• Premonition Becomes Reality

    January 1, 1970 pendari Spotlight

    Burned out from years as an interpreter at a trauma center in eastern North Carolina, USA, Paul Camarena accepted a position as Director of Hispanic Outreach at the University of North Carolina General Clinical Research Center (UNC GCRC) in Chapel Hill. When investigators from the UNC AIDS Clinical Trials Group (ACTG) Network’s site conducted their study visits with Latino participants at the GCRC, Camarena, a Mexico native, would help them bridge the language gap.

    “I thought the ACTG clinicians were different,” Camarena says. “They are brilliant and self-driven, but at the same time they are really fun and relaxed. I knew I would be working with them one day and here I am.”

    Camarena made the switch to Patient Care Coordinator for the UNC ACTG site three years ago. Ensuring patients face no barrier to their appointments is a key part of his job. Camarena assists study volunteers with renewing their medication assistance, arranging transportation to study visits and interpreting during appointments.

    “Being able to translate what our researchers, nurses and site staff are saying into our patients’ native language is so important,” Camarena says. “Being able to speak both English and Spanish, I try to do everything I can to help our study volunteers and staff have a successful visit. Their success is my success.”

    Kristine Patterson, MD, an Investigator at the UNC site, says Camarena’s work ethic and personality make it easy for staff to collaborate with him and for study volunteers to connect with him.

    “Paul has been a wonderful addition to our group. He has been instrumental in engaging the Latino population into research, but he is also invaluable in maintaining linkage to clinical care,” says Patterson. “Many participants maintain contact with Paul long after the study has ended knowing he is a valuable resource. While he is diligent in his work, there is also a fun-loving spirit in him and he brings that perspective to work with him everyday.”

    Camarena also manages Health on Wheels, a mobile research clinic that allows ACTG staff at UNC to bring trials into the community and conduct study visits in the field. Started in 2010, the mobile clinic comes equipped with the tools needed to check patients’ vitals, draw labs and even perform an electrocardiogram (EKG). A research nurse coordinator and a research assistant/phlebotomist operate the mobile research clinic, seeing UNC study participants all over North Carolina.

    “There’s no waiting, no traffic and no worrying about trying to find a place to park,” says Camarena of the benefits the mobile clinic offers patients versus traveling to the UNC campus. “Our participants love this because we show up where they need us. It’s a stress-free experience for them.”

    On a lighter note, Camarena jokes that he is the UNC site’s self-appointed photographer, videographer and staff archivist. He admits he loves putting these talents to good use as a member of the unofficial UNC site’s party planning committee. His enthusiasm does not go unnoticed by his colleagues.

    “Paul is just full of surprises!” says David Currin, RN, UNC’s Clinical Research Site Coordinator. “Not only is Paul a great team member and works really well with our study participants, but his creativity and craft at doing really cool audio visual projects is amazing! He has surprised many of our staff at special events and going away parties with unique ‘motion picture’ tributes. Everyone is aware that Paul may be filming at any time, so always be on your best behavior.”

    In addition to his role at the ACTG’s UNC site, Camarena sits on the Network’s Outreach, Recruitment and Retention subcommittee. Since recruiting patients is a part of this job at UNC, he enjoys sharing best practices during the group’s monthly calls and annual session during the ACTG’s meeting in Washington, DC each summer.

    “At my first meeting in DC two years ago, I met a good friend in the OR&R, Michael McDonald from the ACTG site in Ohio,” Camarena says. “He and I took over the Library of Recruitment Materials. Sadly, Michael passed away soon after that and I’ve helped keep the library going. The library serves as a repository of useful recruitment tools (i.e. flyers, brochures, handouts) that the Network is encouraged to access. As my time in the OR&R begins to wind down, I will now pass on the torch.  Moving forward, I’m hoping to join the ACTG’s Underrepresented Populations Committee (UPC). It sounds like an interesting group to be a part of.”

    When he is not coordinating patient care, interpreting during study visits and scheduling the mobile research clinic, Camarena enjoys playing volleyball and paddle boarding at a lake near his home. He and his wife make it a point to take one big trip a year. Their favorite destinations include the Hawaiian Islands and Disney cruises to the Caribbean.

    “Each December, we take off,” says Camarena with a laugh. “When it starts getting cold here is when we plan our escape.”

    Click here to learn more about the ACTG’s site at UNC.

  • Pharmacy Career Leads to Africa

    January 1, 1970 pendari Spotlight

    Gene Morse, Pharm D, admits his green thumb needs a little bit of work.

    “The tomatoes and peppers are the happiest vegetables in the garden while the beans and eggplants never quite get the start they need each spring,” he says.

    One of the reasons Morse cannot give his garden his full attention is because he travels to Zimbabwe once or twice a year. Morse is the Director of the AIDS Clinical Trials Group (ACTG) Network’s Clinical Pharmacology Core and chairs the ACTG Clinical Pharmacology Advisory Group. Morse is the Principal Investigator for the University of Buffalo (UB) Pharmacology Specialty Laboratory (PSL) and a Co-Investigator of the University of Rochester Clinical Trials Unit. Morse and his staff have a separate National Institute of Allergy and Infectious Diseases (NIAID) contract to provide a global HIV clinical pharmacology quality assurance program that includes pharmacokinetics research methods training to the ACTG’s 60 sites around the world as well as all of the other NIAID HIV research networks and PSLs. They also support a National Institutes of Health (NIH) Fogarty International Center AIDS International Training and Research Program with the University of Zimbabwe (UZ). The grants and contracts UB holds under Morse’s direction led to his receiving the Volweiler award. The award is a nationally recognized honor from the American Association of Colleges of Pharmacy.

