Enhancing Community Participation in HIV Prevention Research Steve Morin, Ph.D. AIDS Policy Research Center AIDS Research Institute University of California,

Enhancing Community Participation in HIV Prevention

Research

Enhancing Community Participation in HIV Prevention

Research

Steve Morin, Ph.D.Steve Morin, Ph.D.

AIDS Policy Research CenterAIDS Policy Research Center

AIDS Research InstituteAIDS Research Institute

University of California, San FranciscoUniversity of California, San Francisco

UCSF Research TeamUCSF Research Team

Stephen F. Morin

T. Anne Richards

Andre Maiorana

Marisa McLaughlin

Nicolas Sheon

Kimberly Koester

Karen Vernon

Sheri Storey

Andrew Herring

AcknowledgementsAcknowledgements

Community Working Group Co-Chairs

Janet Frohlich

Mike Shriver

Family HealthInternational

Stella Kirkendale

Wayne Wilson

Specific AimsSpecific 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

BackgroundBackground

Community Advisory Boards (CABs) in AIDS Community Advisory Boards (CABs) in AIDS research have their roots in AIDS activismresearch have their roots in AIDS activism

AZT trial in 1987 pointed to need for AZT trial in 1987 pointed to need for partnership with communitypartnership with community

Educated and desperate people with HIV Educated and desperate people with HIV organize to demand a seat at the tableorganize to demand a seat at the table

NIH History of CABsNIH History of CABs

Community Constituency Group formed Community Constituency Group formed

NIH guidance to AIDS clinical trials units to NIH guidance to AIDS clinical trials units to establish local CABs establish local CABs

Role -- to provide advice and communicate Role -- to provide advice and communicate community preferencescommunity preferences

With HIVNET, CABs go internationalWith HIVNET, CABs go international

HPTN continues emphasis on community HPTN continues emphasis on community participationparticipation

QuestionsQuestions

Do CABs work….Do CABs work….

In the absence of organized activists?In the absence of organized activists?

In prevention trials v. treatment trials?In prevention trials v. treatment trials?

Rapid AssessmentRapid Assessment Goal is a preliminary, qualitative Goal is a preliminary, qualitative

understanding understanding

Field teams visit for five days to get Field teams visit for five days to get picture at one point in timepicture at one point in time

Triangulation of data sourcesTriangulation of data sources secondary reportssecondary reports

ethnographic observationsethnographic observations

semi-structured interviewssemi-structured interviews

Site Interviews Site Interviews Researchers CAB Participants Total

Birmingham 5 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

SitesSites

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

Philadelphia

Harare

Birmingham

Chiang Mai

Lima

Los Angeles

Ra

pid

As

se

ss

me

nt - 6

mo

nth

s

na

ps

ho

t

Data AnalysisData Analysis

Interviews transcribedInterviews transcribed

Data entered into EthnographData entered into Ethnograph

Reviewed for broad themes and Reviewed for broad themes and subthemessubthemes

Codes assigned and verifiedCodes assigned and verified

Summaries and cross-site analysisSummaries and cross-site analysis

Conflicting World ViewsConflicting World Views

ResearchersResearchers

Scientific questionsScientific questions

Randomized trials Randomized trials

Recruitment/retentionRecruitment/retention

CommunityCommunity

ParticipantsParticipants

Basic life needsBasic life needs

Medical care Medical care

HIV & STD screeningHIV & STD screening

ResearchResearch

World ViewWorld View

What is the role of the CAB?

CAB As BridgeCAB As Bridge

CAB Members View of RoleCAB Members View of Role

Bridge, link, go-between, liaison Bridge, link, go-between, liaison

Provide advice on protocolsProvide advice on protocols

Identify potential research ideasIdentify potential research ideas

Clearinghouse for ethical issues Clearinghouse for ethical issues

Legitimize research in communitiesLegitimize research in communities respond to misinformationrespond to misinformation

provide accessprovide access

social marketing/public relationssocial marketing/public relations

Conflict in RoleConflict in Role

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

-- CAB -- CAB MemberMember

Representation:How do you put a

CAB together?

