Effectiveness of a psychological intervention delivered by general nurses for alcohol use disorders in people living with HIV in Zimbabwe: a cluster randomized controlled trial.

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.

Intervention for alcohol use disorders at an HIV care clinic in Harare: a pilot and feasibility study.

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.

Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative.

Biobanks and human genomics applications are key for understanding health, disease and heredity in Africa and globally. Growing interest in these technologies calls for strengthening relevant legal, ethical and policy systems to address knowledge disparities and ensure protection of society, while supporting advancement of science. In Zimbabwe there is limited understanding of ethical, legal, and societal issues (ELSI) for biobanking and genomics. The Genomics Inheritance Law Ethics and Society (GILES) initiative was established in 2015 to explore the current status and gaps in the ethical and legal frameworks, knowledge among various stakeholders, and to establish capacity for addressing ELSI of biobanking and genomics as applied in biomedical and population research, and healthcare. A multi-methods approach was applied including document reviews, focus group discussions and in-depth interviews among health and research professionals, and community members in six provinces comprising urban, peri-urban and rural areas. Emerging findings indicates a need for updating guidelines and policies for addressing ELSI in biobanking and genomics research in Zimbabwe. Emerging terminologies such as biobanking and genomics lack clarity suggesting a need for increased awareness and educational tools for health professionals, research scientists and community members. Common concerns relating to consent processes, sample and data use and sharing, particularly where there is trans-national flow of biospecimens and data, call for nationally tailored ELSI frameworks aligned to regional and international initiatives. This paper describes the strategy undertaken for the development and implementation of the GILES project and discusses the importance of such an initiative for characterisation of ELSI of human biobanking and genomics in Zimbabwe and Africa. Conducting this explorative study among a wide range of stakeholders over a countrywide geographical regions, established one of the most comprehensive studies for ELSI of human biobanking and genomics in Africa.

Perceptions of alcohol use in the context of HIV treatment: a qualitative study.

BACKGROUND: Alcohol use is associated with poor HIV treatment outcomes. This study aimed to understand patients' perceptions of the impact of alcohol use in the context of HIV care. METHODS: The study design was a descriptive qualitative study of HIV positive individuals receiving antiretroviral treatment. The study involved four focus group discussions with male and female participants at a tertiary center, city clinic, and rural church. We employed convenience sampling and invited patients coming for their routine visits and medication refills to participate. RESULTS: Participants had an awareness of both the direct and indirect effects of alcohol use. The direct effects related to the incompatibility of HIV medication and alcohol. The indirect effects related to the negative impact of alcohol on treatment adherence. Participants proffered reasons why HIV infected individuals on HIV treatment drink and felt that patients had to make a deliberate choice to stop drinking. Participants displayed some knowledge of interventions for drinking cessation and highlighted the use of pharmacological interventions to stop drinking. Participants indicated that they preferred HIV counselors to provide counseling services in view of the existing relationships that patients had with counselors. CONCLUSION: People living with HIV have adequate knowledge of the effects of alcohol use in the context of HIV treatment. Stigma and the time taken to engage in an alcohol use intervention appeared to be the main impediments to uptake. The current model of HIV treatment, based on trust with the HIV care team, and maintenance of this trust, could bolster the uptake of an intervention. Involvement of HIV patients in their treatment is necessary to improve treatment outcomes in the context of alcohol use.