The following document was initially drafted by representatives from various NIH sponsored research groups (the National CAB Transition Team) as a guidance for potential applicants under the HIV Vaccine Trials Network and the Prevention Trials Network (http://www.niaid.nih.gov/daids/vtn-ptn), a new research structure being developed by the National Institutes of Allergy and Infectious Diseases (NIAID). However applicable, the principles and recommendations outlined in this document, represent what the National CAB Transition Team believe should be in place as a basic standard for good community practice under any community research network.

1. Community Advisory Boards
2. Protection of Research Subjects
3. Materials Development and Dissemination
4. Collaboration and Partnership Development
5. Community Education/Relations
6. Issues Management

• physical disturbances, disability, or death suffered by the participant as a result of trial participation;
• discrimination or other social effects such as fractured family and personal relationships, job discrimination, inability to travel in some foreign countries, loss of insurance and potential discrimination if incarcerated;
• ethical breeches such as incomplete or unequal access to information or care;
• enrollment in research that is unnecessarily risky;
• enrollment in research that carries no benefit to the populations where the study is being conducted;
• enrollment in research without a complete informed or autonomous consent process;
• enrollment in research that is so poorly designed as to be a waste of volunteers' time and good faith.

  Recommendation: At all levels including design, informed consent process, and the implementation of study protocols, efforts should be made to ensure that every precaution is taken to minimize potential harms to research subjects. To ensure timely resolution of and/or treatment for any physical, social or ethical harms, each funded site must have a system in place to identify, examine, report, and resolve harms that may arise as a result of trial participation. Potential bidders should incorporate plans for:

  • developing mechanisms for identifying, reporting, and mitigating research harms;
  • training staff to assist them in identifying, assessing and managing incidents of research harms;
  • assessing participant comprehension of potential research risks and benefits;
  • ensuring confidentiality of study data and test results - provision of confirmatory HIV testing; and
  • developing an appeals system for trial participants who believe they have not received adequate response and/or resolution to issues raised.

  3.Materials Development and Dissemination

  Designing, developing and disseminating culturally and linguistically appropriate and relevant educational materials pertinent to clinical research, particularly vaccine research, other biomedical HIV prevention strategies; protocol development; social and behavioral

  interventions; the processes of informed consent and potential harms resulting from research participation; and the challenges and benefits of conducting community-based research, particularly related to community relations, readiness, and preparedness for clinical trials are imperatives under either the VTN or PTN.

  Recommendation: Potential bidders should outline a process and time-line for creating, translating and disseminating materials prior to the start of specific research studies. Funds should be allocated in the budget submitted by all sites for materials development and dissemination. At all local sites, working collaboratively with members of the community, efforts should be taken to assess and identify the appropriate type of educational materials which need to be developed to accurately educate potential trial participants and the community at-large about the research agenda of the network and the processes and technical aspects of the research being conducted at local sites. Where appropriate, all information should be developed at appropriate reading levels and translated into applicable languages. Materials developed should be reviewed by community members to evaluate its appropriateness prior to mass dissemination. Information pertaining to the initiation and ongoing implementation of studies should be disseminated broadly and in a timely fashion that will enable study participants, CAB members, and identified infected and affected communities to remain informed about and engaged throughout the research process.

  4.Collaboration and Partnership Development

  HIV research, particularly vaccine research, is by necessity, a broad and interdisciplinary activity. The expertise required to successfully conduct HIV research requires more than a simple understanding of how to conduct the clinical aspects of trials. Indeed, the range of behavioral, political, social, legal, and psychological issues particularly raised by vaccine research requires not only broad expertise, but active collaborations with other community groups and resources which can assist trial sites, trial participants and communities affected by vaccine research in dealing with these issues. In particular, HIV vaccine research requires a close degree of communication and collaboration with communities of color which have suffered from long-standing and diverse forms of harmful discrimination in both medical research and clinical practice, while also bearing a disproportionate burden of HIV infections.

  The goals of these collaborations will be somewhat different, depending on the community. Overall, the goals of community collaborations should be:

  • To leave the community better off than when the research began, regardless of the ultimate result of any particular vaccine trial.
  • To create community investment in research, and to take a long-term approach to fostering community relationships.
  • To make the research an activity which not only benefits the world, or science as a whole, but also the specific communities in which it takes place.

    Recommendation: Research sites should demonstrate their ability to maintain informal and/or formal ongoing and substantive relationships with community groups and advocates. They should realistically plan for how they will work to nourish these relationships. This should include, but must be more than, quickly reporting relevant local data to interested local parties. The evidence of collaborative relationships must be more than basic letters of support, and must speak to the actual potential results of these relationships. Applications which are the most successful in this category will demonstrate that the research site is embedded in the community in which it is located; that the community will value the site's presence in concrete ways; and that the research site will work for the direct and immediate benefit of the community in which it works.

