| HIVNETworknews
(HIVNET National Newsletter)
Winter 1996 - Spring 1998 - Fall 1998 Following are articles from the HIVNETworknews, the national newsletter for the HIV Network for Prevention Trials (HIVNET). The HIVNET is a network of clinical research sites funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health to conduct trials of promising HIV prevention strategies, including HIV vaccines, in both the United States and abroad. These articles are in text only format. If you are interested in obtaining hard copies of the newsletter, please contact Joy Workman at Abt Associates. Are you interested in being added to our mailing list? Click here to sign up. A Look at the HIVNET Mission Welcome to our inaugural issue! Our goal is to communicate with HIVNET study participants and Community Advisory Board (CAB) members locally and across the U.S. We want to provide meaningful and understandable information on new methods for preventing HIV and AIDS, and HIVNET=s role in developing and testing these methods. HIVNET, which stands for the HIV Network for Prevention Trials, is a group of research sites studying new ways to prevent HIV infection and preparing for large-scale trials of vaccines. HIVNET was established in 1993 by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. HIVNET has eight research sites in the U.S. (see map) and nine sites in Africa, Asia, the Caribbean, and South America. Within six months, in 1995, the eight U.S. HIVNET sites recruited 4,892 participants. Each participant visits his or her HIVNET site every six months to respond to a questionnaire, and receive risk reduction counseling and HIV-antibody testing. About two-thirds of the participants are gay/bisexual men, one-fourth are male and female injection drug users, and the remaining 10 percent are non-injecting women at risk of infection through heterosexual intercourse. Almost 40 percent of study participants are non-white. More than 90 percent of participants returned for a Month 12 follow-up visit. Participants will be followed for a total of 18 months and then may be eligible to participate in one or more HIV prevention studies, including a possible vaccine efficacy trial tentatively planned for late 1998. Helping to Stop the Epidemic One goal of the HIVNET is to gather information about what motivates people to volunteer for a prevention trial and to continue to participate in the study. About three out of four HIVNET participants indicated they would probably or definitely be willing to participate in trials of HIV vaccines or other prevention methods. The reasons most often given for willingness to take part in trials were to help find a vaccine or stop the epidemic. While HIVNET study participants show a strong volunteer spirit, they also express a need for information about vaccines and how clinical trials are conducted. As a result, HIVNET staff, study participants, and CAB members are at work on a comprehensive plan for educating participants and communities at large about the science of vaccines, how clinical trials work, and social and ethical issues related to vaccine trials. HIVNET is also seeking answers to questions such as:
Preventing HIV Infection The establishment of HIVNET is one response to the HIV epidemic, which continues to grow worldwide in spite of major advances in understanding HIV infection and treating the disease. While promising HIV vaccine products are in various stages of development, it will be at least a number of years before an effective vaccine is available. Therefore, control of the epidemic requires improved methods and strategies for preventing HIV infection. Interventions to be evaluated by HIVNET participants in the U.S. include HIV vaccines, topical microbicides, sexually transmitted disease (STD) treatment, and strategies to reduce behavioral risk. At present, participants are taking part in studies of topical microbicides, home collection of specimens for early detection of HIV infection, computer-assisted interviews, and people who are exposed to HIV but remain uninfected. To move closer to our goal of preventing HIV, we need volunteer participation in HIVNET and continued sharing of information. This newsletter was created as a joint effort by site coordinators, study participants, and CAB members from all eight U.S. sites.
COMMUNITY INVOLVEMENT KEY TO HIVNET SUCCESS The success of HIV prevention studies requires researchers and members of communities at risk for HIV infection to build trust by engaging in open, ongoing dialogue. Trust is critical since public confidence in the safety and integrity of medical research can be undercut by the legacy of previous medical abuses such as the Tuskegee syphilis study. HIVNET recognizes the many valuable contributions community members make in all phases of the research process, from helping with recruitment to communicating study results to the community at large. Each HIVNET site has a Community Advisory Board (CAB) made up of study participants and community leaders. In addition to the local CABs, there is a HIVNET National CAB Network composed of CAB members from each site. Researchers, site staff, and CAB members hold regular meetings and conference calls to foster mutual understanding of HIV prevention issues. Their collaboration ensures that HIVNET studies address social concerns and respect cultural and ethnic differences among participants. Last February, HIVNET brought four or more CAB members from each study site to Washington D.C. so they could discuss issues face to face and learn more about HIVNET prevention research. A second national meeting of CAB members took place in November. A variety of factors motivate people to become involved in their local CAB. Robert Banker, a study participant in Chicago, says, "Becoming involved in the HIVNET study was my way of being part of the solution to the health crisis facing our communities. CAB membership represented one more step in my involvement." Fellow Chicago CAB member Walter Mathews became involved to help ensure the safety of study participants. He explains, "I want to make sure that the overall well-being of study participants is considered in every aspect of this project. It is the volunteers who make this study successful. We should be heard, respected, and our views considered." Once involved with their local CAB, members contribute in different ways. Some help local site staff develop effective plans for recruiting and retaining study participants. Others help scientists understand how being in a research study affects the participant=s family, friends, and daily activities. Still others strive to make everyone aware of the "word on the street" and media hype affecting those who might be thinking about participating in HIVNET. Finally, some CAB members serve on national groups which create policy, and help design and follow research studies. HIVNET encourages each local CAB, and the national CAB, to develop its own mission and goals. These goals vary from site to site, reflecting the diversity of participants and locations. However, all CABs share one critical goal. They provide a forum for HIVNET scientists and members of communities affected by HIV prevention research to talk about issues and concerns. This active dialogue makes sure that HIVNET studies are conducted in a way that is honest, scientifically sound, and respectful of the lives of