Session III. Role of the Community Advisory Board and Outreach Activities

Discussion Leaders: Anne Madey, R.N., Research Nurse Coordinator, University of Tennessee Health Science Center, Memphis, Tennessee, and Matthew Murguia, Director, Office of Program Operations and Scientific Information, Division of AIDS, NIAID, NIH, Bethesda, Maryland

Ms. Anne Madey is the research nurse coordinator for the NIAID study titled "African American and Caucasian Response to the Standard Therapy for Hepatitis C," which involves the treatment, followup, and side effects of the standard therapy for hepatitis C sequelae. Her presentation described her work on another project--a hepatitis C screening and education program in the Memphis community, which involves interacting with a community advisory board. Ms. Madey focused on the following question: What is the connection between a health care provider and the community in which he or she works? Her presentation offered facts and demographics about Memphis and its population, described the University of Tennessee's commitment to the community, and gave detailed information about elements of the model program.

Facts and Demographics

Memphis is the 18th largest city in the United States, with a population of about 661,000; however, the population of the metropolitan statistical area is about 1.1 million. In Shelby County-where the city of Memphis is located--the African American and Caucasian populations are evenly distributed at about 48 percent, with Asian/Pacific Islanders and others at 3.2 percent. In terms of employment, the population is 40 percent blue collar and 60 percent white collar. Thirty percent of the jobs are service oriented, 18 percent are in the retail field, 14 percent are government related, 12 percent involve transportation and communication, and 11 percent are in manufacturing. The highest educational level attained for 30.7 percent of the population is high school graduate, and 15.3 percent of the residents have bachelor's degrees. The median age of the population is 33, and the average annual salary per household is close to $40,000.

University of Tennessee's Commitment to the Community

The University of Tennessee mission statement calls for involvement with business, industry, and local, State, and Federal governments to facilitate programs and services for the community. The university's health career programs reach out to African Americans to promote interest in health care research beginning at the elementary level and continuing through postbaccalaureate studies. Ms. Madey also mentioned the efforts of the Office of Special Events, the Communication and Marketing Departments, and the Seeds of Discovery program, all of which testify to the university's significant community outreach efforts.

The Hepatitis C Screening and Education Program

Ms. Madey provided some information about the hepatitis C virus (HCV) for the laypersons in the audience, noting that 85 percent of the people who contract the virus will develop chronic liver disease. HCV is the major reason for liver transplants. Called "the silent killer," the virus can be present in the body for up to 30 years before it presents symptoms. About 4 million people in the United States have tested positive for antibodies to HCV. The rate of HCV is higher in African Americans than in whites-about 3.2 percent versus 1.5 percent, respectively. The replication of the virus is higher in African Americans than in whites, and about 10 percent of African American men between the ages of 40 and 49 have tested positive for HCV.

Ms. Madey described the model screening and education program for HCV at the University of Tennessee. She discussed the program's goal, objectives, and purpose; population identifiers; information dissemination; implementation; and evaluation.

• Goal, objectives, and purpose. The goal of the screening program was to provide education about the disease. Children are vaccinated against hepatitis A and B, but there is no vaccine for HCV; therefore, education is key to preventing the spread of the disease and making people aware of the treatment options for those who have contracted the virus. Launching a screening program for HCV requires both interaction with the community to be screened and fostering a working relationship with health care providers.

• Population identifiers. An organization called "Memphis Healthy Churches" was instrumental in helping to arrange for nurses and nurse practitioners to conduct screenings. Focus groups also were used to identify populations to be screened, as were community centers in neighborhoods. The number of screened individuals at group sites or functions was low at first because of people's resistance to having their blood drawn.

• Information dissemination. The dissemination efforts were successful because many individuals in the community do not have access to health care or a one-on-one interaction with a health care professional.

• Implementation. Implementation of the screening program required coordination with a phlebotomist and a medical laboratory to get free HCV antibody screens. Many people were afraid to have their blood drawn, and personal attention and discussion were needed to address issues such as confidentiality and distrust of medical personnel. In addition, the program offered followup care.

