Transcript Future Rectal Microbicide Trials in South America: Would men who have sex with men and transgendered women participate? Pedro Gonzales1, Jerome Galea2,

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
• 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
Results
Characteristics
“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]
• 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
“We should constantly have monthly medical checkups and in particular, they should be free.”
[Guayaquil, Closeted]
ALL 3 Cities
(Lima, Iquitos, Guayaquil)
TOT N
102*
%
100
Indigenous
Mestiza
White
Black
Asian
Other
4
72
16
5
2
2
4
7
16
5
2
2
18-29
30-39
40+
Education – highest level
attained
No formal education
Primary
Secondary
Superior or technical
Sexual orientation
Gay
Bisexual
Transgender
Heterosexual
Other
Primary sexual role
Exclusively active
Mostly active
Sometimes active and
sometimes passive
Mostly passive
Exclusively passive
Condom during last anal
sex with male?
Yes
No
80
11
6
82
11
6
3
4
57
52
3
3
49
45
35
26
16
9
12
36
27
16
9
12
20
16
27
20
16
27
23
14
23
14
70
23
75
25
1. Yes, I would participate:
“And what will we earn?” [Guayaquil, Closeted]
• Group participants were potential users of a future
RM: men who have sex with men (MSM) and
transgendered women (TGW)
Sample Characteristics
Participants voiced a range of opinions regarding potential
participation in future RM trials, grouped into 6 major themes:
Race/ethnicity
Age
“…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]
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]
• 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
"What are the risks we will run?" [Guayaquil, Closeted]
• Sixty-minute groups were audio recorded and
transcribed verbatim
"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]
• Content analysis was performed using Atlas.ti v.6.2
“We are not lab rats.” [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]
6. No, I would not participate: I am not a conejillo de india [lab rat]!”
“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
If there were a future study on RMs, would you
participate? Why or why not? Would your friends?
Discussion and Conclusions
Probes:
 Even in the absence of RM trials, participants expressed a range of views regarding their potential
participation in future studies of RM.
• Have you participated in other HIV prevention studies?
Which?
 Participants who would consider participating wanted more information about the study including its risks
and benefits (both financial and health services related) before deciding.
• You would be asked to use a product in your rectum
when you have anal sex; what do you think about that?
 “Extremes” – from definitely participating to definitely not participating – were also represented including a
concern about being a “lab rat.”
• 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?
 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- [email protected]