ACceptability of long-acting ART in Cognitive ImpAirment (ACACIA)
Research type
Research Study
Full title
An exploratory study of the acceptability, and impact on health-related quality of life of long-acting cabotegravir + rilpivirine in people with HIV and cognitive impairment
IRAS ID
322785
Contact name
Jaime Vera
Contact email
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
People living with HIV who experience cognitive impairment report lower quality of life than those without cognitive impairment. One of the factors influencing lower quality of life is related to concerns and difficulties associated with remembering to take their HIV medication (combination antiretroviral therapy, cART) and the impact this has on health.
Long-acting injectable cART such as cabotegravir+rilpivirine (CAB+RPV), has the potential to improve cART medication adherence in those that, because of cognitive impairment, are more likely to forget to take medications. An injection of long-acting CAB+RPV administered every two months has been found to be safe and effective against HIV. Long-acting injectable CAB+RPV is NICE recommended and now part of routine care for those eligible to have it and those wanting to make the switch to injectable therapy.
The aim of this study is to see whether the long-acting injectable CAB+RPV is acceptable and could potentially be beneficial for people living with HIV with cognitive issues through improvements in health-related quality of life.
Thirty-six people living with HIV with clinically significant cognitive impairment will be recruited from HIV clinics at University Hospitals Sussex NHS Foundation Trust. Participants will complete health-related quality of life questionnaires, a treatment satisfaction questionnaire and a computerised cognitive assessment (CogState) at three time points (at baseline (week 0), following an oral 'trial' of CAB+RVP (week 4) and at 11 months (study end)) from when they first switch to injectable cART. These questionnaires and assessments have been used on people living with HIV and cognitive issues previously, and are effective tools for measuring the study outcomes. They will be administered with assistance from a research nurse. Additionally, a one-to-one nested qualitative study will be conducted with a sub-sample of participants to explore patient experience.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
23/WM/0053
Date of REC Opinion
16 Mar 2023
REC opinion
Favourable Opinion