    “We travel to Zimbabwe and their faculty, fellows and staff travel to the United States to ensure the UZ pharmacology lab they have developed runs smoothly. The lab is three years old now and is gearing up to assay samples from ACTG studies,” Morse says. “During my first trip to Zimbabwe, I spoke at a community center to 600 people about the ACTG’s research studies and the importance of participation. When I first started my career, I never would have dreamed I would be talking in Africa about research and contributing to the global effort against HIV/AIDS. That moment in Africa and receiving the Volweiler award reaffirmed my goals and professional path toward contributing to the global HIV epidemic and trying to have an impact on reaching an AIDS-free generation.”

    Charles Maponga, PharmD, is the Director of the Pharmacology Specialty Laboratory at the ACTG’s University of Zimbabwe Parirenyatwa site.

    “Gene Morse has an extraordinary ability to articulate new ideas,” Maponga says. “He is the most generous American I have ever met.”

    Morse was one of the original investigators and laboratory directors when the ACTG was formed in 1987 and has been with the Network ever since. He completed a research fellowship at UB in New York in 1984.

    “That’s when the AIDS epidemic was just beginning,” Morse says. “I remember there was no treatment for AIDS and people were dying between 1982-1987 and then the anti-HIV drug AZT was approved. Then in 1996, the first combination antiretroviral therapy was approved and new hope was born among the field of HIV/AIDS researchers and clinicians, but mostly for patients. As a pharmacologist, I could appreciate that these new combination regimens would be difficult to provide to all patients because of complex drug interactions, and that there was a need to develop more effective, safer drugs. Our success is really due to the dedication of the entire UB HIV pharmacology laboratory research staff, residents, fellows and other young faculty who have given their all to contribute to the research that is conducted by the ACTG.”

    Morse says the most interesting ACTG study he has worked on during his tenure is A5146. This protocol was the only randomized trial of therapeutic monitoring and individualized dose adjustment of a class of anti-HIV medications called protease inhibitors.

    “All ACTG sites participated and the University of Buffalo Pharmacology Specialty Laboratory acted as the central clinical pharmacology site that completed drug assays in real-time and contributed to the individualized dosing approached in patients with protease inhibitor resistance,” Morse says. “This group research model allows us to accomplish things you could never do at a single university.”

    Robert Coombs, MD, PhD, is the Director of the ACTG’s Laboratory Center and an investigator at the Network’s University of Washington site in Seattle. He and Morse serve together on the ACTG’s Executive Committee.

    “Gene has always been very ambitious about moving the ACTG pharmacology agenda forward both domestically and internationally; as such, he has been responsible for developing the Clinical Pharmacology Quality Assurance program to assure the quality of the pharmacology data that the Pharmacology Specialty Laboratories produce for our protocols,” says Coombs. “In short, Gene never met a drug that he didn’t want to ionize, in a quality assured way, of course!!”
    Being able to work jointly on studies with researchers and staff from different disciplines within the ACTG’s global research network and knowing he’s improving the lives of people living with HIV are what keep Morse excited about his career, even though his garden suffers.

    “Each year is a new challenge for my garden,” Morse jokes. “But it is worth it. The ACTG has achieved tremendous success as a clinical trials and therapeutics network due to the efforts of all of the individuals at each of its sites; community groups; and laboratory, statistical, data management, and operations support groups. Working with these individuals on a daily basis over the many years has helped guide my own decisions and setting of priorities in all of my academic interests; clinical care and research programs for patients; and mentoring activities for students, residents and fellows.”

  • Sharon Maxwell Tackles Stigma

    January 1, 1970 pendari Spotlight

    Sharon Maxwell has made fighting the stigma associated with having HIV in rural America her mission. As Co-Chair of the AIDS Clinical Trials Group’s Global Community Advisory Board (ACTG GCAB) and living with HIV since 1994, Maxwell has firsthand knowledge of the disease and the scientific studies being conducted in the ACTG’s labs around the world.

    “I was at the post office in the small town in Illinois (USA) where I live and I was taking out some paperwork from my box that had the HIV/AIDS red ribbon on it,” she says. “One of my neighbors said, ‘Sharon, why do you have that information? HIV only infects gay people and there aren’t any gay people here.’ I thought for a moment and I realized I knew quite a few gay people in our county. And here I was married to a man and living with HIV. I realized then how much education was needed in rural America.”

    When Maxwell’s husband was diagnosed in the mid-1990s, she got tested and learned she too was living with HIV. She immediately began looking for a support group that included other women and found locating her peers was not easy.

    “I was a married woman,” Maxwell says. “There were a lot of men to talk to, but finding women was important to me because it affects us differently. I wanted to talk to other women about side effects of the medications that were available at the time.”

    Maxwell’s search led her to the ACTG’s site at Washington University in St. Louis, Missouri, about 50 miles west of where she lived in Illinois. There, she found answers to her questions from people who were infected and affected by HIV. One of the women she met who was affected by HIV was advocate Allegra Cermak, the ACTG’s Community Coordinator. The two continue to work together to this day with the ACTG and have become great friends.

    “Sharon joined the Washington University Community Advisory Board (CAB) in the mid 90’s,” Cermak says. “We shared a background in art and Sharon was clearly someone who tackled work with energy. We were shortly serving together on the CCG (Community Contingency Group, now called the Community Scientific Subcommittee or CSS). Sharon added a great deal to the group – as a woman, as someone living in a small town and as someone with professional experience in her field.  She soon was taking a leadership role as member of the AEC (ACTG Executive Committee) on the Site Evaluation Committee. It’s been a long, happy and productive friendship.”

