• Keeper of Regulatory Compliance and Bees at UC Denver – A Honey of a Job

    November 23, 2015 pendari Community

    Meet Pat Kittelson

    As a previous librarian at both public and academic libraries, Pat Kittelson, Regulatory Coordinator, University of Colorado, Denver, did not anticipate working in the field of clinical research. Her research career began with an IRB position in 2003. Wanting to learn more about the field of clinical research, and with a desire to gain more experience on the other side of the desk, Pat transferred to research administration with the General Clinical Research Centers/Clinical Translational Research Centers.  It was there where she honed her protocol budgeting and regulatory submission skills, while at the same time reflecting on her personal connection to HIV/AIDS research.  Since the 1980’s Pat has been very interested in HIV/AIDS and those who are impacted by the disease.  She recalls watching the public health system and the gay community grapple with HIV/AIDS through the 1980’s while surrounded by negative attitudes, lack of compassion, and much fear and misinformation.

    “One of my favorite authors, Arnold Lobel of “Frog and Toad” fame died in 1987 at only 54 years old and his cause of death was listed as cardiac arrest.  In conversation with another author who knew Mr.  Lobel, it was revealed to me that he actually died of complications arising from AIDS,” recalls Pat.  “I remember feeling terribly sad that this truth was deemed too controversial to share.  It somehow made me grieve not only for the loss of a wonderful storyteller and illustrator, but also for our society’s inability to address the truth.” 

    Pat notes that she is often inspired by our study participants with their incredible personal determination to contribute to the scientific knowledge to take us one step closer to curing HIV.  She particularly enjoys Community Advisory Board meetings that provide both scientific presentations and a gathering place for community members. 

    “I am so grateful for the willingness of HIV/AIDS infected people to step up and participate in those first clinical trials so that such astounding progress could be made in treatment and detection,” said Pat. “So many of our participants have lost friends, partners, and family to HIV/AIDS, and yet they continue to live and give of themselves.”

    With regards to her everyday regulatory work at our UC Denver site, Pat enjoys getting protocols approved through all of the appropriate channels which she describes as a “working a puzzle” that provides her with rewarding satisfaction when a protocol opens and enrolls. In addition to IRB approvals, Pat’s other regulatory duties include ongoing reviews, updates and amendments, as well as safety and adverse event reporting.

    “I work with a group of wonderful people and we have an office environment that encourages me to do my best work. I am detail oriented and an organizational nut which they happily put up with,” said Pat. “I am passionate about my work and am inspired by my colleagues on a daily basis to continue to learn as much as I can about HIV virology and pharmacological regimens, not to mention the on-going health concerns for those living with HIV.”

    Pat is not just passionate about her work with the ACTG Network; she is also passionate about a unique hobby she has picked up over the past few years – beekeeping.  As she gets closer to retiring, she has decided to become a hobbyist beekeeper. More specifically, Pat is working on developing beekeeping educational programs in partnership with a museum in Denver and hopes to manage a small apiary or two and advocate for honey bee habitat within urban spaces.

    “Pat has been a fantastic addition to our team.  We had no idea that a librarian/beekeeper would be the perfect regulatory coordinator, but she is,” said her colleague, Graham Ray, Study Coordinator, University of Colorado, Denver.  “Pat has the perfect blend of attention to detail, compassion and humor and we feel very lucky to have her.”

    Pat is also a new member of the ACTG Network Outreach, Recruitment and Retention (OR&R) Committee.  She notes that she has learned that there is tremendous variation on recruitment and retention methods across sites and how there is much to be shared to shape best practices.  Pat has noticed that as protocols are getting more specific, and therefore requiring fresh approaches to recruiting participants, it is exciting to explore strategies with the OR&R Committee.

    “My job doesn’t allow much room for creativity and I thrive on creativity.  The OR&R Committee provides an outlet for me to use that fun part of my brain while getting to know people from across the ACTG Network,” said Pat. “I hope that at some point in the future to work with the OR&R Committee to develop a Smartphone APP for HIV clinical trials similar to what have been developed as part of the Apple Research Kit for asthma, diabetes, breast cancer and cardiovascular disease.”

    Pat feels extremely fortunate to have the opportunity to work in a research area that has accomplished so much in such a short time.  Although she does not see herself on the scientific front lines so to speak, Pat is more than happy to be “pushing the paperwork” through the processes as she puts it.  However, we BEElieve her contribution is much more than that.

