In a previous issue, we spoke to Professor Miles Witham about his work to facilitate the participation of older people in clinical trials. Now we hear from Sarah Montague about a trial engaging homeless people in research.
Researchers face a challenge striking the balance between getting people to participate and getting the appropriate people to participate. If they set the criteria for participation too broad, their data may not be reliable enough to answer their question. Too stringent, and they may not be able to recruit enough patients.
The National Institute for Health Research (NIHR) Clinical Research Network (CRN) South London helps to increase the opportunities for people to take part in clinical research.
The NIHR CRN South London is supporting a project taking a different path to recruitment; The Access To Treat in the Community (ATTIC) trial.
Sarah Montague, Research Associate and Clinical Trials Manager at King’s College Hospital NHS Foundation Trust explains more about their work.
“Typically, clinical trials have strict criteria for participation, with a lengthy document outlining what’s required of a candidate. These parameters tend to be specific and unbending in terms of who’ll they’ll accept, meaning few people meet the requirements.
“In addition to which, the practicalities of attending multiple appointments at hospital presents another set of challenges, with lifestyle, mobility, the cost and difficulty of accessing transport all preventing involvement.
“Our trial aims to remove these barriers by taking our trial to people, rather than expecting them to come to us. We also take a different approach to recruitment by recognising and accepting that many of our participants face multiple challenges from mental health issues to drug dependency. By doing so, we are engaging with a much underrepresented group in clinical trials, the homeless.”
The ATTIC trial aims to test and treat homeless people with Hepatitis C in areas where infection rates are high. In doing so, the trial is supporting NHS England’s ambition to eliminate the virus as a public health threat in England by 2025, and the World Health Organisation’s global goal of 2030.
Crucially, the trial clinic is mobile, using a converted bus as its base, enabling the team to reach participants more easily. Supported by CRN South London, the bus is run day-to-day by a joint team from the King’s College Hospital NHS Foundation Trust, supported by The Hepatitis C Trust.
When the trial began in late 2018, the bus initially visited homeless shelters and day centres and Sarah is quick to remark how helpful local homelessness organisations have been in helping them engage with the homeless community. As time progressed and the team knew the community better, they began taking the bus directly to the homeless, at local railway stations, for example.
Barriers to participation were also reduced by keeping the paperwork, tests and criteria to an absolute minimum. A simple finger prick test is used to test for the Hepatitis C antibody, giving a result that is ready in a mere 15 minutes. If the test proves positive, then further blood tests are undertaken.
Not only does this trial represent a sea change in how a trial is carried out, but it also represents a change in attitude to treatment accessibility. “Previously, some patients with Hepatitis C were expected to live with the condition due to the poor treatment options,” explains Sarah. “In the last few years, however, treatment has progressed, Hepatitis C can be treated quickly and effectively and there are fewer unpleasant side effects than was once the case.”
For those who test positive, treatment is given by the healthcare team working from the bus, no hospital visits are required. The tablet antiviral drug Zepatier is used to treat people with the genotype 1a, 1b and 4 Hepatitis C infection, stopping the virus from multiplying. 12 weeks after the course of Zepatier is completed, patients have a blood test to determine whether they have been cured. Whilst those with a different genotype access standard NHS treatment.
“The aim of this trial is not only to increase testing, so we can discover new cases, but also to demonstrate we can deliver Hepatitis C treatment to the homeless community away from the hospital in the community,” observes Sarah.
Improved detection and inclusivity are crucial as an estimated 113,000 people are living with the virus in England, around half of whom are undiagnosed. Left undiagnosed and untreated, HCV can be extremely damaging, potentially causing fatal cirrhosis and liver cancer. Reaching more people, earlier in the disease progression and being inclusive in the delivery of treatment is vital.
The ATTIC trial also focuses on enabling participants to complete their treatment, with the on-board healthcare team providing extensive follow-up and support. Working flexibly is also required to meet the needs of the community, dispensing a month’s worth of treatment, for example, proving impractical when the recipient has nowhere to store it, so some standard procedures are being rethought.
Peer support plays a particularly significant role, with a key member of the on-board team having experienced both homelessness and hepatitis. Whilst the project also demonstrates the value of nurses working in the community.
The success of the project indicates that in this area at least, the typical model of outpatient care needs changing. Whilst the multi-agency approach, with the NHS, charities and other local organisations working together, speaks volumes about how best to deliver both a trial and treatment. As for the ATTIC bus, the wheels will keep turning for the rest of the year and potentially beyond.