people who participate. --Allen Drexel (Community Relations Coordinator, Chicago), Steve Wakefield (CAB member, Chicago; leader of the HIVNET National CAB Network), Kathleen Weber (CAB member, Chicago). News From Our Local Sites Boston/Rhode Island -- Project ACHIEVE In October, the Boston/Rhode Island Project ACHIEVE CABs met to discuss the shared community issues men and women face and to learn from our different perspectives on HIV prevention. In Rhode Island, a vaginal microbicide study will begin soon and 21 women are enrolled in the HIV Early Detection Study (HEDS). The Boston CAB is strongly advocating the study of the female condom as an anal condom. CAB members report that an anal condom would give receptive partners another means of protection from HIV infection. Project ACHIEVE is delighted to announce that the Rhode Island sites hosted a women's workshop in November to address the cultural and gender issues related to female participants in HIVNET. Staff and CAB members from New York, Philadelphia, and Chicago attended the workshop. Chicago Chicago's Howard Brown Health Center (HBHC) has begun conducting computer-assisted interviews with 150 participants from the Sexually Active Men (S.A.M). study's cohort of roughly 500 gay and bisexual men. The HBHC site had a great turnout at the "Summer Soiree" in August, with over 150 participants and friends attending the event. Planning is currently underway for a similar party for women participants at the Cook County Hospital and University of Illinois/Chicago sites. Chicago's overall participant retention rate currently stands at 92 percent. The Chicago CAB has recently set up an information and comment line for study participants. CAB members are also planning a city-wide forum on vaccine research to take place in March. All three Chicago sites look forward to involvement in future vaccine trials as well as new behavioral interventions being developed. Denver -- Project WIN Thanks to the efforts and commitment of study participants and staff, Project WIN has retained 92 percent of the 675 participants enrolled in the cohort. As of September 30, Project WIN was the first site to fulfill its enrollment goal for the HIV Early Detection Study (HEDS) by enrolling 70 participants. Project WIN's CAB adopted a mission statement, goals and bylaws earlier this year, which established CAB officers and committees. At the CAB's October meeting, the acting chairperson and secretary/treasurer were succeeded by elected officers. In June, the CAB and staff members participated in PrideFest, marching in the parade and staffing a booth at the post-parade celebration. On October 18, the CAB presented an educational forum to allow study participants to meet with the investigators, staff, CAB members and other participants. New York -- Project ACHIEVE The women's Bronx site continues to create ways to offer support to participants beyond regularly scheduled visits. A community breakfast was held in July and holiday parties are planned for October and December. We offer a weekly drop-in group for women. We were involved in planning the women's workshop in Rhode Island for staff, CAB members and participants, to increase the visibility of women in HIVNET. In October, the Brooklyn and Manhattan men's cohorts moved into one new clinic ready for Phase II trials. Working together with our CAB and community organizations, Project ACHIEVE completed a new round of HIV-negative groups, referred participants to exposed-but-uninfected (EBU) and early intervention studies, and completed a series of community presentations on vaccine research. If you're in New York, come visit us! New York -- NYU The New York University Medical Center CAB worked diligently in preparation for a local meeting on women's issues. The meeting covered several topics of interest to women in the community that relate to HIV, e.g., disclosure of infection, substance abuse, battered women, transmission and family issues. The timing for this meeting was ironically right before the HIVNET women's conference in Rhode Island. Great minds think alike! We shared our local empowerment with the larger national group. The Beth Israel/Harlem site is making plans to hold a conference among Beth Israel participants to promote further HIV awareness, reinforce safer behaviors, and possibly to form support groups in November. The Bellevue site is going to plan a similar meeting after the "uptown" group meets. Philadelphia -- Risk Assessment Project (RAP) The latest news from RAP is the completion of the ALVAC/gp120 prime-boost educational video, "No Easy Answers." The video employs a Q&A format to address concerns of individuals considering participation in the upcoming Phase II ALVAC/gp120 prime-boost vaccine trial. The effectiveness of the video as an educational tool will be assessed. Copies of the video will be made available to HIVNET sites once an evaluation strategy has been outlined. The Philadelphia AIDS Walk took place on October 20. In an effort to support Prevention Point Philadelphia (PPP), the local needle exchange, the Philly CAB joined forces with PPP to create a unified team of AIDS Walk participants. The 12-mile walk route covered one of the more scenic vistas in the city as it looped around the art museum and the River Drive. San Francisco Greetings from HIVNET San Francisco! In 1996 we've worked on building awareness about HIV vaccine research and development in an effort to promote continued community involvement. Staff and CAB members made presentations at the March HIV/AIDS Update Conference and the July National Lesbian and Gay Health Conference. In September, our community education team gave a presentation to local HIV service providers at the San Francisco Department of Public Health. In the near future, we have plans to reach out to local and national organizations working in other areas of the fight against AIDS. For instance, we sent a representative to the annual conference of LLEGO, the National Latina/o Lesbian, Gay, Bisexual, and Transgender organization. Developing connections with various communities will be a major focus in the coming months. Seattle -- Be A Hero Be A Hero, Seattle's HIVNET site, cosponsored a successful July community forum on HIV vaccine research entitled Mission Possible. A distinguished panel included local principal investigators Dr. Connie Celum (HIVNET), Dr. Julie McElrath (AVEU), and the University of Nairobi's Medical Microbiology chair, Dr. Ndinya-Achola. They explained what new vaccines are about to be tested and how these would work; what a volunteer in a vaccine trial could expect; and what the Seattle community could do to prepare for a large-scale trial. When the floor was opened for questions, the sizable audience demonstrated considerable knowledge about these topics and was eager to learn more. Be A Hero feels encouraged that occasional community forums would be welcomed as information on breakthroughs in vaccine research becomes available. --Dave Pierce, a Denver CAB member, coordinated the gathering of information for this page. The HIVNET National CAB — A Status Report Greetings from Seattle, Washington! My name is Peter Myers and I am excited to introduce myself to all of my fellow Community Advisory Board (CAB) members, HIV Network for Prevention Trials (HIVNET) study participants and site Principal Investigators and staff as the