  • Community Representative Serves as Study Participant Voice for REPRIEVE Protocol Team

    October 29, 2015 pendari Community

    Meet Paris Mullen

    Paris Mullen is one of the dedicated ACTG Network Community Scientific Subcommittee Representatives and Community Advisory Board (CAB) members at our University of Washington, Seattle clinical trial site. Each ACTG Network clinical trial site has a CAB made up of members from the local area that are affected by or living with HIV. The CAB holds regular meetings with site investigators and also hosts events open to the community to educate people about HIV/AIDS and ACTG Network clinical trials. In addition to his duties on the Scientific Subcommittee and CAB, Paris also serves as a designated Community Representative for the REPRIEVE trial. REPRIEVE, a randomized trial to prevent vascular events in HIV, will test whether a daily dose of a statin will reduce the risk of cardiovascular disease among people living with HIV.

    “I wanted to serve as a Community Representative for REPRIEVE because this trial presents a unique opportunity to advocate for the heart health of those living with HIV,” said Paris. “The REPRIEVE trial offers hope and a ‘fighting chance’ for those living with HIV as it pertains to decreasing inflammation of the arteries and potential heart disease.”

     To be effective in the role of Community Representative, Paris notes that it is imperative to gain the respect, trust and support of the greater HIV/AIDS community at large.  Community Representatives facilitate dialogue between researchers, clinicians, principle investigators and the lay community as it relates to clinical trial research and study participation.  In addition, they help ensure that concerns, questions and perspectives of the community are always conveyed in a timely and effective manner.

    For years, Paris has been an outspoken advocate for research and believes that without clinical trials, researchers will not be able to answer crucial scientific questions that may ultimately save, sustain and improve the quality of life of those living with HIV.  Simply stated, he believes, “people need research and research needs people.” 

    As an advocate for the HIV/AIDS community, Paris works to help increase general scientific literacy by distilling HIV/AIDS science in a comprehensive and culturally appropriate manner.  More specifically, he works with the African American population to help facilitate and mobilize community activism that includes leadership opportunities.  

    “Researchers sometimes have a lack of knowledge about the cultural differences among underrepresented ethnic populations and this can result in ineffective communication strategies regarding clinical trial research at all stages, including recruitment, enrollment, and retention,” said Paris. “Recruiting marginalized and underrepresented populations for clinical trials can require additional investments of time and resources to learn what methods may work in distinct communities to improve acceptance of clinical research and therefore improve participation.”

    The REPRIEVE trial presents an interesting dichotomy with regard to the potential study participant population who is now living longer with HIV but is at higher risk for developing heart disease compared to the general population. Heart disease is evident even among younger individuals and occurs despite having HIV under control. In particular, it is extremely important to understand how to recruit, enroll and retain individuals who are physically the healthiest they have ever been.  Understanding the benefits and barriers this population faces when considering enrolling in REPRIEVE is one of the main challenges Paris faces when advising the protocol team.  However, he is honored to collaborate with fellow REPRIEVE Community Representative, Aaron Laxton, to help in these efforts.  Paris has a great deal of respect for Aaron and what he brings to the table.

    “Aaron is a dynamic community leader with a steel will and determination to advocate for communities disproportionately impacted by HIV,” said Paris. “He is a compassionate visionary, a change agent and has courageously and publicly shared many aspects of his life in order to encourage, educate, raise awareness and advocate for the fight against HIV.”  

    Paris also commends his friend, mentor and colleague, Michael Louella, Outreach Coordinator at the ACTG Network’s University of Washington, Seattle clinical trial site for always being there to support him and encourage his advocacy efforts.

    “Michael embodies, equally, a love for people and science. He keeps the plight of the human experience at the center of the fight against HIV.  He is a tireless advocate who singlehandedly does the work of a team of people,” said Paris. “I am always amazed at his ability to engage and raise awareness amongst communities through his social media and marketing expertise. Michael is pillar in the global HIV/AIDS community.” 

    Paris has a message for Community Representatives of other ACTG Network clinical trials:

    “Do all that you can to help ensure that participants in studies proportionately represent the marginalized populations which are disproportionately impacted by HIV/AIDS.  Community participation on protocol development committees is essential.  It allows us to establish and leverage strong cohesive relationships with not only the lay community but also all research site personnel. Additionally, I would encourage Community Representatives to remember to practice self-care and to incorporate practices that help ensure their mental-emotional-physical-spiritual health and long term sustainability.”

