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:
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:
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