new co-chair of the National CAB (NCAB). Together with Kevin Galligan from the Boston/Rhode Island site, it is my honor and privilege to assume the chair duties for the NCAB. A very big and appreciative THANK YOU to Steve Wakefield from Chicago who has served as NCAB chair up to this point. On behalf of Kevin and myself and the NCAB, we are all grateful for the leadership and insight Steve has provided as chair and continues to provide as Chicago’s NCAB representative. Thank you Steve! I became involved with the HIVNET in November a couple of years ago with Seattle’s Vaccine Preparedness Study (VPS), locally known as the Be A Hero Study. I was invited to join the CAB because of the perspectives I bring from my work at Stonewall Recovery Services for Sexual Minorities. I work with youth and families in prevention and education issues around substance abuse and HIV. I was also a participant in the rectal microbicide study, which gave me insight into what is required of a study participant. I enjoy being involved with the HIVNET and feeling that, in some way, I am contributing to helping find measures to prevent HIV. The great thing about the HIVNET and its studies is they all share the same goal in preventing HIV but take different avenues to get there. If microbicides, vaccines and behavioral counseling can help prevent persons from becoming HIV infected, then all should be used. No vaccine is 100% effective. While for many people it may seem like a vaccine is the quick and easy way of preventing HIV, studies that look at behaviors and encourage people to consider safer sex are equally important. It is only a combination of these that will assist us in preventing HIV. Vaccine development and research take a lot of time and commitment. The use of microbicides and behavioral counseling should not be overlooked or thought of as second rate in comparison to vaccine development. All are important and hopefully all will help meet the goal of HIV prevention. As the eleven HIVNET sites around the US begin new studies and continue phase II of the vaccine preparedness study, it is important to revisit what we have learned so far, particularly from the VPS, to be successful. First and foremost, we learned it is possible to recruit and retain high-risk cohorts for vaccine and non-vaccine intervention trials. In Seattle, our goal was to recruit 500 HIV negative men in six months, and we recruited 578. On a national scale, 4,892 HIV negative persons were recruited. That is an amazing feat when you consider that participants knowingly agreed to 18 months of active participation in a study. Over 2/3 of study participants said they would "definitely" or "probably" be willing to enroll in a future vaccine trial. People are ready and willing to help in any way if there is a possibility to defeat HIV. The fact that there was an 85% retention rate of participants helps support that claim. While HIVNET sites have things in common, each site has its unique concerns and issues that can be addressed with the help of the NCAB. The strength of the NCAB lies in the conveyance of concerns from local CABs to facilitate discussions for the improvement of HIVNET. For example, changes in the 014 protocol were the result of local CABs’ concern that, in the initial informed consent and agreements with manufacturers, no provisions were made for medical costs related to the vaccines. This was addressed by further negotiations between the National Institute of Allergy and Infectious Diseases (NIAID) and the manufacturers, and now is a provision of the study consent form. Currently, the NCAB is very active in the EXPLORE study and what it will look like in future phases and discussing the exigencies of the study on Post-Exposure Prophylaxis (PEP). Additionally, keeping the VPS cohort together and monitoring what is being done with them at individual sites is a topic of important conversation. Some of the questions and concerns I have as we look to the future of HIVNET studies are: 1) how do we recruit participants that are of the highest risk and would benefit most from these studies; 2) are our local CABs reflective of the populations that are most at-risk; and 3) what do we need to do to ensure that diversity is reflected in all our activities? I encourage all CABs and sites to continue having discussions about their education plans and recruitment strategies. It should be the goal of every CAB member to invite at least one person to visit a CAB meeting. Our commitment to our communities needs to be evidenced by our willingness to have a constant supply of fresh perspectives and insights. I look forward to what these next years will provide for HIV research. The goals that HIVNET has set forth through its studies are very exciting and ambitious. Here in Seattle, we take pride in that we can follow in the footsteps of our sister program, AIDS Vaccine Evaluation Unit (AVEU), which is now co-located with HIVNET. Both CABs continue to work together and pursue opportunities that are advantageous to both studies and study participants. Your involvement, whatever it may be, is crucial to the continuing success of the HIVNET and its mission. Thank you for your time, energy, thoughts, advice, expertise and commitment to preventing HIV. I hope that I will have the time to visit with some of you, either here in Seattle or at your local site. Kevin and I are available via telephone and/or e-mail; please don’t hesitate to contact either one of us for any questions and/or comments. Good luck with the studies and I wish everyone a happy and healthy year. -- Peter Myers (Co-chair, NCAB & CAB member, Seattle) We Have a "BIT More To Do..." Pilot studies for a new behavioral intervention trial for men who have sex with men, known as EXPLORE and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), began in October, 1997 at six domestic HIVNET sites. The purpose of this study was to see how effective behavioral interventions are in preventing HIV infection among men who have anal sex with men. In theory, results generated from the study will also help inform the development of more effective behavioral interventions in the future. The pilot phase of EXPLORE continued during this quarter with each site enrolling an average of 40 participants. Sites continue to test and refine site specific recruitment, intervention, and retention strategies, as well as test all aspects of trial implementation. Implementation of the actual trial is estimated to begin in July, 1998. Participants will be randomly assigned to two groups. One group will have ten individual sessions with a counselor within the first three months of enrollment, with follow-up sessions occurring every three months after that until the end of the study. Depending on participant needs, these sessions may be held at off-site locations, like community centers, or even by telephone. The other group will receive the Centers for Disease Control and Prevention's standard HIV testing and counseling every six months. All participants will receive pre/post-test risk reduction counseling, HIV-antibody tests at six month intervals and will be reimbursed for their time and travel. The most important goal of this study will be to provide information on whether one behavioral intervention reduces new HIV infection more effectively than the other. The full EXPLORE study will involve 4,000 men who have