The international study on alcohol and infectious diseases: three priorities for research

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A technical consultation held in Cape Town in February 2012 identified three priorities for research aimed at taking the alcohol and infectious diseases agenda forward. This agenda has the potential to be a catalyst for changes in how health services treating HIV and/or tuberculosis (TB) patients address harmful use of alcohol.

As a follow up to prior meetings held in Cape Town in 2008 [1] and in Stockholm in 2009, a technical consultation on alcohol and infectious diseases took place in Cape Town in February 2012. Specific objectives included designing research projects that would speak to the issues of measuring alcohol use and alcohol use disorders (AUDs) among people with HIV/AIDS and/or TB; evaluating the effect of drinking on HIV/AIDS and/or TB incidence, clinical course and treatment outcomes; and assessing the feasibility and impact of interventions for problem drinking and AUDs for people living with HIV/AIDS and/or TB as part of an integrated treatment and management package to be provided within healthcare settings. In addition, the general aim was to increase our understanding about alcohol as a causal factor for both HIV/AIDs [2] and TB [3].

The meeting was organized by the South African Medical Research Council (MRC) in consultation with, and with the support of, the World Health Organization (WHO) Headquarters and Regional Office for Africa and the Canadian Centre for Addiction and Mental Health. The 28 participants came from Canada, India, Kenya, Nigeria, South Africa, Tanzania, Thailand and the USA. The group also included three technical experts from the WHO and one technical expert from the Centers for Disease Control (CDC) (based in Botswana).

The group identified three areas of research that should be prioritized to better understand the relationship between alcohol and infectious diseases and inform policy and practice for interventions. 1) Prevalence studies among the HIV and TB patient populations to obtain baseline information on patterns of drinking, sexual HIV risk behaviours and information on treatment, including adherence for those on ART and TB medication. 2) Randomised control trials (RCTs) to evaluate evidenced-based, alcohol-focused interventions on reducing the risk of acquiring HIV among uninfected person. 3) RCTs to evaluate evidenced-based alcohol-focused interventions on treatment adherence and response among persons initiating treatment for HIV and/or TB.

Studies in Area 2 would seek to answer the question of whether an intervention to reduce hazardous and harmful use of alcohol would result in reduced risk of infection for HIV. There was consensus that the study should be a randomised clinical trial (RCT) at an African site among populations with high risk for acquiring HIV, such as persons going to HIV counselling and testing (HCT) centres, persons going to clinics to be treated for sexually transmitted infections (STIs), or persons frequenting bars or other liquor outlets displaying signs of hazardous and harmful drinking [assessed using the Alcohol Use Disorders Identification Test (AUDIT) [4]]. The manipulated experimental conditions would comprise a brief intervention (BI) for alcohol [5] which could be delivered together with other interventions. A control group would be given a nutritional intervention of similar length to the BI, but not address drinking behaviour. Outcomes identified included self-reported risky sex, STIs and alcohol consumption, supported by assessment of biomarkers, such as semen in the vagina and anus (for STIs), and a linear combination of gamma-glutamyl-transferase (GGT) and carbohydrate-deficient transferrin (CDT) [6] for heavy alcohol use.

Studies in Area 3 would seek to evaluate the impact of alcohol-related interventions in persons who were initiating HIV or TB treatment recruited from healthcare settings, such as HIV or TB clinics. Co-infected patients could be a focus in future research. In one study focusing on TB patients, all patients would be screened for HIV; those testing positive would be excluded. Potential participants would also be screened for hazardous/harmful alcohol use using the 3-item AUDIT-C [7] or full 10-item AUDIT [4]. The Mini International Neuropsychiatric Interview [8] could also be undertaken. Study participants would be assigned randomly to either the experimental or control conditions. The control condition would comprise ‘standard care for TB’ and the experimental/intervention condition would comprise three sessions of BI focusing on alcohol and other health issues (including management of TB). Outcome measures would include adherence to TB treatment, TB cure/treatment completion, defaulting from TB treatment, treatment failure, death and also alcohol use, including biomarkers (GGT-CDT). The HIV track (among HIV patients initiating HIV treatment) is similar to that described earlier for TB patients with the exception that such patients would be screened for TB and those patients testing positive would be excluded. Outcomes would include measures of adherence to HIV treatment (such as stopping or defaulting on treatment), viral load, CD4 counts, treatment failure, resistance testing and biomarkers for heavy alcohol use (GGT-CDT).

Research protocols corresponding to the efficacy and effectiveness studies will be prepared. They will need to be considered by the WHO Ethical Review Committee and then submitted for endorsement as part of the broader WHO International Research Initiative on Alcohol, Health and Development. Once this has occurred they can be made available to researchers around the world to access and an open, virtual network will be established by the MRC. Prospective collaborators in the network will be encouraged to prepare national applications drawing on/guided by the methodology set out in the model protocols. The intention is to have all collaborators share core elements of the protocol and in this way comparative analyses will be possible. The rollout of the WHO International Collaborative Research Project on Alcohol and Infectious Diseases will thus occur as a result of a step-by-step process, with more and more countries being added over time as they secure funding for national studies.

The technical consultation provided a platform for taking the alcohol and infectious diseases agenda forward by clarifying three priorities for future research. Substantial progress was made in designing particular research projects that could be undertaken by countries as funding becomes available. This agenda has the potential to be a catalyst for a range of research initiatives, ensuring that they answer questions that are important for both theory and practice. It also has the potential to act as a stimulus for on the ground programmatic changes in how health services treating HIV and/or TB patients address harmful use of alcohol.

Declaration of interests

None.

Acknowledgements

The technical consultation meeting and the preparation of this report were supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the US Centers for Disease Control and Prevention (CDC) under the terms of Cooperative Agreement Number U2G/PS001137-03. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the CDC or the World Health Organization.

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