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