Multidisciplinary Site Multidisciplinary Site Development and Clinical Development and Clinical

Care Working Group ReportCare Working Group Report

28 July 200428 July 2004

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ACCOMPLISHMENTSACCOMPLISHMENTS

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ACCOMPLISHMENTS OVER ACCOMPLISHMENTS OVER PAST YEARPAST YEAR

One urban site - 1 Military Hospital – is open and One urban site - 1 Military Hospital – is open and seeing on average 30 patients per dayseeing on average 30 patients per day

One rural site – Mtubatuba Sickbay – is open One rural site – Mtubatuba Sickbay – is open and seeing on average 8 patients per dayand seeing on average 8 patients per day

Resources at two other sites – 2 Military Hospital Resources at two other sites – 2 Military Hospital and Umtata have been increased so that they and Umtata have been increased so that they should open within the next three monthsshould open within the next three months

Site PIs have begun to have weekly conference Site PIs have begun to have weekly conference callscalls

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ACCOMPLISHMENTS OVER ACCOMPLISHMENTS OVER PAST YEARPAST YEAR

The format for Site Standard Operating The format for Site Standard Operating Procedures has been established and 1 Mil, Procedures has been established and 1 Mil, Mtubatuba and 2 Mil are well on their way to Mtubatuba and 2 Mil are well on their way to completing them:completing them: Part I: Site Specific ProceduresPart I: Site Specific Procedures

clinic schedule, staff contact information, staff coverage clinic schedule, staff contact information, staff coverage policies, hospital admissions, etc.policies, hospital admissions, etc.

Part II: Protocol Manual of OperationsPart II: Protocol Manual of Operations Specific information for performing each protocolSpecific information for performing each protocol Developed by DMCOC Regulatory SectionDeveloped by DMCOC Regulatory Section

Part III: Phidisa PoliciesPart III: Phidisa Policies Travel, cell phone, etc.Travel, cell phone, etc.

Part IV: Staff Position DescriptionsPart IV: Staff Position Descriptions

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ACCOMPLISHMENTS DURING ACCOMPLISHMENTS DURING THIS CONFERENCETHIS CONFERENCE

Phidisa Site Governance:Phidisa Site Governance:

Site PrincipalInvestigator

SocialWorker

CommunityWorkerPharmacist

Site NurseCoordinator

Dietician PsychologistChaplain LaboratoryTechnician

SiteAdministrator

ReceptionistNurse CaseManager(s) Secretary

LaboratoryAssistant

Essential Site Personnel (SANDF or Ngidi )

Essential SANDF PersonnelOptional Site Personnel

(SANDF or Ngidi)

MedicalOfficer(s)

PharmacyAssistant

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ACCOMPLISHMENTS DURING ACCOMPLISHMENTS DURING THIS CONFERENCETHIS CONFERENCE

Site Position DescriptionsSite Position Descriptions Site Position Descriptions have been reviewed Site Position Descriptions have been reviewed

and approved by this groupand approved by this group Additional Site Position Descriptions are being Additional Site Position Descriptions are being

written, and final drafts will be available on written, and final drafts will be available on Thursday 29 July:Thursday 29 July:

Social WorkerSocial Worker PsychologistPsychologist DieticianDietician ChaplainChaplain Community WorkerCommunity Worker

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GOALS OVER GOALS OVER NEXT YEARNEXT YEAR

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OPEN FOUR REMAINING OPEN FOUR REMAINING PHIDISA SITESPHIDISA SITES

2 Military to open 6 September 20042 Military to open 6 September 2004 Umtata to open 4 October 2004Umtata to open 4 October 2004

Both sites will complete Phases 2 and 3 of “Development of Both sites will complete Phases 2 and 3 of “Development of New Phidisa Sites” guidelines (document to be submitted to New Phidisa Sites” guidelines (document to be submitted to EC) before these datesEC) before these dates

Bloemfontein and PhalaborwaBloemfontein and Phalaborwa Site PIs will communicate with Site Development Working Site PIs will communicate with Site Development Working

Group and commence Phase 1 (Assessment of Current Site Group and commence Phase 1 (Assessment of Current Site Status) of the “Development of New Phidisa Sites” by 1 Status) of the “Development of New Phidisa Sites” by 1 November 2004November 2004