• Evaluation. One of the ways to evaluate the program's success was to consider the trust issue. Time and cost were other issues to be considered. Adjusting the screening schedule for the convenience of the participants was crucial. Ethical issues and confidentiality also were key concerns. Regarding future programs, Ms. Madey announced a plan to screen the Shelby County jail personnel who work with prisoners.

Community Advisory Boards

Mr. Matthew Murguia began his discussion by defining what a community advisory board (CAB) is. The community component of a CAB involves those members of a community who are either infected or affected by a particular disease and in need of clinical or research intervention. The community can include current and former clinical trial volunteers, national organizations, family members with infected relatives, health care professionals who serve and treat the participants affected by the disease, and vulnerable populations such as children, pregnant women, the elderly, the medically underserved, and the transgender community. The definition must be flexible enough to fit the needs of the population being researched and inclusive enough to reflect where the research is being conducted.
The advisory component of a CAB involves the board's role in providing input and guidance in all aspects of clinical trials. CABs provide guidance, but they do not have any legal or formal authority to require changes in a trial or how it is implemented.

The Mission of a Community Advisory Board

The CAB's mission is to decide what role it should play in the community and, ultimately, in the clinical trial. For the most part, CABs ensure that the needs of the community are considered in all matters regarding the provision of research-related care, program management, and the establishment of the scientific agenda. Mr. Murguia stated that the last point often causes an interesting dilemma for the CAB and the principal investigator. Researchers coming into the community may want to carry out certain tasks within the study that the community does not fully understand. A balance must be struck between the CAB and the principal investigator when establishing the scientific agenda for the trial.
Mr. Murguia gave an example of a mission statement from a CAB in Washington, DC, the Capital Area Vaccine Effort (CAVE). The mission statement reads as follows: "CAVE is a volunteer panel of individuals from the general public and from the diverse communities affected by AIDS. CAVE is organized to assist and advise AIDS vaccine trials in the metropolitan DC area." The key words used in a CAB mission statement are "volunteer," "diverse," "assist," and "advise."
A CAB such as CAVE wants to assess the concerns of the community it represents and to serve as an advocate for individuals in the trial and the general public as a whole. A CAB acts as a liaison and ombudsman between researchers and those interested in the research. As part of its mission statement, the composition of a CAB reflects the affected populations it represents. As appropriate, a CAB encourages participation in clinical trials and acts as a community educator. A CAB also assesses the ethical and social implications and the impact of a trial.

The Functions of Community Advisory Boards

CABs carry out the following functions:

• CABs serve as the eyes and ears of the community regarding the conduct of research. They are the main link between the researchers and the community. Their members are from the community and know about the community.
• CABs represent the trial volunteers in interaction with the site staff. They engage in conflict resolution, discuss volunteer retention issues, and provide insight into how sites are managed.
• CABs provide advice on all aspects of conducting a clinical trial, including identifying research priorities, reviewing the protocol to ensure it is written in plain language or in the native language of the participants, monitoring the informed consent process, dealing with ethical issues, and advising on standards of care.
• CABs serve as information sources, ambassadors, and liaisons to staff and volunteers. They help foster a supportive environment, serve as mentors to new CAB members, and provide legitimacy to the research site.
• CABs help build trusting relationships in the community. They can serve as a sounding board for community members, provide recruitment advice, and ensure that the site conducts all activity in a culturally and linguistically appropriate manner.

Community Advisory Board Activities

Mr. Murguia explained the types of activities that CABs engage in. CABs can help researchers focus their message by suggesting outreach activities, such as community forums, town halls, and brown bags. They also can suggest materials development, including the production of brochures, factsheets, flyers, and print and radio advertisements, and they can review the materials to ascertain whether they are readable, understandable, and written at the right level of education. CABs also can determine the appropriate educational level for the community and define what the community already knows.
CABs also can be involved in information sharing about the trial with other concerned community advocates by writing letters to the editor and newsletter articles and by pursuing other avenues for informing the community about participating in research. In addition, CABs can serve as media resources by helping research investigators to focus their messages, develop advertisements, and place their ads. CABs act as liaisons to other communities.

