Transcript Change in Perceptions Associated with More Effective Therapies

Enhancing Community
Participation in HIV Prevention
Research
Steve Morin, Ph.D.
AIDS Policy Research Center
AIDS Research Institute
University of California, San Francisco
UCSF Research Team
Stephen F. Morin
T. Anne Richards
Andre Maiorana
Marisa McLaughlin
Nicolas Sheon
Kimberly Koester
Karen Vernon
Sheri Storey
Andrew Herring
Acknowledgements
Family Health
International
Community Working
Group Co-Chairs
Stella Kirkendale
Janet Frohlich
Wayne Wilson
Mike Shriver
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
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
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
Questions
Do CABs work….
In the absence of organized activists?
In prevention trials v. treatment trials?
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
Site Interviews
Birmingham
Researchers
5
CAB Participants Total
6
4
15
Philadelphia
5
6
5
16
Los Angeles
4
6
5
15
Chiang Mai
7
6
6
19
Harare
5
6
7
18
Lima
5
6
6
17
Total
31
36
33
100
Sites
1993
1994
Harare
Birmingham
Chiang Mai
Lima
Los Angeles
1996
1997
1998
1999
2000
2001
Rapid Assessment - 6 month snapshot
Philadelphia
1995
2002
Data Analysis

Interviews transcribed

Data entered into Ethnograph

Reviewed for broad themes and
subthemes

Codes assigned and verified

Summaries and cross-site analysis
Conflicting World Views
Researchers
Participants

Scientific questions

Basic life needs

Randomized trials

Medical care

Recruitment/retention

HIV & STD screening

Community

Research
World View
What is the role
of the CAB?
CAB As Bridge
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
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
Representation:
How do you put a
CAB together?
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
Population Specific Model

Needs of a specific group
 African Americans
 Women
 IDUs
 MSM

Protocol driven (Philadelphia, Birmingham)

Preparedness driven (LA, Peru)
Recruitment &
Retention:
Why do people
serve on CABs?
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
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
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
CAB Barriers -- Retention

Disparities in knowledge

Practical concerns -- e.g. time,
transportation, child care

Illness -- people living with HIV

Setting reasonable expectations
Disparities in Knowledge
“It’s frustrating when you got to
keep interrupting to tell them
could you explain that? Or, could
you talk in layman’s terms? They
make you feel stupid.”
-- CAB Member
What do CAB and
research team
members want
from each other?
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
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
Why do people
participate in
prevention trials?
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
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
What is the role
of the CAB in
identifying and
resolving ethical
issues?
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
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”
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
Beneficence --Risk/Benefits

Established CABs have been involved in
debate about risks and benefits of
participation studies

But emerging CABs have not
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 Pandora’s Box and
that person is positive. What then?”
-- CAB Member
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?”
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.”
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 you’ve got to tell
people.”
Right to Know
“...the issue wasn’t about can we predict how
people are gonna react, but do people have
a right to know. ...if you’re testing
something from their bodies … these are
not just people who are here for you to draw
specimens from.”
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
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
Recommendations

Stipends to support CAB service
 Need to remove disincentives

Develop plans for timely feedback of
research findings to communities

Develop plans for sustainability