; how the research findings benefited or were applied in other countries including the US; change in service system capacity to meet local mental health needs; evidence-based policy development; cost- effectiveness or budgetary impact of task-shifting/ task-sharing models new researcher- policymaker and/or researcher-provider collaborations; other secondary impacts (e.g. job creation, economic benefits); public communication of the research study and its impact on public awareness and public health priority of mental health.

Implementation or enhancement of programs. Outcomes/Metrics may include: assessment of new or enhanced programs implemented; how well did the program facilitate communities of practice and help to move the field forward with new science, consolidation of data sources, additional sources of funding, etc.; how well did the program contribute to building connections and relationships with local policymakers and strengthen evidence-to-policy practices?

2.2.2. Kick-Off Meeting

The Contractor shall contact the Contracting Officer’s Representative (COR) after the contract is signed to schedule a conference call/or in-person meeting with the NIMH Program Officers (POs), Contracting Officer (CO), and other relevant NIMH staff. The meeting goals include discussing the development of a work plan, roles of participants, and timeline. The contractor shall outline a systematic approach to obtain the necessary information required and outlined under section 2.2.1 above, including a framework of needed information, data sources required, and an assessment plan, which could include, but is not limited to: interviews with PIs and /or key personnel from each Hub;

peer-reviewed publications; conference abstracts and proceedings; government reports and memos;

white papers; internal operating documentation; interviews with policymakers.

2.2.3. Site Conference calls

The contractor shall arrange with each of the 5 Hubs listed below to develop a signed agreement with the Hubs teams to collaborate and provide required information and resources needed to complete this project which should include: 1) an identified research liaison who shall be supported by this contract and shall coordinate securing the necessary information; 2) an approved work plan for data collection to complete the items mentioned in section 2.2.1; and 3) develop a plan to address any other issues impacting successfully accomplishing this project.

1. Africa Focus on Intervention Research for Mental Health – AFFIRM

PIs: Crick Lund, Atalay Alem, Ezra Susser Activity Sites: Ethiopia, Ghana, Malawi, South Africa, Uganda, Zimbabwe

2. Latin America Treatment & Innovation Network in Mental Health – LATIN-MH PIs: Paulo Menezes, Ricardo Arraya Activity Sites: Brazil, Colombia, Ecuador, Guatemala, Peru, United States

3. Partnership for Mental Health Development in Sub-Saharan Africa — PaM-D PI: Oye Gureje Activity Sites: Ghana, Kenya, Liberia, Nigeria, South Africa

4. Regional Network for Mental Health Research in Latin America — RedeAmerica PIs: Ezra Susser, Sandro Galea, Ruben Alvarado, Graciela Rojas Activity Sites: Argentina, Brazil, Chile, Colombia, USA

5. South Asian Hub for Advocacy, Research & Education on Mental Health — SHARE PIs: Vikram Patel, Atif Rahman Activity Sites: Afghanistan, Bangladesh, India, Nepal, Pakistan, Sri Lanka

2.2.4. Site Reports

The contractor shall provide a report of each of the conference calls which will include: the signed agreements with the Hubs and an outline the necessary resources to complete this project; details of the work plan and SOPs developed; specific actions that were discussed during the call, including potential issues that may impede data collection and a plan to resolve them; and a timeline for data collection. Through these discussions the need for a site visit may be addressed and will require specific justification for the visit. The format and content of this report shall be based on the guidance and direction of the COR.

2.2.5. Reports

The contractor shall provide NIMH with a semi-annual progress report and final report with an analysis of the data collected based on the content of research outlined in the SOW framework, consisting of data compiled from site calls, research conducted, and site visits if relevant and any other areas of data collection. This report shall include tasks completed, outcomes of each, timelines within which they were accomplished, challenges encountered and how they were resolved, lessons learned, and a summary of outcomes, and customer feedback where applicable. The final report also should present the findings of each Hub based on the multi-level framework described on section

2.2.1 by which different aspects of the Hubs goals will be evaluated. Those aspects should include, but are not limited to: Knowledge development; Strength of partnerships developed and/or enhanced;

Development of research capacity; Impact on policy or practices. Implementation or enhancement of programs. The final report should also present an analysis of those findings with summary of outcomes and lessons learned. This material may be used by NIMH for development of a manuscript.

Additionally, the Contractor shall keep abreast of all changes in Federal specific requirements governing NIMH policies related to this scope of this contract. The Contractor shall update SOPs, as necessary, within thirty (30) calendar days of the effective date of all such changes; and submit updated SOPs to the COR for review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written NIMH POs and COR approval.

2.2.6. Budget Reports

The Contractor shall prepare and submit a semi- annual budget report and a final report, in chart format, showing task and sub-tasks, and, the amount allocated for the task. The report shall also include the budget expenditures for the month, the remaining balance, and the percentage of funds used to date.

2.2.7. Level of Effort

The following table depicts the estimated LEVEL OF EFFORT in unit number of hours per labor category per contract year that the Government anticipates will be required for the contractor to successfully perform the requirement described in this Statement of Work. The Program Director, Data Analyst, and Researcher requires a Ph.D. or M.D, and the Project Manager requires a Master’s Degree or experience in Project Management.

Data: survey, qualitative and quantitative tools, among others.

Quantity Labor Category Year 1

Year 2

1 Program Director Level expertise: PhD or MD Time calendar year: 8-16 hr./week

20-40%

20-40%

1 Data analyst Level expertise: PhD or MD Time calendar year 4 h/week

40 60

5 Research Coordinator Liaison at each Hubs involved from the Collaborative Hubs for International

1 Research (CMIRMH) Level expertise: PhD or MD Time calendar year: 20hr/week

50 50

1 Project Manager Level expertise: may be only required to have a Master’s Degree or experience in PM.

Time calendar year 20hr/week

50 50

2.2.8. Government Responsibilities

The Government will participate in conference calls with the Contractor every 6 months to discuss the content, and requirements described above.