sex with men. Six HIVNET sites — Boston, Chicago, Denver, New York City, San Francisco and Seattle — will take part, with 600 to 700 participants at each site. This study will run from mid 1998 through mid 2001. The counseling sessions in EXPLORE have been developed to address challenges in men's lives that may make it difficult for them to stay healthy, such as drug use and relationship issues. Since HIV risk and behavior change may be experienced differently by individuals who may be at different stages of their lives, the interventions will be individually tailored for each participant. "This study will provide gay and bisexual men a safe place to talk about the tough things that really matter in trying to stay safe," says Cevero Gonzalez, Community Educator for Project ACHIEVE, at the Fenway Site, Boston. Although some people had expressed doubt that men would be willing to participate in such a 10 session program, Michael Iatesta, protocol specialist at Abt Associates Inc. for the EXPLORE study notes, "During the pilot phase of this study, the HIVNET sites successfully reached their goal of enrolling a diverse cohort of participants. Participant Satisfaction Surveys administered to study participants at the completion of ten weeks worth of counseling indicate that study participants found the counseling sessions extremely helpful in their self-EXPLORATION. Additional feedback collected from study participants and those individuals who declined participation will be used to make necessary modifications to the content for the counseling sessions in the larger trial." -- Kevin Galligan & Christopher Broughton (CAB members, Fenway, Boston) Updated and Reprinted from Fall issue of ACHIEVEMENTS Fenway, Boston. Getting Clarity on Post-Exposure Prophylaxis In several of the HIVNET cities recently, PEP-- more formally known as post-exposure prophylaxis or post exposure prevention--has been in the news. PEP is the practice of giving a month's worth of AIDS drugs to someone who has recently been exposed to HIV usually for a month after the episode. PEP has already been tried among healthcare workers who are exposed to HIV-infected bodily fluids through needlesticks or other kinds of occupational accidents or injuries. Preliminary results seem to indicate that PEP may have sometimes worked to prevent infection among healthcare workers. Now HIVNET researchers and other medical scientists are considering whether PEP might work for people who've been exposed to HIV because of unsafe sex. The theory of PEP is that by using anti-HIV drugs like AZT and 3TC to stop the virus from replicating before it takes hold in the body, the immune system might be able to clear HIV from the body and prevent infection. We know for sure that PEP doesn't work all the time. Now many people are asking, how often does PEP work? Does it work well enough to justify spending the money and making the effort it would take to make PEP more widely available? Does it work well enough to counterbalance any changes in people's behavior that might take place as a result of PEP becoming more widespread (for instance, people deciding to have unsafe sex on the belief that they could use PEP to stop infection)? Several other researchers (for instance, projects in San Francisco and Boston) are setting up "demonstration studies" in which they simply see what sort of people would end up taking PEP, and for what sorts of exposures. However, HIVNET, with its ability to quickly recruit large groups of people at risk for HIV infection, is in a unique position to try to learn whether there is a chance that PEP actually works. This Summer, HIVNET researchers plan to begin a nine month study of PEP. This study will examine whether a program that provides very easy, immediate and free access to PEP works significantly better than what is already available in communities and whether such a program may be cost-effective. PEP is a complicated and expensive strategy, and it may not work in stopping HIV infection from unsafe sex. Only by composing a special program to facilitate access to PEP with what is currently available, can we learn if this complex and costly approach can help reduce HIV infections. That in turn would help everyone decide whether PEP is an appropriate public health prevention strategy. -- Joe Wright, Community Educator, San Francisco HIVNET HIVNET Community Educators Are Making a Connection! The success of HIV prevention studies requires researchers and members of communities at risk for HIV infection to build trust by engaging in open, ongoing discussion. Trust is critical since public confidence in the safety and integrity of medical research can be undercut by the legacy of previous medical abuses, such as the Tuskegee Syphilis Study. Preparing and educating the community about the HIVNET and HIV vaccine trials is a central activity of the HIVNET. At all HIVNET sites across the country community educators are talking to community members about fears and concerns related to government-sponsored research, helping community members to understand the science of HIV/AIDS and vaccines, explaining the methods of research and clinical trial processes, and responding to the educational needs of the community. Building strong relationships and a sense of trust between HIVNET researchers and the community is crucial to the success of the HIVNET. Community educators of the HIVNET are working to facilitate connections between researchers and the community. If you are interested in talking with one of the HIVNET community educators contact the site nearest you and make a connection. News From the Local HIVNET Sites Boston/Rhode Island Vaccinations for the Phase II 014 vaccine study began in New England in September. In anticipation of this study, CAB members and staff organized community events and fora reaching more than 500 people to discuss and debate the impact of a national HIV preventive vaccine trial. Panelists at the fora included NIAID and pharmaceutical company representatives, as well as vaccine recipients in previous studies elsewhere. Project ACHIEVE partnered with two community based organizations in Rhode Island to cross train staff in HIV prevention vaccines, domestic violence, and case management issues. In Rhode Island, 20 women completed use of a vaginal microbicide in the first such safety study in the HIVNET. Fenway in Boston is working with other AIDS service organizations to recruit men at high-risk of infection as a part of the EXPLORE study. Chicago The Chicago Prevention Research Project hosted "Plain Talk About HIV/AIDS Vaccines: An Open Community Forum on Preventative Vaccine Research in Chicago" in March 1997. The event was attended by over 100 researchers and interested community members of the community at large. Howard Brown Health Center (HBHC) completed the VPS with an exceptional retention rate, one which underscores the overwhelming success of participant appreciation events such as the "Summer Soiree" in July and the holiday celebration in December. The University of Illinois/Chicago (UIC) held a participant dinner last June, and recently began enrolling a new cohort of women in VPS-II. Both sites report that the 014 Phase II vaccine trial is progressing well, as is the Behavioral Intervention Trial - EXPLORE at HBHC. In order to prepare for the PEP trial, HBHC has held several meetings with local