A clinical trial: through the eyes of the community

[Rituu B. Nanda]

I recently had an opportunity to view a film about a clinical trial on DVD. The Development of Anti-retroviral therapy (DART) in Africa trial was a six year clinical trial evaluating how to manage anti-retroviral therapy ART in 3,300 patients with advanced HIV or AIDS in Uganda and Zimbabwe. The trial aimed to find out whether the lab-based strategies used to monitor ART to people with HIV infection in resource rich countries were essential in Africa, where around four million people still need ART urgently and resources are limited. The major finding was that 12-weekly monitoring for toxicity had no impact on disease progression, nor did CD4 monitoring during the first two years on ART. After that CD4 monitoring had a small but important benefit. The trial results mean that ART delivery can be decentralised to communities and health centres without putting patients at risk.Read more:
http://www.ctu.mrc.ac.uk/dart/files/DART%20IAS%202009%20-%20interpr...

Why I liked this trial documentary?
The documentary is well made, quite interesting, very moving and full of hope. It is not run-of-the-mill medical narration but tells the story of the research and what it means from the perspective of the trial participants and the communities where they live. A doctor proudly proclaims his role in the trial, whereas a patient shares significance of the trial in his life. My heart goes out for this young mother who covers a 60-mile journey with a week-old baby to collect her medicine.

Community involvement in the trial
The research team used collaborative and participatory methodology to engage with the community during the research process. TASO in Uganda was used as an entry point to approach the community. Intense discussions were held with the community members, government functionaries, village heads and church leaders, and extensive media campaigns were launched. Once the community was involved and engaged there was no looking back. Community support and belief in the trial was so high that resistance from some groups in Uganda and the deteriorating security situation in Zimbabwe did not hamper the trial. Loss to follow-up was very low – 7 per cent – during the six long years of the trial. The community had understood that the trial brought in medicines and a new hope for a healthy and productive life; and that the research issue was of real relevance to their lives.

The trial ended but its impact lingers on. A positive woman yearned to be a mother and ART has given her the opportunity to be one. In another village, there is a strong HIV positive group mostly made up of DART patients. They run prevention campaigns to persuade people to go for testing and counselling.

Co-principal investigator Professor Charles Gilks of Imperial College London and now UNAIDS, notes: "DART has been a landmark trial in Africa in many ways, not only in the numbers involved and its length, but for the way the patient communities were involved and engaged. For example, the strong partnerships developed with the pharmaceutical industry in a trial that was looking at treatment strategies, rather than comparing one product with another, and the exceptional participation, survival and low loss to follow-up that we achieved… "

To get a flavour of the film and the DART study findings, you can check out this YouTube trailer:
https://www.youtube.com/watch?v=MSyFmbiR-Hc

Read stories from the community at:
http://www.mrc.ac.uk/Newspublications/News/MRC006231

[Rituu B. Nanda]

Dear Friends,

This has been short-listed by Lancet paper of the Year! This paper is the only one of the eight short-listed from all the major medical publications (NEJM, Nature etc). If you want to vote, and of course cast your vote for the most appropriate paper, then it is very simple …

Go to www.thelancet.com, click on ‘read the eight shortlisted papers and vote’ in the Announcements box on the home page, tick the bullet point next to the paper, and click next. No need to register or log in, takes a couple of seconds.

Warm regards,

Rituu

[Rituu B. Nanda]

Dear All,

My sincere thanks to all who responded to this blog. Their sharing leaves me encouraged and motivated.
- MariJo who spoke of how personalisation can make a difference in treatment
- Ian Campbell who shared the church clinic community partnership (CCCP) approach to ART. This was further elaborated thanks to Laurence.
-Onesmus from Kenya was motivated to see the village leaders take a lead in ensuring access and adherence to ART
- Jean-Louis Lamboray succinctly observed that local communities play a central role in health action
- Emile Schmitz linked distribution of ARV to Base of the Pyramid strategy (!)
- Amrik Kapoor who had a long stint in Africa was delighted to see that the trial had a beneficial impact on the communities
- Marie Lamboray followed Charles interviews over the years of the trial and related it to ACP
- Last but not the least those like Gaston who conveyed thier appreciation over the email.

Efharisto! Asante Sana! Merci! Thanks! Kalomay!

