HIV Prevention Trials Network Update Africa Regional Working Group 20 May 2003.
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Transcript of HIV Prevention Trials Network Update Africa Regional Working Group 20 May 2003.
HIV Prevention Trials NetworkHIV Prevention Trials NetworkUpdateUpdate
Africa Regional Working GroupAfrica Regional Working Group20 May 200320 May 2003
HPTN PurposeHPTN Purpose
Established in 1999 by NIH Consortium – Established in 1999 by NIH Consortium – NIAID, NICHD, NIMH, and NIDA, NIAID, NICHD, NIMH, and NIDA, including support from Fogarty and including support from Fogarty and OAR:OAR: To address a continuing unmet need in HIV To address a continuing unmet need in HIV
prevention science in six research areasprevention science in six research areas
To evaluate highest priority non-vaccine To evaluate highest priority non-vaccine HIV prevention approaches in diverse HIV prevention approaches in diverse settingssettings
HPTN UniquenessHPTN Uniqueness
HIV prevention endpointsHIV prevention endpoints
Worldwide clinical trials networkWorldwide clinical trials network
Multi-site, multi-trial capacityMulti-site, multi-trial capacity
Multidisciplinary approachMultidisciplinary approach
Oversight by NIH DSMB, and Oversight by NIH DSMB, and External Advisory GroupExternal Advisory Group
Science Science Development Development
and and PrioritizationPrioritization
Resource Resource MobilizatioMobilizatio
n and n and OptimizatiOptimizati
onon
SiteSitePreparation Preparation and Supportand Support
HPTN HPTN TRIALSTRIALS
The HPTN ComponentsThe HPTN Components
Identify, develop, and evaluate HIV Identify, develop, and evaluate HIV prevention interventions in six research prevention interventions in six research areasareas
Antiretrovirals for HIV PreventionAntiretrovirals for HIV Prevention
PerinatalPerinatal
MicrobicidesMicrobicides
STD Control for HIV PreventionSTD Control for HIV Prevention
BehavioralBehavioral
Substance UseSubstance Use
HPTN Scientific AgendaHPTN Scientific Agenda
19991999 20002000 20012001 2002 2002 20032003
HPTN Science Agenda - HPTN Science Agenda - EvolutionEvolution
Ongoing StudiesOngoing StudiesScience DevelopmentScience Development Science ImplementationScience Implementation
ApplicationApplication Site Site SelectionSelection New Protocol DevelopmentNew Protocol Development
New Study InitiationNew Study InitiationConcept Concept PrioritizationPrioritization
Leadership Leadership SelectionSelection
Capsule Capsule SelectionSelection
HPTN Key Accomplishments - 1HPTN Key Accomplishments - 1
10 HIVNET studies overseen10 HIVNET studies overseen 19 protocols developed19 protocols developed 15 studies in field since 199915 studies in field since 1999 9 studies completed9 studies completed 14,000 participants enrolled14,000 participants enrolled >90% participants retained>90% participants retained
HPTN Key Accomplishments - 2HPTN Key Accomplishments - 2
15 New international sites/subsites15 New international sites/subsites 12 AITRP (Fogarty) awards per year 12 AITRP (Fogarty) awards per year Research Ethics Guidance Research Ethics Guidance
DocumentDocument Community coordinators in all sitesCommunity coordinators in all sites Documented Good Clinical Documented Good Clinical
Practices (GCP) training in all sitesPractices (GCP) training in all sites
HPTN Central Laboratory (CL)
Johns Hopkins/Univ of Pittsburgh
HPTN Central Laboratory (CL)
Johns Hopkins/Univ of Pittsburgh
HPTN Coordinating and Operations Center
(CORE)
Family Health International
HPTN Coordinating and Operations Center
(CORE)
Family Health International
HPTN Statistical and Data
Management Center (SDMC)
FHCRC/UWash
HPTN Statistical and Data
Management Center (SDMC)
FHCRC/UWash
Central Leadership in HPTNCentral Leadership in HPTN
Site Leadership in HPTNSite Leadership in HPTN
BostonProvidenceNew YorkPhiladelphia
Birmingham
San FranciscoLos Angeles
Seattle
Perú
Brazil
Uganda
TanzaniaMalawi (2)
ZambiaZimbabwe
SouthAfrica
India (2)
Thailand
China (2)
Russia
HPTN GovernanceHPTN Governance
Executive Committee
Prevention Leadership Group
Perinatal
Microbicides
Behavioral STD Control
Antiretroviral
Substance Use
Community Working Group
Ethics Working Group
Science Working Groups
Structure of the CWGCWG Strategic Planning Meeting – Washington, DC, 02-2002
CWG15 members total
(2 Co-chairs, 6 RWG reps, 2 EC reps,and up to 5 Additional Members)
Americas(2)
Africa(2) Eurasia
(2)
HPTN ExecutiveCommittee
Additional Members:• Ex-officio Advisors (3-5)
Ethics Legal Social Sciences
• Representative to EC (2)
Activities of RWGs & CWG are supported by the HPTN Community Involvement Program (CIP) staff
METHODS OF COMMUNICATION• CWG monthly/bi-monthly calls• Annual face-to-face Meeting