    Paris shares a deep appreciation for the study participants of RERIEVE and other current and previous clinical trials for their tremendous sacrifices. Regardless of the REPRIEVE trial’s outcome, he strongly believes that all study participants have advanced the fight against HIV/AIDS and are amongst the nameless and faceless who deserve applause and praise for advancing the well-being of human kind.

    In closing, Paris also has a message for ACTG Network researchers and clinicians:

    “I would like to express my humble gratitude for their sacrifices, dedication and tireless advocacy to help end the HIV/AIDS pandemic. I encourage ACTG Network researchers and clinicians to go out of their way to engage the participation and contribution of Community Representatives and CAB members in protocol development, review and implementation. I hope that researchers and clinicians are willing to help ensure that marginalized populations are afforded increased access to mentorship programs, scholarship opportunities and other volunteer positions for educational and Q&A opportunities.  

    REPRIEVE is funded by the National Heart Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH), with significant support and collaboration from the National Institutes of Infectious and Allergic Disease (NIAID). In addition, Kowa Pharmaceuticals America, Inc. will be providing the study drug and additional financial support.

    For more information about REPRIEVE, please visit www.reprievetrial.org


  • Community Advisory Board Member Advocates for Women and Minorities to Participate in ACTG Network Clinical Trials

    August 11, 2015 pendari Community

    Danielle Campbell has served on the AIDS Clinical Trials Group (ACTG) Network’s Community Advisory Board (CAB) at the University of California, Los Angeles (UCLA) clinical trial site since 2012. Each ACTG Network clinical trial site has a CAB made up of members from the local area that are affected or infected by HIV/AIDS. The CAB holds regular meetings with site investigators and also hosts events open to the community to educate people about HIV/AIDS and ACTG Network clinical trials.  In addition to serving on the UCLA CAB, Danielle is also a member of the Network’s Community Scientific Subcommittee (CSS) where she provides input to ensure that the ACTG scientific agenda reflects the needs of all people living with HIV/AIDS. More specifically, Danielle is proud to provide a voice promoting and advocating for the inclusion of women and minorities as study participants in ACTG Network clinical trials.

    “I choose to advocate for women and minorities to enroll in ACTG Network clinical trials because I believe in the power of science to affect biological and clinical change,” said Danielle. “I believe that it is imperative for those most marginalized in this epidemic to take part in the transformative science of the ACTG, and any and all treatment, curative and advocacy efforts contained therein.“

    Through her participation as a CAB member, Danielle has had the opportunity to foster relationships with other members. She notes that her relationship with fellow CAB member Liz Barr has had a significant personal impact on her life and helps to remind her of the important reasons why she is an advocate for those impacted by HIV/AIDS. Danielle cherishes the relationship she has built with Liz through their joint advocacy efforts. She takes every available opportunity to connect with Liz to gauge her impressions about women’s health issues and life in general. Danielle feels extremely fortunate to be part of a group of brilliant thinkers, advocates and leaders of the CSS, Liz being one. It is not surprising that Liz has a mutual admiration for Danielle as well.

    “Danielle is a tireless advocate for women and people of color in our trials, and also for younger members in the CSS,” said Liz. “She is a prime example of what we can accomplish together and I have so much respect for her as a person and an advocate. It is an honor to work with Danielle, not only as a colleague but also as a dear friend.”

    Over the past few years, there have been considerable efforts taken to increase the number of women who participate in ACTG Network clinical trials.  These efforts are motivated by the need to accurately represent all populations infected with HIV/AIDS, which has proven to be a challenge for the ACTG Network in the past. However, Network investigators are acutely aware that active and well-represented participation of women in trials allows them to explore sex-based differences as primary and secondary study objectives or develop exploratory studies that examine screen failures among women. In addition, Network investigators understand that minorities face an array of multi-cultural issues that should be addressed and incorporated into protocol development.

    Danielle has a message for ACTG Network leadership and investigators:

    “We have proven that there is added value in partnerships fostered between clinicians, researchers and the CAB. In this light, we look forward to continued invitations to participate in trials, sit on protocol teams, community advisory boards, leadership committees, conference support and in other capacities as needed.  I will continue my efforts to advocate for the enrollment of women and minorities in ACTG Network clinical trials and will work with you to help you achieve these important enrollment goals”

    She also has a message to anyone who is considering enrolling in ACTG Network clinical trials:

    “The road ahead will be filled with uncertainties, rest assured. Stay connected. Get to know your clinical research site staff, clinicians and researchers. Ask questions, ask questions, and did I say, ask questions!? Compassion is the key! We need to work together to support one another in this endeavor.”