Broad Community ModelBroad Community Model Cross-section of larger community Cross-section of larger community

(Zimbabwe & Thailand)(Zimbabwe & Thailand) government officialsgovernment officials

educatorseducators

religious leadersreligious leaders

NGO representativesNGO representatives

people living with HIVpeople living with HIV

Long term view of missionLong term view of mission

Want sustainabilityWant sustainability

Population Specific ModelPopulation Specific Model

Needs of a specific group Needs of a specific group African AmericansAfrican Americans

WomenWomen

IDUsIDUs

MSMMSM

Protocol driven (Philadelphia, Birmingham) Protocol driven (Philadelphia, Birmingham)

Preparedness driven (LA, Peru)Preparedness driven (LA, Peru)

Recruitment & Retention:

Why do people serve on CABs?

CAB MotivationCAB Motivation Concern about impact of HIV on their Concern about impact of HIV on their

community or populationcommunity or population

Personal experience. e.g., HIV-infectedPersonal experience. e.g., HIV-infected

Opportunity to learn about other Opportunity to learn about other agencies, research, influence policyagencies, research, influence policy

Reimbursement -- lunch, tokens, travel Reimbursement -- lunch, tokens, travel and stipends and stipends

Prestige -- self worth; having something Prestige -- self worth; having something to contributeto contribute

Self Worth & MeaningSelf Worth & Meaning

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

-- CAB Member-- CAB Member

CAB Barriers -- RecruitmentCAB Barriers -- Recruitment

Site needs to decide on a modelSite needs to decide on a model

Need to recruit accordinglyNeed to recruit accordingly Find community leaders with time to Find community leaders with time to

commit to the projectcommit to the project

Identify and retain members from Identify and retain members from marginalized populationsmarginalized populations

CAB Barriers -- RetentionCAB Barriers -- Retention

Disparities in knowledgeDisparities in knowledge

Practical concerns -- e.g. time, Practical concerns -- e.g. time, transportation, child care transportation, child care

Illness -- people living with HIVIllness -- people living with HIV

Setting reasonable expectations Setting reasonable expectations

Disparities in KnowledgeDisparities in Knowledge

““It’s frustrating when you got to It’s frustrating when you got to keep interrupting to tell them keep interrupting to tell them could you explain that? Or, could could you explain that? Or, could you talk in layman’s terms? They you talk in layman’s terms? They make you feel stupid.” make you feel stupid.”

-- CAB Member-- CAB Member

What do CAB and research team members want

from each other?

Research Team WantsResearch Team Wants

Feedback -- constructive criticism to help Feedback -- constructive criticism to help improve protocolsimprove protocols

Limits -- help in clarifying to participants Limits -- help in clarifying to participants what will not be providedwhat will not be provided

Understanding -- why people do or do not Understanding -- why people do or do not participate in protocolparticipate in protocol

Access -- ability to move research into new Access -- ability to move research into new areas -- access to communities, populationsareas -- access to communities, populations

CAB WantsCAB Wants Validation - respect for their expertise and Validation - respect for their expertise and

recommendations recommendations

Standing -- to be seen as resource for Standing -- to be seen as resource for information in communityinformation in community

Training -- HIV, research details, translating Training -- HIV, research details, translating scientific languagescientific language

Feedback -- research findings to Feedback -- research findings to community community

Action -- impatient to act nowAction -- impatient to act now

Why do people participate in

prevention trials?

MotivationsMotivations

Altruism - desire to help communityAltruism - desire to help community

Reimbursements -- need moneyReimbursements -- need money

Access to HIV & STD testingAccess to HIV & STD testing

Access to quality medical care Access to quality medical care

Support networksSupport networks

Gain knowledge about HIVGain knowledge about HIV

BarriersBarriers Lack of knowledge about researchLack of knowledge about research

Distrust of medical establishmentDistrust of medical establishment

Distrust of researchersDistrust of researchers

Fear of HIV testingFear of HIV testing

Fear of needlesFear of needles

HIV-related stigmaHIV-related stigma

Fear of being identified with a Fear of being identified with a stigmatized groupstigmatized group

What is the role of the CAB in

identifying and resolving ethical

issues?

