Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014

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Research Institute for Health Sciences, Chiang Mai University, Thailand

Research Institute for Medical Sciences (RIHES), Chiang Mai
University in Thailand, conducts biomedical, clinical,
epidemiological and behavioral research on priority public
health topics of concern to Thailand and its neighboring
countries. The emphasis is on research studies that will
have an impact in shaping national health and social policy
and will yield findings that have an immediate practical
benefit which can be extrapolated for use in the rest of
Thailand, or other countries in Southeast Asia or elsewhere.
The Institute has three major roles: (1) conduct research
relevant to the local context; (2) carry out research
training; and (3) serve as a resource center on public health issues.

Website: www.rihes.cmu.ac.th

International Rectal Microbicide Advocates (IRMA)

Created in 2005, the International Rectal Microbicide Advocates (IRMA) is a network of over
1,200 advocates, policymakers and leading scientists working together to advance a robust
rectal microbicide research and
development agenda, with the goal of
creating safe, effective, acceptable and
accessible rectal microbicides for the
women, men, and transgender
individuals around the world who engage
in anal intercourse. Our priorities
include pushing for safe, condom-
compatible sexual lubricants, and concerted advocacy for adequate access to these important
products for people all over the world. IRMA works to confront the institutional, socio-cultural
and political stigma around the public health need for rectal microbicide research, and to
increase funding and commitment within this field of inquiry. AIDS Foundation of Chicago is
the IRMA Secretariat.

Website: www.rectalmicrobicides.org

Citizen News Service (CNS)

Citizen News Service (CNS) believes that experiential and lived knowledge of key affected
populations should be central to driving responses to specific
health and development issues. Recognizing community
competence as an expertise along with those of other
constituencies (such as doctors, scientists, policy makers,
among others) is one of the key principles of health and
science journalism at CNS. CNS also provides communications
solutions to health and development agencies globally.

Website: www.citizen-news.org
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
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Introduction 4

Research study to test anti-HIV gel for gay men and transgenders 6
commences in Chiang Mai

'Community Advisory Board is a bridge between 11
researchers and community'

Call to strengthen clinical research trial management in 16
South-East Asia

Communities are equal partners in clinical research 21

'Serving the larger good by participating in anti-HIV gel study' 27









For further information please contact:
Shobha Shukla and Bobby Ramakant
Citizen News Service (CNS)
C-2211, C-block crossing, Indira Nagar, Lucknow-226016. India
Phone: +91-(0)-522-2358230 | Email: editor@citizen-news.org
Twitter: @cns_health | Facebook.com/CNS.page
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
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Rates of sexually transmitted infections (STIs) including HIV are alarmingly high in
men who have sex with men (MSM), transgender people and heterosexual partners
having anal sex. Diagnosis and management of anal STIs is often delayed if not
neglected altogether. Current prevention options for STIs and HIV are perhaps not
being fully utilized by heterosexual partners as well as MSM and transgender people
for a varied range of reasons.

Rectal microbicides are critically important for men, women and transgender people
who are not able to negotiate the use of existing HIV prevention options with their
partners. HIV prevention options such as rectal microbicides will help expand the
range of choices for women and men if found safe and effective in years to come.

CNS team (Shobha Shukla and Bobby Ramakant) visited Research Institute for Health
Sciences (RIHES), Chiang Mai University, Chiang Mai, Thailand which has been one of
the key sites for HIV prevention research over the years. First-ever, phase II study of a
rectal microbicide (formally called MTN017) is being done here. Thailand is the only
country in Asia and the Pacific where phase II study of rectal microbicide is currently
undergoing. Other sites are in South Africa, Peru and USA.

In June 2014, CNS had interviewed the key researchers and scientists, community
advisory board (CAB) members, CAB coordinator, laboratory scientists, counsellors,
nurses and most importantly, the study participants in confidentiality. Due consent
was taken for these interviews and all photographs clicked at this site are with prior
consent. CNS did not click any image of the study participant as a policy.

This publication is a compilation of the news feature article series done by CNS which
got syndicated and published in a range of print and online media channels, mostly in
Asia and Africa.

Rectal microbicides– in the form of gels or lubricants – are
products that are currently under research and are 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 as
the rectal lining is only one-cell thick, the virus can more
easily reach the immune cells and infect them.
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
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Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
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Research study to test anti-HIV
gel for gay men and transgenders
commences in Chiang Mai

Overall new HIV infection rates have dipped by 26% in Asia and the Pacific region
since 2001, but not for key populations such as men who have sex with men (MSM) and
transgender people (source: UNAIDS Asia Pacific report, November 2013). According to
estimates, between 15% and 25% MSM of this region are living with HIV, largely in
major cities. In China, Indonesia, Malaysia, Myanmar, Thailand and Viet Nam, the
estimated national HIV prevalence for MSM is over 5%. And it continues to rise in
several cities and regions within these countries, as well as in India, Mongolia and the
Philippines, underlining the need for a greater attention for HIV prevention.

Despite limited research on HIV prevalence among transgender people, the little data
that is available shows a high HIV prevalence among them too: 30.8% in Jakarta,
23.7% in Port Moresby and 18.8% in Maharashtra, India.

Current HIV prevention options, such as condoms, are clearly not arresting the rate of
spread of HIV among MSM and transgender people in Asia and the Pacific region.
Condom use also remains much lower than desired. It is also known that those MSM
and transgender people who use condoms also use lubricants (or lubes) during anal
intercourse. Importantly, the use of condom-compatible lubes has been associated
with a decreased risk of breaking or slipping of condoms. However, condom-
compatible lubricant is inaccessible for most people who engage in anal intercourse.