  5.Community Education/Relations

  Aware, knowledgeable, and engaged communities throughout the research process and beyond is an imperative under either the VTN or PTN. Providing communities with the tools for engagement and a true partnership between researchers and the community, requires that communities have ongoing access to up-to-date culturally and linguistically appropriate information; facilitated opportunities for ongoing learning and participation; and ongoing interaction with site staff. Community education/relations should be encouraged to complement the research efforts conducted by the site.

  Educational strategies should focus on increasing participation in and awareness of trial participants, members of communities infected and affected by HIV and the community at-large about HIV prevention research including HIV preventive vaccines; new movements and trends in HIV prevention; scientific concerns in the design and development of clinical trials; and the overall efforts of the research network. At the same time, community education efforts should also include strategies that increase the knowledge level of researchers and staff about historical, cultural, social and political issues and needs of the community and facilitate ongoing reciprocal learning and interaction between community members and researchers. Overall, it should be noted that community education is not recruitment, but rather an ongoing process that helps to lay the foundation for recruitment and ongoing dialogue between community members and researchers.

  Recommendation: Potential bidders should describe the vision for community education (the overall goals, objectives and scope) and outline specific plans for providing oversight and operational management to ensure the coordination and integration between materials development and dissemination; collaboration and partnership development; and the ongoing education of trial participants, researchers and the community at-large. A budget and human resources should be dedicated to assist in facilitating the ongoing development, implementation and coordination of community education initiatives at

  each funded site. A site-specific educational plan should be developed in partnership with community advisory board members and should be supported by a community assessment identifying community education needs, potential benefits and barriers, and appropriate educational strategies to be employed. This educational plan should be accompanied by a site monitoring and evaluation plan.

  6.Issues Management

  Politically charged, medically and legally complex and, psychosocially intricate, community-based research on HIV/AIDS, particularly vaccine research, has generated unprecedented debate, passionate activism, and emotionally charged public discourse. Volatile issues that can arise from the public circulation of misinformation in the media or other forms of mass communication, about the nature of the research; the products or interventions being tested; the treatment of trial participants; or the conduct of researchers in communities during the course of designing, developing and implementing community-based HIV/AIDS research, is a critical area for funded sites to be prepared for. Establishing a state of readiness requires site staff to engage in a process that will create awareness of, and sensitivity to, potentially controversial issues. It should also include a clear plan for managing issues. Ongoing assessment of the information and educational needs of the community, consistent and frequent communication with trial participants and the community-at-large about the status of the research being conducted, and building the capacity necessary to manage issues associated with the research that may arise is at the core of issues management.

  Recommendation: Success in conducting this type of research requires a certain degree of public confidence and trust. Therefore, sites conducting research should take the steps necessary to identify, confront, manage and resolve unforseen issues that may impact public confidence in the site and the research being conducted throughout the course of the project. Working with staff and through community contacts, sites should try to determine any potential controversial issues and evaluate their capacity to respond appropriately. Does the site have the necessary infrastructure, staff, resources, equipment, internal and external relationships (such as those with local and/or national media) to respond to issues? With a clear understanding of the site’s state of preparedness, a written issues management plan should be developed that will outline a decision-tree for implementing the plan, the staff roles and responsibilities in managing issues including the key contact for decision making, and the available and accessible mechanisms for rapid internal and external communication.

  
  Case Studies on Best Practices From The HIVNET
  Community Education/Community Participation

  Collaboration/Partnership Development:
  NYU Medical Center's Experience with El Regreso Foundation

  The collaboration between New York University Medical Center and the El Regreso Foundation was forged as way of achieving the research goals mandated by HIVNET's Vaccine Preparedness Study. It grew out of the recognition that the staff of a medical center faces unique challenges in conducting human subject research such as HIV prevention in minority underclass neighborhoods that may be infested with drugs and other manifestations of social and cultural alienation.

  The goal of the HIV prevention research project was to assemble a cohort of injection drug users at high risk for HIV and determine if their seroincidence rate was adequate to conduct clinical trials of an HIV vaccine in this population. Secondary goals were to educate communities with high-risk populations about vaccines and other HIV/AIDS prevention strategies, and assess the willingness of participants from those communities to participate in clinical vaccine trials.

  Methods for achieving these goals were to conduct HIV pre and post-test counseling, administer a questionnaire about risk behavior, and refer individuals in need of other services to the appropriate organization.

  Recruitment of individuals at high risk of HIV from drug injection was especially difficult. Needle exchange programs, drug treatment centers and other prevention services were prevalent in neighborhoods around NYU Medical Center. We decided that the best approach would be to go directly to communities that lack these services. For that purpose we purchased a Mobile Research Unit that could travel to areas of high drug use and from which we could outreach substance abusers as well as conduct the study.