Timelines for Phase 2 (Closing the Gap of Needs) and Timelines for Phase 2 (Closing the Gap of Needs) and Phase 3 (Site Initiation and Program Roll out) will depend Phase 3 (Site Initiation and Program Roll out) will depend upon the needs found in the Phase 1 assessmentupon the needs found in the Phase 1 assessment

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OPEN FOUR REMAINING OPEN FOUR REMAINING PHIDISA SITESPHIDISA SITES

Rural Site ConsiderationsRural Site Considerations The group discussed the challenges of :The group discussed the challenges of :

Clinical care related to study participants traveling from Clinical care related to study participants traveling from remote areas to rural study sites remote areas to rural study sites

Staff recruitment and retention at rural study sitesStaff recruitment and retention at rural study sites Study participant recruitment and retention at rural Study participant recruitment and retention at rural

study sitesstudy sites

The group recognizes that DMCOC Deputy The group recognizes that DMCOC Deputy Director for Clinical Affairs is preparing a Director for Clinical Affairs is preparing a summary of options for the DMCOC Director to summary of options for the DMCOC Director to address these issuesaddress these issues

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COMPLETE SOPs and PDsCOMPLETE SOPs and PDs

SOPsSOPs 1 Military, Mtubatuba and 2 Military will complete their SOPs 1 Military, Mtubatuba and 2 Military will complete their SOPs

by 1 September 2004by 1 September 2004 Umtata will complete its SOPs prior to the Site Initiation VisitUmtata will complete its SOPs prior to the Site Initiation Visit Bloemfontein and Phalaborwa will begin their SOPs and Bloemfontein and Phalaborwa will begin their SOPs and

complete them prior to the Site Initiation Visitcomplete them prior to the Site Initiation Visit

PDs: The group PDs: The group requestsrequests that: that: All PDs be completed and submitted to the EC by 15 All PDs be completed and submitted to the EC by 15

August; and thatAugust; and that The EC approve a final version of the PDs by 1 September The EC approve a final version of the PDs by 1 September

so that they can be signed by all Phidisa personnel so that they can be signed by all Phidisa personnel (particularly new personnel at 2 Mil and Umtata)(particularly new personnel at 2 Mil and Umtata)

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INCREASE ENROLLMENTINCREASE ENROLLMENT Projected Enrollment over next year:Projected Enrollment over next year:

SITESITE Current Number Current Number of Daily Visitsof Daily Visits

Goal Daily Visits Goal Daily Visits (new + follow-(new + follow-

ups)ups)

Goal Annual New Goal Annual New EnrollmentEnrollment

1 Military1 Military 3030 4040P1: 1600P1: 1600

P2: 400P2: 400

MtubatubaMtubatuba 88 1515P1: 750P1: 750

P2: 150P2: 150

2 Military2 Military n/an/a 1010P1: 800P1: 800

P2: 150P2: 150

UmtataUmtata n/an/a 1010P1: 750P1: 750

P2: 150P2: 150

BloemfonteinBloemfontein n/an/a 1010P1: 70/month*P1: 70/month*

P2: 10/month*P2: 10/month*

PhalaborwaPhalaborwa n/an/a 1010P1: 70/month*P1: 70/month*

P2: 10/month*P2: 10/month*

* Once sites are open to enrollment

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Phidisa Sites and SAMHSPhidisa Sites and SAMHS

Increase “buy-in” from appropriate SANDF infrastructureIncrease “buy-in” from appropriate SANDF infrastructure 1-, 2- Mil an Bloemfontein to get service agreements with relevant 1-, 2- Mil an Bloemfontein to get service agreements with relevant

servicesservices All Site PIs to attend monthly meetings with their respective OICs, OCs All Site PIs to attend monthly meetings with their respective OICs, OCs

and SO1 to update them on the progress and needs of the projectand SO1 to update them on the progress and needs of the project Rotate SAMHS doctors through Phidisa clinicsRotate SAMHS doctors through Phidisa clinics

Each site will develop a structured teaching curriculum to educate Each site will develop a structured teaching curriculum to educate rotating physicians on HIV, AIDS and clinical researchrotating physicians on HIV, AIDS and clinical research

Each site will work to accredit the rotation for CPD pointsEach site will work to accredit the rotation for CPD points Phidisa doctors and nurses will attend ward roundsPhidisa doctors and nurses will attend ward rounds

