A new clinical trial is introducing a biannual injection designed to lower the risk of HIV transmission for sexually active women in select regions of England.
This research will be conducted across France and the UK, with locations in Birmingham, Manchester, London, and Brighton.
Participants in the trial will receive a novel injectable form of PrEP (pre-exposure prophylaxis) named Lenacapivir, administered twice a year.
While PrEP is currently available on the NHS as a daily oral tablet—which substantially decreases HIV risk when taken consistently—this study explores an alternative delivery method.
Dr. Steve Taylor, who serves as a principal investigator for the Purpose 5 trial and leads the Clinical Service at Birmingham Heartlands HIV service, expressed, “These injectable PrEP solutions hold the potential to revolutionize HIV prevention both in the UK and globally.”
He noted that the Purpose 1 Trial in Africa yielded a remarkable outcome, with none of the 2,134 women receiving Lenacapivir testing positive for HIV.
Dr. Taylor stated further, “This trial seeks to assess whether these injections offer additional advantages as an HIV prevention approach and if they are a desirable option for women.”
Women are being specifically targeted for participation since they tend to be less likely to take daily PrEP tablets to mitigate their HIV risk.
Data from government sources indicate that in 2023, 75% of men who have sex with men, identified by NHS sexual health services as needing PrEP, had either initiated or continued its use, contrasting with under 4% of PrEP prescriptions being issued to women in the UK.
Yet, women who have sex with men now represent the largest group of new HIV diagnoses in England, accounting for 46% of all new sexual HIV transmissions in 2023, while men who have sex with men made up 28% and men who have sex with women represented 26%.
Participants will either receive a daily pill or the new six-month injection. The trial will continue for at least two years, with around four clinic appointments required each year.
Dan Hartland, the chief executive of the West Midlands HIV support charity Saving Lives, remarked, “Long-acting injectable PrEP is a significant leap forward in HIV prevention, especially for women. To meet the government’s objective of eradicating new HIV transmissions by 2030, we must adopt a multi-faceted strategy involving testing, treatment, and preventive mechanisms.”
Dr. Taylor encouraged women who are interested in taking part in the Birmingham trial to reach out to the research team via email before the end of April.