    Danielle notes that one of the most rewarding aspects of being a CAB member has been connecting with other HIV/ AIDS advocates across the globe. She is encouraged by the construct of the ACTG Network CAB that allows members a space to have meaningful conversations about the significance of clinical trials, share exciting scientific research and advocate for study participants during protocol development.

    In the future, Danielle will continue her advocacy work promoting the enrollment of women and minorities in ACTG Network clinical trials.  Nevertheless, she is always mindful of the past and offers this closing message to all of those who have participated in ACTG Network clinical trials over the years:

    “There are no words to express the depth of my thanks to you for your sacrifice. Your selfless actions will forever benefit generations of people impacted by HIV/AIDS. I stand with you, for you, and beside you, from now until we find a cure.”

  • Durban International Clinical Trial Unit

    January 1, 1970 pendari Community

    (Durban, South Africa)

    During 2011, the Durban CAB participated in three main events: Community Outreach, Peace & Solidarity March, and World AIDS Day. These events were mainly focused on education and awareness related to research, HIV/AIDS, and domestic violence.

    The Community Outreach event (Research & Community Benefits) was held on May 1, 2011, in the semi-rural area of Nsizwakazi in the Province of Kwa Zulu Natal, South Africa. The event was focused on “What is Research” and how would the Community benefit. Both the members of CAB and ACTG Research Staff made presentations. The event ended in a healthy and fruitful interaction.

    The members of the Durban CAB responded to the invitation extended by the Chatsworth & District Partnership Against AIDS (CADPAA) to participate in the “Peace & Solidarity March” in commemoration of the 16th Days of Activism Against Gender Violence & Child Abuse. This event was held on the 25th of November 2011, in the township of Chatsworth, south of Durban. The event ended with the lighting of the candle in solidarity to all those who have been a victim and those who have died tragically.

    The Durban CAB hosted a special event on December 1, 2011, in commemoration of World AIDS Day. Both the trial participants (ie, ACTG/IMPAACT), and the site staff were also invited to attend. The event highlighted the significance of World AIDS Day in particular to encouraging greater involvement of People Living with AIDS and in addressing issues of stigma and discrimination. The event ended with gifts presented to all participants and the provision of a sumptuous meal to all who attended.

  • ACTG A5217: The Setpoint Study

    January 1, 1970 pendari Community

    Source: The Journal of Infectious Diseases, Volume 205, Issue 1
    Please click here for the JID website source article


    The benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved.

    A5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log10 HIV-1 RNA level at week 72 (both groups) and 36 (DT group).

    At the June 2009 Data Safety Monitoring Board (DSMB) review, 130 of 150 targeted participants had enrolled. Efficacy analysis included 79 individuals randomized ≥72 weeks previously. For the primary end point, the IT group at week 72 had a better outcome than the DT group at week 72 (P = .005) and the DT group at week 36 (P = .002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group. The DSMB recommended stopping the study because further follow-up was unlikely to change these findings.

    Progression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment.


  • The Community Scientific Sub-committee

    January 1, 1970 pendari Community

    [Spotlight originally posted November, 2011]

    The Community Scientific Subcommittee represents community concerns and issues on ACTG science committees and protocol teams. It is a big commitment for a small group of volunteers. Recently, the CSS welcomed several members to the group. Some were former members and some were first time applicants. The ACTG community includes many dedicated volunteers, and the CSS is only one way in which they contribute. Two of the current members share their stories.

    Eric Lawrence has a long history with the ACTG scientific community. Beginning as a local CAB member at Washington University, St. Louis, USA in 1999, he went on to become an advocate for clinical trials as a CCG (Community Constituency Group) member and then a second term as a member of NCAB (Network Community Advisory Board), in which he served as co-chair of the committee. After a 3-year break, as a policy advocate for the AIDS Foundation of Chicago, Eric was recently selected to serve a third term on the Community Scientific Subcommittee (CSS). When asked why he does this, his answer is “It’s simple; I am alive today because of great science and the tireless effort of all those wonderful people who previously advocated on my behalf, many of them no longer with us. It is my honor and duty to ensure that there will always be good life-sustaining medications available for those behind me until there is a cure.”