Rituu

[Marie Lamboray]

Dear Ritu,

Here I hope to help you, extracts from an interwiew of Charles Gilks by the Aids Care Watch in august 2006 :
http://acw-interview.blogspot.com/2006/08/acw-interview-dr-charles-gilks_15.html

"Our public health approach has been to try and simplify and standardise these interventions so that they can be rolled out outside of specialist centres."

(...)

The following is were ACP can help, is'nt it?

"What we haven’t done as well, is been clear, right from the start, to say that the treatment issue that we focussed on was plugging a gap, but there were existing prevention interventions that also needed to be strengthened and reinforced. Whilst we’ve put a lot of our energy into filling the gap, we should have spent more energy on reinforcing prevention, because ultimately in the long term, if we don’t prevent infection, if we just treat it alone, this won’t be sustainable."
(...)
"ACW: Many – if not almost all – HIV-related interventions are concerned with doing things or providing material for people. In what ways do you think affected people can be empowered to take more control of their own health? What impact do you think this would have on their day-to-day lives?

CG: When the communities are mobilised around health as a right rather than something that they are scared to ask for, I think that is an important step. Where this has happened in Europe and in North America, I think it has actually transformed the doctor-patient relationship, making it less authoritarian in its approach, much more a relationship of information-sharing. I hope that transformation will happen in resource poor countries as well, as it has happened to great positive effect in the North."

Marie

[Amrik]

Dear Rituuji,

Having returned to my mail after a fortnight, I profusely thank you for making my effort worthwhile. Actually I am not amazed at the way the clients took this trial in such a meaningful way. Africans were the earliest to bear the brunt for this lethal pandemic and their suffering has been compounded by brazen onslaught of poverty and other shortcomings. Such a trial was overdue. Six years is period in human life and believing and have confidence in the face of catastrophic forebodings is not ordinary. I give a lot of credit to the inherent values among African people alongside the meticulous planning and vigorous follow up by the people who conducted this onerous trial.African People Living with HIV/AIDS have been keenly, sincerely and hopefully participating in many ART trials since more than a decade. Every participant used to look for some good raise in their CD 4 counts while for many it will just add to their levels of despair. Though the studies might not have had much to offer, the African people, built as they are, have been clinging to every particle of hope. Let me say all sluch trials are not painless for the participants for there are instances when they have just been taken to be ginni pigs. It complicates matters for well meaning efforts also for nothing is certain on the manifestos or pronouncements. I have observed these

trials quite closely.



It is heartening to learn that this trial made some difference for the participants Particularly because of the involvement of community. It was hence natural that it brought out encouraging results for the entire world. I am very happy that trial results fill us with certainty that ART delivery can be decentralized to communities and health centres without any harm.

amrik kapoor

[Emile Schmitz]

Interesting point you raise Rituu.
It seems that the distribution of ARV's is not constrained to having a lab anymore. This provides great new ways of distribution and scaling up. Basically, the challenge at hand doesn't differ much from the challenge most multinationals face when wanting to tap into the Base of the Pyramid. I'm greatly interested in BOP strategies and feel that, when conducted in the right way, it can ensure sustainable development. When looking at BOP-cases, we see different examples of distribution.

Unilever uses Shakti-ladies in India. Probably already known to you as you're from India, but still interesting. Unilever recruits Shakti-ladies from self-help groups. These ladies buy Unilever products (e.g. Lifebuoy soap, Annapurna Salt) and sell them locally in rural villages. They not only earn a decent income, they also gain status in these villages. However, this is just Shakti 1.0. The next level would be to really leverage this network and listen to the end consumers through the ladies or to deliver different products along the same lines. This could be of course ARV's...

Danone uses ladies (again ladies, they are simply most reliable..) to distribute their Shokti Doi yoghurts in Bangladesh. Shokti Doi is a fortified yoghurt that was born through a Joint Venture of Danone and Grameen Bank. They use carts to move around and sell these affordable yoghurts to even rural areas. The crucial thing with distribution is; make it attractive for the distributor to go all the way to the villages and visit those who need it (e.g. ARV's) i.e. get your incentives right.

Another initiative that would leverage strong Private sector networks for the distribution of medicine (ORS) is Colalife: www.colalife.org. It is still to be accepted by Coca Cola, but seems to be a great idea.