  Both recruitment and community education activities entailed significant personal risk in these communities. HIVNET staff involved in outreach activities found themselves being mistaken for narcotics officers or drug dealers or users. During one particularly harrowing episode in the Sunset Park section of Brooklyn, staffers were surrounded by undercover police with guns pointed at their heads.

  So drug ridden are these neighborhoods that a large park in the center of the Bushwick section of Brooklyn was named for a mother murdered in the early '90s for attempting to curb drug dealing in the neighborhood - Maria Hernandez Park. This soon became the epicenter of our project.

  It became apparent to staff that the precondition for working safely in communities with high incidences of substance abuse and HIV infection was the establishment of a close collaboration with community-based organizations that were known and respected. We knew that we must quickly achieve a modus vivendi, not only with potential participants among the "hard to reach" populations but also with the local police precincts, merchants, and drug dealers. The selling of illicit drugs is an important part of the local economy of these neighborhoods. To appear in any way to threaten that economy is dangerous.

  Accordingly, in order to work from our Mobile Research Unit (a converted recreational vehicle) in and around Maria Hernandez Park, various barriers to our goals had to be eliminated and many issues confronted besides physical security. The fact that a high-risk subpopulation of addicts is a vulnerable population raises obvious questions of potential social harms from human subject research. Working effectively within such a community therefore involved achieving credibility. The fact we were not law enforcement had to be communicated through local networks. As well our research mission had to be understood as a positive for the community. Simply put, before we could begin the essential education about HIV prevention research agenda we had to be educated.

  One of our community educators took an exploratory trip to Williamsburg. His object was to make contact with local organizations working with drug addicts and HIV. Through these initial contacts he learned about the El Regreso Foundation. El Regreso is a highly respected not-for-profit residential and ambulatory drug treatment program that serves and advocates for Latino substance abusers from Brooklyn. It has deep social roots and established political alliances in the Bushwick and Williamsburg area. The community educator, a Latino with long experience in community activism and HIV/AIDS prevention, walked in to El Regreso one day and introduced himself. He was given a tour of the South Street facility and eventually met with Carlos Pagan, the founding director of El Regreso.

  Among communities in the El Regreso catchment area are Williamsburg, Bushwick and Greenpoint, each of which have been devastated by drugs and HIV/AIDS. The four Bushwick zip codes "demonstrate some of the highest need for AIDS services in all New York City," according to the Brooklyn AIDS Task Force. Included in El Regreso's target populations are homeless male street youths that are at very high risk of HIV infection.

  El Regreso's primary residential treatment facility is comprised of two three-story former shooting galleries, located in the Williamsburg section of Brooklyn. The facility was renovated with $1.1 million in funding provided by the U.S. Department of Housing and Urban Development's and the New York State Department of Substance Abuse Services (NYOASA). A license to operate a 54-bed drug free residential program was received on October 19, 1991. Since then, El Regreso has offered the only comprehensive bi-lingual (English and Spanish), bi-cultural drug rehabilitation program in Brooklyn. In early 1998, New York State awarded El Regreso funds to develop, design and construct a 40-bed drug free residential program for women.

  El Regreso understood our target population as well as the geographic make-up of the neighborhoods we wanted to reach. Almost from the initial contact, common ground was recognized between the goals of our research and El Regreso's function in the community. We needed to recruit and educate. They needed to maximize their contact with the "hard to reach" addicts who might benefit from services they are mandated to deliver. A decision was reached to conduct a joint street outreach operation. NYU MC staff would interview, screen and recruit study participants from our Mobile. The El Regreso staff would support these activities by providing us with instant credibility as they themselves offered addicts with medical and social service referrals.

  The NYUMC-El Regreso collaboration has benefited both organizations. NYUMC gained from the help of El Regreso's staff in making our presence more tolerable to local police precincts and to local drug-users and dealers. This provided an invaluable element of safety to our staff and the mobile research unit. It also greatly facilitated our recruitment effort. El Regreso benefited because our outreach, educational efforts, and compensation for research studies attracted the population they wish to serve. Direct referrals to their services became part of our protocol when operating in Brooklyn. We also provided a program to "train the trainers" among El Regreso's outreach staff, focusing on the HIVNET HIV risk reduction and counseling modules. NYUMC collaborated with El Regreso in a grant proposal to the Center for Disease Control and Prevention in response to a RFP for community partnerships in continued HIV prevention efforts in high risk, low-income neighborhoods in NYC.

  Our experience and resources for grant writing were welcomed as a funding source for some of El Regreso's activities. Both sites benefited from the cross-cultural exchange of ideas and insights between university based research and community based service.

