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

2. 2 ACCOMPLISHMENTS

3. 3 ACCOMPLISHMENTS OVER PAST YEAR One urban site - 1 Military Hospital – is open and seeing on average 30 patients per day 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 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 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 Site PIs have begun to have weekly conference calls

4. 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: 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 Part I: Site Specific Procedures clinic schedule, staff contact information, staff coverage policies, hospital admissions, etc. clinic schedule, staff contact information, staff coverage policies, hospital admissions, etc. Part II: Protocol Manual of Operations Part II: Protocol Manual of Operations Specific information for performing each protocol Specific information for performing each protocol Developed by DMCOC Regulatory Section Developed by DMCOC Regulatory Section Part III: Phidisa Policies Part III: Phidisa Policies Travel, cell phone, etc. Travel, cell phone, etc. Part IV: Staff Position Descriptions Part IV: Staff Position Descriptions

5. 5 ACCOMPLISHMENTS DURING THIS CONFERENCE Phidisa Site Governance:

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

7. 7 GOALS OVER NEXT YEAR

8. 8 OPEN FOUR REMAINING PHIDISA SITES 2 Military to open 6 September 2004 2 Military to open 6 September 2004 Umtata to open 4 October 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 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 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 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 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. 9 OPEN FOUR REMAINING PHIDISA SITES Rural Site Considerations Rural Site Considerations The group discussed the challenges of : The group discussed the challenges of : Clinical care related to study participants traveling from remote areas to rural study sites Clinical care related to study participants traveling from remote areas to rural study sites Staff recruitment and retention at rural study sites Staff recruitment and retention at rural study sites Study participant 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 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. 10 COMPLETE SOPs and PDs SOPs SOPs 1 Military, Mtubatuba and 2 Military will complete their SOPs by 1 September 2004 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 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 Bloemfontein and Phalaborwa will begin their SOPs and complete them prior to the Site Initiation Visit PDs: The group requests that: PDs: The group requests that: All PDs be completed and submitted to the EC by 15 August; and 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) 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. 11 INCREASE ENROLLMENT Projected Enrollment over next year: Projected Enrollment over next year: SITE Current Number of Daily Visits Goal Daily Visits (new + follow- ups) Goal Annual New Enrollment 1 Military 3040 P1: 1600 P2: 400 Mtubatuba815 P1: 750 P2: 150 2 Military n/a10 P1: 800 P2: 150 Umtatan/a10 P1: 750 P2: 150 Bloemfonteinn/a10 P1: 70/month* P2: 10/month* Phalaborwan/a10 P1: 70/month* P2: 10/month* * Once sites are open to enrollment

12. 12 IMPROVE COMMUNICATIONS: Phidisa Sites and SAMHS Increase buy-in from appropriate SANDF infrastructure Increase buy-in from appropriate SANDF infrastructure 1-, 2- Mil an Bloemfontein to get service agreements with relevant services 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 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 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 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 Each site will work to accredit the rotation for CPD points Phidisa doctors and nurses will attend ward rounds 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 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. 13 IMPROVE COMMUNICATIONS: Phidisa Sites and DMCOC The Working Group requests open, consistent and clear lines of communication between all 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: 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) Critical personnel changes (site and DMCOC) Policy changes Policy changes Protocol progress Protocol progress Access to EC meeting minutes, or relevant EC meeting outcomes (posted on website or emailed) 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) 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 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 When requested, sites will provide the DMCOC Communication Section with site information in a timely fashion

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

15. 15 IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (2) Site Nurse Coordinators: Site Nurse Coordinators: Conference call Conference call Thursdays at 1400 Thursdays at 1400 Chair: Starting with 1 Mil Site SC Chair: Starting with 1 Mil Site SC Participants: Site SCs and other nurses as necessary Participants: Site SCs and other nurses as necessary Content: clinical, administrative and protocol issues Content: clinical, administrative and protocol issues Joint Site PI/SC Conference Joint Site PI/SC Conference Attend one joint site PI and SC conference annually Attend one joint site PI and SC conference annually Chair: Rotating among PIs 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 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. 16 IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups (3) Social Workers: Social Workers: Conference call Conference call Wednesdays at 1300 Wednesdays at 1300 Chair: Ms. Biyela Chair: Ms. Biyela Participants: Social Workers Participants: Social Workers Content: relevant study participant issues 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 Other Site role groups to consider having conference calls if needed, but increased communication (email, telephone calls) will be promoted

17. 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 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 Each role group will submit an agenda to the DMCOC Deputy Director for Clinical Operations prior to the annual Phidisa conference

18. 18 IMPROVE COMMUNICATIONS: Within a Site Each site will have, at minimum: Each site will have, at minimum: One weekly administrative/management meeting to include the Site PI, SC and Administrator 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 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 One weekly interdisciplinary meeting to discuss patient issues

19. 19 RESOURCES AND BUDGETS

20. 20 Personnel Requirements Role Group 1 Mil Mtubatuba 2 Mil Physician 3 (2) 3 (1) 5 rotating (5) Nurses 6 registered (4) 2 enrolled (0) 5 registered (3) 1 enrolled (0) 3 registered (1) 1 enrolled (0) Laboratory 4 (2) 2 (1) 2 (0) Pharmacist 3 (2) 2 (1) Social Worker 1 (1) Chaplain Dietician 1 (0) 1 (1) Psychologist Com. Worker 4 (4) 4 (3) 0 (0) Administrator 1 (1) 1 (0) Secretary 1 (1) Receptionist 1 (0) 1 (1) ( )=current number in role

21. 21 Personnel Requirements Role Group UmtataBloemfonteinPhalaborwa Physician 2.5 (1) Nurses 4 registered (1) 2 enrolled (0) 2 registered (1) 2 enrolled (0) 2 registered (0) 2 enrolled (0) Laboratory 2 (0) Pharmacist 1 (0) Social Worker 1 (1) Chaplain 1 (0) Dietician 1 (1) 1 (0) 1 (1) Psychologist 1 (0) Com. Worker 4 (4) 3 (0) 3 (3) Administrator 1 (0) Secretary Receptionist ( )=current number in role

22. 22Budgets 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 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