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

Shobha Shukla and Bobby Ramakant, CNS
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. 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 partcipants 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 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 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."

Also read:

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

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