Abstract
Unhealthy alcohol use is associated with
a range of adverse outcomes among people with HIV
(PWH). Testing the efficacy and promoting the availability
of effective interventions to address unhealthy alcohol
use among PWH is thus a priority. Alcohol use outcomes
in intervention studies are often measured by self-report
alone, which can lead to spurious results due to
information biases (eg, social desirability). Measuring
alcohol outcomes objectively through biomarkers, such as
phosphatidylethanol (PEth), in addition to self-report
has
potential to improve the validity of intervention studies.
This protocol outlines the methods for a systematic review
and individual participant data meta-analysis
that will
estimate the efficacy of interventions to reduce alcohol
use as measured by a combined categorical self-report/
PEth variable among PWH and compare these estimates to
those generated when alcohol is measured by self-report
or PEth alone.
Methods and analysis We will include randomised
controlled trials that: (A) tested an alcohol intervention
(behavioural and/or pharmacological), (B) enrolled
participants 15 years or older with HIV; (C) included both PEth
and self-report
measurements, (D) completed data collection
by 31 August 2023. We will contact principal investigators of
eligible studies to inquire about their willingness to contribute
data. The primary outcome variable will be a combined
self-report/
PEth alcohol categorical variable. Secondary
outcomes will include PEth alone, self-report
alone and HIV
viral suppression. We will use a two-step
meta-analysis
and random effects modelling to estimate pooled treatment
effects; I2 will be calculated to evaluate heterogeneity.
Secondary and sensitivity analyses will explore treatment
effects in adjusted models and within subgroups. Funnel
plots will be used to explore publication bias.
Ethics and dissemination The study will be conducted
with deidentified data from completed randomised controlled
trials and will be considered exempt from additional ethical
approval. Results will be disseminated through peer-reviewed
publications and international scientific meetings.
PROSPERO registration number CRD42022373640