    In January 2010, Ashish Gupta was introduced to the ACTG—University of California San Francisco clinical research site when he needed to start HIV medications. Ashish had been positive for nearly 10 years. His primary care doctor is also one of the key researchers in the field, and he listened to her recommendation and became part of a study. Ashish said he was very impressed by the professionalism of the team and the level of care that he received. Within a few months he had referred several friends for studies as well. The study team’s research nurse suggested to Ashish that he attend a Community Advisory Board (CAB) meeting. The result was an immediate interest in reviewing protocols and understanding the science behind the studies. “As an active CAB member I’ve been able provide some input into the studies we’ve looked at, but more importantly, the information and understanding I’ve gained has allowed me to help people in my community and other affected communities make informed choices about possible treatment.”

  • Community Advisory Board

    January 1, 1970 pendari Community

    [Spotlight originally posted July, 2011]

    The ACTG Network Meetings provide an opportunity for CAB members to learn about more than research – they learn about each other.  At the ACTG Network Meeting (June 20-24, 2011), four CAB members gave presentations about their local clinical research sites’ CABs and communities. This meeting session has become a regular event at the ACTG meeting. This year, CAB members from Eldoret, Dallas, Johannesburg, and San Juan talked about the CAB and site activities and how the epidemic has affected their communities.

    Carlos Velez (pictured above) presented information on the demographics of the epidemic in San Juan, Puerto Rico. Puerto Rico ranked 10th in AIDS diagnoses through 2009 in State/Dependent Areas of the USA. Infection in males represents 73.9% of reported HIV cases, and injection drug use accounts for the largest proportion of those cases. The CAB at the Puerto Rico – AIDS CRS meets monthly and discusses open protocols, recruitment and retention issues, drafts of upcoming protocols, and educational topics. They participate in community events such as World AIDS Day, Thanksgiving Day, and Gay Pride events. The CAB has been successful in educating community members about the relevance of research and benefits of clinical trials and collaborated with other community-based organizations. Their goal is to achieve an increase in participation and contact with primary care physicians.

    David Morelle explained some of the outreach activities of his CAB in Johannesburg, South Africa. David reviewed the statistics of the epidemic and the social and political challenges of dealing with so many HIV positive individuals. Over 1 million persons in South Africa are on antiretroviral therapy. The Wits HIV CRS is taking part in both ACTG and HPTN studies. The CRS CAB includes 15 members with backgrounds in education, social work, and HIV/AIDS activism; most members are female, and most have been participants in clinical trials. There is no limit to tenure on the CAB. CAB members discuss ongoing studies and community issues, participate in community outreach, and have spoken about research on the radio.

    Lionel Hillard showed the group how his site in Dallas, Texas, has expanded and is moving into new quarters. The CAB at the Peabody Health Center CRS at AIDS Arms includes individuals affected by HIV and other members of the community, with a special focus on including those populations that have a disproportionate ratio of infection. Members on the CAB serve renewable one-year terms and provide input on effectiveness of services to the community. They review how accessible site materials are for the consumer. Lionel also discussed the CAB’s confidentiality policy, so important in community contact.

    Amina Shali presented information on her very active CAB in Eldoret, Kenya. In providing background on the epidemic in Kenya, Amina reported that 1.5 million Kenyans are living with HIV and 1.2 million children have been orphaned by HIV. Amina spoke proudly about Eldoret, an agricultural town which boasts world class marathon athletes, Moi University, and the very successful HIV program, AMPATH – Academic Model Providing Access to Health Care. Amina also explained how the epidemic had followed the route of truck drivers and first affected sex workers. The Moi University CAB is small but does outreach with schools, churches, hospital support groups, and women’s groups and has been successful in reaching the Muslim community. They have educated their community on HIV and clinical trials, and the site is planning future participation in several ACTG studies.

    Every day at the ACTG Group Meeting is educational, but this annual opportunity adds to our understanding of the work, successes, and challenges each community faces.