    CAB members at each of the ACTG’s sites can choose to apply for one of 28 positions on the CSS. Representatives to the CSS serve four-year terms and sit on protocol teams, advising the ACTG’s researchers and site staff about studies from the community’s perspective.

    Maxwell applied in 1996. Not only was she accepted, she was elected to serve as the CSS rep on the AEC, Performance Evaluation Committee (PEC) and Women’s Health Committee. The AEC oversees the scientific direction and research agendas of the ACTG and is responsible for oversight of all clinical trials activities and timely analysis and dissemination of study results. The PEC evaluates the progress of each of the ACTG’s 75 research sites from the mix of protocols being conducted at each location to how funding is being allocated.

    But perhaps her most fitting committee membership occurred when she became the CSS rep to the Women’s Health Committee. After starting her own quest to find women she could relate to several years earlier, Maxwell joined one other female CSS rep on the committee, providing feedback from the community’s perspective about the two studies the ACTG had at the time for women.

    “One protocol was about HIV and pregnancy and the other was about HIV and genital secretions,” Maxwell says. “The other female CSS rep and I had no plans to become pregnant and I remember her saying, ‘I’m more than genital secretions.’ Neither of these studies applied to us and we wanted other studies about women and HIV to be researched as well. We were concerned about the long-term effects of the antiretroviral (ARV) drugs. We wanted to know about HIV and menopause. ACTG leadership asked for our feedback and listened, which was very important.”

    Because they spoke up, the number of studies enrolling women jumped from two to 11 by the end of Maxwell’s term. She and Cermak, along with newer CSS rep Liz Barr, continue to advocate today for research about how women are uniquely impacted by HIV as many studies focus on the male population. It is also much harder to recruit women in the United States into clinical trials than it is internationally.

    “Allegra, Liz and I are all members of the Women’s HIV Research Collaborative (WHRC),” Maxwell says. “I am the Co-Chair along with Annet Davis-Vogel from the University of Pennsylvania. The coalition meets annually and includes women from the ACTG as well as other HIV research networks including IMPAACT (International Maternal Pediatrics Adolescent AIDS Clinical Trials group) and MTN (Microbicide Trials Network).”

    The WHRC is a working group of the Legacy Project. The Legacy Project works nationally to increase awareness of HIV research by addressing factors that influence participation of historically underrepresented communities, like women. WHRC brings together a “diverse and growing group of individuals who are infected, uninfected, and affected by HIV. Their interests, careers and experiences have led them to be involved in ensuring that culturally appropriate HIV clinical research addresses the lifespan of women.”

    “Sharon Maxwell, WHRC Co-Chair, brings a wealth of knowledge and experience in terms of raising critical issues around the impact of HIV on women in the US,” says Jessica Mooney, Community Engagement Officer and Project Manager for the Legacy Project. “She has been an integral presence on our leadership committee for highlighting urgent priorities in prevention and therapeutic research.”

    Maxwell says HIV and aging as well as violence against women who reveal their status, especially overseas, are two timely topics she would like to see further researched. She also hopes to see the concept of designing studies with women’s accrual in mind written into all ACTG protocols.

    In addition to her committee duties as CSS rep back in the late 1990s, Maxwell also sat on three to four protocols as the CSS rep, including a study to treat cytomegalovirus (CMV). CMV retinitis is a condition that can lead to blindness and was a condition she had at the time.

    “When I was living with CMV in the 1990s and realized the researchers really cared about me and didn’t think I was some lowly person in the community with HIV, that’s when I really began to love my work with the ACTG,” Maxwell says. “It is one of my most memorable moments. They really wanted me to be there so they could understand what people living with HIV were going through. It was really inspiring and I remember thinking, ‘I’m going to be a part of every study I can.’ I really liked being able to give my feedback.”

    Once her term on the CSS was done, Maxwell continued to work at the CAB-level and then she decided to try for a position on the newly formed Global Community Advisory Board or GCAB in 2009. Every ACTG site has a CAB and each CAB elects one person to serve on the GCAB. The CSS is an autonomous subcommittee of the GCAB, but someone could be a member of their CAB, their CAB’s rep to the GCAB and a CSS rep. Four years after the GCAB was created, Maxwell is serving the last year of her second term as GCAB Co-Chair.

    “Because it was a new organization, I wanted to be a part of it and find a way to make the community’s voice heard in a cohesive way that would be acknowledged by leadership,” Maxwell says. “The ACTG’s leadership has always been and continues to be so accepting of community ideas.”

    Eric Lawrence, CSS Co-Chair, met Maxwell at a Living with HIV retreat near St. Louis shortly after he moved to the area after being diagnosed in the mid 1990s in LA. He credits Maxwell for giving him the motivation he needed to redefine his life.

    “Sharon is the most skilled and compassionate advocate for people living with HIV,” Lawrence says. “She is a tremendous role model, yet very modest. She has an amazingly strong voice and has been a wonderful mentor.”

    Since she has been a part of the ACTG for nearly 20 years, Maxwell smiles when she reflects on the Network’s many successes. “I think the ACTG’s research into aging and co-infections such as tuberculosis (TB) and hepatitis C virus (HCV) have been several of our successes,” she says. “I also like seeing the new people come up in the ranks like Liz and Aaron Laxton, who is a new CSS member at my site in St. Louis. The epidemic is different for them than it was for us in the older generation when we began advocating in the 1980s and 1990s. To see them find interest in our group is amazing.”

