CNS: Community engagement is key as rectal microbicides research progresses ahead

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.

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.

Udom Likhitwonnawut
a Community Advisory Board
member in Thailand
Photo credit: IRMA

"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 all 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...