  • Awards Presented

    January 1, 1970 pendari Community

    [Spotlight originally posted March, 2011]

    The Community Advisory Boards of the NYU Medical School, NYU Langone Medical Center, and Bellevue Hospital ACTU, CFAR, IMPAACT, HVTN, and The Men’s Sexual Health Project held its annual CAB appreciation dinner at a midtown Manhattan restaurant on January 21st. The dinner was hosted by the ACTU’s Dr. Judith Aberg and IMPAACT’s Dr. William Borkowsky and is an opportunity for the staff to show its appreciation for the hard work by the CAB and community efforts by the members throughout the year. The 11 present members of our CAB work with almost two dozen HIV-related organizations throughout the five boroughs of New York City. The CAB has been in continuous existence since the very early 1980s when the first cases of AIDS were treated by NYU’s Dr. Fred Valentine who immediately started meeting with members of the gay community.  Officially organized in 1986 and passing bylaws and electing officers in 1996, the CAB meets 10 times annually at evening meetings preceded by a light supper.

    They then have a two-hour meeting including officers’ reports, protocol reviews, CAB Draft discussions and questionnaires, and educational discussions with the PIs often using the “white board” and markers to amplify their lectures. The meetings are always fully attended by both CAB members and staff who serve in an ex officio capacity and who play a critical role in educating in all aspects of HIV treatment and prevention.

    This year’s awardees included both CAB members and staff members. The awardees are:

    Emerline Lam, ACTU Staff Honor Award
    Carlos Mavestutto, MD, ACTU Fellow Honor Award
    Demetre Daskalakis, MD, ACTU Researcher Honor Award
    Michelle Cespedes, MD, ACTU Researcher Honor Award
    Richard Silvera, MPH, ACTU Researcher Honor Award
    Richard Hutt, RN, ACTU Researcher Honor Award
    Karen Cavanagh, RN, ACTU Researcher Honor Award
    Janet Forcht, RN, ACTU Researcher Honor Award


    CAB Members:
    Gayle Dorsky, Outstanding CAB Member Award
    Lydia Mercado, CAB Member Honor Award
    Lorenzo Penn, CAB Member Spirit Award
    Jannet Tollinche, CAB Member Spirit Award
    Father Jonathan Sampson Cossey, CAB Member Humanitarian Award and the ACTG CAB Bridget Murtagh Award

    Initiated in 2010 by CAB Chair Don MacIver, the walnut-framed award certificates are a tangible recognition of the many years of dedication and service by both staff and community volunteers. The dinner was a complete success on a cold snowy night in New York City — the Big Apple!

    Written by Don MacIver, CAB Chair and GCAB Co-chair
    Photos by Bill Bahlman, CCS Member and GCAB Alternate

    (Pictured above: Don MacIver, Dr. Michelle Cespedes and her daughter)
    (Pictured below: Gus Vianna Biehler, Bill Bahlman, Fatime Velasquez, Don MacIver, Janet Tollinche, and Dr. Judith Aberg)

  • Global Community Advisory Board

    January 1, 1970 pendari Community

    [Spotlight originally posted November, 2010]

    The Global Community Advisory Board (GCAB) is an important part of the ACTG, providing insight into community concerns regarding current and future research and taking research information back to the members’ CRS CABs. Community participation in the ACTG began in 1989 and has increased steadily over the years, with community members sitting on each protocol team and ACTG committee, reviewing developing studies, commenting on proposed research, contributing to the CAB newsletter and participating in educational calls.

    In June 2010, 82 community members from 70 sites attended the ACTG Group Meeting, discussing several research issues and needs in their communities and participating in the science and support sessions.  Getting to know a group that large, which meets annually, is a challenge. This year attendees were asked to share what is beautiful about their homes. A display of flags was created by a CAB member, including all the states and countries represented by the ACTG.  It helped everyone feel like they were connected and had a stake in the far flung homes of their peers.

    Pictured top: Don MacIver and Sharon Maxwell, GCAB cochairs

  • Teacher Turned Advocate

    January 1, 1970 pendari Community

    Watching a patient’s transformation from life to death is what inspired Michael Louella to passionately fight to transition his temporary job as a front desk receptionist into a full-time outreach coordinator position at the AIDS Clinical Trials Group Network’s University of Washington Seattle AIDS Clinical Research Site.

    “I had originally moved to Seattle from New Orleans with my partner in January 2000 and I was looking for work,” Louella says. “I had visited Seattle three months prior to the move and attended this Native American dance ceremony where they told me it would change my life. I felt something at play that night in Seattle other than luck. So then I moved three months later and went to the University of Washington Seattle AIDS CRS to get my partner’s sister’s house key from her roommate who worked there. That’s when I learned about the receptionist job. I’ve been here 13 years now, so that dance ceremony was right about Seattle changing my life!”