  In the first six months of 1998, our staff of phlebotomist/interviewers and community relations personnel, working in close conjunction with El Regreso and other CBOs, interviewed and HIV screened over 1,200 individuals at high risk of HIV infection, including 943 drug-injectors and 329 women at heterosexual risk. Screenings were conducted in minority neighborhoods of New York City, including Harlem, the Lower East Side, Bushwick and Coney Island.

  We learned a great deal during these screenings. Over 500 of the screenings used the Murex SUDS rapid HIV test with which test results can be returned within 20 minutes, as opposed to the usual two weeks. The very positive response of the community to this new method suggested substantial demand for rapid HIV screening among lower income persons. Our staff also had a positive response to the method, as it eliminated the otherwise large fraction (up to one third) of persons tested who have not returned for test results when standard methods are used.

  Senior El Regreso officials, through our collaboration, came to see the general benefits for a medically-underserved community of being associated with a medical research center. Most practically, they became aware that a mobile unit providing rapid HIV testing and risk reduction counseling can be a powerful behavioral intervention. This awareness led El Regreso, and another drug treatment center in the Bronx that we accessed through El Regreso, BASICS, the Bronx Addiction Services Integrated Concepts Systems, Inc., to desire the continuation of rapid HIV testing and counseling in their communities after the conclusion of HIVNET's Vaccine Preparedness Study.

  The process of building trust proved not an easy thing to accomplish. Much patience was required to deal with the inevitable conflicts arising from our differing agendas: our's research and goal-focused and their's social service-oriented and on-going. But even here there was room for creative effort to assure that the collaboration or at least the benefits of our partnership would outlast the accomplishment of our short-term research goals. Maintaining the credibility of our commitment to fighting the spread of HIV suggested that we would be well advised to capitalize on the existence of our community partnership. We therefore began efforts to help El Regreso and its network of community organizations to construct a permanent HIV prevention platform and, in doing so, to help develop a constituency for continued HIV prevention research among those most at risk of HIV infection.

  We believe that HIV vaccine education of "hard to reach" substance abusers and women at heterosexual risk is greatly facilitated by a collaborative partnership such as the one between NYU MC and El Regreso. As the partnership developed, and with it our credibility within the community, doors opened to us at the political level, proving how HIV prevention research can be piggybacked on the research center's demonstrated goodwill to the community.

  For instance, our HIVNET site was able to take advantage of El Regreso's strong political connections to accomplish a primary goal of the first HIV/AIDS Vaccine Awareness Day, which was to obtain the support of elected officials across the country for HIV prevention research. On our behalf, El Regreso contacted State Assemblyman Vito Lopez of District 53. Lopez, the influential Chair of the Housing Subcommittee of the New York State Assembly, who agreed to circulate the HIVNET petition through both houses of the state legislature. The petition (which the Mayor of New York City also signed) honors the contribution of HIV vaccine volunteers in our 014 clinical trial at NYUMC and at 8 other sites across the nation.

  In summary, our experience is that community educators, through partnerships with CBOs, can accomplish a spectrum of HIV prevention goals, from establishing credibility for government sponsored research in minority communities to building a national infrastructure for Phase III trials. Specific means for achieving these goals include: 1) a strong HIV prevention infrastructure such as the modules developed by HIVNET, 2) a commitment of resources for new and creative projects such as the Mobile Research Unit, 3) the establishment of local HIV prevention services, such as the use of the rapid HIV screening method. In these ways community educators can prepare the way for successful future trial networks among the "hard to reach."

  Community Advisory Board/Principal Investigator Partnership Development At the New York Blood Center/Project Achieve

  Project Achieve History

  The Laboratory of Epidemiology of New York Blood Center has conducted studies among gay men in New York City since the mid-1970's. Initially, the major focus of the Laboratory was the epidemiology of hepatitis B virus (HBV), culminating with large-scale trials of hepatitis B (HB) vaccine efficacy in gay men, as well as in other populations at risk of HBV infection. Studies of nearly 9,000 men in the late 1970's were carried out on the epidemiology of HBV infection to gather baseline data for a HB vaccine efficacy trial. The Laboratory conducted the first efficacy trial of HB vaccine in the United States among 1,083 HBV-susceptible gay men from 1978 to 1981. Following this groundwork, several hepatitis B vaccine trials were carried out and as a result, the first hepatitis B vaccine was licensed in the United States in 1982.

  In 1984, the Laboratory began its Prospective AIDS Study, a natural history study of HIV infection, in a cohort of 850 gay men in New York City which included many of the men who had participated in the earlier studies of HBV infection. In collaboration with the New York City Department of Health, we have also investigated AIDS mortality over more than a decade (1978-90) in the cohort of gay men from the original HBV studies.