medical providers and interested community members. Denver Thanks to the selfless effort of participants to advance HIV vaccine knowledge, Project WIN, at the beginning of 1998, had vaccinated 31 participants in the 014 Phase II vaccine trial. Project WIN’s CAB has been invaluable, locally and nationally, for its support and guidance. Attempts to keep the original VPS cohort together, which included the second annual educational forum on November 13th, efforts to reach a wider community (such as Project WIN’s booth at PrideFest), and offering HIV testing to the entire cohort, will be important as other studies get underway. New York Blood Center The men’s site at Union Square has moved to new offices to accommodate the 014 Phase II vaccine trial and EXPLORE. The new space has sweeping views of the city and an open, spacious feel to welcome guests. Two of our 014 Phase II participants were filmed by "Good Morning America" for a segment on HIV vaccines, which aired on Sunday, November 30, 1997. In the coverage, the Union Square site was prominently featured as a vaccine study site in New York City. Our Bronx site, proudly, is one of the first sites to complete the Exposed But Uninfected (EBU) study. This study examined differences in immune responses between women repeatedly exposed to HIV but uninfected and women of low risk. To accommodate our expanding needs in the Bronx, the project has also moved to larger office space. New York University The New York University Medical Center (NYUMC) staff and CAB members continue to educate study participants about vaccine trials. NYUMC CAB members have increased their participation on the National CAB Network, the Vaccine Science Direction Group, the Community Education/Media Relations Group, and the Exposed But Uninfected Team. CAB members are also involved in the recruitment of a new cohort of injecting drug users. Provided with HIVNET/NYUMC photo IDs, CAB members accompany the community educator into local communities to distribute flyers and HIVNET information. The CAB also established a voicemail to provide study participants better access to CAB members, who, unlike staff, are not stationed in the site office. We would like to thank the HIVNET for continuing to support the concerns of injecting drug users. Philadelphia In addition to implementing the 014 Phase II trial, Philadelphia is one of five sites that participated in the women's 24-month follow-up. Also, recruitment well underway for the HIVNET-sponsored study of high-risk, injection drug users. Videotapes produced at our site over the past year have been used throughout the HIVNET. "We All Have Our Reasons" documents the community context in which people make decisions about vaccine trial participation. "No Easy Answers," produced in both English and Spanish, has been incorporated into the 014 screening process for all sites. The CAB has recently been reorganized to include representation from community members involved in service delivery to injection drug users. New members include staff from the needle exchange and local drug treatment programs. San Francisco As we continue to work towards our long-term goal of ensuring that San Francisco's gay and bisexual men are well-prepared for large vaccine trials, the San Francisco site is continuing to make presentations to community groups about vaccine issues. A community forum about vaccines, co-sponsored by our site and the activist group Vaccine Advocates, took place in December. Meanwhile, the San Francisco CAB has been active in working on a number of issues, ranging from Spanish translation of study documents to the design of the HIVNET's upcoming study of safe sex counseling. Seattle In February 1997, the Seattle HIVNET moved to a more convenient location at the Cabrini Medical Tower. We are adjacent to the AIDS Vaccine Evaluation Unit, which permits us to benefit from their expertise and share staff. In 1997, we successfully concluded the VPS with more than a 90% retention rate. We also concluded a rectal microbicide Phase I trial with 35 gay couples. In June, we presented our preliminary findings from these studies at a public forum attended by more than 150 participants and community members. With the addition of our website http://weber.u.washington.edu/~hivnet, we have expanded our ability to provide information to the community as well as recruit for studies such as EXPLORE. As 1998 continues, we will take part in a post exposure prophylaxis study and continue preparing Seattle for more vaccine studies. Los Angeles In Los Angeles, the HIVNET is a multi-site collaboration consisting of seven sub-sites; three are recruitment/enrollment sites and the other four are recruitment and referral sites. The recruitment/enrollment sites are the Minority AIDS Project (MAP), Charles Drew University and the Gay and Lesbian Community Services Center. The recruitment sites are the Asian Pacific AIDS Intervention Team (APAIT), Van Ness Recovery House, Bienestar Latino AIDS Project and Satellite Testing Office for Research and Evaluation (S.T.O.R.E). Weekly training sessions have been held with the Site Coordinators and Interviewers of all the sites to review forms, procedures and protocols as well as to devise strategies to educate and recruit participants. Los Angeles is also assembling its Community Advisory Board (CAB). There have been several meetings thus far and it is expected that the full CAB will be in place by June, 1998. THE 12TH WORLD CONFERENCE ON AIDS — COMMUNITY PERSPECTIVES HIVNET was on the scene at the 12th World AIDS Conference in Geneva, Switzerland, held from June 28th to July 3rd of this year! Among the more than 12,000 participants at this event were several HIVNET investigators and staff giving talks and presenting posters, as well as two HIVNET CAB members, Luis Santiago from New York and Tom Warne from Chicago. We were chosen to represent the CAB and HIVNET as community representatives, where we joined ranks with hundreds or maybe thousands of other community attendees from around the world. For one week this summer, we were in the middle of a huge conglomeration, bringing together a wide spectrum of scientists, policy-makers, activists and people from impacted communities, working on HIV and AIDS. For community representatives like us, it was an opportunity to have a crash-course in the cutting-edge science, as well as an incredible opportunity to meet with and learn from our community comrades working on HIV prevention, treatment and advocacy, around the world. Over 6,000 abstracts were presented at the conference in the four scientific tracks, which included basic science, clinical science and care, epidemiology/prevention/public health, and social/behavioral science. On top of that, community symposia, skills-building sessions and cultural programs were held throughout the week, and many satellite meetings, press conferences and receptions were scheduled in the margins. These community symposia, workshops and meetings resulted in a series of key recommendations in the areas of social and medical treatment, political and ethical concerns, skills building and community organizing. For the full text of these recommendations visit the conference website at http//www.aids98.ch. The real challenge given its size, was prioritizing the sessions to attend, because there were always at least 3 or 4 interesting topics to