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

Shobha Shukla and Bobby Ramakant, CNS
Dr Suwat Chariyalertsak, RIHES
at PIMAN Centre
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 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 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, RIHES
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, RIHES, CMU
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, 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 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.

AIDS 2014
XX International AIDS Conference (AIDS 2014) will open next month on the theme: "Stepping up the pace." 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.

Also read:

Shobha Shukla and Bobby Ramakant
Citizen News Service - CNS
9 June 2014

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