The Government will be responsible for reviewing and approving reports and final products generated under the contract. The Contractor shall guarantee strict confidentiality of the information/data obtained from any participant on the project. No government furnished property shall be provided. No government workspace, desktop computers and telephones for contractor personnel will be provided. The Contractor will not require routine access to government facilities

2.2.9. End Results/ Deliverables

The following tables describes 1) the products and tangible end results that are expected from each task contained in the previous section, 2) the date each deliverable is due, and 3) the Government acceptance criteria. All days are business days unless otherwise specified.

End Result/Deliverable Due Date Acceptance Criteria

Multi-level framework

Within 5 days of award.

Description on 2.2.1

Kick-Off Meeting Within 5 days of award.

The kick-off meeting must be scheduled in coordination with the COR in accordance with SOW section 2.2.2

Site Conference Calls Within 30 days of award directed by the PO

The site conference calls must be scheduled with each of the five hubs. The contractor shall schedule a total of five (5) site conference calls in accordance with SOW section 2.2.3 and 2.2.4.

Site Report for AFFIRM Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for LATIN-MH Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for PaM-D Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for RedeAmerica Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for SHARE Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Semi-annual progress report Within 180 days after the kick-off meeting.

The semi-annual progress report shall be in accordance with SOW section 2.2.5.

Final Report Within 360 days after the kick-off meeting.

The final report shall be in accordance with SOW section 2.2.5.

Semi-annual budget report Within 180 days after the kick-off meeting.

The semi-annual budget report shall be in accordance with SOW section 2.2.6.

End Result/Deliverable Due Date Acceptance Criteria

Final budget report Within 360 days after the kick-off meeting.

The final budget report shall be in accordance with SOW section 2.2.6.

2.2.10. REPORTING REQUIREMENTS:

All site reports, semi-annual, annual reports, semi-annul budget, and final report shall be delivered electronically to NIMH as described above in section 2.2.8.

3. OTHER CONSIDERATIONS

3.1.1. Travel

If determined necessary, one Contractor person shall perform a site visit to one or more of the Hubs from the CHIRMH FOA. The purpose of the SV would be to gather information to complete this assignment as described above on specific requirements item 4.

3.1.2. Key Personnel

The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follow:

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows;

Quantity Position

1 Program Director

1 Program Manager

1 Research Analysist

5 Research Coordinator Liaison at each Hubs involved from the Collaborative Hubs for International Research (CMIRMH)

The key personnel specified in this contract are essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) are essential to the work being performed here under:

Name Title To be determined in the contract award

3.1.3. Information System Security Plan

TBD

3.1.4. Data Rights

The CGMHR shall have unlimited rights to and ownership of all deliverables provided under this contract including any reports, recommendations, briefings, work plans, and all other deliverables. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” and is hereby incorporated by reference and made a part of this contract.

3.1.5. Section 508 Electronic and Information Technology Standards The Contractor shall use Electronic and Information Technology (EIT) in the performance of the SOW. The public will NOT have access to the EIT.

[In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established information technology accessibility standards for the federal government. Section 508(a)(1) requires that when federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology (EIT), they shall ensure that the EIT allows federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a federal department or agency. Section 508 text is available at http://www.opm.gov/HTML/508-textOfLaw.htm or http://www.section508.gov/index.cfm?FuseAction=Content&ID=14] http://www.opm.gov/HTML/508-http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

3.1.6. Publications and Publicity

The Contractor shall ONLY write or publish articles of data produced as a result of the requirements of the SOW with agreement of NIMH staff and sites involved, who will also participate on the manuscript.

3.1.7. Confidentiality of Information

The Contractor shall have no other rights to use the confidential information involving patients and providers for any purpose other than as set forth under Project Purpose of this Agreement.

a. Confidential information, as used in this article, means information or data of a personal nature about individual or proprietary information or data submitted by or pertaining to an institution or organization.

b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential.

Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

f. Contracting Officer’s determinations will reflect the result of internal coordination with appropriate program and legal officials.

g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

The Contractor personnel shall be required to submit signed NDAs to the COR.

3.1.8. REFERENCES

1Bruckner, T et al. The mental health workforce gap in low- and middle-income countries: a needs-based approach. Bull World Health Organ [online] 2011; 89(3).

2Kakuma R, Minas H, van Ginneken N, Dal Poz MR, Desiraju K, et al. Human resources for mental health care: current situation and strategies for action. Lancet 2011; 378: 1654–1663.

3Prince M, Patel V, Saxena S, et al. No health without mental health. Lancet 2007; 370: 859-877.

4Bolton P, et al. Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial. JAMA 2003; 289; 3117-3124.

5Rahman A, Patel V, Maselko J, Kirkwood B. The neglected ‘m’ in MCH programmes – why mental health of mothers is important for child nutrition. Trop Med Int Health 2008; 13(4): 579-583.

6Patel V, Prince M. Global Mental Health: A New Global Health Field Comes of Age. JAMA2010;303(19):1976-1977

7Kakuma R, Minas H, van Ginneken N, Dal Poz MR, Desiraju K, et al. Human resources for mental health care: current situation and strategies for action. Lancet 2011; 378: 1654–1663.

8The Collaborative Hubs were established in September 2010: https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html. The FOA was reissued in September 2011.

9https://www.nimh.nih.gov/about/organization/cgmhr/globalhubs/index.shtml https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://www.nimh.nih.gov/about/organization/cgmhr/globalhubs/index.shtml