RECTAL MICROBICIDES
Undoubtedly, we need to expand the range of HIV prevention options for those
practicing anal sex. Rectal microbicides– in the form of gels or lubricants – are
products that are currently under research and are 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 as the rectal lining is only one-cell
thick, the virus can more easily reach the immune cells and infect them.

MTN017 Study in Chiang Mai
The first-ever phase-II extended-safety study (formally called MTN017) of a rectal
microbicide in the Asia-Pacific region has begun in Chiang Mai, Thailand since
February 2014. Research Institute for Health Sciences (RIHES), Chiang Mai University,
which has been a research site for over 35 major International studies in the past
years, is one of the sites for MTN017. In total, there are 8 study sites including Chiang
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Mai, such as: CDC Bangkok (where
study will commence very soon),
South Africa, Peru and in US.

The objective of this rectal
microbicide study is to study the
safety and acceptability of a rectal
microbicide gel for now. This
study will perhaps also give
information on issues such as
adherence of study participants to
the study product. Depending
upon the outcome of this study (if
study product is found safe and
acceptable) efficacy studies will
be conducted later.

MTN017 study product (PrEP)
Pongpun Saokhieo, Coordinator for this study at RIHES, said: In this study every
participant will have the same duration of exposure (eight weeks) to three different
regimens (with a one week gap between each regimen):
- oral Truvada/PrEP daily for eight weeks,
- rectal gel (reduced glycerin and tenofovir gel) daily for eight weeks, and
- sex dependent rectal gel for eight weeks (applied anytime during the window
period of 12 hours before and 12 hours after having anal sex). In case there is
no sexual activity for one week, gel has to be applied anyway.

So for each participant the entire duration of the study period is 6 months. There is
no placebo arm in the study.

MTN017 study product (rectal gel)
In an earlier study on Pre-Exposure Prophylaxis (PrEP), researchers had found that
participants were not taking study products as much as they had self-reported. To
ensure that the participants were using study products in MTN017 study, a
pharmacokinetics (PK) component was included in this MTN017 study protocol.
Adherence to study products is very important to learn whether it is safe and
effective or not.

WHO ARE THE STUDY PARTICIPANTS?
MTN017 study participants have to be HIV negative and healthy MSM or transgender
people. They should be Thai citizens above 18 years of age. They should be receptive
partners in anal sex and should have had receptive anal sex at least once in the last
three months. If they have haemorrhoids or sexually transmitted infections (STIs) they
are not enrolled. Their liver function test should be good and they should not be
anaemic. If they become HIV positive during the study period, they are excluded from
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the study and linked to HIV treatment, care and support services. They should be
willing to undergo all the three regimens of the study, although they can opt out of
the study at any point. Once they satisfy these criteria, they are explained about the
study in detail. If they are willing to join the study they sign the informed consent
form (in Thai language).

Pongpun Saokhieo added that "They also have to take a 'test of understanding' – a set
of 20 questions – and answer correctly at least 80% of them. This ensures that they
really understand the study and nurse counsellors are available round-the-clock on
mobile phone helpline with whom they can seek help if any concern arises."

MTN017 phase II study in Chiang Mai will have 24 study participants. 13 study
participants have been recruited (7 MSM and 6 transgender) by June 2014. 11 more
study participants will be recruited by October 2104 and the study at this site is
expected to finish by the end of first quarter of 2015.

SITE SELECTION
Dr Suwat Chariyalertsak, Director of RIHES, Chiang Mai University, and key researcher
at this MTN017 site, informed that the Institutional Review Board (IRB) had approved
the Chiang Mai site and training by Microbicides Trials Network (MTN) was also
conducted in the recent past. Drug-under-research has also been procured and
approval from the Division of AIDS has been received. Ethical committees,
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Community Advisory Board (CAB)
and other such mechanisms were
set up as per the study protocol.

Dr Suwat Chariyalertsak led RIHES
has been acknowledged globally for
excelling in clinical trial
management. HIV Prevention Trial
Network (HPTN) has recognized
RIHES and awarded it for best
retention, community involvement,
and laboratory performance, in the
past years. RIHES has also received
awards for best recruitment of
study participants.

"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 MSM and transgender trial
participants are happy to spend two hours in the clinic once every month and develop
a relationship of confidence with their doctors and nurses. They are at liberty to talk
to their healthcare providers 24 hours round the clock and nurses take duties to
attend to these calls. We should support trial participants as much as possible
because they are sacrificing themselves for the greater common good by volunteering
to participate in the research trials," said Dr Suwat.

COMMUNITY CONSULTATION BEFORE SITE SELECTION
Dr Suwat Chariyalertsak said that, "In January 2012 about 25 MSM and transgender
people participated in a consultative community 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 up a strong case to engage transgender people too in MTN017 study."

As an outcome of this, transgender people along with MSMs are involved in this
MTN017 phase II study at Chiang Mai and other sites.

EXPAND RANGE OF HIV PREVENTION OPTIONS
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
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times and in different contexts, and
also 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 have been
going up since the last five years.
Presently, HIV incidence rate in
Chiang Mai among MSM and
transgender people is about 15%
whereas in the heterosexual
population it is less than 1%.
Another challenge is that about half
of the 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, and to promote the use
of condoms in them. At times they
have many partners, so the
challenge will be on how to involve
them too in HIV related
programmes" said Dr Suwat.

