Thousands of people receiving HIV prevention medication in a pivotal NHS trial face uncertainty as the charity leading the research closes down.
St Stephen's Aids Trust, which partnered with Public Health England and the NHS last year to trial pre-exposure prophylaxis, known as PrEP, is to shut amid financial concerns, HuffPost UK has learned.
St Stephen's was "working with researchers to co-ordinate and lead the trial" day-to-day through its clinical research arm.
It comes as the situation at the charity is described as "dire" by staff, who said they fear the decision to close down just eight months into the three year trial may affect patients.
St Stephen's said the closure will not affect the impact trial or patients.
The Charity Commission and Companies House records show St Stephen's Aids Trust has failed to submit its latest financial accounts, in contravention of strict governance guidelines.
The Charity Commission's website said one filing was, as of Tuesday, 97 days overdue.
The watchdog said in a statement on Tuesday: "The Commission is aware of financial concerns regarding the St Stephen's Aids Trust.
"We are considering information as a matter of urgency and will be engaging with the trustees to assess their compliance with their legal duties to protect and safeguard the charity's assets."
PrEP, taken regularly as a pill before sex, reduces the risk of HIV infection by 86%. The trial was described by the head of NHS England, Simon Stevens, as a "major new intervention" to prevent HIV.
Launched in September 2017 with St Stephen's Aids Trust as the managing delivery partner, the trial had funding for 10,000 patients. Latest figures state there are currently over 5,600 participants across 121 sites.
A west London NHS foundation trust is now preparing to take over management of the trial.
Professor Brian Gazzard, the chair and founder of St Stephen's Aids Trust, resigned from his role as director of its subsidiary research company on 28th March, alongside three other board members.
St Stephen's explained the resignations came after the decision to "wind down" its operations was taken.
It said Prof Gazzard remains chief investigator of the PrEP trial. His office did not respond to a request for comment.
NHS England has yet to publish a report from the latest meeting of the PrEP programme oversight board, which meets once a month to discuss the trial.
The last report available, of a board meeting in March, suggested the trial was progressing as expected.
Meanwhile employees at St Stephen's say they are worried about compulsory redundancies. Previous accounts show the charity reported a loss of over £1.2m in 2015-16.
Wendy Fisher, the acting CEO of St Stephen's, said previous financial losses were among "many different reasons" for the decision to close the charity.
St Stephen's Aids Trust was founded by Prof Gazzard in 1991 and employs 49 people, according to latest figures.
Chelsea and Westminster Hospital NHS Foundation Trust will take over management of the PrEP trial on June 1.
The trust said in a statement: "There will be no immediate impact for any patients, and the Trust will make every effort to ensure there will be a commitment to continue [St Stephen's] important research and that their legacy will endure into the future."
Public Health England referred a request for comment to NHS England. NHS England had yet to respond to a request for comment at the time of publication.
The introduction of PrEP in the UK has been controversial, with critics saying it incentivises unsafe sex.
The campaign for the NHS to provide PrEP, which can cost as much as £84-a-month privately, has been fought over many years.
The Court of Appeal ruled that the NHS had the legal power to fund PrEP in November 2016.
The trial will be the first step to full provision as a prescription through the health service in England. PrEP is already available through the NHS in Scotland.
What is PrEP?
PrEP is a course of HIV drugs taken by HIV negative people before sex to reduce the chance of getting HIV.
Results in trials have been very successful, with PrEP significantly lowering the risk of becoming HIV positive and without major side effects.
The medication used for PrEP is a tablet called Truvada, which contains tenofovir and emtricitabine (which are drugs commonly used to treat HIV).
Source: Terence Higgins Trust (THT)