Background Alcohol use in HIV infected patients is associated with risky sexual behaviour, poor adherence to Highly Active Antiretroviral Therapy, treatment failure and increased physiologic harm. The objectives of the study were to pilot the outcome assessments to be used in the trial proper, assess the feasibility of delivery of a brief MI/CBT intervention compared to an WHO mhGAP intervention for problematic alcohol use in PLWH in Zimbabwe, and pilot the effectiveness (on alcohol use, functionality and CD4 count) of these interventions at 3 months in a randomised controlled trial design. Methods An intervention for HIV infected patients with problematic alcohol use, developed through adaptation of existing evidence based psychological treatments, was assessed for its feasibility at a tertiary HIV care clinic in Zimbabwe. Registered general nurses, using a manualised protocol, delivered the intervention. Forty patients were recruited and randomised to receive either an MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n = 20 patients per group). Results Out of 40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23%. There was a statistically significant decrease in AUDIT score over time in both groups ( p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70. For the CD4 count, the median and interquartile ranges at baseline for MI/CBT and WHO mhGAP IG groups were 218 (274) and 484 (211.50), respectively. At follow-up, median and interquartile ranges for the CD4 count for MI/CBT and WHO mhGAP IG groups were 390 (280) and 567 (378), respectively, indicative of improvement in immunological parameters in both arms. Conclusion The findings from this pilot study suggests that a brief MI/CBT delivered by Registered General Nurses for problematic alcohol use is feasible in this population but will require the implementation of additional measures to improve retention. However, mechanisms to improve retention need special attention. Trial registration Pan African Clinical Trial Registry, current PACTR201509001211149
Introduction There have been very few randomized clinical trials of interventions for alcohol use disorders (AUD) in people living with HIV (PLWH) in African countries. This is despite the fact that alcohol use is one of the modifiable risk factors for poor virological control in PLWH on antiretroviral therapy. Methods Sixteen clinic clusters in Zimbabwe were selected through stratified randomization and randomized 1: 1 to Intervention and Control arms. Inclusion criteria for individual participants were being adult, living with HIV and a probable alcohol use disorder as defined by a score of 6 (women) or 7 (men) on the Alcohol Use Disorders Identification Test (AUDIT). In the Intervention clusters, participants received 8 to 10 sessions of Motivational Interviewing blended with brief Cognitive Behavioural Therapy (MI‐CBT). In the control clusters, participants received four Enhanced Usual Care (EUC) sessions based on the alcohol treatment module from the World Health Organisation mhGAP intervention guide. General Nurses from the clinics were trained to deliver both treatments. The primary outcome was a change in AUDIT score at six‐month post‐randomization. Viral load, functioning and quality of life were secondary outcomes. A random‐effects analysis‐of‐covariance model was used to account for the cluster design. Results Two hundred and thirty‐four participants (n = 108 intervention and n = 126 control) were enrolled across 16 clinics. Participants were recruited from November 2016 to November 2017 and followed through to May 2018. Their mean age was 43.3 years (SD = 9.1) and 78.6% (n = 184) were male. At six months, the mean AUDIT score fell by −6.15 (95% CI −6.32; −6.00) in the MI‐CBT arm, compared to a fall of − 3.09 95 % CI − 3.21; −2.93) in the EUC arm (mean difference −3.09 (95% CI −4.53 to −1.23) ( p = 0.05). Viral load reduced and quality of life and functioning improved in both arms but the difference between arms was non‐significant. Conclusions Interventions for hazardous drinking and AUD comprising brief, multiple alcohol treatment sessions delivered by nurses in public HIV facilities in low‐income African countries can reduce problematic drinking among PLWH. Such interventions should be integrated into the primary care management of AUD and HIV and delivered by non‐specialist providers. Research is needed on cost‐effectiveness and implementation of such interventions, and on validation of cut‐points for alcohol use scales in low resource settings, in partnership with those with lived experience of HIV and AUD.
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