Developing effective HIV prevention options for key populations-in-need is certainly a
priority as current options fail to protect all people from HIV, especially the most at
risk populations. Ensuring that community engagement remains central, as research
drives forward, is equally important so that when these new tools become available,
they succeed in meeting unique needs of people in-need; are actually used; and help
in achieving the goal of zero new HIV infections.


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'Community Advisory Board is a
bridge between
researchers and community'


Engaging communities genuinely in scientific research and keeping them updated is of
paramount importance to ensure that ethical issues are addressed as science moves
ahead. The Community Advisory Board (CAB) plays a very crucial and important role in
involving the community with the actual implementation of any clinical study. In an
interview given to Citizen News Service (CNS), Dr Suwat Chariyalertsak, Director of
Research Institute for Health Sciences (RIHES), Chiang Mai University, told that the
Chiang Mai site in Thailand has two CABs-- the prevention CAB (for MTN017 study)
around HIV prevention research and the treatment CAB (for HTPN 052 study) for
treatment related research.

Dr Suwat Chariyalertsak-led RIHES has been acknowledged globally for excelling in
clinical trial management. HIV Prevention Trial Network (HPTN) has recognized RIHES
and awarded it for best retention, community involvement, and laboratory
performance, in the past years. RIHES has also received awards for best recruitment
of study participants. CNS team witnessed active engagement of not only key
populations such as men who have sex with men (MSM) and transgender people around
RIHES centres in Chiang Mai but also met CAB members to learn more about their
experience of involving community in scientific research.

CNS spoke to CAB Coordinator and also to a member associated with MTN017 study,
which is a phase-II extended-safety study of a rectal microbicide which has begun
since February 2014 in RIHES, Chiang Mai University site. Rectal microbicides - in the
form of gels or lubricants - are products that are currently under research and are
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
as the rectal lining is only one-cell thick, the virus can more easily reach the immune
cells and infect them.

WHO ARE THE MEMBERS OF CAB?
Members of the CAB for MTN017 include people living with HIV (PLHIV),
representatives of MSM and transgender networks, people from the community like
the village heads, public health officer, Buddhist and Christian religious heads like
monks and priests, University and College teachers, lawyers, broadcast journalists
among others.

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Representatives of two major networks of MSM and transgender people are actively
engaged with CAB of MTN017. Caremat (Care for men and transgender living with HIV)
which is represented on CAB, helps MSM and transgender living with HIV in Chiang Mai
with counselling, and helping access HIV treatment, care and support services.
Another MSM and transgender network in Chiang Mai, MPlus, is also represented on
CAB of MTN017. MPlus works with young MSMs and transgender and young MSM and
transgender sex workers.

CAB IS THE BRIDGE BETWEEN RESEARCHERS AND COMMUNITY
Wipada Cheewawat, is the CAB coordinator of the MTN017 study. Wipada keeps CAB
members informed about the study and also educates the staff to do to the study as
per the regulations, following the study protocol. She shared with Citizen News
Service (CNS) the importance of having a CAB in any study. She said that, "The CAB
acts as a bridge between the researchers and the community. It is important to
understand the viewpoints and perspectives of the community people regarding the
study. So we meet the community, talk with them, help them understand the study
and take suggestions from them. It is like having a participatory collaboration with
the community, which is very important since the study is done for them and with
them. We should not be doing anything which the community does not understand or
does not agree with. They should know why the study is important for them and what
would be the good or bad effects of the study on the community and the participants.
As our CAB members come from different groups/parts of society, we get to know and
share viewpoints of a diverse range of people."

The CAB in Chiang Mai functions in a manner to ensure meaningful and continuous
participation of the community. In the CAB meetings held regularly once every two
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months, the CAB members are kept
updated about new and ongoing clinical
trials. For the ongoing MTN017 study,
updates are presented so that all are
informed and aware of what is currently
happening in the study; feedbacks from
the members are taken on what the
community thinks about the study-- their
problems and concerns if any. Periodical
training of CAB members is also done
and once every three years they go on a
retreat. There is collaboration between
the 2 CABs in Chiang Mai and the CAB in
Bangkok at Thai Red Cross (TRC) site.

CAB NEWSLETTER
Dr Suwat informed that the CAB also
publishes a newsletter in Thai language
once every 2 months. 4000 copies of
every newsletter are printed and
distributed in 5 provinces around Chiang
Mai at the village and sub-district level.
He said that, "This newsletter is in Thai
language and gives information about
HIV research updates from not just our RIHES site but from around the world,
interviews of CAB members, among other things. We publish regular updates on
clinical trials to keep recipients up to date on information, especially the high risk
groups. Likewise we published information around MTN017 to advertise and to inform
people, and when people, especially men who have sex with men (MSMs) and
transgender (TGs), read it, they contacted us for further information. Sometimes we
also disseminate small posters with the newsletter for the recipients to exhibit at
clinics or hospitals in their community. When our staff at RIHES visits regional or
global HIV science events we request them to write an update in a simple manner in
Thai language and include it in our CAB newsletter.”

CAB IS INVOLVED IN RESEARCH ALL THROUGH
CAB members are not only updated at every
meeting, but also kept involved all through the
study (how the trial is proceeding, are there any
problems faced by participants, etc) so that they
can ask about any issue and clarify their doubts.
Constructive and healthy criticism by CAB
members is also important as it helps them get
in-depth knowledge about the study and address
key concerns - its benefits and importance, the
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standards of care for study participants, the possible side effects and how they will be
taken care of by the researchers.

