Enhancing Community Participation in HIV Prevention Research

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Enhancing Community Participation in HIV
Prevention Research

• Steve Morin, Ph.D.
• AIDS Policy Research Center
• AIDS Research Institute
• University of California, San Francisco

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UCSF Research Team

• Stephen F. Morin
• T. Anne Richards
• Andre Maiorana
• Marisa McLaughlin
• Nicolas Sheon
• Kimberly Koester
• Karen Vernon
• Sheri Storey
• Andrew Herring

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Acknowledgements

• Community Working
• Group Co-Chairs
• Janet Frohlich
• Mike Shriver

Family Health International Stella
Kirkendale Wayne Wilson
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Specific Aims

• To assess the views of CAB and research team
  members regarding community consultation in HIV
  research
• To assess motivation and barriers to
  participation in prevention trials

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Background

• Community Advisory Boards (CABs) in AIDS research
  have their roots in AIDS activism
• AZT trial in 1987 pointed to need for partnership
  with community
• Educated and desperate people with HIV organize
  to demand a seat at the table

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NIH History of CABs

• Community Constituency Group formed
• NIH guidance to AIDS clinical trials units to
  establish local CABs
• Role -- to provide advice and communicate
  community preferences
• With HIVNET, CABs go international
• HPTN continues emphasis on community participation

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Questions

• Do CABs work.
• In the absence of organized activists?
• In prevention trials v. treatment trials?

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Rapid Assessment

• Goal is a preliminary, qualitative understanding
• Field teams visit for five days to get picture at
  one point in time
• Triangulation of data sources
• secondary reports
• ethnographic observations
• semi-structured interviews

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Site Interviews
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Sites
Rapid Assessment - 6 month snapshot
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Data Analysis

• Interviews transcribed
• Data entered into Ethnograph
• Reviewed for broad themes and subthemes
• Codes assigned and verified
• Summaries and cross-site analysis

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Conflicting World Views

• Researchers
• Scientific questions
• Randomized trials
• Recruitment/retention
• Community

• Participants
• Basic life needs
• Medical care
• HIV STD screening
• Research

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World View
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What is the role of the CAB?
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CAB As Bridge
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CAB Members View of Role

• Bridge, link, go-between, liaison
• Provide advice on protocols
• Identify potential research ideas
• Clearinghouse for ethical issues
• Legitimize research in communities
• respond to misinformation
• provide access
• social marketing/public relations

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Conflict in Role

• To whom is the CAB accountable? Is it to the
  community? Is it to the local municipal
  authorities? Or, is it to the research programs?
  That is a gray area. That is an area we are
  struggling with.
• -- CAB Member

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Representation How do you put a CAB together?
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Broad Community Model

• Cross-section of larger community (Zimbabwe
  Thailand)
• government officials
• educators
• religious leaders
• NGO representatives
• people living with HIV
• Long term view of mission
• Want sustainability

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Population Specific Model

• Needs of a specific group
• African Americans
• Women
• IDUs
• MSM
• Protocol driven (Philadelphia, Birmingham)
• Preparedness driven (LA, Peru)

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Recruitment Retention Why do people serve on
CABs?
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CAB Motivation

• Concern about impact of HIV on their community or
  population
• Personal experience. e.g., HIV-infected
• Opportunity to learn about other agencies,
  research, influence policy
• Reimbursement -- lunch, tokens, travel and
  stipends
• Prestige -- self worth having something to
  contribute

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Self Worth Meaning

• Just being part of something that means
  something. Sometimes when you are a drug user or
  ex-drug user. You know, being a part of
  something good and right means something.
• -- CAB Member

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CAB Barriers -- Recruitment

• Site needs to decide on a model
• Need to recruit accordingly
• Find community leaders with time to commit to the
  project
• Identify and retain members from marginalized
  populations