    And just as she did years ago, Maxwell still keeps the fight against stigma in small town America on her radar. Along with Lawrence, she is a member of AIDS Foundation of Chicago and the Illinois Alliance of Sound AIDS Policy (ASAP). She visits local representatives and senators’ offices to let them know how important HIV funding is to their local constituents. She also works with the Illinois Department of Health and the Ryan White Care Act lead agency in her area as a client representative.

    “Stigma in rural America is horrible. Many people in my county have tested positive, but only a handful of them are in care. They do not want to get their care here or fill their prescriptions at the local pharmacy because then their family and neighbors will know. So they choose to travel hours west to St. Louis or hours south to Vanderbilt in Tennessee,” Maxwell says. “I am worried about the sequestration and how that will impact research. I hope the ACTG can continue its research and possibly explore collaborating with other networks and organizations like the Ryan White Care Act to help transport folks in rural areas to research sites. Stigma in rural America will continue to be my personal fight. I take our local clients to lunch and some days we even go antiquing. But I make sure they get to a support group and come lobbying with me as well.”

  • Cooperation Moves Research Forward

    January 1, 1970 pendari Spotlight

    Alan Landay, PhD, never ceases to be impressed by the dedication he and his colleagues within the AIDS Clinical Trials Group (ACTG) Network have to HIV research.

    “You might be on a conference call and hear a lion’s roar,” Landay says with a laugh. “Someone is on safari, but committed to being on that call. We have a great team.”

    Trained as an immunologist, Landay was working as a post-doctoral fellow in the lab of world-renowned immunologist Max Cooper, MD, at the University of Alabama Birmingham (UAB) in the early 1980s. A hematologist came to the lab asking for assistance in diagnosing a mysterious disease plaguing people with hemophilia, a rare bleeding disorder in which the blood doesn’t clot normally. That disease turned out to be HIV, which hemophiliacs acquired through blood transfusions.

    “We were treating one of only three known people with hemophilia and an AIDS diagnosis at the time, so essentially we were caring for one-third of all cases,” Landay says. “I remember reporter Geraldo Rivera came down to UAB to film a segment for Good Morning America.”

    In 1983, Landay left Birmingham for Chicago, where he became the Director of the Clinical Immunology Labs at Rush University Medical Center and an assistant professor in the Immunology/Microbiology Department. In 1985 he was a part of another HIV research milestone as he worked with Abbott Laboratories to develop the first antibody and antigen tests for HIV diagnosis.

    Rush became an ACTG site in 1988. More than 25 years later, ACTG study A315 remains Landay’s favorite trial to have worked on because it was the Network’s first foray into how highly active antiretroviral therapy (HAART) impacted the immune system.

    “We were investigating new ways of reconstituting the immune system,” Landay says. “A315 kickstarted our immunology focus.”

    In 2003, Landay became chair of the ACTG’s immune-based therapy research agenda committee. He currently serves on the ACTG’s End-Organ Disease and Inflammation Transformative Science Group (TSG) and is Chair of the Immune Activation Focus Group of the Inflammation TSG. Landay believes controlling inflammation is critical to the health of people living with HIV.

    “Inflammation drives end-organ disease and we have so many questions we need to answer,” Landay says. “Why does inflammation persist in some people? Is it because HIV is persisting or is this inflammation due to a co-infection? How are other people living with HIV able to keep it in check? And if we can block inflammation, can we block a non-HIV co-morbidity like cardiovascular disease? More research into inflammation is needed and these studies have implications for other fields, too. There is a real opportunity for collaboration and potential synergy.”

    Cara Wilson, MD, is an investigator at the ACTG’s University of Colorado Clinical Research Site. She serves with Landay on the End-Organ Disease and Inflammation TSG and is Vice Chair of the Immune Activation Focus Group of the Inflammation TSG.

    “Alan is tireless in his efforts to push the envelope in clinical HIV research, and his longstanding commitment to the pursuit of novel therapies for HIV disease is inspiring,” says Wilson. “His outgoing nature, endless enthusiasm for science and uncanny ability to multitask have allowed him to bring together investigators with diverse expertise to collaboratively address important questions in HIV research. He is truly a leader in this field.”

    Michael Lederman, MD, is Principal Investigator of the ACTG’s Case Western Reserve University site. He is Chair of the End-Organ Disease and Inflammation TSG and worked with Landay on the A315 study. He admires Landay’s belief in collaboration to tackle global health problems.

    “In another age and another venue, Alan would have been a shidduch (a matchmaker),” says Lederman. “He’s a catalytic character who gets enormous satisfaction from getting scientists to work together, and within the ACTG has been the driving force behind a number of highly successful collaborative projects.”

    Landay has worked in the past with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Word Health Organization (WHO), the Clinton Foundation, the Gates Foundation and the World Bank. He recently completed a research sabbatical at Utrecht University in the Netherlands.

    “I ask myself ‘what can I do for global health?’ And the answer is to collaborate with colleagues everywhere,” Landay says. “I feel it is a tremendous opportunity to take our research findings and apply them to impact the lives of our patients. We are really moving bench to bedside and working with our study participants to show the importance of our research outcomes. And many of our studies have implications for other diseases. That’s the most exciting part – being able to bring immunology research into other disciplines.”

  • Meet the Man Behind the ACTG websites

    January 1, 1970 pendari Spotlight

    Past positions with CarMax and the Discovery Networks gave Larry Lawrence the communications skills and technical know-how to land the job of Website Content Specialist at the AIDS Clinical Trials Group’s (ACTG) Network Coordinating Center (NCC) in Silver Spring, Maryland, USA.