Sometimes there are concerns about issues around social harm. For example, in one
clinical study, parents of a study participant became concerned when they saw that
the study product (PrEP) used in the study was otherwise used for treating PLHIV.
Then it was only CAB members who had to explain and counsel them that PrEP (Pre
Exposure Prophylaxis) is for HIV prevention although the drug used in PrEP is also used
as part of antiretroviral therapy to treat HIV. The role of CAB to address concerns that
may arise in the community about research is also vital.

Rathchadet Reankhomfu (Louis), Project Manager, Caremat, who is also a CAB
member, was very
appreciative of the
information sharing at the
CAB meetings. He told
CNS that, "In these
meetings I get updated
about clinical trials that
are happening not only in
Chiang Mai but in any
place in the world. The
CAB newsletter in Thai
language is very helpful
as it gives study updates
from other parts of the
world too and, as my
organization works with
MSMs and transgender
people, these updates are
very helpful for them also. I also get a chance to be
critical about a new upcoming trial—whether it is good
or not good for the participants or how they will be
taken care of in the study.”

“Caremat had a chance to do some outreach activities
with MSMs and transgender where I shared information
about the MTN017 study which I had got through
attending CAB meetings. Most of them were very
excited about a possibility of a gel that will protect
them from HIV. They wanted to know where the trial is
going on, how the drug is applied, and when it will be
available. Even though they were told clearly that there
is no rectal microbicide as yet, the concept of putting
HIV prevention drug into the gel was exciting for them.
They wanted to follow the study updates and we gave
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them our study brochure. We also make all efforts to convince them to use existing
HIV prevention methods while the rectal microbicides study moves ahead. Rectal
microbicide gel is maybe for the future but not for now, and we should use existing
HIV prevention options to protect ourselves from HIV and other STIs.”

CAB has helped the MTN017 staff in making the study participants understand fully
about the study so that they are full and willing partners in the process. There is
mutual trust between study staff and study participants. "There is no coercion
whatsoever at any stage and so retention rates of participants enrolled in the study
are very high at the Chiang Mai site" said Wipada.
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Call to strengthen clinical
research trial management in
South-East Asia

Since South-East Asian nations share a significant burden of major health challenges,
it is important to strengthen clinical research management processes in these nations
so that they can find relevant health solutions in their local contexts and ground
realities. Thailand is undoubtedly an exception in South-East Asia with robust clinical
research trials happening there since the past many years. But a lot remains to be
desired in terms of clinical trial management capacity in countries such as Laos,
Cambodia, Viet Nam, Myanmar, Indonesia, and Philippines, among others.

One example of a Thai research site, which not only has demonstrated an impressive
track record of successfully conducting over 35 clinical research trials in the past
years but also has been globally acknowledged for excellence in community
involvement, recruitment and high retention of study participants, is Research
Institute for Health Sciences (RIHES), Chiang Mai University. RIHES has collaborated
with global leaders in health research such as National Institutes of Health (NIH), USA;
Contraceptive Research and Development Programme (CONRAD); Microbicides Trial
Network (MTN); HIV Prevention Trial Network (HPTN); HIV Vaccine Trial Network
(HVTN); World Health Organization (WHO); among others.

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Dr Suwat Chariyalertsak,
Director of RIHES and key
researcher at this site for a
long list of HIV prevention
and treatment trials, said to
Citizen News Service (CNS)
that, "Since we have lot of
experience in clinical trial
management, we opened a
course on clinical trial
management last year. So
doctors, nurses, researchers
from other medical schools
and hospitals can come and
see how we manage the
clinical trial sites. It is good for our country if we have more medical schools with
good clinical trial units, so in future it will be more easy to have a network of good
research sites. Right now we have two sites, one here in Chiang Mai and the other in
Thai Red Cross in Bangkok."

Added Dr Suwat: "We are also thinking to open this training programme for
participants of other countries of South East Asia as they also need to strengthen
clinical trial capacity in their countries. If you look in this Asian region, India, Japan,
South Korea and Singapore have very strong clinical trial management capacity
followed by Thailand. But countries such as Indonesia, Viet Nam, Cambodia, Laos,
Myanmar, Philippines, etc have very limited clinical research trial management
capacity right now. They need to strengthen their basic infrastructure as well as
competencies of clinical investigators’ team, and also need some support or sponsors.
WHO in this region is interested in building the capacity of other member countries
such as Indonesia, Myanmar, etc in clinical trial management. It is good for these
countries too because they too are dealing with major health challenges. So it will be
most appropriate for their doctors and other clinical researchers to be involved with
these clinical research trials. We are thinking of engaging these countries of the
region from next year for training. We will inform our colleagues in this region and if
they are interested they can join."

RIHES has its main administrative and clinical research management office in the
medical campus of Chiang Mai University (CMU) which also has a 1800 bedded hospital
attached to a prestigious medical college. This RIHES campus also houses very well-
equipped bio-safety level II and III laboratories to help strengthen diagnostic
capacities and complement health research.

RIHES started about 40 years back to help respond to major health crises back then:
anaemia and malnutrition in children. Those children who survived malnutrition and
recovered to health 30-40 years back, are still being followed by RIHES. So
undoubtedly RIHES has a very long cohort, said Dr Suwat.
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Vitamin A deficiency was another major problem addressed by RIHES. Night blindness
is one of the complications due to Vitamin A deficiency but now it is very rare limited
only to very remote areas where access to healthcare services is very sparse.

