The CAB Bulletin HIV Vaccines and the Community

Planning for PrEP My First Time By Genevieve Meyer, HVTN Community Education Unit By Dino Martino, On November 23rd, 2010, the results of the iPrEx study were released. The Orlando, FL CAB member. 2,499-person study demonstrated that a daily dose of oral Truvada®, (a With nervous excitement I accepted combination of two antiretroviral medications, emtricitabine and tenofovir) could the offer to attend my first HVTN reduce new infections of HIV in gay men, transwomen and other men who have conference. As a member of the sex with men (MSM) by an average of 43.8%. The HVTN salutes the sponsors, newly formed CAB in Orlando, this study team, and volunteers in the 11 sites throughout Brazil, Ecuador, Peru, South Africa, Thailand and the United States who contributed to this study’s success. was another “first time” opportu- nity in a series of events that I have The results of the iPrEx study have added increased vigor to the HVTN’s search had the pleasure to be a part of in for a safe and effective HIV vaccine. One central question being asked at the HVTN support of the work of the HVTN. right now is what these results mean for participants in HVTN 505, a study which is also enrolling MSM and transwomen who are at risk of contracting HIV. As a pharmacist for nearly two de- cades, scientific conferences are not The Network has set up a working group to solicit feedback from community new to me; still, each one brings stakeholders about possible changes to HVTN 505 based on the iPrEx results. This a new prospect for growth both process will initially involve a series of conference calls, to be completed by late professionally and personally. So with wide eyes and an open mind …continues on page 2 I stepped into the first of many meetings that would enlighten Engaging Transgender Women me, give me pause, and challenge By Michele Andrasik1, Annet Davis-Vogel2, Marcus Bolton3, Borris Powell4, Gail Broder1, Erica me. HVTN for First Timers on the Avant3, Aamina Morrison2 and Kevin T. Jones2. 1. HVTN Core 2. University of Pennsylvania 3. Emory University, Hope Clinic 4. HANC Legacy Project first morning was a great primer for what lay ahead. In addition to The U.S. Community Session at the Clinic’s engagement model and learning more about the structure HVTN November Conference focused stressed the importance of building of the HVTN, I enjoyed learning on increasing understanding and relationships with other community- from the questions and concerns knowledge about reaching out to and based organizations (CBOs) and voiced by other attendees. While engaging male to female transgender …continues on page 4 barely comprehending the con- individuals. The workshop began cepts and complex science being with opening remarks by Borris Powell presented during the plenary ses- of the Legacy Project who provided sions, I could not help but revel in an overview of why community the creativity and genius of those engagement with consciousness presenting. It’s one thing to learn is essential for recruitment. His about research in journals, but remarks were followed by in-depth …continues on page 2 presentations of engagement models currently used by two HVTN 505 sites. Orlando CAB member, Dino Erica Avant and Marcus Bolton from Martino. the Emory University Hope Clinic () presented their model, which illustrates the effectiveness of hiring a transgender staff person, building strong relationships with community leaders and providing Aamina Morrison of TIPS in regular cultural competence trainings speaking on the diversity for site staff. Marcus explained the of the transgender community. www.hvtn.org December 2010 | 1 Planning for PrEP continued from page 1

