Experiences of adults in the peri/post-menopausal period or aged =60 years switching HIV treatment Other
Conditions
Interventions
This is a multi-centre, mixed-methods observational study conducted at UK NHS HIV treatment centres, incorporating both prospective and retrospective components, alongside a nested qualitative element
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Age
40 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults with HIV-1 2. The potential participant has the mental capacity, and is willing to, provide informed consent to participate in the study. 3. The individual falls into one of the two populations of interest: 3.1. Adults who are 60 years of age or older 3.2. Individuals assigned female sex at birth who are between the ages of 40 to 60 years 4.The participants must belong to one of two cohorts: 4.1. Routine data cohort: The individual is already receiving B/F/TAF, or has received B/F/TAF any time in the past OR 4.2. PROMs prospective cohort: The individual will be switching HIV treatment to either B/F/TAF or to an alternative ART regimen
Exclusion criteria
Exclusion criteria: 1. In the opinion of the research team, the individual is unable or will be unwilling to comply with the study requirements 2. The individual has not provided informed consent 3. Data completeness is inadequate in the eyes of the site principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported outcomes before and after switch of HIV treatment measured using patient-reported outcomes on sleep (PROMIS questionnaire), mood Patient Health Questionnaire-9 (PHQ-9), treatment satisfaction (HIV Treatment Satisfaction Questionnaire (HIVTSQs12)), and quality of life (HIVPROM questionnaire) at baseline, then 2 months and 6 months post HIV treatment switch | — |
Secondary
| Measure | Time frame |
|---|---|
| Lived experiences of switch to B/F/TAF measured using qualitative data from in-depth interviews with patient participants analysed using reflexive thematic analysis at 2-6months post switch to B/F/TAF;Clinician perceptions and experiences of HIV treatments including B/F/TAF measured using qualitative data from focus groups with clinical teams analysed using reflexive thematic analysis at at any point during the study;Treatment durability measured using proportion of participants who remain on B/F/TAF without discontinuation at over 12, 24, 36, 48 and 60 months;Virological efficacy (routine data cohort) measured using cumulative proportion of participants maintaining undetectable HIV viral load (<50 copies/mL) and cumulative incidence of virological failure at at 12, 24,36, 48 and 60 months post-switch;Safety outcomes (routine data cohort) measured using Renal function (eGFR), bone density (T score at hip and spine via DEXA scan), weight and incidence of clinically significant weight gain, Hb1Ac and lipid profiles (blood test), CD4 T cell count (blood test) at from start of regimen for the duration of follow-up in the routine data cohort;Frailty measured using FRAIL scale score at baseline, then 2 months and 6 months post HIV treatment switch | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactKate Alford
Outcome results
None listed