    Louella admits that he didn’t fall in love with the HIV research being conducted at the Seattle site overnight. He noticed patients coming and going and those who were not enrolling in clinical trials, in which new drugs were being tested, were becoming visibly ill. In many cases, patients were dying. Yet one man’s voyage from the brink of death back to health is what motivated Louella to inquire about staying on at the Seattle site and in a greater capacity.

    “Protease inhibitors started to change the epidemic, but people living with HIV were afraid of these new medications, likening them to poison. Many refused the treatments at first. I saw patients die before my eyes,” Louella recalls. “Then, there was this one patient whose hair turned gray and he became very feeble. So he decided to enroll in a trial and I watched him veer toward death and then come back to life. He joked with me that it was vanity that finally drove him to try the new medications, but it worked. He gained weight and his hair grew back in without the gray. That’s when I truly learned all those conspiracy theories out there about HIV clinical trials were wrong and I became a proponent of research because medications are only perfected through trials.”

    The road has been anything but smooth though for Louella, who is a former high school English teacher by trade. Bumps along the way include a loss in funding to the Seattle site when the ACTG Network reapplied for its competitive grant for federal funding in 2007. Seattle’s budget was cut to only support 10 to 12 of its 24 staff. Louella was initially laid off. Since he had a trip to Thailand already booked to celebrate his 40th birthday, he took his five-week vacation and let the universe decide his fate. He returned from his trip to learn that he still had a full-time job, but that the position was a patchwork of roles rolled into one.

    Presently, 90 percent of his time is spent working on ACTG studies through outreach efforts as well as in an administrative capacity for ACTG Network researchers Ann Collier, MD, Seattle’s ACTG Principal Investigator, and Joanne Stekler, MD. The other 10 percent of this time is spent in a similar capacity for an HIV trials network outside of the ACTG called the HIV Prevention Trials Network (HPTN). Stekler is a member of the ACTG Network and a principal investigator for HPTN’s 069 study in Seattle.

    “I’ve known Michael for 12 years, and in the last few I’ve really seen the teacher in him come through,” says Stekler. “He’s been incredibly passionate about educating the community, whether about prevention or treatment or about the possibility of a cure.”

    Louella also wears the hat of Chair of the ACTG’s Outreach, Recruitment and Retention (OR&R) subcommittee. His two-year term ends on May 31, 2013. It was a role he fell into after realizing early on in his work in Seattle that the ACTG could use a centralized place for all of its 73 sites to turn to for assistance with branding and publicizing studies open to enrollment. He joined OR&R in 2008 after encouragement from Collier.

    “Michael has been a valued member of the UW ACTU team for 12 years,” says Collier. “His creativity, dedication and passion for sharing knowledge are phenomenal! We are so lucky to have his help and advocacy for HIV research.”

    Once elected to the committee, he made a presentation at the ACTG annual meeting in DC that July.

    “The most fun anecdote I know about Michael was when one of my colleagues at an ACTG meeting sat down and was waxing enthusiastically about a session she had just been to about OR&R – how helpful, relevant, interesting, etc., it was – and then I learned she was talking about a session that Michael had led,” Collier says.

    Channeling his skills from his high school English teacher days, Louella stepped out from behind the requisite podium during the session to give investigators, site staff and community members a crash course in effective poster creation.

    “I was shocked because 200 people attended my session and I opened the presentation by showing an example of an awful flyer that had actually been used to publish a study,” he recalls. “I walked all around the room and talked about the importance of font size, contrast and color. We had all these nurses, site staff and patients with incredible medical knowledge about the studies, but they needed that graphic design help to get the message out. OR&R then created the Library of Recruitment Materials on the ACTG member site to give Network members access to effective recruitment posters.”

    In his role organizing the OR&R monthly calls with members from ACTG sites all around the world and with his work in Seattle, where he competes with HPTN and the HIV Vaccine Trials Network (HVTN) for attention, Louella has become increasingly aware of the need for the ACTG to brand itself as it moves into 2013 and the future.

    “The engine for ACTG recruitment in the United States in 1980s and 1990s was built out of that need for survival,” he says. “Now that this need is over, clinical research has taken a step back in people’s minds. There’s a new generation or two that we are now trying to reach who really take research for granted and how HIV medications that work today came into being. We now have to think like the other networks who have been honing their recruitment and educational skills for the past three decades. That will be our challenge moving forward.”