follow at any given hour of the day. The struggle to make sense of it all was worthwhile, resulting in the opportunity to learn about latest scientific findings, see the processes of scientific and policy debate, and share experiences with community people active in the fight against HIV/AIDS. Introduction to the conference was facilitated by two special events which helped to familiarize community people with the workings of this huge scientific meeting: a Community Rendezvous and the Community Treatment Activists Satellite Workshops. These were held starting a few days ahead of the conference, giving community attendees the opportunity to meet one another, learn about how the conference works, plan their own priorities for the conference, and to find ways to network throughout the week. The Treatment Activists workshop was also an invaluable opportunity to have small group tutorials on the breaking scientific issues, and to have discussions about community relevance of these issues, in advance of the formal scientific sessions. The people attending the workshops continued to meet for breakfast throughout the week of the conference, to share information on breaking news and events, and to have focussed discussions about the interface of science, communities and activism. The friendships and networks made through these sorts of events, both formal and informal, were among the most important aspects of the conference. The theme of the conference was "Bridging the Gap", referring to the gap in resources between countries in "the North" versus "the South", and also to the gaps between science, private industry, and communities. There was much talk at the conference about bridging these gaps and recognizing that the gaps are in fact becoming ever wider. The epidemic is exploding in some developing nations, and among subpopulations in developed nations. In the U.S., half of all new infections are occurring in young people and 57% of newly infected persons are African American. Around the world, there are 31 million people living with HIV, including 21 million in sub-Saharan Africa alone. In some nations, such as Zimbabwe and Botswana, more than 25% of the population is HIV+. On a few fronts, the news was hopeful. Research into more feasible methods of preventing mother-to-infant transmission (MIT) in the South is moving toward programs that will save children's lives. A European initiative will bring AZT to several nations for MIT programs. UNAIDS also announced a program to bring drugs for antiretroviral therapy to several nations at one-fourth the usual price. But throughout the week people from the South consistently and eloquently reminded the scientists and drug companies from the North that this bit of progress is not enough. While there is better hope for babies, there is little good news for the mothers. While drug prices may be dropped for a few nations, that may only bring false hope to some PWA communities where antiretroviral therapy will still not be sustainable in the long run. While scientists and drug companies from the North focussed on technical advances toward controlling or eliminating HIV infection, people from the South expressed frustration and anger that more is not being done to fight a present-time epidemic devastating their communities progressively more and more every year. A strong part of the community response, both from the South and the North, was a call for an HIV vaccine which is safe, effective and accessible to the millions of persons at risk for HIV around the world. While the conference pointed to progress for vaccine development, the pace of discovery and the priority of vaccine science in the midst of all HIV/AIDS research seemed inadequately matched to the reality of an expanding worldwide epidemic. _ Tom Warne, Howard Brown Health Center CAB member Vaccine Ethics: A Community Perspective One important achievement on the vaccine front was the development of a guidance document on ethical issues concerning the conduct of Phase III efficacy studies in different countries. In a meeting which took place 2 days before the 12th World Conference on AIDS, researchers, ethicists, and community activists from different countries reviewed a draft document on the subject that was prepared by a special UNAIDS committee after several regional discussions. It was overwhelmingly agreed that some of the current guidelines that require that a vaccine be tested first in the sponsoring country (where it is made) were too restrictive and paternalistic. As long as the host (testing) country had a proper ethics review committee and followed the informed consent and other ethical requirements, all participants agreed that it was acceptable that they initiate the studies first. It was also agreed that more work had to be done to ensure a proper informed consent process, and that nothing can substitute individual consent. There was no agreement on whether individuals participating in these trials are entitled to the state-of-the-art medical treatment by Western standards, which in many countries is unavailable for the general infected population. In lieu of a "substance" agreement, a "procedural" agreement was reached: countries will decide what treatments they will provide, but nowhere less than the "highest-attainable standard". Developments As far as other significant basic and clinical highlights of the Conference, there are at least three worth mentioning: 1) While the possibility of totally eradicating HIV from the body seems less likely, there appears to be at least a potential for achieving HIV "remission", where an individual’s own immune system is capable of keeping a low amount of HIV in check. Ironically, achieving HIV remission may involve the use of "therapeutic vaccines", a strategy that had almost been abandoned by researchers and companies (except for Immune Response) after initial study results were discouraging. Vaccine manufacturers have moved quickly to seize this opportunity, with Pasteur-Merieux starting therapeutic studies with their ALVAC product. 2) The cause of lipodystrophy syndrome, the abnormal distribution of body fat associated with HAART (Highly Active Anti-Retroviral Therapy), is still not clear. This and other metabolic abnormalities are being more widely reported, and this is expected to continue as people are in these new combination therapies for longer periods of time. With eradication not likely in the short term, questions are being raised again on when people with HIV should start these therapies, which may be for life. 3) A search for protease-sparing regimens, which hopefully (although we don't know) will see a reduced incidence of these metabolic disorders, has yielded at least three potential combinations that appear to be as effective as PI-containing regimes: Efavirenz (Sustiva), AZT, 3TC; Abacavir (1592), AZT, 3TC; and ddI, d4T, hydroxyurea. Even though this Conference raised more questions than it answered, there was a sense of slow but steady progress in search for better therapies. There is a lot of work ahead, but at least the agenda is clearer now than it was some years ago. -- Luis Santiago, New York Blood Center CAB ETHICS CONFERENCE HELD IN SOUTH AFRICA The HIVNET site at Durban, South Africa recently hosted a workshop entitled "Ethical Issues in the Conduct of HIV Vaccine Trials." Four questions were considered in this conference:
