Vaccine Advocacy and Community Leadership Pedro Goicochea, MSc, MA Clinical Trials Unit - Peru Investigaciones Medicas en Salud Good morning! I want to thank the organizers to invite me to share the experiences we have had in moving things forward in HIV prevention research in Peru and Ecuador

SAMPLE SLIDE 2 “…The services I got in this clinic have been very good, the environment is very pleasant, warm and you feel at home, thus, it made me feel very good. Well I want to thank you for this at iPrEx. I will put all of my effort to collaborate and make something very big for the history of humankind that is to find an alternative to prevent HIV/AIDS. Well, no much else to say, thanks for your attention to this…” Screened participant at iPrEx in one of the Andean Sites, 2007 - 2008 Computer Assisted Self Applied Interview I want to start by sharing with you a very inspiring quote from one screenees in the Chemoprophylaxis for HIV Prevention in Men study being implemented in Peru, Ecuador and the US. This is a final comment to a behavioral survey applied by Computer Assisted Self-Applied Interview at the screening visit of the study: READ The quote speaks for itself, what HIV prevention participants want to do something about the epidemic but, by doing so, they want to feel comfortable, at home

Background Peru & Ecuador have a concentrated epidemic in gay men, Trans and other men who have sex with men Prevalence: ~ 14% - 28% Incidence: ~ 3.1 - 6.1 Impacta, Lima, Peru, 2000 Community preparedness: Raise awareness on HIV/AIDS & HIV Prevention Research Community Advisory Board Community Forums Community Engagement Activities Site Expansion Iquitos, Loreto, Peru, 2001: ACSA Pucallpa, Ucayali, Peru, 2002: AC Cayetano Heredia Guayaquil, Guayas, Ecuador, 2006: Equidad/FAMIVIDA Lima, Peru, 2007: INMENSA So I want to continue with a little background about the Clinical Trials Unit in Peru. Peru has a concentrated epidemic in gay men, other MSM and the trans population. Impacta started in Lima, Peru, back in the year 2000 as an HIV/AIDS research organization with a very large community involvement program to raise awareness of HIV/AIDS and HIV prevention research. These activities initiated by the creation of a community advisory board Organization of community forums and community engagement activities Impacta HIV prevention activities expanded to other cities in the region; especially in the jungle of Peru, Iquitos working with Asociacion Civil Selva Amazonica Pucallpa working with Asociacion Civil Cayetano Heredia in Guayaquil, Ecuador working with Fundacion Ecuatoriana Equidad and Amigos por la Vida And in Lima, Peru working with Investigaciones Medicas en Salud

Research Activities 2000 - 2008 Study type # of studies Population # enrollees Cross Sectional 6 GTB, women 5430 Prospective cohorts 5 530 Prevention: Vaccines 3 General population GTB 500 Prevention: Clinical Interventions 2 GTB 2400 Treatment 9 PLWHA 240 Training Health Care Workers, PEPs 2300 TOTAL 28 11400 This is table that gives and idea of the activities at the CTU. The CTU has enrolled nearly 9,100 people in research studies and nearly 2300 people in research activities. Among the studies we implemented we had The SMART study, continuous vs. episodic ART. The study was stopped because it showed that interruption ART was an inferior strategy to continues ART Herpes suppression for the prevention of HIV infection in HSV-2 positive MSM. 1500 enrollees. The study did not show the expected outcome Merck HIV vaccine study, 500 enrollees. Study stopped by the Data Safety Monitoring Board in 2007. The study had unexpected outcomes Chemoprophylaxis for HIV prevention in men, the iPrEx study, starting in July 2007 and enrolled 1010 men so far. Dealing with these situations have made us work and strategize hardly on different approaches

Lessons learned Involve communities and work with them. Include them in the decision making process. Assess what is it that they want Do not patronize the communities, they know what they are looking for Be prepared for the unexpected: communications Protocols do not always have expected results Keep community trust Faithfully continue in the search, communities are observing and still want to do something, do not fail on them These are the lessons we have learned so far from these challenging experiences

“…most of the gay population is willing to participate…[we] are the population that contribute the most [on finding] a solution to HIV…” (Focus group, Gays 18-30 y.o. Lima, 2008) “…[HIV prevention research] build it with them [GTB organizations] and involve the State, we are always open to work together…” (Interview, AIDS Officer, MoH, Ecuador, Quito, 2008) I just want to finish with another quote of a Formative Research process we are undergoing recently to assess the feasibility of the implementation of an HIV prevention trial THANK YOU