BACKGROUND: Accurately quantifying alcohol use among persons with HIV (PWH) is important for validly assessing the efficacy of alcohol reduction interventions. METHODS: We used data from a randomized controlled trial of an intervention to reduce alcohol use among PWH who were receiving antiretroviral therapy in Tshwane, South Africa. We calculated agreement between self-reported hazardous alcohol use measured by the Alcohol Use Disorders Identification Test (AUDIT; score ≥8) and AUDIT-Consumption (AUDIT-C; score ≥3 for females and ≥4 for males), heavy episodic drinking (HED) in the past 30 days, and heavy drinking in the past 7 days with a gold standard biomarker--phosphatidylethanol (PEth) level (≥50 ng/mL)--among 309 participants. We used multiple logistic regression to assess whether underreporting of hazardous drinking (AUDIT-C vs. PEth) differed by sex, study arm, and assessment time point. RESULTS: Participants mean age was 40.6 years, 43% were males, and 48% were in the intervention arm. At 6 months, 51% had PEth ≥50 ng/mL, 38% and 76% had scores indicative of hazardous drinking on the AUDIT and AUDIT-C, respectively, 11% reported past 30-day HED, and 13% reported past 7-day heavy drinking. At 6 months, there was low agreement between AUDIT-C scores and past 7-day heavy drinking relative to PEth ≥50 (sensitivities of 83% and 20% and negative predictive values of 62% and 51%, respectively). Underreporting of hazardous drinking at 6 months was associated with sex (OR = 3.504. 95% CI: 1.080 to 11.364), with odds of underreporting being greater for females. CONCLUSIONS: Steps should be taken to decrease underreporting of alcohol use in clinical trials.

BACKGROUND AND AIMS: Reduction of alcohol consumption is important for people undergoing treatment for HIV. We tested the efficacy of a brief intervention for reducing the average volume of alcohol consumed among patients on HIV antiretroviral therapy (ART). DESIGN, SETTING AND PARTICIPANTS: This study used a two-arm multi-centre randomized controlled trial with follow-up to 6 months. Recruitment occurred between May 2016 and October 2017 at six ART clinics at public hospitals in Tshwane, South Africa. Participants were people living with HIV, mean age 40.8 years [standard deviation (SD) = 9.07], 57.5% female, and on average 6.9 years (SD = 3.62) on ART. At baseline (BL), the mean number of drinks consumed over the past 30 days was 25.2 (SD = 38.3). Of 756 eligible patients, 623 were enrolled. INTERVENTION: Participants were randomly assigned to a motivational interviewing (MI)/problem-solving therapy (PST) intervention arm (four modules of MI and PST delivered over two sessions by interventionists) or a treatment as usual (TAU) comparison arm. People assessing outcomes were masked to group assignment. MEASUREMENTS: The primary outcome was the number of standard drinks (15 ml pure alcohol) consumed during the past 30 days assessed at 6-month follow-up (6MFU). FINDINGS: Of the 305 participants randomized to MI/PST, 225 (74%) completed the intervention (all modules). At 6MFU, retention was 88% for the control and 83% for the intervention arm. In support of the hypothesis, an intention-to-treat-analysis for the primary outcome at 6MFU was -0.410 (95% confidence interval = -0.670 to -0.149) units lower on log scale in the intervention group than in the control group (P = 0.002), a 34% relative reduction in the number of drinks. Sensitivity analyses were undertaken for patients who had alcohol use disorders identification test (AUDIT) scores ≥ 8 at BL (n = 299). Findings were similar to those of the whole sample. CONCLUSIONS: In South Africa, a motivational interviewing/problem-solving therapy intervention significantly reduced drinking levels in HIV-infected patients on antiretroviral therapy at 6-month follow-up.

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.