Lenacapavir Acceptability and Perceptions (LEAP Study) V1

• Research type

  Research Study

• Full title

  Exploring perceptions, barriers, facilitators and unmet need for injectable lenacapavir in the management of HIV

• IRAS ID

  316331

• Sponsor organisation

  University of Sussex

• Clinicaltrials.gov Identifier

  n/a, n/a

• Duration of Study in the UK

  1 years, 0 months, 31 days

• Research summary

  Significant advances in the potency and tolerability of antiretroviral therapy (ART) have led to very high rates of virologic success for most who remain adherent to therapy. However, a significant risk of virological failure is still present for those patients who cannot engage with HIV treatments in the form of daily oral medication. Barriers to ART adherence are well described and range from issues related to the drug regimen such as pill burden, tolerability, dosing frequency to psychological factors and structural barriers related to the social context surrounding HIV and ART. These can include substance abuse and mental health, inequitable gender norms and roles as well as stigma and discrimination. Injectable long-acting (LA) agents have the potential to address some of these barriers, particularly in patient groups at risk of poorer ART adherence and viral suppression such as adolescents and young people, and highly treatment experience patients. However, best practice around the implementation of injectable ART remains to be determined.

  Unlike cabotegravir and rilpivirine LA, lenacapavir (LEN), a potent LA inhibitor of HIV-1 capsid could be administered subcutaneously every 6 months. The advantages of this novel LA agent are evident when we consider that most people living with HIV (PLWH) now attend clinic six-monthly, and there is a possibility for self-administration of LEN. Recent data has shown that injectable LEN was safe, well tolerated and led to high rates of viral suppression in treatment naive and highly treatment experienced patients supporting its potential use for treatment and prevention of HIV.

  The UK Medical Research Council framework for the development and evaluation of complex interventions highlights the importance of using a variety of research methods at different phases of the evaluation process, including qualitative research. Although the success of LA ART in the context of clinical trials is evident, questions remain regarding its use in every-day clinical practice. To ensure that LEN is optimally provided to those individuals who have most to benefit, we need to understand the barriers and facilitators for implementation and uptake of LA ART among a diverse group of patients and healthcare professionals (HCPs). Considering the significant potential of LEN for the management and prevention of HIV, we propose a comprehensive qualitative study exploring the ‘why’ and ‘how’ and providing unique insights into the multifaceted phenomena related to LEN access and delivery.

  This study will provide important data to inform the best practice around future implementation of LEN with a view to enhance its adoption and sustainability in clinical practice in both the UK and beyond. Such information will be valuable to key stakeholders including international HIV treatment guideline writers, NHS England, National Institute of Clinical Excellence, HIV service providers, HIV advocacy groups, and may reveal efficient, even transformative, ways of strengthening capacity for implementation of injectable ART in real-world settings.
  

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  22/YH/0152

• Date of REC Opinion

  16 Aug 2022

• REC opinion

  Further Information Favourable Opinion