adapting the ryan white hivaids program diagnostic compliance ...

1. Adapting the Ryan White HIV/AIDS Program Diagnostic Compliance Tool for International Application Scientist Professional Category (Sci-PAC) U.S. Public Health Service Professional Conference June 2, 2009 LCDR Matthew Newland US Department of Health and Human Services Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) Division of Community Based Programs (DCBP)

2. Presentation Outline Statement of the Problem: The HIV/AIDS Pandemic The President�s Emergency Plan for AIDS Relief (PEPFAR) Diagnostic Compliance and Assessment Tool Background & Methodology Domestic and Title XXVI of the PHS Act as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White Program) The Process of Adapting the Tool for International Application Literature review on clinical evaluation in international settings and organization analysis Conclusion

3. Statement of the Problem: The HIV/AIDS Pandemic Over 33 million people infected with HIV/AIDS globally Over 90% live in sub-Saharan Africa, the Caribbean and Southeast Asia Current capacity and quality of care within existing health care systems is limited HIV-related morbidity and mortality has dropped, yet reductions are uneven due to unequal access to care and variable quality of services

4. 33 Million People Estimated to be Living with HIV/AIDS in 2008

5. US Commitment At the inception of PEPFAR (2003), the U.S. developed a five-year strategy that devoted $15 billion to programs in the following way: $10 billion for the 15 focus countries $4 billion for other PEPFAR countries and for additional activities including HIV/AIDS research $1 billion over five years for the Global Fund to Fight AIDS, Tuberculosis, and Malaria The U.S. Government (USG) met this commitment and exceeded its contribution to the Global Fund

6. PEPFAR Reauthorization: Continuation & Expansion Congress Reauthorized PEPFAR in 2008 for 5 additional years (2009 � 2013), $48 billion for HIV/AIDS, Tuberculosis (TB) and Malaria Continuation: HIV/AIDS care, prevention and treatment are life-long needs and the USG will continue to support those served during PEPFAR�s first five years Expansion: PEPFAR will expand efforts to Strengthen health systems Collaborate with programs that address malaria, TB, child and maternal health, clean water, food and nutrition, education and other needs USG responsible for transitioning of PEPFAR funding from US to local organizations

7. HRSA & PEPFAR HRSA is an implementing agency in PEPFAR with: US Centers for Disease Control and Prevention (CDC) US Agency for International Development (USAID) Participating Countries: Botswana, Cambodia, Cote d�Ivoire, Ethiopia, Guyana, Haiti, India, Kenya, Malawi, Mozambique, Namibia, Nigeria, Russia, Rwanda, South Africa, Tanzania, Uganda, Vietnam, Zambia, Zimbabwe HAB provides experience gained administrating the Ryan White HIV/AIDS Program Providing HIV/AIDS Services to the underserved

8. Ryan White Diagnostic Compliance and Assessment Tool Diagnostic Compliance and Assessment Tool A formal means to analyze and improve health care delivery systems Used for official documentation and monitoring grantees for legislative compliance and programmatic expectations Four distinct Modules Administrative Clinical Fiscal Health Management and Information Systems (HMIS)

9. Diagnostic Compliance and Assessment Visit Process Project Officer and Branch Chief identify grantee in need of a visit Establish a date with the grantee and select site visit team members with expertise in each area: Admin., Clinical, Fiscal and HMIS Pre-Site Visit Conference call Provide modules to the site to complete Request documents and personnel to be available to the team during the visit

10. Diagnostic Compliance and Assessment Visit Process The team visits the site (2-3 days) Chart Review Consumer Panel Site leadership, staff & stakeholders Document Review Holds a formal entrance and exit conference to share preliminary findings Team Leader finalizes report with Project officer HAB sends the formal report to the site and the grantee prepares a formal response

11. Diagnostic Compliance and Assessment Visit Process The final report and the grantee�s response then serve as a tool to work on outstanding problems or provide technical assistance (TA) when necessary The items in the tool are not scored but the findings are divided into three categories: Legislative Findings Programmatic Findings Best Practices Ideally, the tool is a stepping stone for capacity building and clinical improvements More challenging scenario: increased monitoring or recommend future funding decisions

12. The Challenge: Adapting the Tool for International Application How can USG sufficiently monitor international clinics supported by PEPFAR funds? Critical after 5 years of PEPFAR and reauthorization There are significant differences between US and international sites: International clinics are more limited in capacity Other entities play significant roles in PEPFAR including the funding and review process: Ministries of Health (MOH), international partners and other Federal agencies (CDC, USAID, State Department)

13. What the Site Visit Tool Is and Is Not A Quality Improvement (QI) vehicle A Guide but not a prescriptive checklist A Tool based on desired �standards� Includes open-ended questions at the beginning of each section Reviewers may develop their own question to facilitate the process Prioritize the most important sections of the tool Use core competency questions to gather information Determine appropriateness of the materials Trigger for �red flag� issues It is not a report card It is not the sole source of issues to be addressed

14. Challenging Questions for International Application What are the key components to be included in each module of the tool to allow flexibility from site to site without diminishing the tool�s effectiveness? Who are the appropriate people to conduct the site visits and how we can create capacity in each PEPFAR funded country? How to follow up and monitor the findings in order to assure improvement?

15. The Diagnostic Tool Adaptation Process Answering the three previous questions is a very long and involved process Success depends on finding a compromise between the tool�s specificity and feasibility Time burden on staff is also a factor Be mindful of the �yes� factor of site staff The tool shall be pilot tested before full implementation is considered A review of literature on clinical evaluation in international settings yields evidence based practices

16. Anticipated Program Impact Ideally, the new diagnostic tool at participating sites will result in: Improved quality of HIV care based on national guidelines and evidence based indicators Lower viral loads Increased CD4 counts Identification and increased focus on selected, important areas for TA Increased collaboration with MOH, other federal agencies and non-governmental partners A standardized approach to assessment visits across sites and countries

17. Responses to Challenging Questions Key Components of the tool: Involving the communities in outreach Efficient staff allocation and appropriate duties to minimize bottlenecks Support clients to remain in care HMIS-computerized for QI and Antiretroviral (ARV) inventory and scheduling Select certain indicators Organizational management Refer clients to support service organizations1

18. Responses to Challenging Questions The appropriate personnel to conduct site visits should have: Both domestic and international experience with Federally funded programs and reporting requirements Sensitivity to other cultural and environmental settings An understanding of the big picture and diplomatically collaborate with multiple agencies and organizations

19. Responses to Challenging Questions There is no evidence that scoring in evaluations such as these is necessarily a best practice. The critical issue is to: monitor the quality of services and make improvements to the clinic and to insure accountability for the donor agency2 The main outcome is to provide managers, administrators and policymakers with the information they need to improve HIV/AIDS care and treatment programs.3

20. Conclusion Formalizing clinical site visits integrates into health care services and the organizational culture Domestic and international partners continue to build on formal site visit efforts to ensure quality health care and Federal compliance Implementing the site visit tool internationally yields lessons learned from the US to developing countries and also vice versa making efficient use of limited resources facilitating capacity building at the facility and national level adaptability to different local settings where HIV/AIDS care and treatment services are provided

21. For More Information http://www.hab.hrsa.gov or telephone 888-ASK-HRSA CAPT Jose Rafael Morales, Chief Medical Officer HAB Global Program Tel. 301 443-3650 LCDR Matthew Newland Tel. 301 443-0296 Email: mnewland@hrsa.gov