  With this background the Laboratory of Epidemiology, in 1992, initiated Project Achieve, a vaccine feasibility study among high-risk participants funded by grants from the National Institutes of Health. In 1993 we opened three clinical sites to recruit men who have sex with men (MSM) and women at heterosexual risk (WAHR) into a Vaccine Preparedness Study. We created the name "Project Achieve" (an acronym for "AIDS Community Health Initiative Enroute to a Vaccine Effort") to establish a study identity within the community.

  Development of CAB/P.I. Partnership

  In preparation to apply for funding from the National Institutes of Health, the Laboratory invited community leaders in New York City to a series of meetings at the New York Blood Center to discuss vaccine trial research in order to provide community perspectives to the Principal Investigators (P.I.s). These leaders included representatives from organizations providing health care and other services to gay men and high-risk women, gay political organizations, the Department of Health, as well as several physicians, scientists and ethicists. This Community Working Group met regularly and developed several recommendations, one of which was that at-risk women should be involved in vaccine feasibility trials. It was noted that failure to study such women at this juncture might preclude their being considered as possible candidates for future domestic vaccine trials. This recommendation led the P.I.s to include women in the grant application.

  However, the NIH review team returned the application to the Blood Center asking that the proposed cohort of women be omitted due to the Laboratory's lack of experience with this population. The Working Group insisted that women participants remain in the application and that we argue our willingness and ability to include women. Thanks to the initiative and persistence of community members, the women's cohort was eventually funded along with the men's cohort. Today the women's site employs 6 people and has involved over 400 women in 7 different trials.

  Since that time the Community Working Group has evolved into the Project Achieve Community Advisory Board (CAB). Its history of advocacy and impact on the research process continues today. There are numerous examples of how this CAB/P.I. partnership contributes to the research. These include:

  • Cross cohort understanding and advocacy. The CAB is made up of women and men who have participated in the studies or who have been recruited to the CAB through community education efforts. Although the idea of separate meetings has been considered, the CAB has maintained the position that joint meetings foster cross cohort understanding and advocacy. We believe the joint meetings have served to enlarge the scope and number of people at the community level who are familiar with HIV prevention strategies for both MSM and WAHR.
  • Advocacy on behalf of the community. For Explore (a MSM behavioral intervention), the CAB wrote a letter of support for funding a full trial based on excellent pilot study results. For the planned post-exposure prophylaxis (PEP) study, the CAB advocated for adequate community education about the issues attached to PEP's research premise and for fair access to the drug regimen for all trial participants (both control arm participants and study arm participants). In the AIDSVAX phase III vaccine trial, our CAB has fought for a national standard for counseling and the informed consent process across all the sites. Although the trial sponsor, VaxGen, is a privately funded, start up company, the CAB has challenged it to expand its collaboration with and responsiveness to community concerns.
  • Education and recruitment within the community. To aide the site in the recruitment phase of VPS2, the CAB offered ideas of where to locate eligible women and one of the CAB members was hired for part-time street outreach work. This CAB member is both a former trial participant and is a member of the trial site community. Based on her superior work (that resulted in 164 women enrolled against a goal of 150), the CAB member is now a permanent part-time outreach worker.

  Suggested Best Practices on Fostering CAB/P.I. Partnership

  Involvement and responsiveness of P.I.s: As an advisory group, the CAB's role is defined by the amount of leverage the leadership team assigns to the group. This leverage will in turn impact the attractiveness of the CAB to potential and current members. Our CAB members express that the P.I.s involvement and responsiveness to CAB concerns acknowledges the value and significance of community input. Moreover, the P.I.s model for the rest of the staff the significance attached to CAB input. To the extent that an agency desires to empower the CAB, we recommend:

  • That at least one Investigator attends every meeting.
  • That the Investigator(s) be available by phone and e-mail.
  • That CAB members are informed of and involved in issues of import (even to include a personal call to CAB members from the P.I.s)
  • That P.I.s show respect for the opinion of the CAB and a willingness to yield to their viewpoint.
  • That agency final decisions be expected to reflect the views of staff and CAB.

  CAB member recruitment: This should be an on-going process wherein new CAB members are added to the CAB over time and older CAB members depart for various reasons. All new CAB members should receive an orientation and background materials prior to their first meeting. It has worked well for us to have prospective members write a statement of interest and have the CAB vote on the person's acceptance or not to the CAB.

  CAB members may be identified in numerous sources. Both staff and CAB members should be encouraged to keep their eyes open for new members. Ideal places to find new members include:

  • Study participants -- Site staff (especially the counselors) should be encouraged to identify participants who would be interested in and could contribute to the CAB.
  • Research advocates -- Efforts should be made to identify research advocates (from ACT- G or other treatment groups) who would be interested in and could contribute to the CAB.
  • Prevention advocates -- Same as above; possible source is the city Prevention Planning Group.
  • Community advocates -- Same as above; possible source is community-based agencies.