Mr. Murguia emphasized that CABs are made up of volunteers. As volunteers, they may have full-time employment, children, and transportation needs. Monthly attendance at CAB meetings, workshops, and brown bags takes time away from their families and other activities. Therefore, researchers must be aware of the fact that CAB members are not recruiters. CABs can have a significant impact on the effectiveness of researchers in the community. If a CAB does not support the proposed research in a given community, it can effectively shut down the investigators' recruiting efforts.

Mr. Murguia added some information about CAB membership. He reiterated that CAB membership reflects the diversity of the community being researched and the community in which research is being conducted. The selection of CAB members should include considerations such as race/ethnicity, gender, sexual orientation, age, the language skills of the individuals and the language they use or feel most comfortable using, educational levels, economic status, religious/medical communities, advocacy groups, and social and fraternal groups. Fraternal groups have strong historical linkages to the communities, are positive beacons of change, and are respected in the communities. They can serve as a useful resource in disseminating messages. Other considerations for inclusion as CAB members are sex workers, injection drug users, prisoners, and students.

Components of a Successful Community Advisory Board

Mr. Murguia explained that a key factor in the success of a CAB is the principal investigator's (PI) involvement and commitment, which can be assessed by answering the following questions:

• Does the PI attend CAB meetings?
• Is the PI easily accessible to answer questions?
• Is the PI visible in the community under study?

Another component of a successful CAB is the existence of clearly defined missions, goals, roles, and bylaws. It is essential that people understand the roles of the CAB. Diverse membership also is extremely important to the success of a CAB; difficulty in recruiting volunteers for CABs can compromise the board's diversity. Another concern involves ongoing support for the CAB; funding is paramount for the successful management of a CAB.

CABs need strong meeting support, which includes a clear agenda, regularly scheduled meetings with advance notice, and sufficient funds for travel reimbursement, if allowed. Successful CABs produce meeting minutes and provide information with adequate time for review. Administrative support should be provided for the CAB, and food and refreshments should be supplied.

Finally, CABs should have planned training activities that encompass orientation and mentoring of the CAB members. The training should cover the terminology of the clinical research trial and a general overview of the science involved in the study.

Parity, Inclusion, and Representation

Mr. Murguia ended his presentation with some comments about parity, inclusion, and representation:

• Parity calls for CAB members to be actively involved in the process so that everyone has the same information and understands it at the same level. Parity may be a new concept to some, but it has been well documented in the AIDS scientific and advocacy communities. The only way to achieve parity is through training, workshops, informational exchanges, and asking questions.
• Inclusion means that all those who have a stake in the issue should be at the table when decisions are made. These stakeholders are individuals who are most affected by the disease or study and are representative of the community as a whole and of the community being researched.
• Representation means that each person should have an equal voice at meetings. No one person should dominate.

Mr. Murguia concluded by listing the following learning points: (1) community input is a must in research, (2) CABs are an integral component of research, (3) CABs must have clearly defined roles, (4) ongoing support of CABs is essential in terms of both money and staff time, (5) diversity in membership is a must, and (6) CABs vary in what they can and are willing to do depending on their location and membership.

Discussion

The breakout session presentations by Ms. Madey and Mr. Murguia prompted the following discussion points:

• An attendee commented on the difficulty of including parity, inclusion, and representation (PIR) in CABs. Inclusion can be facilitated by guaranteeing a convenient time and place for meetings or by offering stipends for cab fares. The representation component of PIR necessitates an examination of the ability of community members to participate on a CAB. The parity component is involved if members of the CAB disagree about a recommendation or advice given to the research site.

• Another attendee mentioned her experience as chair of a CAB in Cleveland. On the issue of parity, she stated that an important strategy is for the investigators, the trial patients, and the community to agree to disagree with each other. The issue of parity must be addressed to defeat institutional racism; in fact, women, especially Latina women, should be part of CABs. Building parity and seeking inclusion are worthwhile activities.