MENTORING, TRAINING, FACILITATION• Meet annually• Regional Calls
REGIONAL MEMBERS:CAB Members , PIs, Site coordinators, CEs
GOAL: Advocate, Empower, Take Action, Build Capacity, Provide Technical Assistance
Advisors• from SWGs and Protocol
Teams will participate in periodic scientific updates
Regional Working Groups (RWGs)
Science flows from SWG foundationScience flows from SWG foundation
Priorities established by Executive Priorities established by Executive CommitteeCommittee
Network QA for scientific excellence Network QA for scientific excellence via 3 standing committeesvia 3 standing committees
Network reviews staged to study Network reviews staged to study progressprogress
HPTN Scientific Processes – HPTN Scientific Processes – Internal GoalsInternal Goals
Executive Committee (EC) members Executive Committee (EC) members applied these criteria to each concept applied these criteria to each concept to arrive at HPTN prioritiesto arrive at HPTN priorities
Scientific meritScientific merit
Public health impactPublic health impact
Research advantage of the HPTNResearch advantage of the HPTN
HPTN Scientific Prioritization – HPTN Scientific Prioritization – CriteriaCriteria
HPTN Science DevelopmentHPTN Science Development
7 “Go” protocols7 “Go” protocols4 pipeline 4 pipeline
5 Preparedness protocols5 Preparedness protocols1 HIVNET protocol1 HIVNET protocol2 Discretionary fund protocols2 Discretionary fund protocols
May 2001May 2001October 2000October 2000
26 capsules 26 capsules From the SWGFrom the SWG
13 concepts13 conceptsFrom the SWGFrom the SWG
HPTN Scientific Quality AssuranceHPTN Scientific Quality Assurance
Science Implementation
Science Dissemination
Science Development
Protocol Review
Committee
Prevention Leadership Group
Executive Committee
Study Monitoring Committee
Manuscript Review
Committee
Infrastructure Building - SitesInfrastructure Building - Sites
$160M to global sites over past decade$160M to global sites over past decade 5 preparedness studies at 13 sites to assure 5 preparedness studies at 13 sites to assure
site operational qualitysite operational quality Fogarty training linkFogarty training link Laboratory training, specimen tracking, Laboratory training, specimen tracking,
storage and shipmentstorage and shipment Internet connectivity and data management Internet connectivity and data management
systemsystem
Infrastructure Building – Infrastructure Building – Ethics/CommunityEthics/Community
Ethical challenges of US-sponsored research Ethical challenges of US-sponsored research in resource-poor countriesin resource-poor countries
HPTN Ethics Guidance DocumentHPTN Ethics Guidance Document Synthesize emerging ethical thinking Synthesize emerging ethical thinking Establish practical procedures for meeting Establish practical procedures for meeting
ethical challenges within HPTNethical challenges within HPTN Enhance and support Community Advisory Enhance and support Community Advisory
Boards at each site, plus 3 Regional Working Boards at each site, plus 3 Regional Working GroupsGroups
Current FY’03 funding - $64MCurrent FY’03 funding - $64M
Supplemental request to NIHSupplemental request to NIH
RO1 supportRO1 support
USAID supportUSAID support
Pharmaceutical supportPharmaceutical support
HPTN Resource Mobilization – HPTN Resource Mobilization – January ‘03January ‘03
HIVNET/HPTN Studies HIVNET/HPTN Studies Completed with HPTN Completed with HPTN
OversightOversight007 016 pilot (3)
USA
Zambia
012
032
020 (4) 023 (2) 025 028 (5)
Zimbabwe
Uganda
Malawi
South Africa
India Thailand
013 (3)
Ongoing/Planned Studies – 2003 Ongoing/Planned Studies – 2003 and Beyondand Beyond
USA015 (6)
035 037
039 (2)049 (4)050 (3)
056
Perú036
039 (2)Brazil040052
Russia
033Zambia
024035 (2)039 (2)
054055 (2)
Zimbabwe
016A (2)035 (2)
039043046052
Malawi016A (2)024
035 (2)052 (2)
Tanzania
024035043046055
So. Africa
035 (2)043046
055 (2)
Uganda
012027046054
China
033 (2)
Thailand
037043052
India033034035047
052 (2)
Network capacity to support large trials Network capacity to support large trials
Product availability for key trialsProduct availability for key trials
Meeting GCP standards across sitesMeeting GCP standards across sites
Laboratory quality in impoverished Laboratory quality in impoverished settingssettings
HPTN Challenges in 2003HPTN Challenges in 2003
Unmet need for state of the art HIV Unmet need for state of the art HIV prevention scienceprevention science
Internal quality assurance for scientific Internal quality assurance for scientific excellenceexcellence
Flagship Network for building Flagship Network for building international HIV research activitiesinternational HIV research activities
Registrational standards being appliedRegistrational standards being applied
ConclusionsConclusions