    “There is that stereotype about people in information technology being a little difficult to communicate with,” says Lawrence. “But you can’t be a car salesman at CarMax and not know how to communicate with people! I also worked for 12 years for the Discovery Networks, bridging their marketing and web development teams. Because I could speak both the technical web hosting language and break it down into laymen’s terms, the NCC hired me.”

    Three years later and Lawrence is the man behind the content posted to the ACTG’s public website. He assists two other colleagues at the NCC with managing the ACTG’s member-only password-protected site.  When asked what people contact him the most for assistance with, Lawrence says password retrieval and set up have always been the number one requests from users in his web career.

    “I function as the primary support person for all the websites, so I may help with passwords, assist in locating content or respond to inquiries about internship opportunities,” Lawrence says. “Beyond that, I function as a project manager overseeing much of the maintenance and improvement efforts to those websites. I often work as an intermediary between the NCC and our development team. Since I have worked on both sides of that fence, it helps when balancing technical requirements against the needs of the end user.”

    At the Discovery Networks (Discovery Channel, TLC, Animal Planet, etc.), Lawrence was part of a team that launched, managed and redesigned Discovery’s first business-to-business website for their affiliate sales and marketing department as well as their second business-to-business website for their press department. That experience taught him the value of brand management, effective marketing and communication, and the importance listening to the needs of the end users. Always interested in public health, when he saw the job working at the ACTG’s NCC literally around the corner from Discovery Networks, he applied.

    “I had been interested in taking my career in that direction for years when I came upon this opportunity,” says Lawrence. “Now I have the chance to apply my skillset every day in support of such a crucial and worthy endeavor that affects the lives of millions of people. I am a small part of a very large and amazing machine, and I couldn’t be happier.”

    The fluid nature of websites is what keeps Lawrence in the web field.

    “I have always liked working on large, complex websites. They are very much like living things because they must grow and evolve over time in order to be successful. They need constant and ongoing attention in order to be certain that they are working as best they can,” says Lawrence. “And it’s always a moving target. Without intending to sound fatalistic, I like to say that there is always something that needs fixing. By that, I mean that there is always room for improvement, and you can always find something that could be updated, reformatted, reworked, repositioned, or possibly removed. It’s an ongoing challenge in the best possible sense to stay on top of that.”

    Lynn Nguyen, Lawrence’s Manager at the Network Coordinating Center, says he is a true asset to the NCC and its clients.

    “He provides outstanding client service because of his technical expertise, effectiveness and clarity in communication, and promptness in completing requests. He is proactive and professional in managing expectations and delivering results,” Nguyen says. “Larry was instrumental in improving many aspects of the ACTG websites and portals such as the recent release of the new and improved website Support Help Desk system. He works well with staff, ACTG members, developers, and collaborators to promote and to improve the ACTG websites, portals, and social media tools.”

    With the Network’s annual meeting taking place in July, Lawrence also worked with the ACTG Meeting Planning Group to prepare the meeting registration site. But he looks forward to this event for a different reason.

    “My favorite part of my job is easily the face to face time with our community members and my colleagues from the ACTG’s Leadership and Operations Center (LOC),” Lawrence says. “The nature of my work is electronic, which I love, but it doesn’t allow me many opportunities to see people in person outside of the NCC. At the Network Meeting, I get a chance to work in person with my friends from the Outreach, Recruitment and Retention (OR&R) subcommittee. They are an amazing, inspiring and fun bunch of folks. I always conduct drop-in website training sessions, which allow me to potentially meet anyone from around the globe, and hopefully, show them something new and useful which might help them a little bit. So it’s an amazing chance to meet people and make new connections.”

    Lawrence also attends the OR&R subcommittee business session. Although not a voting member of the committee, he provides the group with any web support their projects require.

    “I began working with OR&R’s Chair, Michael Louella, about two years ago because I found that he and I shared a similar vision for the role that social media might play in and for our network,” says Lawrence. “Working together with him, Luis Lopez-Detrez, who manages our Facebook page, and our Communications Specialist Morag MacLachlan, we have really made a tremendous amount of progress in a short time.”

    Louella recalls his first encounter with Lawrence and how supportive Lawrence was of OR&R’s social media ideas.

    “I’ll always remember Larry’s first appearance at our OR&R business session in D.C.,” says Louella. “I had a big agenda for OR&R – my wish list of projects to build a more dynamic, engaging Internet presence for the ACTG by creating a blog, some wikis, and a YouTube channel. I was ready to debate, argue and plead why these things were necessary. As we went down my wish list point by point, this stranger named Larry would announce to the group that it was already done or was on the way. I think we were all dumbfounded by this man, who seemed like a Web 2.0 Santa Claus fulfilling every wish.”

    Lawrence and MacLachlan will hold web, social media and communications drop-in hours during the ACTG’s annual meeting on Tuesday, July 30, and Wednesday, July 31, from 10 a.m. – 3 p.m. in the Independence Level foyer outside the Cherry Blossom room at the Grand Hyatt Washington Hotel, Washington, DC. The ACTG now has a presence on Facebook, Twitter, YouTube, Google Plus, Tumblr and Instagram. Lawrence continues to stay on top of the latest applications, like Vine, as well as draft social media guidelines for people interacting with the ACTG’s channels. Being social media savvy not only helps Lawrence professionally, but also helps him relate to his children.

    “Spending time with my wife, son and daughter is where you’ll find me in my spare time,” says Lawrence. “But my son is 14 and my daughter is 12, so in all honesty, I am probably not spending as much time with them at the moment. They usually have better things to do, until tech support is required! On the plus side my wife and I have started going to movies again. She and I met at the University of Maryland (Go Terps!), so we love going to football and basketball games whenever we can. And now that it’s summer in Maryland that means two things: the beach and crabs.”

