Communities are equal partners in clinical research

Shobha Shukla and Bobby Ramakant, CNS
"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.

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.

Dr Suwat Chariyalertsak, RIHES
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 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.

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]

Information about MTN017 study and call for study participant recruitment was widely disseminated through bimonthly Thai-language CAB Newsletter, Chiang Mai University 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.

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 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.”

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.

Dr Suwat explaining CASI
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 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 chambers
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.

Radchanok Songsuna
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 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.

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.

Also read:

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