RIHES has two more buildings in the main CMU campus near the mountains, one of
which manages activities such as surveys, programmes in villages on substance abuse,
injecting drug use, alcohol consumption, etc. "We also have some nutrition projects,
environmental science research, pesticide contamination, air pollution, etc" said Dr
Suwat.

RIHES has four sub-units: Centre for Substance Abuse Research, Centre for Molecular
and Cell Biology for Infectious Diseases, Centre for AIDS and STIs, and Centre for
Applied Health Science Research.

Major clinical research trials that are currently going on at RIHES include: MTN017 (a
phase-II extended safety rectal microbicide study with MSM and transgender
participants), IMPAACT, iPrex, among others. [Read CNS update on MTN017 from June
2014 here]

IMPAACT (International Maternal Paediatric Adolescent AIDS Clinical Trials Network) is
aiming to significantly decrease incident HIV and HIV-associated infections and to
decrease mortality and morbidity due to HIV and HIV-associated infections and co-
morbidities among infants, children, adolescents and pregnant/postpartum women.

PIMAN
Another major hallmark for RIHES is the setting up of PIMAN clinic (Prevention of
Infection in Man). PIMAN also has a Thai meaning “heaven or paradise”. Not only
PIMAN clinic does not even remotely look like a clinic or any healthcare facility but
also it is located outside the hospital campus near one of the most happening streets
in Chiang Mai. "Prevention research trials often involve healthy MSM and transgender
people who may not like to come to a hospital; rather they may feel more
comfortable to come to PIMAN." said Dr Suwat.

Data Management Unit is also very well established at RIHES.

CAB NEWSLETTER
Two Community Advisory Boards (CABs) function at RIHES-- one for HIV prevention
research and the other for HIV treatment research.

Dr Suwat informed that the CAB also publishes a newsletter in Thai language once
every 2 months. 4000 copies of every newsletter are printed and distributed in 5
provinces around Chiang Mai at the village and sub-district level. He said that, "This
newsletter is in Thai language and gives information about HIV research updates from
not just our RIHES site but from around the world, interviews of CAB members, among
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
19
other things. We publish regular updates on clinical trials to keep recipients up to
date on information, especially the high risk groups. Likewise we published
information around MTN017 to advertise and to inform people, and when men who
have sex with men (MSMs) and transgender read it, they contacted us for further
information. Sometimes we also disseminate small posters with the newsletter for the
recipients to exhibit at clinics or hospitals in their community. When our staff at
RIHES visits regional or global HIV science events we request them to write an update
in a simple manner in Thai language and include it in our CAB newsletter.”

LABORATORY CAPACITY AND SPECIMEN PROCESSING
Dr Suwat said that, "Good quality specimens are sent from other hospitals and clinics
to our laboratory at RIHES which is very well equipped. There are some tests that can
be done at the clinics itself such as HIV rapid test. If we can do tests here in our
laboratories we do it here, but when absolutely necessary then only we send samples
to laboratories in the US, and sometimes in India."

Dr Kittipong Rungruengthanakit, Laboratory
Director and Deputy Director of RIHES said to
CNS: "Some specimens might be tested onsite
but some specimens need to be shifted to the
laboratories to be tested centrally. One of the
key issues is that the quality of the specimen
has to be really high, and should not be
compromised at any stage-- from the time it is
collected until it reaches the testing
laboratory."

Dr Kittipong added: "Specimen collection
(plasma, serum, etc) is in a vial or tube as per
the requirement of the testing laboratory.
These units are responsible for managing the
specimens and also for storage in deep
freezers in liquid nitrogen, and then we make
the shipment to the testing laboratory as per
the study protocol. To do the shipment we
have to deal with the regulatory issues such as
import and export permits. We have to comply
with the dangerous good regulations for biological hazards. We have to pack them in
proper containers, and abide by other regulatory safety measures according to the
guidelines of International Air Transport Association (IATA). Sometimes we need to
test the samples without delay for the safety of the study participant, and we also
maintain a cohort for future testing."

Strengthening clinical or health research trial management capacities across the
South East Asian region will perhaps help find relevant solutions for local challenges
that key populations face. Let us hope that as XX International AIDS Conference opens
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
20
on the theme of "Stepping Up The Pace" next month, strengthening clinical research
trial management in the low- and middle- income countries remains as one of the
priorities.

Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
21
Communities are equal partners
in clinical research


"Community engagement starts before a research trial begins and continues alongside
as science moves forward" said a Community Advisory Board (CAB) member of MTN017
study. MTN017 study is a rectal microbicide phase-II extended safety study to prevent
HIV transmission among men who have sex with men (MSM) and transgender women.
Citizen News Service (CNS) team visited the MTN017 study site in Research Institute
for Health Sciences (RIHES), Chiang Mai University in early June 2014 and interviewed
key researchers, nurse counselors, CAB coordinator, CAB member, MSM study
participant, transgender study participant, laboratory director, among others.

CLINIC IS COMMUNITY FRIENDLY
One of the big positive hallmark at RIHES we felt was that the 'clinic' where study
participants come regularly for physical examination, blood tests, counselling, and
other purposes as per the study protocol, does not look like a clinic at all. Located
outside of a hospital or clinical setting, near one of the most happening downtown
streets of Chiang Mai where gay spa and sauna centres also operate, it is aptly named
PIMAN.