  • Why Women?

    January 1, 1970 pendari Spotlight

    Women account for one in four people living with HIV in the United States, according to the Centers for Disease Control and Prevention (CDC). Globally, HIV is the leading cause of death for women of reproductive age (14-49), says UNAIDS. But this doesn’t have to be the case. Groundbreaking research is occurring at the AIDS Clinical Trials Group (ACTG) Network’s sites around the world to help women control the virus and live a normal lifespan. Yet these trials and the Community Advisory Boards that provide researchers with valuable input need women’s involvement in order to be successful. Whether you are infected or affected by HIV, listen below to our staff, trial participants and Community Advisory Board (CAB) members share 10 reasons why women are critical to furthering HIV research.

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    Click here for 10 Reasons Women Are Needed for HIV Research: 1-5

    Click here for 10 Reasons Women Are Needed for HIV Research: 6-10

  • Going the Extra Mile to Build Trust

    January 1, 1970 pendari Spotlight

    Betsy Adams, RN, says flexibility is the key to rolling with the many twists and turns her average day takes as she manages the AIDS Clinical Trials Group (ACTG) Network’s Clinical Research Site at Boston Medical Center (BMC).

    “You can plan your day out, but it will never go that way,” she says with a laugh. “But that’s also what I love because no day is ever the same.”

    One recent example, a patient who had been on an ACTG study several years ago called Adams to talk about his experience witnessing the Boston Marathon bombings. The call lasted nearly an hour and Adams was happy to stay on the line.

    “We serve a large minority population at BMC and many of our patients have been or are homeless or substance abusers,” Adams says. “Trusting someone else is hard for them and we do extra things to build that trust. I tell my patients to call or drop-in any time, not only when they have an appointment. We screen a lot of patients for studies and not all of them can enter, but they can still call and talk to me. I am here for them 24/7.”

    It’s this accessibility that Adams says she associates with the call to be a nurse.

    “The ACTG is such a nurse-driven research network,” Adams says. “HIV care is incredibly interesting and also medically complicated. It really is a nurse-oriented field because patients need so much TLC (tender loving care) and education. We interact with patients during each study visit, checking their labs and taking care of any other patient care issues they may have. I have been at the ACTG’s BMC site for 12 years so I have developed long term relationships caring for many of our patients here.”

    Charlene Gaca, RN, BSN, worked with Adams for a year at New England Medical Center before they both came to the ACTG’s site at BMC. Colleagues for 13 years now and the only two study nurses at the site, Gaca says she and Adams have a great working relationship and friendship.

    “Working with Betsy has been a wonderful experience,” says Gaca. “We work well together.”

    For Adams, the calling to be an HIV study nurse grew out of her love of biology and caring for people.

    “I majored in biology in college and then took a part time position in a lab,” she says. “But I missed interacting with people.”

    Her experience with HIV began when Adams took a position as a medical assistant at Planned Parenthood in New Haven, Connecticut, in the 1980s, and lost a colleague to the virus before testing was available. She was also struck by the fact that health insurance companies treated a positive HIV diagnosis as a pre-existing condition that would not be covered when people identified themselves as an IV drug user or a sex worker. These two incidents solidified her passion for community health and motivated her to pursue a second bachelor’s degree in nursing.

    “This is why I love clinical research because it combines my love of science and caring for people,” Adams says.

    As the coordinator for the ACTG’s clinical trials unit at BMC, Adams splits her time seeing patients on study and managing the research site. She credits her colleagues for helping the site run smoothly, especially Gaca as well as Alison Coe, MA, Data Manager and Regulatory Coordinator, and Allison Schmale, MPH, Research Assistant and Study Recruiter.

    “Our researchers here, like Drs. Ben Linas and Ioana Bica, are wonderful, too,” says Adams. “I actually used to work with Dr. Bica when she was a resident at New England Medical Center. She, Charlene and I now all work together again at BMC, so that is nice. I think working in community health is a special calling and you will work again with same people if you stay in this field.”

    Adams and Gaca currently follow between 50 – 60 patients. Nine studies are currently underway at BMC including A5294, which tests new medications for people living with HIV and hepatitis C virus (HCV) with the hope of eradicating the HCV.

    “Forty percent of our patients at BMC are living with the HIV-HCV co-infection,” Adams says. “We see a lot of patients with cirrhosis here who are waiting for treatment. We study their lab values, educate them and hold their hands. This co-infection is tough on them. It is exciting to think that we may actually cure their HCV.”

    Looking to the future of the ACTG’s research agenda with her patients in mind, Adams says HIV and aging is a real concern.

    “Our patients are getting older and none of us know exactly what lies ahead,” Adams says. “But I think exploring studies on HIV and aging is an area the ACTG will excel in.”

    Boston Medical Center is one of five ACTG sites that make up the Partners/Harvard AIDS Clinical Trials Unit in the Boston, Massachusetts and Providence, Rhode Island area. Adams enjoys having her research nursing counterparts nearby to consult with at Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital and The Miriam Hospital/Brown University.

    “I think of my job as CTU Coordinator as a problem-solver, but I couldn’t do it without the support of my co-workers including all the wonderful and smart nurses at all the sites within the Harvard/BMC/Brown Clinical Research Unit. It’s great to be able to pick up the phone and get assistance or help from them,” says Adams. “I think everyone who works in HIV in general is very nice, but the nurses in this field are especially amazing. Being in research is exciting, especially when you are part of a study that changes treatment guidelines. The mix of experienced and younger nurses at the ACTG’s five sites in the Boston-area is great because you are always learning. I love learning and taking new ideas to see if they will change the way we care for our patients. And I truly love my patients at BMC.”