Identifying Ethical IssuesIdentifying Ethical Issues Ethical issues permeated interviews Ethical issues permeated interviews

with both CAB members and research with both CAB members and research team membersteam members

CABs view themselves as protecting CABs view themselves as protecting vulnerable peoplevulnerable people

Participants and CAB members often Participants and CAB members often from poor or stigmatized groupsfrom poor or stigmatized groups

Respect for Persons --Informed Consent

Respect for Persons --Informed Consent

CABs worked to assure that participants CABs worked to assure that participants had adequate information about had adequate information about procedures and risksprocedures and risks

““People must know what are the People must know what are the consequences and advantages are consequences and advantages are before going into the study”before going into the study”

Problems with Informed Consent Problems with Informed Consent

Emphasis on forms rather than processEmphasis on forms rather than process

Individual autonomy may be a culturally Individual autonomy may be a culturally bound conceptbound concept

CABs see their role as protecting CABs see their role as protecting vulnerable people, rather than individuals vulnerable people, rather than individuals protecting themselvesprotecting themselves

Little discussion of extent to which Little discussion of extent to which participation is voluntary; often viewed participation is voluntary; often viewed no real alternativesno real alternatives

Beneficence --Risk/BenefitsBeneficence --Risk/Benefits

Established CABs have been involved in Established CABs have been involved in debate about risks and benefits of debate about risks and benefits of participation studiesparticipation studies

But emerging CABs have not But emerging CABs have not

HPTN Problem HPTN Problem

CABs identified problem of lack of CABs identified problem of lack of treatment or social support for people treatment or social support for people who are diagnosed with HIV and not who are diagnosed with HIV and not eligible for trialeligible for trial

-- “We open that Pandora’s Box and -- “We open that Pandora’s Box and that person is positive. What then?”that person is positive. What then?”

-- CAB Member-- CAB Member

Distributive Justice Distributive Justice

““Guinea pig” term was used by Guinea pig” term was used by participants or CAB members at 4 sitesparticipants or CAB members at 4 sites

--- “Why is a vaccine study being --- “Why is a vaccine study being conducted in Peru since they might not conducted in Peru since they might not see benefit from it.” see benefit from it.”

--- “Are we being sacrificed in order to --- “Are we being sacrificed in order to develop a better product?”develop a better product?”

International Sites International Sites

Research must be practical for host Research must be practical for host country -- need to leave something country -- need to leave something behind behind

-- “Historically researchers came in, -- “Historically researchers came in, drew blood and left to write their drew blood and left to write their papers.”papers.”

An ExampleAn Example Important debatable question brought to Important debatable question brought to

CAB -- Should participants be give the CAB -- Should participants be give the results of CCR-5 testing?results of CCR-5 testing?

Briefing provided by research team Briefing provided by research team member in lay language with Q & Amember in lay language with Q & A

CAB debates and outlines many reasons CAB debates and outlines many reasons not to give feedbacknot to give feedback

““In the end, the CAB said you’ve got to tell In the end, the CAB said you’ve got to tell people.”people.”

Right to KnowRight to Know

““...the issue wasn’t about can we predict how ...the issue wasn’t about can we predict how people are gonna react, but do people have people are gonna react, but do people have a right to know. ...if you’re testing a right to know. ...if you’re testing something from their bodies … these are something from their bodies … these are not just people who are here for you to draw not just people who are here for you to draw specimens from.”specimens from.”

RecommendationsRecommendations Develop strategies to make CAB meetings Develop strategies to make CAB meetings

more productivemore productive Bring debatable issues to the tableBring debatable issues to the table

Bring participants into meetingsBring participants into meetings

Continuous formal and informal training to Continuous formal and informal training to respond to disparities in knowledgerespond to disparities in knowledge cross site networking for CAB memberscross site networking for CAB members

Train researchers in talking to communityTrain researchers in talking to community

RecommendationsRecommendations

Work with CABs to develop alternative Work with CABs to develop alternative methods of genuine informed consentmethods of genuine informed consent Greater emphasis on processGreater emphasis on process

Increase attention on voluntary participationIncrease attention on voluntary participation

Community building and leadership Community building and leadership training as part of CAB developmenttraining as part of CAB development Before organizing a meeting, may need to Before organizing a meeting, may need to

organize a communityorganize a community

RecommendationsRecommendations

Stipends to support CAB service Stipends to support CAB service Need to remove disincentives Need to remove disincentives

Develop plans for timely feedback of Develop plans for timely feedback of research findings to communitiesresearch findings to communities

Develop plans for sustainabilityDevelop plans for sustainability