PIMAN is the acronym for Prevention of Infection in Man. In Thai language PIMAN also
means 'heaven or paradise'. PIMAN clinic is a free HIV testing and counselling centre
for MSM and transgender people in Chiang Mai, providing HIV and sexually transmitted
infections (STIs) related services. It is also the site for MTN017 study in Chiang Mai. "It
does not look like a clinic at all; rather it looks like a saloon or a spa" rightly said Dr
Suwat Chariyalertsak, Director, RIHES and key research investigator for MTN017 for
this site.

"PIMAN is situated close to Chiang Mai University and also to the House of Males - a
spa and sauna centre for gay men. Nimmanhaemin Street is also close by where there
are lots of restaurants/bars and shops. PIMAN is open five days a week from 9am to
6pm, and, at times, open on weekends too if required. Because of its good location
and a very client-friendly atmosphere, MSM and transgender feel more comfortable
coming to PIMAN rather than going to the hospital. The clinic also organizes activities
outside its premises, such as beauty contests for transgender women. Sometimes MSM
and transgender organizations use the meeting room of PIMAN for their activities"
informed Dr Suwat.

The ground floor of PIMAN houses the warm reception and office area. On the 1st
floor is the actual clinic where physical examination (including proctoscopy and rectal
examination) is performed, study participants take an online questionnaire about
their behaviour related to the study in three private chambers, and three counselling
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22
rooms function too. On the 2nd floor of PIMAN is the office to keep data and
documents pertaining to the study, and it has a meeting room as well.

STUDY REGIMEN
The objective of MTN017 is to study the safety and acceptability of tenofovir-based
rectal microbicide gel. Researchers will also perhaps get more information about
adherence to the study product in this study.

In this study every participant will have the same duration of exposure (eight weeks)
to three different regimens (with a one week gap between each regimen):
- oral Truvada/PrEP daily for eight weeks,
- rectal gel (reduced glycerin and tenofovir gel) daily for eight weeks, and
- sex dependent rectal gel for eight weeks (applied anytime during the window
period of 12 hours before and 12 hours after having anal sex). Also, in case
there is no sexual activity for one week, gel has to be applied anyway.
So for each participant the entire duration of the study period is 6 months. There is
no placebo arm in the study. [latest CNS update on MTN017 dated June 2014 is online
here]

PARTICIPANT RECRUITMENT
Information about MTN017 study and call for study participant recruitment was widely
disseminated through bimonthly Thai-language CAB Newsletter, Chiang Mai University
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
23
Public Relations office, among other
mechanisms. One MSM study
participant of MTN017 who was
interviewed by CNS said that he got
the information from Public Relations
office of the university. Another
transgender study participant of
MTN017 we spoke to had received
this information from PIMAN
counsellors as she had visited PIMAN
before for routine services.

MTN017 study participants have to be HIV negative and healthy MSM or transgender
people. They should be Thai citizens above 18 years of age. They should be receptive
partners in anal sex and should have had receptive anal sex at least once in the last
three months. If they have haemorrhoids or sexually transmitted infections (STIs) they
are not enrolled. Their liver function test should be good and they should not be
anaemic. If they become HIV positive during the study period, they are excluded from
the study and linked to HIV treatment, care and support services. They should be
willing to undergo all the three regimens of the study, although they can opt out of
the study at any point. Once they satisfy these criteria, they are explained about the
study in detail. If they are willing to join the study they sign the informed consent
form (in Thai language). They also have to take a 'test of understanding' – a set of 20
questions – and answer correctly at least 80% of them. This ensures that they really
understand the study and nurse counsellors are available round-the-clock on mobile
phone helpline with whom they can seek help if any concern arises.

MTN017 phase II study in Chiang Mai will have 24 study participants. So far 13 study
participants have been recruited (7 MSM and 6 transgender) by June 2014. 11 more
study participants will be recruited by October 2014 and the study at this site is
expected to finish by the end of first quarter of 2015.

INFORMED CONSENT PROCESS
All those people who are interested to know more about MTN017 are welcome to
come individually to the PIMAN clinic where they are explained about the details
regarding MTN017. These information sharing sessions usually spread over more than
one meeting till people are satisfied that all their concerns have been addressed by
the counsellors. If they agree and if they meet the eligibility criterion then they go
through the screening process. Even for screening process they need to give informed
consent. In the informed consent process they are given detailed information
pertaining to the study, and also the benefits and the harms if any, and how their
confidentiality will be maintained while participating in the study. They also have a
right to withdraw anytime they want during the study.

Dr Suwat Chariyalertsak informed that, “Basic contents of the Informed Consent Form
are same for all MTN017 sites. For Thailand sites, the form was translated from
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
24
English into Thai (and approved by the Thai Ethical Review Committee) to make sure
that Thai people understand its contents. Participants are allowed to keep a copy of
the form with them, but if they do not want it then they have to state that they do
not want a copy and then we keep it for them in our records. We keep their
confidentiality and do not share their information without their consent.”

WHAT HAPPENS IN CLINIC VISITS?
Participants once enrolled have to visit the clinic once every month. They are always
informed and reminded beforehand that they have to come on that particular day. If
someone has a problem, his visit is rescheduled as per his convenience but within the
window period. Some may want to come late in the evening or even on a weekend
(when the clinic is normally closed) and the clinic staff abides by their wishes just to
make the process more client-friendly.

Every visit lasts for 2 hours and involves activities such as: counselling, HIV testing,
physical examination, collecting blood and rectal secretion samples for
pharmacokinetics (PK), explaining them how to use the product (as the study product
changes every two months), recording their medical history, asking about and
attending to any difficulty they are having in using the product like itching, or any
side effects/complications of the product (like possible diarrhoea), telling them again
about the objective of the study and giving them condoms and lubricant to use.