  • Jeffrey Lennox, MD

    January 1, 1970 pendari Spotlight

    HIV Researcher Searches for Cure & Gems

    Jeffrey Lennox, MD, spends his days searching for answers. As the Principal Investigator of the AIDS Clinical Trials Group (ACTG) Network’s Emory HIV/AIDS Clinical Trials Unit in Atlanta, he researches safer, more effective treatment options for people living with HIV. As an avid treasure hunter, Lennox mines for amethyst, rubies and other gems to give as presents to family and friends. His job and his hobby require similar characteristics – patience and perseverance.

    Initially, Lennox rejected a career in research. But what he saw in the infectious diseases clinic changed his mind.

    “I worked for three years as a full-time infectious diseases clinician when the anti-HIV medications DDI and AZT were the only treatments,” he says. “Not everyone responded well to these drugs and many had horrible side effects. I realized I was not helping my patients by making it easier for them to die. I decided to make clinical research for better drugs my focus.”

    A244 was Lennox’s first study with the ACTG in 1992. It proved that measuring a person’s resistance to a drug through a blood test and guiding treatment based on the results was more effective than waiting until the person stopped responding.

    “This was before resistance testing was widely available,” Lennox says. “In the late 1980s and early 1990s, people didn’t think about antiretroviral resistance testing. But now it is widely accepted.”

    Lennox points to pivotal trials like ACTG’s A5142 study as studies that changed the treatment paradigm. This trial compared alternatives for first line therapy and established that a simple anti-HIV drug combination that included once daily efavirenz worked best, especially for people who had never been on treatment.

    “From 1996-2005 many ACTG treatment trials were studying people living with HIV who were treatment experienced,” Lennox says. “With A5142, we gave treatment naïve patients highly active antiretroviral therapy (HAART). Month after month, they were able to suppress their viral loads and we realized that full viral suppression was our new goal. When I got into this work, I never thought we would be seeing people living 30 years and longer with HIV.”

    In addition to groundbreaking research results, Lennox finds serving as a mentor to young investigators rewarding. He is especially proud of the opportunities the ACTG affords international researchers.

    “The ACTG expanded internationally because we knew we had to conduct research where the epidemic was expanding,” Lennox says. “But we didn’t want to just be tourist researchers and conduct a study and then leave. We wanted to establish sites and train local researchers to do the work.”

    Lennox mentors Nigerian immigrant Ighovwerha Ofotokun, MD, MSc, at the Emory ACTG site. Ofotokun is a former participant in the ACTG Minority HIV Investigator Mentoring Program (MHIMP). The MHIMP allows a site within the ACTG Network to offer a mentorship to a junior minority investigator with an interest in studying virology, immunology, pharmacology or another aspect of HIV/AIDS research.

    “Dr. Lennox is a dedicated clinician scientist with a drive to make a difference in the lives of his patients,” says Ofotokun. “He possesses a clear understanding and a deep insight on the issues in the field of HIV clinical research. Dr. Lennox is detail-oriented and has a common sense approach to science, always seeking practical ways to translate scientific findings into patient care. As a mentor, he set clear and attainable goals for his mentees and he led by example. Due to the effectiveness of his leadership style, the A5257 study was fully developed and ready for recruitment within 12 months of approval and was fully implemented in record time.”

    Lennox is Co-Chair and Ofotokun is Co-Vice Chair of A5257, a study comparing three anti-HIV medication combinations in 1,800 people living with HIV who have never been on treatment.

    “I’m trying to put a plan in place for when I keel over so that our research is carried forward,” Lennox says. “Watching a mentee become successful and begin collaborating on study teams is the best part of being in the ACTG. Without the ACTG, it would have been much harder for me or other young investigators to succeed.”

    Lennox admires the Network’s leadership. He says holding executive positions within the ACTG is an enormous personal and professional commitment.

    “It is really admirable of them because this is a seven year sacrifice,” Lennox says. “They are donating huge amounts of their time to the ACTG and their entire focus is on the Network and the patients we serve. The ACTG really is a like a family. It’s a group of people you grow to love and can bounce ideas off of. It is a community of people working together to conduct meaningful research.”

    Thinking toward the future scientific agenda, Lennox hopes the Network focuses resources on aging, co-infections and cure research.

    “Our patients now understand that a cure is possible and we have to deliver it.” He says. “In Atlanta, young black men who have sex with men account for the most new infections. They don’t want to be on a triple-drug anti-HIV therapy until they are 85. We really want to cure them.”

    Lennox will also continue his hobby searching for the best gems. His description of how it can feel tedious to dig all day under the hot, Southern sun for one precious stone can be applied to the diligence needed to find a cure for HIV.

    “Sometimes you need to dig for a long time, but when you find one, it’s like winning the lottery,” he says.

  • An Academic and an Advocate

    January 1, 1970 pendari Spotlight

    When you learn about Liz Barr’s educational background, it comes as no surprise that she is turning her academic accolades into advocacy.

    Barr holds a bachelor’s degree in art as activism as well as a second bachelor’s and a master’s degree in women and gender studies. She is currently pursuing her doctoral degree in rhetoric, politics, and culture at the University of Wisconsin, Madison, USA. Her introduction to the AIDS Clinical Trials Group (ACTG) Network came as a result of a class assignment.