Each site will send a doctor and nurse to all inpatient rounds (Internal Each site will send a doctor and nurse to all inpatient rounds (Internal Medicine and Infectious Diseases) and – as possible – to other Medicine and Infectious Diseases) and – as possible – to other meetings such as journal clubs, departmental meetingsmeetings such as journal clubs, departmental meetings

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Phidisa Sites and DMCOCPhidisa Sites and DMCOC

The Working Group The Working Group requestsrequests open, consistent and clear open, consistent and clear lines of communication between all sites and DMCOC:lines of communication between all sites and DMCOC: An every two-week newsletter from DMCOC to all Phidisa staff An every two-week newsletter from DMCOC to all Phidisa staff

summarizing all important events related to Phidisa, including:summarizing all important events related to Phidisa, including: Critical personnel changes (site and DMCOC)Critical personnel changes (site and DMCOC) Policy changesPolicy changes Protocol progressProtocol progress

Access to EC meeting minutes, or relevant EC meeting outcomes Access to EC meeting minutes, or relevant EC meeting outcomes (posted on website or emailed)(posted on website or emailed)

A current Phidisa personnel directory containing contact A current Phidisa personnel directory containing contact information (posted on website or emailed)information (posted on website or emailed)

DMCOC SOPs outlining timelines for response to site queries, and DMCOC SOPs outlining timelines for response to site queries, and next steps if timelines are not metnext steps if timelines are not met

When requested, sites will provide the DMCOC Communication When requested, sites will provide the DMCOC Communication Section with site information in a timely fashionSection with site information in a timely fashion

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups Among Phidisa Sites/Role Groups

(1)(1)

Site Principal Investigators/Physicians:Site Principal Investigators/Physicians: Conference callConference call

Every two weeks: 1Every two weeks: 1stst and 3 and 3rdrd Mondays at 1830 Mondays at 1830 Chair: DMCOC Chief Medical OfficerChair: DMCOC Chief Medical Officer Participants: Site PIs and other physicians as necessaryParticipants: Site PIs and other physicians as necessary Content: 30 minutes clinical issues, 30 minutes administrativeContent: 30 minutes clinical issues, 30 minutes administrative

Site PI ConferenceSite PI Conference Every four months (to coincide with National HIV Clinicians Every four months (to coincide with National HIV Clinicians

meetings when possible)meetings when possible) Chair: Rotating among PIsChair: Rotating among PIs Participants: Site PIs, DMCOC Deputy Director for Clinical Participants: Site PIs, DMCOC Deputy Director for Clinical

Operations, Chief Medical Officer, Medical Monitor and other Operations, Chief Medical Officer, Medical Monitor and other physicians as necessary. physicians as necessary.

One meeting annually will be a joint Site PI and SC conferenceOne meeting annually will be a joint Site PI and SC conference

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups Among Phidisa Sites/Role Groups

(2)(2)

Site Nurse Coordinators:Site Nurse Coordinators: Conference callConference call

Thursdays at 1400Thursdays at 1400 Chair: Starting with 1 Mil Site SCChair: Starting with 1 Mil Site SC Participants: Site SCs and other nurses as necessaryParticipants: Site SCs and other nurses as necessary Content: clinical, administrative and protocol issuesContent: clinical, administrative and protocol issues

Joint Site PI/SC ConferenceJoint 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 PIsChair: Rotating among PIs Participants: Site PIs, Site Nurse Coordinator DMCOC Deputy Participants: Site PIs, Site Nurse Coordinator DMCOC Deputy

Director for Clinical Operations, Chief Medical Officer, Medical Director for Clinical Operations, Chief Medical Officer, Medical Monitor and other physicians and nurses as necessaryMonitor and other physicians and nurses as necessary

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups Among Phidisa Sites/Role Groups

(3)(3) Social Workers:Social Workers:

Conference callConference call Wednesdays at 1300Wednesdays at 1300 Chair: Ms. BiyelaChair: Ms. Biyela Participants: Social WorkersParticipants: Social Workers Content: relevant study participant issuesContent: relevant study participant issues

Other Site role groups to consider having Other Site role groups to consider having conference calls if needed, but increased conference calls if needed, but increased communication (email, telephone calls) will communication (email, telephone calls) will be promotedbe promoted

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Among Phidisa Sites/Role Groups Among Phidisa Sites/Role Groups

(4)(4)

