Community Engagement Is Key As Rectal Microbicides Research Progresses Ahead
Bobby Ramakant – CNS
(CNS): While interviewing a range of experts involved with research, development and advocacy of new HIV prevention
tools at the recently concluded XIX International AIDS Conference (AIDS 2012), I was reminded of a transgender woman who
had said to me in an interview four years back that: "There is no doubt that we need more HIV prevention options -
current options don't work especially for people like us... and this is the only possible reason to motivate me to
advocate for new prevention options." This community expert further added: "...'perfect' technologies that disregard
social realities don't necessarily deliver results..." The need to engage affected communities as research moves ahead,
and engage them with dignity as equal partners is the key to ensure that finally we develop products that are efficient
and also when they become available, are actually used by populations in need.
Agreed Dr Suwat Chariyalertsak, Director, Research Institute for Health Sciences (RIHES), Chiang Mai University,
Thailand, who recently received a global award for best retention of clinical trial participants in the HIV Prevention
Trial Network (HPTN) 052 study: "We got the retention award for having 99.0% retention in HPTN052 trial. I think the
secret for increasing adherence or retention is to develop clinics or research sites as 'second homes' for the trial
participants. Most of the trial participants are happy to spend one to two hours in the clinic and have a relationship
of confidence with their doctors or nurses. Men who have sex with men (MSM) and transgender trial participants of iPrEx
trial were happy to talk to their healthcare providers round the clock. They call the nurse 24 hours round the clock and
nurses take duties to attend to these calls. Participants call them for a range of reasons not just limited to the trial
– such as discussing problems in their lives. Sometimes as they are very young, 19-20 years, at times they have a broken
heart and they want to find somebody to talk to in confidence. We should support trial participants as much as possible
because they are sacrificing themselves for greater common good by volunteering to participate in the research trials."
Dr Suwat is also the key investigator for Chiang Mai, Thailand site where rectal microbicides phase II clinical trials
will be conducted soon. This study is called MTN017. MTN017 is an extended safety study (in phase II now). Participants
will be randomized either in daily rectal formulation of tenofovir gel, the same gel with associated rectal sex, or oral
Truvada (Tenofovir - TDF/emtricitabine - FTC).
"We are about to launch a first ever phase II trial of rectal microbicides. It is based on vaginal tenofovir gel earlier
used in CAPRISA004 study but we have actually reformulated it with reduced amount of glycerin. The reason for
reformulation is that we had found out in a much smaller previous trial, that this formulation of gel used in CAPRISA004
study was not rectal friendly as we would like it to be. Some of the participants had some side effects. We reformulated
it with reduced amount of glycerin to make it more acceptable to use" explained Clare Collins, Associate Director
(Communications and External Relations), Microbicide Trials Network (MTN).
COMMUNITY ENGAGEMENT IN MTN017 - RIGHT FROM THE START...
Clare Collins and her colleagues strongly believe in community engagement before the MTN017 study goes ahead in four
countries: US, Thailand, Peru and South Africa. Said Collins: "This is the first time we are going to look at rectal
microbicide use in international setting, that is why it was very important to listen to different stakeholders and
communities if they think such a product like rectal microbicides will work? What do they think of the draft protocol of
the MTN017 study? Is there anything in their cultural context we need to be aware of? And we also wish to give them a
background on rectal microbicides research update and why are we engaging in the phase II study."
That is why Clare Collins and her colleagues and partners at MTN conducted consultations in each of the proposed sites
of MTN017 study. "First such consultation was held in October 2011 in Cape Town, South Africa; where we learnt that the
protocol design of MTN017 study was really confusing and people had a hard time following it. Our researchers looked at
that and came up with a revised design that was easier for people to understand of what we are asking from the
participants. Also we learnt what stakeholders and communities in each of the trial sites thought about who should
participate in this study – transgender women, MSM, women? Based upon the input received from these consultations, we
decided to focus the study on transgender women and MSM."
"Some of those discussions also related to the amount of compensation for the trial participants. We were asking the
participants to do a lot. We were asking the participants to use this gel around the time of sex for eight weeks, then
have a break, and again use the gel daily for eight weeks, and then take a break, and then take oral tablet of truvada
for eight weeks. There was lot of time and commitment involved to go through each of those three regimens. Also what
might be adequate compensation in US might not be adequate somewhere else so we really had to look into that. Another
issue that came up during consultation was around use of applicator. We use these applicators in the study because it is
important for exact measured dose of the gel to be applied as per the study protocol. Participants felt that a lot of
time will go in explaining the trial participants on the use of these applicators and there might be some concerns
around the use of applicator. Informed consent as an issue also came up in these consultations to make sure that people
really understood the entire process thoroughly. We really did draft a very thorough informed consent form which we do
for all our studies but in this case there are a lot of questions around it because this is relatively a new product.
