Multidisciplinary Site Development and Clinical Care Working Group Report

1. Multidisciplinary Site Development and Clinical Care Working Group Report 28 July 2004

2. ACCOMPLISHMENTS

3. ACCOMPLISHMENTS OVER PAST YEAR • One urban site - 1 Military Hospital – is open and seeing on average 30 patients per day • One rural site – Mtubatuba Sickbay – is open and seeing on average 8 patients per day • Resources at two other sites – 2 Military Hospital and Umtata have been increased so that they should open within the next three months • Site PIs have begun to have weekly conference calls

4. ACCOMPLISHMENTS OVER PAST YEAR • The format for Site Standard Operating Procedures has been established and 1 Mil, Mtubatuba and 2 Mil are well on their way to completing them: • Part I: Site Specific Procedures • clinic schedule, staff contact information, staff coverage policies, hospital admissions, etc. • Part II: Protocol Manual of Operations • Specific information for performing each protocol • Developed by DMCOC Regulatory Section • Part III: Phidisa Policies • Travel, cell phone, etc. • Part IV: Staff Position Descriptions

5. ACCOMPLISHMENTS DURING THIS CONFERENCE Phidisa Site Governance:

6. ACCOMPLISHMENTS DURING THIS CONFERENCE • Site Position Descriptions • Site Position Descriptions have been reviewed and approved by this group • Additional Site Position Descriptions are being written, and final drafts will be available on Thursday 29 July: • Social Worker • Psychologist • Dietician • Chaplain • Community Worker

7. GOALS OVER NEXT YEAR

8. OPEN FOUR REMAINING PHIDISA SITES • 2 Military to open 6 September 2004 • Umtata to open 4 October 2004 • Both sites will complete Phases 2 and 3 of “Development of New Phidisa Sites” guidelines (document to be submitted to EC) before these dates • Bloemfontein and Phalaborwa • Site PIs will communicate with Site Development Working Group and commence Phase 1 (Assessment of Current Site Status) of the “Development of New Phidisa Sites” by 1 November 2004 • Timelines for Phase 2 (Closing the Gap of Needs) and Phase 3 (Site Initiation and Program Roll out) will depend upon the needs found in the Phase 1 assessment

9. OPEN FOUR REMAINING PHIDISA SITES • Rural Site Considerations • The group discussed the challenges of : • Clinical care related to study participants traveling from remote areas to rural study sites • Staff recruitment and retention at rural study sites • Study participant recruitment and retention at rural study sites • The group recognizes that DMCOC Deputy Director for Clinical Affairs is preparing a summary of options for the DMCOC Director to address these issues

10. COMPLETE SOPs and PDs • SOPs • 1 Military, Mtubatuba and 2 Military will complete their SOPs by 1 September 2004 • Umtata will complete its SOPs prior to the Site Initiation Visit • Bloemfontein and Phalaborwa will begin their SOPs and complete them prior to the Site Initiation Visit • PDs: The group requests that: • All PDs be completed and submitted to the EC by 15 August; and that • The EC approve a final version of the PDs by 1 September so that they can be signed by all Phidisa personnel (particularly new personnel at 2 Mil and Umtata)

11. INCREASE ENROLLMENT • Projected Enrollment over next year: * Once sites are open to enrollment

12. IMPROVE COMMUNICATIONS: Phidisa Sites and SAMHS • Increase “buy-in” from appropriate SANDF infrastructure • 1-, 2- Mil an Bloemfontein to get service agreements with relevant services • All Site PIs to attend monthly meetings with their respective OICs, OCs and SO1 to update them on the progress and needs of the project • Rotate SAMHS doctors through Phidisa clinics • Each site will develop a structured teaching curriculum to educate rotating physicians on HIV, AIDS and clinical research • Each site will work to accredit the rotation for CPD points • Phidisa doctors and nurses will attend ward rounds • Each site will send a doctor and nurse to all inpatient rounds (Internal Medicine and Infectious Diseases) and – as possible – to other meetings such as journal clubs, departmental meetings

13. IMPROVE COMMUNICATIONS: Phidisa Sites and DMCOC • The Working Group requests open, consistent and clear lines of communication between all sites and DMCOC: • An every two-week newsletter from DMCOC to all Phidisa staff summarizing all important events related to Phidisa, including: • Critical personnel changes (site and DMCOC) • Policy changes • Protocol progress • Access to EC meeting minutes, or relevant EC meeting outcomes (posted on website or emailed) • A current Phidisa personnel directory containing contact information (posted on website or emailed) • DMCOC SOPs outlining timelines for response to site queries, and next steps if timelines are not met • When requested, sites will provide the DMCOC Communication Section with site information in a timely fashion

14. IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (1) • Site Principal Investigators/Physicians: • Conference call • Every two weeks: 1st and 3rd Mondays at 1830 • Chair: DMCOC Chief Medical Officer • Participants: Site PIs and other physicians as necessary • Content: 30 minutes clinical issues, 30 minutes administrative • Site PI Conference • Every four months (to coincide with National HIV Clinicians meetings when possible) • Chair: Rotating among PIs • Participants: Site PIs, DMCOC Deputy Director for Clinical Operations, Chief Medical Officer, Medical Monitor and other physicians as necessary. • One meeting annually will be a joint Site PI and SC conference

15. IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (2) • Site Nurse Coordinators: • Conference call • Thursdays at 1400 • Chair: Starting with 1 Mil Site SC • Participants: Site SCs and other nurses as necessary • Content: clinical, administrative and protocol issues • Joint Site PI/SC Conference • Attend one joint site PI and SC conference annually • Chair: Rotating among PIs • Participants: Site PIs, Site Nurse Coordinator DMCOC Deputy Director for Clinical Operations, Chief Medical Officer, Medical Monitor and other physicians and nurses as necessary

16. IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (3) • Social Workers: • Conference call • Wednesdays at 1300 • Chair: Ms. Biyela • Participants: Social Workers • Content: relevant study participant issues • Other Site role groups to consider having conference calls if needed, but increased communication (email, telephone calls) will be promoted

17. IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (4) • The group requests that, at each annual Phidisa conference, time be allotted for site role group meetings • Each role group will submit an agenda to the DMCOC Deputy Director for Clinical Operations prior to the annual Phidisa conference

18. IMPROVE COMMUNICATIONS: Within a Site • Each site will have, at minimum: • One weekly administrative/management meeting to include the Site PI, SC and Administrator • One weekly didactic meeting to train all clinical staff on aspects of HIV/AIDS, clinical research, internal medicine, etc. • One weekly interdisciplinary meeting to discuss patient issues

19. RESOURCES AND BUDGETS

20. Personnel Requirements ( )=current number in role

21. Personnel Requirements ( )=current number in role

22. Budgets • Each Site PI is working with the HJF Project Coordinator to produce annual budgets which will be submitted to the EC on Thursday 29 July