December, 2010. Groups both inside and outside the network The findings from the iPrEx study show effectiveness in are being solicited for feedback and include CAB members, reducing HIV infection in MSM and transwomen. But more Community Educators and Recruiters, Network personnel and studies are needed to evaluate the effectiveness of PrEP NHVREI partners. On a local level, sites are soliciting input in other populations such as women, injection drug users from participants about what the iPrEx results mean to them. (IDU) and heterosexual men, not to mention studying the Updates to this feedback process will be available on the HVTN long-term effects of taking the medication as prevention, website at: http://www.hvtn.org/community/iprex.html. and addressing questions about adherence and cost. Participants in the iPrEx study were More immediately, HVTN sites were counseled that the effect of PrEP as provided with a letter for distribution to What is PrEP? prevention was unknown and to HVTN 505 participants notifying them protect themselves using other risk of the iPrEx study results. The letter Pre-Exposure Prophylaxis (PrEP) reduction methods. Will adherence included resources about the study, who improve once participants know that to call locally if they had questions, and a is an experimental approach the product is effective? If adherence reminder that they would be re-contacted to HIV prevention where HIV improves, will it increase the overall if any changes were made to 505. treatment drugs are given to effectiveness? Finally, who will pay for this medication? A monthly Some people may ask why the HVTN is HIV uninfected persons to try to supply of Truvada for HIV treatment paying so much attention to the results protect against infection. for someone without comprehensive of a trial testing a non-vaccine method insurance can reach US $1400. The of HIV prevention. One reason is that the Network has an cost of this medication alone is yet another reason why ethical obligation to provide the best proven standards of finding an effective HIV vaccine remains at the forefront of prevention to participants, as they become available. In biomedical HIV prevention efforts, and why the mission of this case, Truvada, commonly used to treat HIV, is already the HVTN remains as important as ever. a licensed product and widely available on the market. Because of the positive findings in the iPrEx study, the To stay up to date on HVTN activities, visit our website, HVTN 505 protocol team has to assess new considerations. www.hvtn.org, or by follow us on Twitter @HelpEndHIV. For example, does the study need to be modified at all to account for individuals who wish to enroll in 505 and report Additional Resources: having taken Truvada in the recent past? Currently they To learn more about the iPrEx study, visit- would be excluded from enrolling. http://www.niaid.nih.gov/news/newsreleases/Pages/ default.aspx; www.globaliprex.net The HVTN 505 protocol team will be working hard over the http://www.youtube.com/watch?v=wrdfwzTl-Oc. next few months to consider all of the possible implications for interactions of pre-exposure prophylaxis (PrEP) and For information about how these results affect the HIV vaccines. Yet the entire field of HIV prevention has many prevention field, go to the AVAC website at http://www. more questions to address. avac.org/ht/d/sp/i/3619/pid/3619.

My First Time continued from page 1

to hear first-hand from the scientists munity Educators, CAB Members themselves is a true treat. Attending and NHVREI partners was inspira- the iPrEx session and seeing some tional. It was quite possible to have preliminary data just days before the someone from South America seated results were released was surreal. on your left and someone from South Africa on your right. The knowledge Apart from the wealth of information and experience of this dedicated presented about studies currently group of individuals was immeasur- underway at the HVTN, probably able. Here, I was given the ability to the most constructive feature of the build on the success of others, and conference was the interaction and the wisdom to avoid and overcome networking with the other attendees. the hurdles they faced. Keith Barsky, recruiter at the new The General Community Session was Orlando site with longtime CAB one of the highlights of the conference I ended my time at the conference member, Dave Crawford. for me. This diverse group of Com- with one powerful and positive …continues on page 3

2 | The CAB Bulletin December 2010 HVTN Conference

From left to right: (l) Chia Thach Butch McKay, (CAB) and Jim Higginbotham (r) Kingdom and Edward Todd Mufhandu (CER) of the Birmingham of Rochester site. with Alejandra Diaz of the New York CAB.

A captive audience Iquitos staff and during the General CAB members are Community Session. all smiles between sessions at this year’s HVTN conference.

From left to right: CAB GCAB co-chair Phineas Malahlela (left) Chip Lohner of the newly members Lisa White and Victoria with Michael Hodge (right), educator formed CAB. Chinnell with -Fenway from New York. educator Jim Maynard. November 15-17, 2010, Seattle, Washington