This is the first time we are doing a phase II rectal microbicides study and this is the very first time we are testing
rectal microbicides in these countries other than US. We have done earlier rectal microbicides study in the US but we
haven’t done these studies yet in Peru, South Africa, Thailand" said Collins to Citizen News Service (CNS).
All documents related to MTN017 study including informed consent form is either already translated or is in the process
of getting translated into local languages used in trial sites. "Every time we start a study we spend a lot of time on
developing these patient (or trial participant) education materials and it is important to find out from the
participants if these materials are really easy to understand" said Collins.
ENGAGING PEOPLE RIGHT FROM THE BEGINNING...
"I will like to emphasize that doing these community consultations can be expensive but is vitally important to really
engage these people in their countries and in their languages when the study is at the design stage. Engaging people
right from the beginning in these studies is an invaluable part of the whole process" emphasized Collins.
COMMUNITY CENTRAL TO CHIANG MAI MTN017 CONSULTATION
Dr Suwat Chariyalertsak, who is the key researcher at the proposed Chiang Mai site of MTN017 study, said that "In
January 2012 about 25 MSM and transgender people participated in this consultative workshop on rectal microbicides
research (MTN017). Many transgender people questioned the researchers that why are transgender people not involved in
the MTN017 research when they are a potential high risk group for this study? We had done a small study on lubricant use
in transgender people earlier and nearly 95% of study participants reported to use lubricants. Introducing rectal
microbicides when found safe and effective for STI/HIV prevention in future might be easier in transgender people
because they are already using lubricants and if lubricants have an added ingredient that provides protection against
STIs including HIV that will be so good. That consultation in Chiang Mai had put a strong case to engage transgender
people too in MTN017 study." As an outcome, transgender people are involved along with MSM members to participate in the
proposed phase II study.
"We did another small survey with 230 MSM and transgender participants to assess acceptability of a product like rectal
microbicides and about 90% of study participants voted for such a product. If we find the rectal microbicides being
researched in phase II of MTN017 safe, then we will move on the larger efficacy study in next few years" said Dr Suwat.
If we are really serious about arresting the spread of HIV, we need to urgently expand the range of HIV prevention
options to meet the unique needs of people at different times and in different contexts - AND - ensure accessibility,
availability and affordability of these prevention options to populations most in need.
"One of the big challenges is that HIV rates in MSM and transgender people in Chiang Mai is going up since past five
years. Presently HIV rates in Chiang Mai among MSM and transgender people is about 15% whereas among heterosexual men it
is less than 1%. Another challenge is that about half of new HIV infections occur in MSM and transgender people aged
18-25 years. The challenge is how to encourage MSM and transgender people to come for HIV testing and counseling,
promote the use of condoms, and as at times they have many partners so the challenge will be on how to involve them too
in HIV related programmes" said Dr Suwat.
According to Jim Pickett, Chair of International Rectal Microbicides Advocates (IRMA) and Director (Advocacy), AIDS
Foundation of Chicago: Rectal microbicides are products currently under research – that could take the form of gels or
lubricants – being developed and tested to reduce a person’s risk of HIV or other sexually transmitted infections from
anal sex. The risk of becoming infected with HIV during unprotected anal sex is 10 to 20 times greater than unprotected
vaginal sex because the rectal lining is only one-cell thick, the virus can more easily reach immune cells to infect.
AIDS 2012 has certainly upped the volume on ending AIDS. Developing effective HIV prevention options for populations in
need is certainly a priority as current options fail to protect people from HIV, especially most at risk populations.
Ensuring community engagement remains central as research drives forward is equally important so that when these new
tools become available, they meet unique needs of people in need and are actually used, to turn the tide... (CNS)
Bobby Ramakant – CNS
(The author serves as the Director (Policy and Programmes), Citizen News Service (CNS) and is a World Health
Organization (WHO) Director-General’s WNTD Awardee 2008. He writes extensively on health and development through CNS.
Email: firstname.lastname@example.org, website: www.citizen-news.org)
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