Preparing for Rectal Microbicides in South America

1. Questions, concerns, and the potential impact of RM on condom use among MSM and TGW in Peru and Ecuador  Jerome Galea, Janni Kinsler, Cesar Nureña, Martin Casapia, Lucia Ruiz, Orando Montoya-Herrera, Luis Fernando Galarza, Patricia Segura, Jorge Sánchez, William Cunningham Preparing for Rectal Microbicides in South America

2. Background • Rectal Microbicide (RM) clinical trials are expanding rapidly and will soon begin in South America • Data suggest that a safe and effective RM would be found acceptable by men who have sex with men (MSM) and Transgendered Women (TGW) in Peru and Ecuador • However, little is known about the specific questions and concerns this population has regarding RM • …which may impact participation in future RM clinical trials and use of an eventual product, including the potential impact on condom use

3. Methods • 12, 60-minute focus groups with 102 MSM/TGW in 3 cities (Lima and Iquitos, Peru; Guayaquil, Ecuador) • Semi-structured interview guide • Groups were audio recorded and transcribed verbatim • Content analysis performed using Atlas.ti v.6.2.

4. Study sites

5. Questions • Knowledge: What have you heard? • Perception: What do you think about the idea? • Why or why not use RM: self and friends • Impact on behaviours: condom use • Views on access and distribution

6. Participant Characteristics

7. Results: 6 main themes • Effectiveness and plausibility of an RM • Sideeffects • Condoms: use with and impact of RM • RM presentation, application and use • Non-HIV protection • Access & distribution

8. Effectiveness • “How much more effective is this, the lubricant…is it more effective [than a condom]?” [IQT-MSM] • “Knowing that it was certified, that there was no risk that a man could get infected with HIV/AIDS or something like that, I’d use it. But knowing that there are doubts, no, I would not use it.” [IQT-TGW]

9. …and plausibility “The vagina is one thing - there’s a hole and a wall, but we have an anus and the anus is llloonnggg…looooong (laughs). If, if we are going to insert the…so-called microbicide...I don’t think the microbicide will cover alllll of the width of the…the anal passage, so, this means, well at least for me, if they tell me that this will be something good for me, I’d say that it would be a lie since the microbicide won’t reach allllll of the anus and when the penis is really huge (laughs) [the microbicide] won’t reach that furthest point. So people may see this as a joke, not as something real, not as something feasible, since our anus is long, while a vagina has a wall, so, no.” [LIM-TGW]

10. Side effects • “Probably it could be imagined, right, that it would destroy everything, everything it came in contact with, it could be a liquid like semen, but at the same time it would touch…it won’t damage our, our walls?” [LIM-MSM] • “…would it be 100% safe?” [GYE-MSM] • “Now, let’s see…he’s a sex worker, doing that every day isn’t it going to cause harm?” [GYE-TGW]

11. Condoms: use with RM • “So the idea is that if you use a condom, then, you can use it together with the microbicide, I mean, that’s possible, right? To..offer additional protection, like double-protection, right?” [IQT-MSM] • “When you use this, do you have to use a condom as well?” [LIM-MSM] • “Can it be used with a condom as well?” [IQT-TGW] • “I don’t know if I’d use that kind of cream, would I no longer have to use a condom?” [GYE-MSM]

12. …and impact of RM on condoms None: • “He who likes to use condoms will use condoms. He who doesn’t: microbicides.” [LIM-MSM] • “…taking the [PrEP] pill without even knowing what pill I was taking, that didn’t mean that I was in any way going to stop using condoms. [GYE-TGW] • “People would continue to use [condoms] as always, whatever happens, people are already trained to use the condom, it’s like trying to call Pepsi ‘Coca-Cola’.” [GYE-TGW]

13. …and impact of RM on condoms Could decrease condom use: • “But yes, condom use could be stopped if we see that this product is effective. As I said in the beginning, sexual pleasure will be greater than when using a condom but only if the microbicide is effective.” [LIM-MSM] • “Because people like bareback sex and if they have a second option they would stop using condoms.” [GYE-MSM] • “…market competition [of the RM versus the condom] will probably be inducing the idea of not using a condom.” [LIM-MSM]

14. …and impact of RM on condoms Condoms and RM will both be used: • “…I insist that, the best thing would be to use it as a complement [to a condom], as a lubricant, that would be, that would be cool…” [LIM-MSM] • “You can protect yourself with both [condom and RM] together, so use both.” [LIM-TGW] • Sure, they’d use both things, because take a look at pills: there are pills that prevent headache, and others that prevent headache with body aches. You buy the product that works for you, and not the other.” [GYE-TGW]

15. RM presentation, application and use • “The gel… it’s a cream or latex?” [GYE-TGW] • “I understand, the idea of this microbicide is only rectal or could it be applied to the penis as well?” [LIM-MSM] • “So it would be only for anal sex?” [IQT-MSM] • “…this gel or cream how long could it…work, I mean, if the sexual relation lasts, for example a half hour, let’s say?” [LIM-MSM]

16. Non-HIV protection • “Would it be as effective for other sexually transmitted infections?” [LIM-MSM] • “[could it work] as a spermicide?” [GYE-MSM] • “The issue or the doubt would be in this case is if it is going to also help prevent other sexually transmitted infections or if I don’t use [a condom], then will I be exposed to contracting another type of infection? Yeah, that would be my concern. HIV is already controlled, but the other infections?” [LIM-MSM]

17. Access and distribution • “What will the cost be?” [IQT-MSM] • “…it’s an additional cost and people are not accustomed to but they are accustomed to being given condoms in campaigns or in the health centers. So, if they aren’t going to buy condoms it is less likely that they will buy lubricants.” [LIM-MSM] • “… if people already make their lives difficult just to be able to ask for condoms, with this it will be even more [difficult]…you’re not going to say, ‘Give me a lubricant for anal sex,’ are you? All the girls that are around will stare at you ‘and that guy?’” [GYE-MSM]

18. Conclusions: 1 • In thisconveniencesample of potential RM userswith little prior knowledge of microbicides, manyquestions and concernsweregenerated. • Efficacy, plausibilityand side effects were the source of many questions, concerns and doubts…some of which the field itself has struggled with (e.g. plausibility).

19. Conclusions: 2 • Impact on condoms: more than only “risk disinhibition” -- this needs to be unpacked in order to fully understand; importantly condom compatibility issues stood out. • Manyotherquestions regarding application and use including queries around protection from other STI or use as a contraception reveal layers of issues to be explored among target users.

20. Next Steps Continue and amplify planning for an actual RM: cost, marketing, distribution are issuesthatpotentialusershave ideas aboutnow. Wheneverpossible, behav. componentsshould explore theseisuesalongside actual trials. CommunityEduactioniskey: IRMA, IRMA ALC, AVAC, Epicentro and othersplay a central role: IRMA Video!

21. Acknowledgements • Study participants: Peru & Ecuador • UCLA AIDS Institute seed grant in international prevention and policy research for HIV/AIDS (# AI28697)