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CAB Barriers -- Retention

• Disparities in knowledge
• Practical concerns -- e.g. time, transportation,
  child care
• Illness -- people living with HIV
• Setting reasonable expectations

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Disparities in Knowledge

• Its frustrating when you got to keep
  interrupting to tell them could you explain that?
  Or, could you talk in laymans terms? They make
  you feel stupid.
• -- CAB Member

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What do CAB and research team members want from
each other?
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Research Team Wants

• Feedback -- constructive criticism to help
  improve protocols
• Limits -- help in clarifying to participants
  what will not be provided
• Understanding -- why people do or do not
  participate in protocol
• Access -- ability to move research into new areas
  -- access to communities, populations

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CAB Wants

• Validation - respect for their expertise and
  recommendations
• Standing -- to be seen as resource for
  information in community
• Training -- HIV, research details, translating
  scientific language
• Feedback -- research findings to community
• Action -- impatient to act now

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Why do people participate in prevention trials?
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Motivations

• Altruism - desire to help community
• Reimbursements -- need money
• Access to HIV STD testing
• Access to quality medical care
• Support networks
• Gain knowledge about HIV

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Barriers

• Lack of knowledge about research
• Distrust of medical establishment
• Distrust of researchers
• Fear of HIV testing
• Fear of needles
• HIV-related stigma
• Fear of being identified with a stigmatized group

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What is the role of the CAB in identifying and
resolving ethical issues?
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Identifying Ethical Issues

• Ethical issues permeated interviews with both CAB
  members and research team members
• CABs view themselves as protecting vulnerable
  people
• Participants and CAB members often from poor or
  stigmatized groups

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Respect for Persons --Informed Consent

• CABs worked to assure that participants had
  adequate information about procedures and risks
• People must know what are the consequences and
  advantages are before going into the study

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Problems with Informed Consent

• Emphasis on forms rather than process
• Individual autonomy may be a culturally bound
  concept
• CABs see their role as protecting vulnerable
  people, rather than individuals protecting
  themselves
• Little discussion of extent to which
  participation is voluntary often viewed no real
  alternatives

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Beneficence --Risk/Benefits

• Established CABs have been involved in debate
  about risks and benefits of participation studies
• But emerging CABs have not

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HPTN Problem

• CABs identified problem of lack of treatment or
  social support for people who are diagnosed with
  HIV and not eligible for trial
• -- We open that Pandoras Box and that person is
  positive. What then?
• -- CAB Member

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Distributive Justice

• Guinea pig term was used by participants or CAB
  members at 4 sites
• --- Why is a vaccine study being conducted in
  Peru since they might not see benefit from it.
• --- Are we being sacrificed in order to develop
  a better product?

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International Sites

• Research must be practical for host country --
  need to leave something behind
• -- Historically researchers came in, drew blood
  and left to write their papers.

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An Example

• Important debatable question brought to CAB --
  Should participants be give the results of CCR-5
  testing?
• Briefing provided by research team member in lay
  language with Q A
• CAB debates and outlines many reasons not to give
  feedback
• In the end, the CAB said youve got to tell
  people.

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Right to Know

• ...the issue wasnt about can we predict how
  people are gonna react, but do people have a
  right to know. ...if youre testing something
  from their bodies these are not just people who
  are here for you to draw specimens from.

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Recommendations

• Develop strategies to make CAB meetings more
  productive
• Bring debatable issues to the table
• Bring participants into meetings
• Continuous formal and informal training to
  respond to disparities in knowledge
• cross site networking for CAB members
• Train researchers in talking to community

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Recommendations

• Work with CABs to develop alternative methods of
  genuine informed consent
• Greater emphasis on process
• Increase attention on voluntary participation
• Community building and leadership training as
  part of CAB development
• Before organizing a meeting, may need to organize
  a community

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Recommendations

• Stipends to support CAB service
• Need to remove disincentives
• Develop plans for timely feedback of research
  findings to communities
• Develop plans for sustainability