    “I was completing an independent study in 2009 with a professor who was part of ACT UP,” Barr explains of the HIV/AIDS advocacy group. “We were studying ACT UP campaigns from the 1990s and this inspired me to want to know what was happening today.”

    Formerly of Baltimore, Maryland, USA, one of Barr’s friends brought her to a meeting of the ACTG’s Community Advisory Board (CAB) at the Institute of Human Virology Baltimore Treatment Clinical Research Site. Each of the ACTG’s 75 sites has CAB participation, either as an individual CAB or as part of a Clinical Trials Unit (CTU) CAB made up of individuals from several ACTG sites in one city. CABs include community members as well as former and current clinical trial participants. Even though she completed her independent study, Barr was intrigued by the work being done at the CAB and joined.

    Two years later in 2011, she applied for and was selected as a representative to the ACTG’s Community Scientific Subcommittee (CSS). Community members who are interested in becoming involved must apply for one of 28 positions on CSS. CSS terms last for four years. CSS reps serve on the ACTG’s many committees as well as each study team, providing the community’s view of the research being proposed and conducted. Barr moved to Madison in the fall of 2012 to begin her doctoral program, but vowed to continue her involvement with the ACTG.

    “I never considered not staying involved,” Barr says.

    One of the reasons Barr cites for keeping her involved with the ACTG despite her grueling doctoral schedule is the sense that her feedback on studies is genuinely considered and, at times, leads to study design changes.

    “The community members on studies can provide researchers and the rest of the study team with personal experience,” Barr says. “I am the CSS rep on a study which initially involved using a vaginal cup to collect samples. I shared the community’s concern that women might not want to use a vaginal cup and a vaginal ring simultaneously and the study was revised. When I see researchers nodding and taking notes when I share my thoughts, I feel listened to. Community members and researchers are a team and they come to research from different perspectives.”

    Drawing on her extensive experience in women and gender studies, Barr took time in between her doctoral classes to draft a letter to ACTG leadership about the inclusion of women in more of the Network’s clinical trials.

    “There is less enrollment of women in research studies in this country than in studies abroad,” Barr says. “This frustrates many of us and I want to move from frustration to action.”

    The letter comes from the CSS and the Network’s Global Community Advisory Board (GCAB). Since HIV affects women differently than men, the letter also asks for sex comparisons as primary and secondary endpoints for all ACTG studies. This is a goal shared by the Women’s Health Inter-Network Scientific Committee (WHISC). The ACTG’s Susan Cohn, MD, MPH, and Cindy Firnhaber, MD, are Co-Chair and Vice Co-Chair of WHISC respectively. They work closely with Arlene Bardeguez, MD, and Mary Paul, MD, the WHISC Co-Chair and Vice Co-Chair respectively from the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group. The primary mission of the WHISC is to develop optimal strategies for the prevention and treatment of HIV disease and related complications among women and to determine the pathogenesis of manifestations that are unique to women.

    “It is so crucial to understand what the community thinks is important and what kinds of studies women are interested in participating in,” says Cohn, an investigator at the ACTG’s Northwestern University Clinical Research Site in Chicago, Illinois, USA, and Co-Chair of the A5316 study Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and Antiretroviral Therapy. “Liz has done a fabulous job articulating the concerns of the CAB, and is a valued, respected member of the WHISC, the A5316 Protocol Team, the CSS and GCAB.”

    Firnhaber, Technical Director of the ACTG’s Clinical HIV Research Unit in Johannesburg, South Africa, and Manager of the Cervical Cancer Program at Right to Care, a South African non-profit involved in the implementation and strengthening of care for HIV infected people, says the HIV epidemic in Africa is 65 percent women and between 25-30 percent women in the US.

    “What I admire about Liz is her passion and incredible energy toward women’s health,” says Firnhaber. “Liz is confident and articulate and not afraid to keep us focused on the task at hand.”

    Barr is also a representative to the Women’s HIV Research Collaborative (WHRC), a working group of the Legacy Project. The Legacy Project works nationally to increase awareness of HIV research by addressing factors that influence participation of historically underrepresented communities, like women. The WHRC brings together a “diverse and growing group of individuals who are infected, uninfected and affected by HIV. Their interests, careers and experiences have led them to be involved in ensuring that culturally appropriate HIV clinical research addresses the lifespan of women.” Women from many of the research networks, like the ACTG, serve on the WHRC.

    “Liz is an incredible asset to the Women’s HIV Research Collaborative,” says Jessica Mooney, the Legacy Project’s Community Engagement Officer and Project Manager. “She is the primary author on a recent manuscript highlighting the need for addressing violence against women within HIV clinical and behavioral research. Her contributions and insights fuel the collaborative spirit of the working group.”

    To increase enrollment of women in studies, Barr says eliminating women’s barriers to care must be explored and implemented. She lists providing extended clinic hours, child care and transportation as incentives that, if offered, could lead to greater involvement of women in clinical trials in the United States.

    “If we make women a priority, we will figure out how to increase their enrollment,” Barr says. “Some people think science is science and research results can be generalized to all populations. But it comes down to basic science and our cells being different than a man’s cells. Not all results can be applied to all populations.”

    Armed with her doctoral coursework in women’s and gender studies and her growing scientific knowledge base thanks to her CSS duties, Barr vows to continue fighting for increased enrollment of women in ACTG studies and the inclusion of sex comparisons in study results.

    “Not coming from a science background, I catch myself sitting in on very technical study meetings and truly understanding what is being discussed,” Barr says. “We are all committed to the cause within the ACTG, but just need to arrange our set up differently to ensure the inclusion of women.”