"It is important to do the PK of the blood and the secretion from the rectum - the
rectal swab - just to ensure that the participant took the drug as per the regimen. PK
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
25
is done during clinic visit every 4 and 8 weeks of each product usage. Participants are
informed that their blood and rectal swab sample (which has the secretion from the
rectal mucosa) is being sent to Pittsburgh in USA for doing PK as part of the study
protocol", said Dr Suwat.

CASI
On every visit the participants also take
an internet based Computer Administered
Self Interview (CASI) to fill an assessment
form, giving their unique participant
number as well as the site code. This
questionnaire asks the study participants
about their behaviour which might impact
the study: how many sexual activities did
they have, did they use the condom, did
they use the study product, did they have
any difficulty in using it, etc. Once they
finish and click on the ‘submit’ button
then all information goes to US and the
clinic does not have any access to it.

The clinic has its own forms also, which participants fill to give information about
product use.

CLIENT CENTERED COUNSELLING
The nurses at PIMAN clinic provide the counselling. One such nurse counselor,
Radchanok Songsupa told that, “Counselling at PIMAN is participant/client centred
and not counsellor centred. So participants are counselled according to their
individual needs. It is always a one-to-one counselling, and never group counselling,
to maintain confidentiality of participants. This makes them feel more comfortable
while talking and sharing their concerns with us. We strive to build a relationship of
trust and confidence with the participants. Their main concerns are about using the
study product and its side effects if any. Counselling helps the participants
understand how to use the product, importance of adhering to it and also helps them
to continue in the study if they so wish. They also share their personal problems with
us. They can call us any time of the day or night or leave a message to which we
respond at the earliest."

Dr Suwat said that, “Participants are counselled to use the product in such a way that
chances of their not taking it are very slim. Of course it is human for them (as for
anyone else) to forget taking the drug for a variety of reasons—they may not want to
let their family know, or they have a new partner and may not want to share with him
that they are taking part in a study. So they have their own reasons to use or to not
use the study product. Through our counselling we make them feel okay to tell us the
truth as they know that we value their reasons. In the very few cases where PK shows
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
26
that there is not enough drug in their blood, we counsel the clients more on the
importance of taking the product.”

There has been amazing client retention in all clinical research studies taking place at
RIHES in Chaing Mai. In previous years it has been applauded as one of the best sites
in the world for drug adherence and client retention.

TEXT MESSAGE HELPS!
As part of the counselling programme, a mobile text message reminder for product
use is sent to each participant every day. This is done in coded language to maintain
confidentiality. The message asks 'did you use the product' and provides multiple
choices to respond, such as '1 or 2 or 3'. This way it is easy to monitor them by
reminding them to use the product as desired in the study and chances of their
forgetting to use it are reduced substantially. Although, most of the times they reply
to the message, but if for some reason they do not respond for 2-3 days, the clinic
staff calls back and follows up with them. CNS spoke to two study participants of
MTN017 and both found these text messages very useful as they help them in not
forgetting to use the product. Both were regularly replying to these text messages as
well.

Community is not just a possible beneficiary, but also an equal partner in clinical
research. Clinical research studies need to find solutions to health challenges the
community faces, which are not only safe and effective but also accessible,
affordable and available to those most in-need. With XX International AIDS
Conference (AIDS 2014) fast approaching, let us hope that as we 'step up the pace' and
accelerate HIV prevention research, community engagement goes hand-in-hand as
equal partners with dignity.
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27
'Serving the larger good by
participating in anti-HIV gel study'


One of the most important voices to listen to, and learn from, in a clinical research
study are those of the study participants. Their experiences, perspectives,
motivations and concerns are of paramount importance, we believe. Two study
participants, who are participating in a first-ever phase-II extended safety study of a
rectal microbicide gel in Asia-Pacific region, agreed to speak with Citizen News
Service (CNS). This study, formally called MTN017, began in February 2014 in Chiang
Mai, Thailand.

COMMUNITY CONSULTATIONS BEGAN LONG BEFORE THE STUDY
"In January 2012 about 25 men who have sex with men (MSM) and transgender people
participated in a consultative community workshop on MTN017 rectal microbicides
research. Many transgender people questioned the researchers that why transgender
people are not involved in the MTN017 research when they are a potential high risk
group for this study? In a small study done by us on lubricant use in transgender
people earlier, nearly 95% of study participants had reported the use of lubricants.
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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 up a
strong case to engage transgender people too in MTN017 study", informed Dr Suwat
Chariyalertsak, Director, Research Institute for Health Sciences (RIHES), Chiang Mai
University, and key researcher at this site
Dr Suwat Chariyalertsak, RIHES

As an outcome of this, transgender people, along with MSMs, are now involved in this
MTN017 phase II study at Chiang Mai and other sites. The objective of the study is to
study the safety and acceptability of a rectal microbicide gel in MSM and transgender.
Till the 1st week of June 2014, 13 study participants [7 MSM and 6 transgender] had
been recruited and begun the study at RIHES in Chiang Mai. 11 more study
participants will be recruited in the next quarter of 2014 and the study should end by
first quarter of 2015. [Read latest CNS update as of June 2014 on MTN017 here]

Voices of the study participants of MTN017
CNS team interviewed two study participants of MTN017 phase II study in Chiang Mai.
One of them is an MSM and the other is a transgender person. CNS did not ask them
their names and addresses, or any other information that might identify them.
Neither did we click any photographs, to respect their confidentiality. Both of them
spoke in Thai language and Wipada Cheewawat, the Community Advisory Board (CAB)
coordinator for MTN017, kindly consented to help with Thai-English translation. [Read
CNS update on Community Advisory Board (CAB) of MTN017 here]

The first MTN017 study participant we spoke with is an MSM person who is 30 years old
and works in a hotel. He got the information about the call for enrolment of study
participants for MTN017 study from the public relations office of Chiang Mai
University. He wanted to be part of this study for the larger social good and was the
first participant enrolled in MTN017 study in February 2014.