Gaston referred to another interesting case of the Aravind Eye Hospital in India. Check this movie for a nice explanation on how they can deliver affordable eye care to the Base of the Pyramid: http://www.youtube.com/watch?v=3cjnNPua7Ag

So these are some examples of how you can use Base of the Pyramid or Private Sector thinking for health purposes. I strongly believe in the co-creation of solutions, bringing together NGO's, Companies, Governments, but above all the end consumer/user.

[Jean-Louis Lamboray]

Health researchers as well as all health professionals must choose: either they continue to operate in the delusion that they are in control of people's health, or they seek to participate in people's lives. Their choice will fundamentally influence the design of reasearch protocols and of health nterventions. Your story illustrates the benefits of the latter choice. Thanks Rituu!

[Onesmus Mutuku]

My visit to Chikankata later in 2006. I was motivated to see village headmen and the communities in the neighborhood of the Hospital so well taking leadership of the ART process.
The village headmen were aware of the people in their village who were on ART, those families that were seeking to know their status. Those families whose patients had not gone back to the hospital to collect their medicine.The community would quickly organise themselves to explore why and agree on next steps to support that family.
Their was a sure sense of a normalized state of the AIDS response in that community.

Thanks Rituu

[Laurence Gilliot]

Ian,

You expressed this so well during the conference in Belgium (June 2007).
Friends, check out this video of Ian: http://aidscompetence.ning.com/video/local-ownership-of-treatment

"In the roll-out of ARV treatment, our experience in many countries is if the grand-mothers and the youth are in charge in the village, it works much better. [...] Trust the capacity of local neighbourhood people to be in charge of that technology, supported by the organisations. [...]".

Laurence

[Ian Campbell]

In 2005, with The Salvation Army international facilitation team we developed the CCCP approach to ART ie church clinic community partnership-proposing that local ownership of responsibility for ART access, storage, adherence, monioring, linkage to care and prevention, and referral is not only possible but vital to 'going to scale' . The 'church' assumes a trusted entity, so there are options. It is not overly optimistic to expect a 10 fold increase in ART 'coverage', in the view of all of us who did that work
Thanks Rituu
Ian

[MariJo]

Dear Rituu,
Thank you for drawing my attention to this subject which is in the core of so many interventions all over the world. It brings to my mind how uncomfortable I felt about the ways studies were conducted, leting participants feel like empty bodies. And it also makes me reflect on how much some people try to decide what is better for other people. And the fact that they do that with good intentions makes it very difficult for them to recognize what is failing in the core of it.

In some ways, I think that it has to do with a despersonalization of the medical interventions, which leads to treat illnesses instead of people, as well as a shift in what is important.

Many times I have found myself trying to give support to HIV positive people that fall into despair when the results of their tests are not as expected: high CD4 counts, low viral load, the right number here or the standard level there... And it is very difficult for them to come up because they feel they have no control over their situation, that all they can know comes from testing and machines they do not understand and do not control. It was difficult to give support when they have been convinced so profoundly that only those ‘objective’ results could tell them how they felt to the point that they have forgotten their own 'inner testing'.

I had that same feeling when I went to the doctor to tell him I was not feeling well and he looked puzzled at me: 'But how it be, the results of your tests are very good'. And of course I did not know how to 'contradict' the external data, even though my body was telling me something different. It is hard to use both kinds of knowledge without one taking over the other.

Of course, it is very helpful to have all those testing machines to help us do precise measures and tests but they do no good when they are used in such a way that they substitute people's perception of their own bodies, when they are led to be oblivious of the knowledge about themselves. When people recover ownership of their own health and the decisions they make about it, then they can still use the technology but they do not need to completely depend on it.

In a similar way, the methodology used to conduct DART shows that when participants are really participating and not just 'objects' of study, then some change can take place in the community where it is being conducted and it is not only a producer of statistics. When participants are included as equals, the study is not only a study, it is also an intervention that introduces changes in the community where it takes place.

And in the end, is it ethical that a clinical trial does only ‘look’ at the situation without adding anything else to those who are taking part in the experience?

I had only heard about DART very briefly, but it is very reasuring to see these results coming out, as they can show that another way of conducting trials is possible.

MariJo