Should South Africa Embark on Clade B Vaccine Trials? Most vaccines that are currently available for testing on human subjects are aimed at providing protection against the clade B strain of HIV. This strain is most common in North America, and is found in South Africa among men who have sex with men. However, the most common strain of HIV in South Africa is clade C virus. Participants at the conference presented arguments for starting trials with a clade B vaccine, based on evidence for cross-clade reactivity. Others suggested that laboratory research on correlates of protection (that is, which measurable immune system responses actually provide protection from infection) continue until a clade C vaccine is available for testing. South Africans clearly want to provide leadership in a scientific agenda that has development of a clade C vaccine as its first priority. Research on cross-clade reactivity, which would primarily benefit the US and Europe, is a secondary priority. During the next few months, South African researchers will work to develop an organization with flexible and entrepreneurial management skills for product development, community preparedness, and scientific collaboration, as preparation for mounting a country-wide effort to test a clade C vaccine. This gathering of almost one hundred participants was seen as the first step in developing a country wide prevention vaccine initiative for South Africa. Attendees included: clinical research scientists, virologists, medical ethicists, social workers, attorneys, epidemiologists, and administrators were joined by representatives from non-government organizations (advocacy and community groups) with an interest in HIV vaccine development. Also attending were representatives from the HIVNET site in Brazil, the International AIDS Vaccine Initiative, the Fogarty International AIDS Training and Research Program, the US HIVNET National Community Advisory Board (Tom Warne and Steve Wakefield), the HIVNET International Master Contractor, the HIVNET Central Laboratory, and the Division of AIDS, National Institute of Allergy and Infectious Diseases. Regional Testing Laboratory for Southern Africa Following the conference on ethical issues, researchers met to discuss the protocol for a laboratory-based study to obtain: (1) data on the distribution of HIV C-subtype variants in southern Africa; (2) data on the HLA genetics of the populations in southern Africa (HLA is a group of molecules that are involved in the immune response); and (3) data for development of a HIV C-subtype vaccine. The protocol will include development of a regional laboratory that will perform CTL assays (tests of one aspect of the immune response to a vaccine). The study will also help to develop the sites' capacity for, and experience with, multisite trials. All five sites in southern Africa (one site each in Zambia, Malawi, and Zimbabwe and two sites in South Africa) will participate in the protocol. — Steve Wakefield, Howard Brown Health Center CAB Member HIVNET at the 12th World AIDS Conference This summer, the 12th World AIDS Conference in Geneva, Switzerland (28 June 28 - 3 July 1998) was the site of a number of presentations by HIVNET investigators and staff. The data presented came from two HIVNET studies: the Vaccine Preparedness Study, and a safety study of a vaginal microbicide. Other HIVNET reports included a presentation on the use of videotapes in educating communities about HIV vaccines. Vaccine Preparedness Study The main goal of the Vaccine Preparedness study was to develop and evaluate ways to conduct HIV vaccine trials and other HIV prevention trials in at-risk populations in the U.S. The study recruited and followed over 4,500 participants for at least 18 months; all participants who received HIV counseling and testing every 6 months. This provide researchers with an estimate of the incidence of HIV infection, that is, the number of people being infected in a specified period of time (usually expressed as the number of HIV infections per 100 person-years). These participants would be considered eligible for trials to test how well a vaccine works to prevent HIV, because they report behaviors that place them at risk for infection. Three types of participants were recruited: men who have sex with men (MSM), injection drug users (IDU), and women at heterosexual risk of HIV infection (WAHR). The study also looked at why people would consider enrolling in HIV prevention and vaccine trials and what might prevent them from participating. The study also explored ways to provide information and knowledge about HIV vaccines and prevention trials to people at high risk of being infected with HIV. George Seage presented enrollment, follow-up, and incidence data from the HIVNET Vaccine Preparedness Study (VPS). The VPS achieved 88% follow-up at 18 months. The incidence rates for HIV-1 seroconversion (that is, the number of people who became infected with HIV during the study) varied among the three at-risk groups (MSM, IDU, and WAHR). The incidence rate was highest among MSM (1.54 infections per 100 person-years [PY]), with slightly lower rates for women IDU (1.26/100PY), WAHR (1.15/100PY), and a much lower rate for male IDU (0.38/100PY). Incidence rates increase if eligibility is restricted to MSM who report unprotected anal sex, and women who report three or more high risk behaviors or who use crack cocaine. The VPS results indicate the feasibility of recruiting, enrolling, and retaining MSM and WAHR in a preventive HIV vaccine trial. A new study (VPS2) has begun to determine whether, by changing the eligibility criteria and recruitment strategy, IDUs at higher risk of HIV infection can be enrolled and followed. Men Who Have Sex With Men Susan Buchbinder presented data from the VPS on risk factors for seroconversion in men who have sex with men (MSM). The behavior most often associated with seroconversion was unprotected receptive anal sex with multiple partners who were HIV-positive or of unknown HIV status. Dr. Buchbinder suggested that risk reduction counseling focus on encouraging use of condoms for anal sex, and on addressing the number of sex partners. She also noted that prevention strategies that require infrequent intervention, such as post-exposure chemoprophylaxis (PEP) — that is, the use of antiviral medications after a high-risk sexual exposure to HIV — would benefit MSM. Other Prevention Modalities A key component of enrollment in any research study is the process of obtaining the potential participant’s informed consent to participate. Anne Coletti reported on the evaluation of a prototype informed consent process for HIV vaccine efficacy trials. She found that VPS participants’ knowledge of ten key items relating to HIV vaccine testing increased significantly after an informed consent process that included reading or listening to a tape of an information booklet and attending a one-to-one educational session. The gains in knowledge were retained for at least 18 months. The items that most participants had difficulty understanding related to the fact that the safety and efficacy of a vaccine is not known at the start of a efficacy trial. This should be emphasized in the informed consent processes for future trials. Michael Gross reported on the results of a self-administered questionnaire on the acceptability of using anti-HIV