Contact: Pedro Gonzales- pgonzales@impactaperu.org

1. Future Rectal Microbicide Trials in South America: Would men who have sex with men and transgendered women participate? Pedro Gonzales1, Jerome Galea2, Janni Kinsler2, Cesar Nureña3, Martin Casapia4, Lucia Ruiz4, Orlando Montoya-Herrera5 , Luis Fernando Galarza5, Jorge Sánchez1, William Cunningham2 1. Asociacíon Civil Impacta Salud y Educacíon, Lima, Peru; 2. University of California, Los Angeles, USA ; 3. Universidad Nacional Mayor de San Marcos, Lima, Peru ; 4. Asociacíon Civil Selva Amazónica, Iquitos, Peru ; 5. Fundacíon Ecuatoriana Equidad, Guayaquil, Ecuador Background Results Sample Characteristics • Participants voiced a range of opinions regarding potential participation in future RM trials, grouped into 6 major themes: • 1. Yes, I would participate: • “In some way, since we have sex without protection, on the one hand I think, yes, yes [my friends] will accept [participating in a RM study].” [Lima, Out / Gay] • "I think, in my case, yes, I’d enter into the study without asking a lot of questions since it’s useless to ask a lot of questions and if not, it’s all the same, I mean, if you accept, you still know what the study is about…how it works [efficacy testing]...and something I can do is ...continue using a condom for example, so there’s that, you are in the project, you are testing a product, but you are protecting yourself as well with, with a condom, so there’s no increased risk than that, right?” [Guayaquil, Out / Gay] • “Personally, this seems to me that it is the first phase of…to test a gel…and to see if it really works or doesn’t work and, yes, I’d like to try it.” [Guayaquil, TGW] • 2. Yes – I would participate but the study would need to be thoroughly explained: • "...the idea would have to be explained well...what it’s like, how it works the…the gel...to what extent will it protect you, I mean, in the study....[...] for example, what happens with the penis when it [RM] is concentrated there? You need to explain that to me.“ [Lima, Out / Gay] • "You have to tell me how the study would be....the disadvantages, they would need to explain to me how everything would be, the whole process. They need to explain what they are going to do to you.” [Iquitos, Sex Workers] • “It’s that, if people aren’t well informed about who they are, who is doing this, for example, this scientific study, no one is going to have faith. But if this is backed-up with seeing who is doing it, how much time it will take, and it’s explained, then it would be very different.” [Guayaquil, Out / Gay] • 3. Yes – but what would the benefits to me be? • “…they don’t [participate in studies] because they are really worried about the existence of HIV or because of STI, that’s why we are here, anyone is at risk of contracting it. They don’t do it only for something in exchange.” [Lima, Sex Workers] • “And what will we earn?” [Guayaquil, Closeted] • “We should constantly have monthly medical checkups and in particular, they should be free.” [Guayaquil, Closeted] • “…I’d present the economic side, look, I’ll give you this and we need that, so, there has to something we do it for, for something, since we need the money. [Guayaquil, TGW] • Rectal Microbicide (RM) research is advancing to Phase-II clinical trials; MTN 017 will be implemented in Lima, Peru in 2012 • RM effectiveness studies are predicted within the next 5 years • Need is to identify willing and eligible volunteers to participate in RM studies • Participation in clinical trials can neither be assumed nor guaranteed; facilitators/barriers for participating specifically in RM research are unknown • This study explored what men who have sex with men (MSM) and transgender women (TGW) in three South American cities – target populations for eventual RM use – think about participating in RM trials. Methods • Focus groups were conducted in three South American cities to explore the motivators and barriers to participating in RM research studies • 12 groups (4 per city) were convened • Group participants were potential users of a future RM: men who have sex with men (MSM) and transgendered women (TGW) • Cities are potential sites for RM studies: Lima, Peru; Iquitos Peru; and Guayaquil, Ecuador • The MSM groups were stratified to include “openly gay”, “closeted” and “sex worker” subgroups • Semi-structured Interview guide employed by trained anthropologist; a range of issued were explored with regards to RM, of which participation in RM trials was one part • Sixty-minute groups were audio recorded and transcribed verbatim • Content analysis was performed using Atlas.ti v.6.2 Due to missing data, not all variables sum to the total N. 4. Maybe, it depends on the risks, study procedures, information: "Yes, it depends...it depends on how it’s done…if it’s convenient…for example if it’s a gel or a lubricant, it shouldn’t be something too uncomfortable to carry, it should be easy to access, I don’t know, but then I would say yes. But if you have to carry it in a tube like a cream or something like that, I don’t think so." [Lima, Out / Gay] “The [but there would be] uncertainties well, I mean, suppose that someone decides utilize [the RM], [they study] uses you to test this chemical, so you have to keep in mind what would happen, if something could happen to you, along those lines". [Lima, Closeted] "What are the risks we will run?" [Guayaquil, Closeted] 5. No, I’m not interested: "With respect to HIV, right on; cool…but, all the same, for me, I will keep my initial distance with respect to whatever this generates, because, sure, it is true it that a microbicide could help, and that could benefit many people, etc. but I can’t put aside many of the things that are being aired..." [Lima Out / Gay] "That’s why I am saying that with the little information that we have now...I don’t know, but I think right now I wouldn’t do anything." [Lima Out / Gay] 6. No, I would not participate: I am not a conejillo de india[lab rat]!” “We are not lab rats.” [Guayaquil, Closeted] “I would think that if were to get sick [in the study], it would be…as if I were like a lab rat.. I mean, that’s what someone thinks, it’s that. [Guayaquil, TGW] Focus Group Guide Discussion and Conclusions • If there were a future study on RMs, would you participate? Why or why not? Would your friends? • Probes: • Have you participated in other HIV prevention studies? Which? • You would be asked to use a product in your rectum when you have anal sex; what do you think about that? • The product may be an actual RM under study or just regular lubricant (explore use/concept of placebo) • The product may not protect against HIV at all; reactions, questions, concerns? • Studies may involve rectal examinations; thoughts? • Even in the absence of RM trials, participants expressed a range of views regarding their potential participation in future studies of RM. • Participants who would consider participating wanted more information about the study including its risks and benefits (both financial and health services related) before deciding. • “Extremes” – from definitely participating to definitely not participating – were also represented including a concern about being a “lab rat.” • Upcoming RM clinical trials in South America should incorporate information from potential participants in order to inform recruitment of study participants and at the same time educate the larger community on RM research aims, risks and benefits. Contact: Pedro Gonzales- pgonzales@impactaperu.org