Efficacy of alcohol reduction interventions among people with HIV as evaluated by self-report and a phosphatidylethanol (PEth) outcome: protocol for a systematic review and individual participant data meta-analysis
Robin Fatch,
E Jennifer Edelman,
Gabriel Chamie,
Susan M Kiene,
Charles Parry,
David A Fiellin,
Vivian F Go,
Judith A Hahn,
Christopher W Kahler,
Robert l Cook,
Isabel Allen,
Jeremy C Kane,
Aaron Scheffler,
Nneka Emenyonu,
Sarah B Puryear,
Priya Chirayil,
Kaku So-Armah,
Jessica F Magidson,
Amy A Conroy,
Sarah Woolf-King,
Julian Adong,
Winnie Muyindike,
Neo Morojele,
Elena Blokhina,
Evgeny Krupitsky
Affiliations
Robin Fatch
Medicine, University of California, San Francisco, California, USA
E Jennifer Edelman
Yale School of Medicine, New Haven, Connecticut, USA
Gabriel Chamie
Medicine, University of California, San Francisco, California, USA
Susan M Kiene
Epidemiology and Biostatistics, San Diego State University College of Health and Human Services School of Public Health, San Diego, California, USA
Charles Parry
Mental Health, Alcohol, Substance Use & Tobacco Research Unit, South African Medical Research Council, Cape Town, South Africa
David A Fiellin
Yale School of Medicine, New Haven, Connecticut, USA
Vivian F Go
Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA
Judith A Hahn
Epidemiology & Biostatistics, University of California, San Francisco, California, USA
Christopher W Kahler
Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island, USA
Robert l Cook
Epidemiology, University of Florida, Gainesville, Florida, USA
Isabel Allen
Epidemiology & Biostatistics, University of California, San Francisco, California, USA
Jeremy C Kane
Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA
Aaron Scheffler
Epidemiology & Biostatistics, University of California, San Francisco, California, USA
Nneka Emenyonu
Medicine, University of California, San Francisco, California, USA
Sarah B Puryear
Medicine, University of California, San Francisco, California, USA
Priya Chirayil
Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA
Kaku So-Armah
School of Medicine, Boston University, Boston, Massachusetts, USA
Jessica F Magidson
Psychology, University of Maryland, College Park, Maryland, USA
Amy A Conroy
Medicine, University of California, San Francisco, California, USA
Sarah Woolf-King
Psychology, Syracuse University, Syracuse, New York, USA
Julian Adong
Makerere University School of Public Health, Kampala, Uganda
Winnie Muyindike
Mbarara National Referral Hospital, Mbarara, Uganda
Neo Morojele
University of Johannesburg, Auckland Park, South Africa
Elena Blokhina
Global Health Institute, St. Petersburg, Russian Federation
Evgeny Krupitsky
V.M. Bekhterev National Medical Research Center for Psychiatry and Neuroology, St. Petersburg, Russian Federation
Introduction 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.