PIMAN
The second study participant CNS spoke with is a transgender person, who came
across as a very charming person. This person works in Chiang Mai University. She has
been a study participant in earlier HIV prevention research studies at RIHES. So the
PIMAN clinic staff had prompted her if she was interested in getting more detailed
information about this study. She wanted to be a part of this study as she thought it
would not harm her in any way and also because the study is good for other people as
a whole. She joined the study in March 2014. [Read CNS update on PIMAN and
community engagement at MTN017 here]

Both of these participants were aware of existing HIV or STI prevention options and
thought that, if found safe and effective, rectal microbicides could prove to be
another good option to prevent HIV and STIs in MSM and transgender populations. It is
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
29
beneficial for society as a whole to
expand the range of HIV and STIs
prevention options so that everyone
can find an effective option to use,
said the transgender study
participant.

The transgender study participant
said that, "There is a proper
recruitment process in place.
Participants are invited to PIMAN
centre 2-3 times before considering
them for the study enrollment. In
these visits they receive all the information pertaining to the study so that they
understand the study details well. Their concerns are addressed by the nurse
counsellors. I also had to do a test of understanding."

"I myself came to PIMAN several times before enrolling as I had some queries and
questions regarding the study. The staff here explained me every detail about the
study and clarified all my doubts. Only when I fully understood the study and was
mentally ready and consented to participate in the study was I asked to sign the
consent form. I know I can quit this study at any point. After signing of the consent
form, I took the written test of understanding at the screening visit. My physical
examination, as well as pathological tests of blood, urine and other things, were done
to see if I qualified for enrollment. Once enrolled, I started coming here every month
as per the study protocol."

The MSM study participant corroborated all that the other transgender study
participant had told us. He said "After the staff here explained the details of the
study and provided all information I had to pass a test of understanding. I think that
this test is important to ensure that study participants understand all the information
about this study."

Both of them explained that: “Once we signed the consent form and eventually
enrolled in the study, we have been coming to this clinic every month. The staff from
PIMAN calls us and gives us an appointment card to come to the clinic on a particular
day. They also call before the appointment just to remind and confirm. In case the
date is not convenient for us we can reschedule the appointment. During our visit, the
staff does our physical examination and takes our blood and rectal secretion samples.
The nurse counsellors explain about the product and study, and address any concern
we might have had. We also get counselling regularly at every monthly visit.
Moreover, every day we get an SMS from the clinic reminding us to use the product.
We find this very useful and we always make it a point to answer the SMS."

MSM study participant told us that he finds regular counselling very helpful as it helps
him to understand about the study product, about its side effects, if any, and also
Voices from the frontlines of rectal microbicides research in Chiang Mai, Thailand | July 2014
30
addresses any concerns he might have about these products. Counselling also helps in
understanding STIs and HIV transmission and prevention.

He said that, “We can call our counsellors or nurses anytime round the clock if we
have any concern about the study product. I talk to my counsellor at the time of
counselling session during my monthly visits. I did not have to call so far, but the very
thought that I can call them any time is very reassuring. I know that if at any stage I
do not understand anything or forget to ask in the monthly visit, my counsellor, who is
always there to help me and satisfy my concerns, is just a phone call away.”

The transgender study participant is also very happy for the good and repeated
counselling she receives at every visit to the clinic. She finds this very helpful in
understanding about the study and the study products, STI and HIV prevention, and
other prevention options. She finds counselling especially helpful as it is one to one
counselling and not group counselling. This maintains confidentiality and is much
more individualized. Like the MSM study participant, she also has no problems in
negotiating condom use with her partner who knows that she is part of the study and
both are using condoms as well as lubricants.

MSM study participant shared with CNS that being a study participant of MTN017 has
helped him in many other ways too. He has been receiving a standard of care which
he would not have received outside the study. "Normally we do not get blood and
physical tests done every month, like we are getting now because we are part of this
study. Some of my MSM and transgender friends who live in the villages often do not
receive blood and physical tests as they live far from the healthcare facility and also
because at times they are afraid of getting blood tests. I donate blood so I know my
HIV status from time to time. But after being part of this study I have realized the
importance of regular health checkups for MSMs and transgender people. So I am
spreading the word around that we should get regular physical and blood
examination. I also share with my friends, information on what I have come to know
about HIV and STI prevention through this study, and encourage them to have physical
and blood examinations done regularly and know about their STIs-- prevention and
also treatment if required. I also tell this to my partner who knows about this study.
Before coming to PIMAN I was not using condoms. But here I received counselling to
use condom. So, now I have started using them, although sometimes we are not
prepared to use condoms. I have no problems in
negotiating condom use with my partner. We do
use lubricants."

Their message to the MSM and transgender
community is: "We need to understand, learn and
seek information all the time about prevention of
HIV and STIs and how to take care of ourselves. HIV
is a problem of the whole world. We do not have any vaccine or cure so far. So, the
best policy is to protect ourselves from the infection by using condoms, till other
prevention options like microbicide gels become a reality."
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