drugs before or after a possible exposure to prevent HIV infection VPS participants answered a questionnaire on willingness to participate in a randomized, placebo-controlled trial. The responses showed that relatively few of the participants (30%) would be willing to be part of a trial if the study involved the need to take medication three times a day everyday and the medication caused side effects. Participants who reported the highest risk behavior expressed greater willingness to enroll, suggesting that any such study must provide clear information and counseling about the uncertainty of the effectiveness of this approach. Michael Gross also presented the results of a self-administered questionnaire on the use of the RealityŠ "female condom" by MSM during anal sex. On average, almost 7% of the men who completed the questionnaire reported using RealityŠ for anal sex. Among men in San Francisco the rate was particularly high at 15%. Those who used RealityŠ for anal sex reported problems that included reduced pleasure and difficulty inserting or keeping RealityŠ in place, discomfort, and sporadic reports of bleeding. Despite the reported problems, most of the men who used RealityŠ said they would consider using it again. Dr. Gross noted that many of the reported problems related to the rectal use of a product designed for vaginal use, suggesting that a redesigned product may be preferable for anal sex. Freya Spielberg reported on a study of the feasibility and acceptability of home specimen collection for early detection of HIV infection. Two hundred and forty-one randomly-selected VPS participants agreed to perform home collection of oral fluid or dried blood spots for HIV testing, every other month for six months. Participants were given the option to receive results by telephone or in person, and 95% chose results disclosure and counseling by telephone. Most participants reported that the specimen collection kits were easy to use, that bimonthly testing did not make them worry more about HIV, and that their risk behavior during the study remained the same or became less risky. Women At Risk Patricia Affleck reported on the enrollment and retention of women in the VPS. She noted that follow-up at the 24-month visit was 70%, and that women older than 35 with a history of injection drug use or an IDU partner were more likely to be followed. She suggested that retention efforts in future trials include targeted efforts to retain younger women. Pamela Brown-Peterside and colleagues reported on their experiences in recruiting and retaining women in the VPS, and found that retention was enhanced by efforts to address the participants’ social service needs (beyond HIV risk issues) through referrals and counseling, and by assistance with transportation and child care. Creativity in scheduling visits, including holding visits in homes, prisons, restaurants, and residential drug treatment centers, also helped with retention. Michael Marmor presented data on women enrolled in the VPS who reported having sex with women. He found that 10% of women enrolled at four of the HIVNET VPS sites reported having sex with a woman in the previous six months. These women reported behaviors that placed them at equal or higher risk for HIV compared to women participants who did not report having sex with a woman. Dr. Marmor recommended that future HIV prevention interventions address risk behaviors and psychosocial factors related to risk in women who have sex with women. Beryl Koblin reported on a study of douching practices among women in the VPS study. The concern is that douching may cause a change in the vaginal environment that could increase risk of HIV infection. Seventy percent of the women who completed a questionnaire about douching said that they had douched in the previous six months, and more than half of these women reported being told that douching was unhealthy. Another 25% had douched in the past but not in the previous six months, and most of them said that they stopped douching because they had heard it was unhealthy. Dr. Koblin recommended that educational approaches to persuade women not to douche be improved. Vaginal Microbicides HIVNET investigators also reported on a study of the safety and acceptability of a new agent, BufferGel, that is designed for use in the vagina to prevent infection with HIV. Besides looking at safety, this study also collected some information on the acceptability of BufferGel. Kenneth Mayer presented results from this study of twenty-seven women who used the product for as long as 28 days, once or twice a day. The women reported only mild problems with BufferGel, such as vaginal itching. BufferGel is now being tested internationally. The BufferGel study included a self-administered questionnaire that participants completed before and after the study to assess the acceptability of gels as vaginal microbicides. Margaret Chesney reported that, before their participation in the study, all of the women indicated a willingness to try microbicides that were in the form of a gel rather than a cream, and that the women did not express a preference for disposable over reusable applicators. After using BufferGel with a reusable applicator, 75% of the women said they would use BufferGel if it were approved for use as a microbicide. Nearly 25% said they would prefer a disposable applicator. Dr. Chesney noted that pre-study attitudes do not seem to predict actual response to the product. The use of vaginal microbicides could be promoted by educational strategies that encourage women to try the product. Community Education Joy Workman reported on the use of videotape in vaccine education initiative. The project involved filming interviews with study staff, study participants, community advisory board members, and local opinion leaders. Approximately 50 hours of videotape was obtained, and cataloged into a central database. The first product generated from the database is a 15-minute video for use in community education and outreach, site preparedness, and for education and training programs entitled HIV Vaccine Trials: What it Takes. This video was screened in three time slots during the Geneva Film Festival and was one of three videos chosen out of 17 submissions to be shown on a large screen during the Geneva Cultural Arts Festival. Ms. Workman noted the use of videotape has been an effective tool used by the HIVNET for both participant education in the informed consent process and education on vaccines to the community at large. Also, being filmed for the project reinforced participants’ commitment to the study and increased their pride in being part of the vaccine effort. Increasing involvement of community groups and opinion leaders in HIV vaccine trial preparedness was the focus of a report by Joe Wright. He noted that when groups were simply given information on HIV vaccine, they were unlikely to take action to prepare for vaccine trials. When groups were directly asked to help, they were more likely to respond with independent action and contributions towards community preparedness. Mr. Wright recommended that researchers request the help of a wide variety of individuals, organizations, and institutions for community preparedness for HIV vaccine efficacy trials. — Sherry Marts, Abt Associates Inc. HIVNET Home | Community Education | Contact Us | Research Sites | |