  Accessibility: Although the details around CAB meetings may seem inconsequential, they go a long way to foster consistency, regularity, and commitment. These include:

  • Location -- The ideal is a location convenient to all; minimally needed is a consistent location.
  • Meeting time & frequency -- This should be determined by the group. For timely feedback, once monthly meetings should be the minimum.
  • Food -- Providing a meal offers a less co-optive way (as opposed to monetary compensation) to acknowledge the value of the members time and input. It also encourages familiarity.
  • Transportation assistance -- To lessen obstacles to meeting attendance, agencies should offer to compensate members for travel costs or provide transportation service, especially for members who travel a lengthy distance.
  • Flexibility towards child care concerns -- As child care concerns take precedence over CAB meeting attendance, it is useful to discuss such concerns with applicable CAB members. If possible, the agency should offer to reimburse child care costs or provide a space/activity for children of members during the meeting time.

  Commitment to the CAB process: Beyond fulfilling a contractual requirement, CABs create an opportunity to contribute to the long-term expertise of individuals and the community. To reach for that level, however, requires an active commitment from the leadership team. Steps in the right direction include:

  • Identify a staff liaison to the CAB who can organize and run the meetings and send timely information and meeting notices.
  • Establish CAB Guidelines in collaboration with the CAB. The P.I.s and staff CAB liaison should ensure that the guidelines are adhered to in order to maintain CAB integrity.
  • Cultivate long time members whose involvement and leadership within the CAB and agency increase over time.
  • Provide financial support for CAB member travel and attendance at relevant meetings and/or conferences.
  • Maintain a vision for developing CAB members who are active in HIV prevention work in connection with and long after their involvement on the CAB.

  Community Collaboration to Protect Participants in San Francisco

  Vaccine trial participants face a variety of potential legal and social harms. For the vaccine research site, this fact poses two problems. First, the possibility of harm means that the site needs to work to protect participants. Second, the site needs to address community and individual concerns about these harms, which might prevent people from enrolling, or might engender community opposition to trials.

  In 1997, the San Francisco HIVNET site was preparing for the potential impacts of a Phase II trial on participants and on the community at large. In addition to preparing for this smaller trial, site staff saw the trial as a chance to anticipate some of the issues of a large Phase III trial. The community educator made an inventory of concerns which a participant might have while entering into a vaccine trial, and attempted to organize local community resources which could help participants address those concerns. For instance, knowing that participants would want to gather information on vaccines before entering a trial, the community educator assessed who had the capacity to provide outside information about vaccine trials. This in turn led to meetings and ongoing relationships with information hotlines and the health librarian at the central city library.

  The most successful moment in this effort came when the community educator met with staff at the AIDS Legal Referral Panel (ALRP). He asked to meet with ALRP in an effort to anticipate potential legal questions, and with the hope of enlisting a group of community experts to answer those questions for potential participants. Through discussing these issues with the community educator, the ALRP staff became interested in the unique legal challenges faced by vaccine trial participants. During the meeting, they managed to quickly unearth a provision of California law which specifically addressed HIV vaccine trial participants' legal issues--a law which neither the trial site or its national legal advisors had known about previously. Clearly, ALRP's expertise would be useful both to the site and to participants.

  Meanwhile, the ALRP saw a benefit for continuing to consider and research the issue. For one thing, their funding and volunteer constituency are attorneys, who appreciate new wrinkles in law, special ethical and legal challenges, and intellectually interesting cases. The situation of vaccine trial participants--who often appear to be HIV-infected without actually being HIV-infected--certainly qualified. And, becoming leaders in this corner of the law would reaffirm ALRP's image as a group of attorneys who know AIDS law backwards and forwards. Finally, and most importantly, knowing that a group of people might have unique legal needs in the future helped ALRP staff prepare in advance for a potential new challenge to their role as AIDS service providers.

  The ALRP staff decided to conduct more legal research, and then decided to produce a question-and-answer style document explaining the key legal issues for vaccine trial participants. They wrote it with technical assistance from the HIVNET site on the logistical and scientific issues of trial participation. The HIVNET community educator then laid out the brochure and printed it (with an ALRP logo) with the site's budget. All of this meant that ALRP only needed to contribute its expertise; the site took care of the logistical and budgetary elements of producing and distributing the brochure. As the process of producing the brochure came to a close, ALRP also pledged to represent vaccine trial participants who might need legal assistance because of trial-related issues.