• A participant described the difficulties involved in recruiting Hispanic community members for CABs in areas with a high proportion of Spanish speakers. The difficulty arose because staff members lacked the ability to speak Spanish. A PI capable of speaking Spanish, as well as translators, can meet with community groups to recruit CAB members. Letters and announcements do not work as well as personal contact.

• Another participant, with extensive involvement with CABs, reiterated the importance of attending community meetings to recruit qualified CAB members, including women and African Americans. A problem was the lack of inclusion of Caucasian or Hispanic members on the CAB. In addition, CABs often do not realize how much power they actually have. CAB members must voice their opinions and refuse to be conceived of as tokens; instead, they must feel like they have ownership of the CAB.

• An attendee called attention to the fact that an individual can be bright and insightful but not necessarily literate. It is a challenge to find a way to include such individuals on CABs.

• A participant remarked on two significant barriers to CAB participation at the Adult AIDS Clinical Trial Group at Duke University. One barrier concerns negative media attention, which has been offset by the community activities of its large, diverse CAB. The other barrier is staff turnover, the effects of which can be avoided by having more than one staff member do outreach in the community.

• A participant from the HIV Vaccine Trials Network made three points about CABs:

1. Research organizations should provide training for PIs to learn how to work with communities just as they provide training for CAB members to understand scientific terminology.
2. CABs can engage in community consultation. For example, if the research involves 18- to 25-year-olds, but no one from that group can be found to sit on the CAB, the CAB members must consult with 18- to 25-year-olds in the community.
3. ABs should build into their structure the people they want to consult with, and they should put community issues at the top of their agendas.

• An attendee from the Capital Area Vaccine Effort pointed out that to ensure diversity, the CAB meeting location can rotate. Depending on the location, a very different CAB might emerge. Also, CABs are powerful and can close down sites, but their goal is to promote research. The question remains about how to ensure community representation.

• An attendee from the HIV Vaccine Trials Unit at Johns Hopkins University (JHU), who is the community liaison for the CAB, reported that the JHU CAB uses an annual schedule of 3-month rotating meeting locations. As a result, the CAB is able to move around in the community and pick up a person or two from each of the locations. Parity, inclusion, and representation are assessed every 3 months through a unit evaluation by the CAB to determine what populations should be added.

• A participant posed some questions about the connection between community advisory boards and the actual increase of diversity in clinical trials. Does increasing diversity in the CAB automatically result in an increase in diversity in the clinical trial? What are some of the specific steps that a CAB can take to increase diversity in trial participants? Diversity is a key piece of a CAB, but what are the other pieces that contribute to getting more people from different walks of life to participate in a trial and stay through until the end? Mr. Murguia asked whose role it is to carry out these tasks: the CAB's role? the community educator's role? the recruiter's role?

• Another participant reiterated the importance of the community outreach aspect of a CAB.

• An attendee from Family Health International, referring to the definition of community, stated that researchers often use the CAB to conceptualize a target population instead of thinking of target populations as objects of research and communities as separate entities. People who enter clinical trials come from a wide range of communities. The issue is really trying to figure out where they are coming from, who the stakeholders are, and how to work together as a group. Defining a community is not more important than discovering who the people are, where they are from, and what their values are. Ms. Madey responded that the question might be as follows: Is the disease the community or is the community the disease? "Community" is difficult to define.

• A participant described a Title IV CAB that she chairs in St. Louis. The trial began with women, children, and youth, and the CAB comprised 8 to 10 people, many of whom did not understand the role of a CAB. The CAB members were educated about physician services, clinical services, and the need for further recruitment for the CAB. A binder of materials disseminated in clinics, an eight-page newsletter published every 3 months, meals, cabs, and childcare were provided. The CAB listened to participants' complaints and brought them back to the investigators. The CAB has expanded its diversity and has been successful at retaining its members.