The group The group requestsrequests that, at each annual that, at each annual Phidisa conference, time be allotted for site Phidisa conference, time be allotted for site role group meetingsrole group meetings

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

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IMPROVE COMMUNICATIONS: IMPROVE COMMUNICATIONS: Within a SiteWithin a Site

Each site will have, at minimum:Each site will have, at minimum: One weekly administrative/management One weekly administrative/management

meeting to include the Site PI, SC and meeting to include the Site PI, SC and AdministratorAdministrator

One weekly didactic meeting to train all clinical One weekly didactic meeting to train all clinical staff on aspects of HIV/AIDS, clinical research, staff on aspects of HIV/AIDS, clinical research, internal medicine, etc.internal medicine, etc.

One weekly interdisciplinary meeting to discuss One weekly interdisciplinary meeting to discuss patient issuespatient issues

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RESOURCES AND RESOURCES AND BUDGETSBUDGETS

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Personnel RequirementsPersonnel RequirementsRole GroupRole Group 1 Mil1 Mil MtubatubaMtubatuba 2 Mil2 Mil

PhysicianPhysician 3 (2)3 (2) 3 (1)3 (1) 5 rotating (5)5 rotating (5)

NursesNurses 6 6 registeredregistered (4) (4)

2 2 enrolledenrolled (0) (0)

5 5 registeredregistered (3) (3)

1 1 enrolledenrolled (0) (0)

3 3 registeredregistered (1) (1)

1 1 enrolledenrolled (0) (0)

LaboratoryLaboratory 4 (2)4 (2) 2 (1)2 (1) 2 (0)2 (0)

PharmacistPharmacist 3 (2)3 (2) 2 (1)2 (1) 2 (1)2 (1)

Social WorkerSocial Worker 1 (1)1 (1) 1 (1)1 (1) 1 (1)1 (1)

ChaplainChaplain 1 (1)1 (1) 1 (1)1 (1) 1 (1)1 (1)

DieticianDietician 1 (0)1 (0) 1 (1)1 (1) 1 (1)1 (1)

PsychologistPsychologist 1 (1)1 (1) 1 (1)1 (1) 1 (1)1 (1)

Com. WorkerCom. Worker 4 (4)4 (4) 4 (3)4 (3) 0 (0)0 (0)

AdministratorAdministrator 1 (1)1 (1) 1 (1)1 (1) 1 (0)1 (0)

SecretarySecretary 1 (0)1 (0) 1 (1)1 (1) 1 (1)1 (1)

ReceptionistReceptionist 1 (0)1 (0) 1 (1)1 (1) 1 (1)1 (1)

( )=current number in role

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Personnel RequirementsPersonnel RequirementsRole GroupRole Group UmtataUmtata BloemfonteinBloemfontein PhalaborwaPhalaborwa

PhysicianPhysician 2.5 (1)2.5 (1) 2.5 (1)2.5 (1) 2.5 (1)2.5 (1)

NursesNurses 4 4 registeredregistered (1) (1)

2 2 enrolledenrolled (0) (0)

2 2 registeredregistered (1) (1)

2 2 enrolledenrolled (0) (0)

2 2 registeredregistered (0) (0)

2 2 enrolledenrolled (0) (0)

LaboratoryLaboratory 2 (0)2 (0) 2 (0)2 (0) 2 (0)2 (0)

PharmacistPharmacist 2 (0)2 (0) 1 (0)1 (0) 1 (0)1 (0)

Social WorkerSocial Worker 1 (1)1 (1) 1 (1)1 (1) 1 (1)1 (1)

ChaplainChaplain 1 (1)1 (1) 1 (0)1 (0) 1 (0)1 (0)

DieticianDietician 1 (1)1 (1) 1 (0)1 (0) 1 (1)1 (1)

PsychologistPsychologist 1 (1)1 (1) 1 (1)1 (1) 1 (0)1 (0)

Com. WorkerCom. Worker 4 (4)4 (4) 3 (0)3 (0) 3 (3)3 (3)

AdministratorAdministrator 1 (0)1 (0) 1 (0)1 (0) 1 (0)1 (0)

SecretarySecretary 1 (0)1 (0) 1 (0)1 (0) 1 (0)1 (0)

ReceptionistReceptionist 1 (0)1 (0) 1 (0)1 (0) 1 (0)1 (0)

( )=current number in role

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BudgetsBudgets

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