My First Time continued from page 2 observation. There was no difference years, everyone shared the same volunteers to participate in trials to in the level of enthusiasm and passion. It was with this passion that find a safe and effective HIV vaccine commitment from the people I I returned to Florida with ideas to and to put an end to this disease. was surrounded by. Whether they further engage the community about were neophytes like me or veterans HVTN 505: dispelling misconceptions Dino Martino joined the newly formed participating in CABs for over 10 and advising the site about finding Orlando CAB in September 2010. www.hvtn.org December 2010 | 3 Engaging Transgender Women continued from page 1 nourishing those relationships over time. Erica discussed accepting of all identities. She stressed the importance of the importance of having a transgender advocate on staff building relationships with the transgender community and at the site to ensure that the transgender community has a specifically within the transwomen community, respecting representative who will make certain that their needs are and acknowledging that the transgender female identity is addressed. She noted that for many transwomen, it can separate from the larger MSM or gay community identity. be a struggle just to survive from day to day. Therefore, Aamina also discussed the importance of encouraging and addressing these needs by providing respecting transgender women, and support, services, and education is advocating that transgender women paramount. The Hope clinic provides a “Many transgender speak up and have a voice for themselves. range of services which include linkages women wonder, ‘Why to health care and social services, Michele Andrasik, the HVTN social training for life (educational and are you thinking scientist, provided a summary statement vocational skill-building), and referrals followed by a question and answer for mental health services. about us now?’” period moderated by Gail Broder of the Community Education Unit. During Aamina Morrison, Kevin Trimell Jones, the Q & A, Aamina and Erica pointed and Annet Davis-Vogel from the Philadelphia site presented out that the community of transgender women has been their model built on establishing a community partnership ignored and discounted for so long that there may be some between the research site and the Trans-Health Information resistance toward attempts to reach out because of mistrust Program (TIPS). The Philadelphia site has fostered a strong and fear. Many transgender women wonder, “Why are you relationship with TIPS, a local CBO serving the transgender thinking about us now?” The women urged the audience community and staffed entirely by members of the to understand that the best way to engage transgender transgender community. Aamina, the TIPS Health Education women is to truly care about what happens to them and to Coordinator, discussed the importance of being aware of demonstrate this by listening, being present and building the diversity within the transgender community and being lasting relationships.

Send suggestions, About CABs questions, and articles Community Advisory Boards (CABs) are one way that the HVTN involves community members in the research process. CABs consist of volunteers from diverse backgrounds who work with local research submissions for the units and advise the site from a community perspective. Community input has been invaluable to CAB Bulletin to: community education efforts, as well as to the development of this bulletin.

Genevieve Meyer, Editor [email protected] CAB Conference Calls Tel: 206 667-5300 If you are interested in joining one of these calls, please email Genevieve Meyer ([email protected]) Fax: 206 667-6366 Global GCAB call Thurs., Jan. 13th, 8 a.m. PT /11 a.m. ET HVTN/FHCRC, Second Thursday of every month Thurs., Feb. 10th, 8 a.m. PT /11 a.m. ET 1100 Fairview Ave. N., LE-500 PO Box 19024 Seattle, Washington 98109 Global Ethics Working Group call Tues., Jan. 4th, 9 a.m. PT /12 p.m. ET First Tuesday of every month Tues., Feb. 1st, 9 a.m. PT /12 p.m. ET Layout: Deborah Cughan Translation: Translation of the CAB Scientific Working Group Call Fri., Jan. 7th, 8 a.m. PT /11 a.m. ET CAB Bulletin from English to First Friday of every month Fri., Feb. 4th, 8 a.m. PT /11 a.m. ET Spanish and French provided by Infinity Translation Services. French Language CAB call Wed., Feb. 9th, 9 a.m. PT /12 p.m. ET www.infinitytranslations.com Second Wednesday of even months Wed., Apr. 13th, 9 a.m. PT /12 p.m. ET Thank you to the many people who helped with this Spanish Language CAB call Thurs., Jan. 20th, 9 a.m. PT /12 p.m. ET issue: Carrie Schonwald, Third Thursday of odd months Thurs., Mar. 17th, 9 a.m. PT /12 p.m. ET Gail Broder, Niles Eaton, Adi Ferrara, Sarah Alexander, African Regional CAB call Thurs., Feb. 17th, 9 a.m. PT /12 p.m. ET and Jim Kublin Third Thursday of even months Thurs., Apr. 21st, 9 a.m. PT /12 p.m. ET

4 | The CAB Bulletin December 2010