People living with HIV who have a cognitive impairment Mental and Behavioural Disorders
Conditions
Interventions
This study is a 23-month (with a 12-month recruitment period and an 11-month follow-up period per participant), single-arm, single-centre, mixed-methods study examining the acceptability, tolerability
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligible for LA injectable ART by the multidisciplinary (MDT) clinical team at University Hospitals Sussex NHS Foundation Trust based on criteria defined by the British HIV Association (BHIVA) 2. HIV-1 positive subjects 3. Age = 40 years old 4. Evidence of clinically significant cognitive impairment, which for this protocol will be defined as participants meeting all of the following criteria: 4.1. Patient-reported symptoms of cognitive impairment (ongoing symptoms) 4.2. Current or past clinical neuropsychological testing reporting cognitive impairment 5. Able to understand the study, sign the consent form, and be willing to undertake all study procedures
Exclusion criteria
Exclusion criteria: 1. Patient deemed not to be eligible for LA injectable CAB+RPV by the MDT clinical team and based on the criteria defined by BHIVA 2. Existing neurological disease that could affect the ability of patients to participate in the study 3. Current history of major depression or psychosis 4. Recent head injury (past six months) 5. Current alcohol abuse or drug dependence 6. Has completed the CogniFit assessment in the last year for clinical or research purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health-related quality of life is measured using patient reported outcome measures (DEMQOL, WHOQOL and HIVPROM) at baseline (day 0), week 4 (following oral CAB+RPV lead-in) and at week 48 (study end) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in cognitive function will be measured using the CogniFit at baseline (day 0) and at week 48 (study end) 2. Acceptability of long-acting injectable CAB+RPV will be assessed based on: 2.1. The proportion of participants who complete all scheduled injections over the study period measured using patient medical records at the study end 2.2. The findings from in-depth qualitative interviews conducted with a representative sample of participants and held between 6 and 11 months post-injection commencement 3. Tolerability will be assessed based on: 3.1. The proportion of participants who receive at least 1 injection and who discontinue receiving injections before the full course of injections due to intolerability of injection, frequency of injections or burden of study procedures measured using patient medical records at the study end 3.2. The proportion of participants with serious clinical adverse events measured using patient medical records and medical laboratory abnormalities after 4, 12 and 48 weeks of switching from any ART-based regimen (PI, NNRTI or INSTI) to LA injectable CAB+RPV 3.3. Proportion of participants with plasma HIV RNA<50 copies per mL measured using the Roche assay at weeks 4, 12 and week 48 captured from patient medical records at the study end | — |
Countries
England, United Kingdom
Contacts
Public ContactKate Alford
Outcome results
None listed