  The brochure became a useful tool for counseling participants and for informing other community organizations about the issues involved in vaccine trial participation. When the community educator--continuing in the effort to work with information providers--gave the ALRP brochure to a local HIV information web site, the brochure became a global resource. It was eventually used by other vaccine trial sites and a private vaccine company in preparations for other trials. Press releases about the brochure also boosted ALRP's visibility in the legal press and the legal community. The site also hoped that the resulting legal newspaper article would put local attorneys--for example, counsel for insurance companies--on notice that this issue could arise in the future.

  A year later, a vaccine trial participant encountered a classic and severe social harm--a TV news story falsely described him as having been "injected with the AIDS virus." While site staff worked to get a correction from the station, they also worked on ensuring that the participant had additional back-up. A quick call to ALRP reaffirmed their commitment: "This is just the kind of thing we prepared for," said the ALRP staff attorney, pledging to represent the participant if he should need to take legal action.

  As it turned out, the station eventually did correct their error, and the participant decided not to take further action. However, the support provided by ALRP was essential for two reasons. First, it provided a back-up to action which the site might have been able to take on the participant's behalf. Second, it meant that a community agency was entirely in the participant's corner. If the participant had wanted to take action that was different than the course chosen by the site, he would have had his own support to consider his options. This reduced the chance that a participants' legal actions would have become hemmed in by the site's own agendas and interests.

  From this example and the rest of our work in San Francisco, we came up with the following loose guidelines:

  1. Use a process of "capacity assessment" to understand who is in a position to lead the community's response to vaccine-related issues. Ask: who has the capacity for action?

  2. Honor community expertise--and capacity for action--by asking for help. This led to useful collaborations much more often than when we went to other agencies to brief them on what we already knew about vaccine issues--an approach which emphasized our expertise, but not theirs.

  3. Understand and support the collaborators' own interests, and minimize the effort and money it takes to enter into the collaboration.

  4. A relationship based on a commonly-held interest in the welfare of trial participants and the well-being of the community at large will ultimately serve participants and their community, and will also enhance the community standing of both parties in the collaboration.

  Assessment through a Phase II HIV Vaccine Trial Participant Focus Groups

  Howard Brown Health Center, Chicago, IL

  Primary Objective:

  1.To educate research staff on vaccine trial participant thoughts and attitudes and make the staff more responsive to the needs of our Phase II HIV vaccine trial participants.

  2.To assess potential barriers to participation in an HIV vaccine trial.

  Methods

  We hosted two dinner focus groups, the first for the vaccine trial participants, and the second for men from our research volunteer cohort who were eligible to participate in the Phase II Vaccine Trial, were contacted, and chose not to enroll. While we hoped that the dinner would be a positive experience for the study volunteers and allow them to get to meet some of the other Howard Brown research participants, we also hoped that the discussions would be able to help us better understand the needs of current and future vaccine trial participants. This event was intended to educate the staff on vaccine trial participant thoughts and attitudes. While we wanted to examine the barriers to enrollment and start to develop a plan for addressing these barriers, this was not a recruitment tool.

  The focus groups were audio taped with participant consent and were transcribed by a professional service.

  Focus Group I

  On Thursday, February 5th we held a focus group of participants who were enrolled in the HIVNET 014 Phase II HIV Vaccine Trial. Attached are copies of the agenda/questions as well as the evaluation form completed by the participants at the close of the focus group.

  Lessons Learned

  A majority of the participants noted that their reasons for joining the trials were altruistic and ranged from a sort of tribute to friends/family members past to furthering AIDS research. Concerns seemed to be largely around the antibody positive results (especially with regard to insurance and/or job status) and unknown long-term effects of the vaccines. Also voiced by most was the concern over who would pay for any adverse effects suffered, especially those associated with the unknown long-term side effects.

  As was observed by study staff during the screening process, many of the participants had discussed possible participation in the trials with partners, friends and/or family members. Most received negative feedback from these sources, even after providing them with additional information. Several participants said that they either chose to tell

  no one, or lied to family members about being in the trials. Most agreed that it would be nice to view the video with other participants and/or partners, friends or family members. Participants seemed to think that it would be useful not only to hear other people's questions but that the response of others might serve to quell some of their concerns.

  Overall, participants felt that the study staff was very accessible and helpful in addressing their questions and concerns. They did voice the desire to have more and varied time slots available for both the screening visits as well as the vaccination visits. It was also mentioned that it would be nice to have refreshments for those early morning visits, especially those requiring blood draws.

  A majority of participants found it useful to meet other research volunteers and to discuss their experiences both from the clinical perspective as well as the personal side. Most also expressed an interest in ongoing group get-togethers.

