HIV Prevention Research: DAIDS and the New Clinical Research Trial Networks

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HIV Prevention ResearchDAIDS and the New
Clinical Research Trial Networks

• Community HIV/AIDS Mobilization Project
• Strategy Lab for HIV Prevention Policy

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Division of AIDS (DAIDS), NIAID

• DAIDS is reorganizing its HIV/AIDS research
• networks to
• Create a consortium of linked trial networks
• Coordinate activities across a broad range of
  clinical research activities
• Increase efficiency through resource sharing
• Increase flexibly to allocate and distribute
  resources in response to priority research
  opportunities
• Leverage complementary strengths and resources
  within and outside the networks

Source http//grants1.nih.gove/grants/guide/rfa-
files/RFA-AI-05-001.html
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New DAIDS Research Networks

• Prevention Networks
• HPTN (HIV Prevention Trials Network)
• HVTN (HIV Vaccine Trials Network)
• IMPAACT (International Maternal Pediatric
  Adolescent AIDS Clinical Trials Group)
• MTN (Microbicide Trials Network)
• Treatment networks (not discussed in this
  presentation)
• ACTG (AIDS Clinical Trials Group)
• INSIGHT (International Network for Strategic
  Initiatives in Global HIV Trials)

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Source Sandra Nusinoff Lehrman, M.D. DAIDS and
the Clinical Trials Groups Evolving
Partnerships presentation. March 28, 2007
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The New Structure Pieces of the Puzzle
Source Sandra Nusinoff Lehrman presentation at
IPMAACT Conference. March 28,2007
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Community Participation in New Research Structure
Goal To incorporate community reps. at each
level of the networks
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New DAIDS Research Networks

• Prevention Research Networks
• HPTN (HIV Prevention Trials Network)
• HVTN (HIV Vaccine Trials Network)
• IMPAACT (International Maternal Pediatric
  Adolescent AIDS Clinical Trials Group)
• MTN (Microbicide Trials Network)

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HIV Prevention Trials Network (HPTN)

• Research focus Evaluating non-vaccine HIV
  prevention strategies
• PI Sten Vermund, M.D., PhD
• Headquarters Vanderbilt University, Nashville
• HPTN has shrunk in size under new structure 6
  trials have shifted to other networks (2 trials
  to MTN and 4 to IMPAACT)
• Challenge Need compelling research agenda to
  compete with other networks for limited funding
• -Sten Vermund

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HPTN Research Site Locations
Boston New York (3) Los Angeles Birmingham Philade
lphia (2) Providence (2) San Francisco Seattle
USA
China
India
Thailand
Uganda
Tanzania
Malawi
Perú
Brazil
Zambia
Zimbabwe
South Africa
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Ongoing HPTN Studies
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Ongoing HPTN Studies cont.
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Ongoing HPTN Studies cont.
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HPTN Community Involvement Structure
Regional Working Groups (RWGs)
REGIONAL MEMBERS CAB Members , PIs, Site
coordinators, CEs

• MENTORING, TRAINING, FACILITATION
• Meet annually
• Regional Calls

Africa (2)
Americas (2)
Eurasia (2)

• METHODS OF COMMUNICATION
• CWG monthly/bi-monthly calls
• Annual face-to-face Meeting

Activities of RWGs CWG are supported by the
HPTN Community Involvement Program (CIP) staff
CWG 15 members total (2 Co-chairs, 6 RWG reps, 2
EC reps, and up to 5 Additional Members)

• Additional Members
• Ex-officio Advisors (3-5)
• Ethics
• Legal
• Social Sciences
• Representative to EC (2)

• Advisors
• from SWGs and Protocol Teams will participate in
  periodic scientific updates

HPTN Executive Committee
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HPTN Concepts in Development

• Circumcision in MSM Acute HIV infection
  identification of partner networks
• Co-morbidities (depression, substance use) in MSM
  PrEP in young adults (heterosexual focus)
• Positive prevention in persons in care
• Co-infection therapy to reduce HIV viral load
• Stimulant (cocaine, methamphetamine) therapy
• Pharmacist-based IDU intervention
• Behavioral intervention in adolescents
  (Africa-focus)
• Vaginal health

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HPTN Concepts in Development

• The Domestic Prevention Working Group (DPWG) is
  developing concepts on
• Gay men/MSM
• Women at Risk
• We will hear more about this on todays call.

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HIV Vaccines Trials Network (HVTN)

• Research focus Evaluating preventive HIV
  vaccines
• PI Lawrence Corey, M.D.
• Headquarters Fred Hutchinson Cancer Research
  Center, Seattle, WA
• Locations HVTN Trial Units are located at
  leading research institutions in 27 cities on
  four continents.
• For complete table of all 18 HVTN trials, see
• http//chi.ucsf.edu/vaccines/
• http//www.hvtn.org/science/trials.html

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HVTN Trial Sites
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HVTN Community Involvement Structure
CAB
Protocol team representatives
CAB
CAB
Protocol
CAB
Protocol team representatives
GCAB
SWG Scientific Working Group
Research Agenda
Scientific Literacy
EWG Ethics Working Group Open to all
interested CAB site staff members
Network Committee Representatives
Network Committee Representatives
Network Committee Representatives
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International Maternal Pediatric Adolescent AIDS
Clinical Trials (IMPAACT)

• Research focus Children, adolescent and pregnant
  women, including PMTCT -- merger of the pediatric
  ACTG and the perinatal committee of the HPTN
• PI Jay Brooks Jackson, M.D., M.B.A.
• Headquarters John Hopkins University School of
  Medicine, Baltimore
• Scope of Network IMPAACT is the largest
  prevention network, including 59 new and
  transitioning trials, and 12 domestic sites
• Funding structure IPMAACT has two components
  one is funded by the National Institute for
  Allergy and Infectious Diseases (NIAID), and one
  by the National Institute of Child Health and
  Human Development (NICHD)

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Studies Transferred from HPTN to IMPAACT
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Studies Transferred from HPTN to IMPAACT cont.
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IMPAACT Community Participation
Other HIV Research Network CABs
Source François-Xavier Bagnoud Center at the
University of Medicine and Dentistry of New
Jersey (UMDNJ)
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Microbicide Trials Network (MTN)

• Research focus Evaluating microbicides for HIV
  prevention
• PI Sharon Hillier, PhD
• Headquarters University of Pittsburgh and
  Magee-Womens Research Institute, Pittsburgh
• MTN is a new network established in 2006 MTN
  plans to conduct 17 clinical trials in Africa,
  India and the US over the next seven years.
• Clinical Trial Units (CTU) NIAID named 12
  institutions in Africa, India and the US as MTNs
  new CTUs. The CTUs are located in seven
  countries, and will conduct multi-center studies
  spanning 17 locations.

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Ongoing Planned MTN Studies
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Planned MTN Studies
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Challenges Transitioning to a New Structure

• Competition within and between networks for
  restrained budget
• Ensuring strong evidence-based research agenda
  that includes communities at high risk, including
  those in the United States
• Ensuring new structures collaborate and avoid
  duplication of efforts. i.e. training,
  harmonizing reporting, coordinating CABs at
  sites with multiple trials
• Incorporating community involvement at every
  level within networks
• Setting up transparent decision-making mechanisms