  Focus Group II

  This group was held on Monday, February 9th and consisted of participants who had made it through the entire screening process but for whatever reason(s) decided not to enroll in the HIVNET 014 Phase II HIV Vaccine Trial. Attached are copies of the agenda/questions as well as the evaluation form completed by participants at the close of the group.

  Lessons Learned

  Half of the group noted that their main reason for refusing participation in the trials was due to concern over insurance or job status. One participant said it was because of a concerned family member (his brother) and the other said it was because of the inflexibility of scheduling appointments. Much like the other group, concerns centered largely around the possibility of antibody positive results and unknown long-term side effects.

  With the exception of one participant, all had discussed the possibility of enrolling in the trials with partners, friends and family members. Again, most received negative feedback. The opinion of this group was mixed however, on the subject of group screenings of the video. One participant had brought his brother to view the video and ask questions of the study staff and still didn't want the participant to join the study. Others felt that it might be uncomfortable to have group screenings because he was concerned about confidentiality. The group did think that it made sense to offer it as an option.

  Participants felt that the study staff was accessible and adept at addressing most of their concerns. Those that were not addressed were the unknowns. It was also mentioned that had this study been conducted by a different health care/medical facility that they would not have even responded to an advertisement or a letter. There was a definite trust of the study staff and the Howard Brown name. All of these participants said that they would seriously consider enrolling in the next phase of clinical trials. More and varied time slots was also mentioned.

  Conclusion

  Overall, the focus groups met our goals of examining ways that we may address current difficulties for trial participants, as well as issues that would prevent a person from participating in a vaccine trial. We were able to come away from the groups with a clear sense that we have to invest more in support networks for our volunteers, and more in educating the community at large about these efforts. Many of the 014 trial participants requested that we have these focus groups on a regular basis, and the small groups seem like a cost-effective way to offer both support and learn about the most pressing issues from our participants.

  Action Taken

  The main result of these focus groups is being realized right now, as we enroll for another HIV Vaccine Trial. We have restructured our vaccine education and informed consent education to reflect the suggestions given in the focus groups. We now offer group sessions and encourage the participation of family members and partners who may have reservations about a participant being in a study. This helps to foster a supportive network of informed individuals for the trial participant. Also, we have made efforts to have more appreciation and informational events for our volunteers so that they may meet other volunteers and discuss their concerns and thoughts with them.

  MODEL — Focus Group I

  Agenda

  I. Welcome (3-5 minutes)

  II.Introductions* (10 minutes)

  III. Overview (5-7 minutes)

  IV. Administration of Questions (50-55 minutes)

  V. Completion of Evaluation (10 minutes)

  VI. Wrap-Up (5-7 minutes)

  Focus Group I Questions:

  1) What is your primary reason for joining the vaccine trials?

  2) What do you get out of being in these trials?

  (a) Are there any benefits?

  3) What were/are your primary concerns and/or questions about the trials?

  (a) Before you started?

  (b) How have they changed?

  4) How comfortable are you talking about being in the vaccine study?

  (a) Who do you tell?

  (b) How do they respond?

  5) As a participant, is there anything more that you would like to see happen at your visits?

  (a) Anything more you would like from the study staff?

  (b) Did you expect anything from the study that you don't seem to be getting?

  (c) Is the study staff accessible enough?

  6) How do you find the visit structure (ie appointment times, length, etc.)?

  (a) Do you have any suggestions on how you might like to see it changed?

  This would be the time to open the floor to any other issues participants may want to discuss.

  MODEL — Focus Group II

  Agenda

  I.Welcome (3-5 minutes)

  II.Introductions* (10 minutes)

  III.Overview (5-7 minutes

  IV.Administration of Questions (50-55 minutes)

  V.Completion of Evaluation (10 minutes)

  VI.Wrap-up (5-7 minutes)

  Focus Group II Questions:

  1) What was your primary reason for deciding not to participate in the trials?

  2)In your opinion, what are the drawbacks to participating in these trials?

  (a) Are there any benefits?

  3) What were/are your primary concerns and/or questions about the trials?

  (a) Before the screening visits?

  (b) After the screening visits?

  4) Was the staff able to address those concerns or answer those questions?

  5) What did you think of the video "No Easy Answers".

  (a) Was it helpful?

  (b) Was there anything else you would've liked to see in the video?

  6) When you were coming in for the screening visits, did you discuss the possibility of these trials with anyone?

  (a) Who?

  (b) How did they respond?

  7) How did you find the visit structure (ie appointment times, length, etc.)?

  (a) Do you have any suggestions on how you might like to see it changed?

  8) At what point in the screening process did you decide not to participate?

  [If at or before the first visit: Why did you continue with the screening?]

  9) Is there anything that could've been done to change your decision?

  This would be the time to open the floor for any other issues that may not have been addressed previously.

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