A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART

According to the World Health Organization (WHO), alcohol abuse is one of the top three causes of health related problems apart from child underweight and unsafe sex [1]. In low and middle income countries, AUDs cause 19.5 million Disability Adjusted Life Years (DALYS) [2]. Harmful alcohol use results in 3.3 million deaths per year globally. In 2012, according to WHO alcohol use contributed 5.1% to the global burden of diseases or 139 million net DALYS. Zimbabwe is a country with one of the highest per capita alcohol consumption rates in the WHO Afro-Region at 5.7 l per capita per year in 2010 [3].

Alcohol consumption is high among people living with HIV/AIDS (PLWHA) especially hazardous alcohol consumption and this is associated with decreased survival [4]. Studies have also shown that alcohol consumption is linked to HIV infection, adherence to the highly effective antiretroviral therapy (HAART), HIV prevention, delayed testing and treatment, and general poor outcome in HIV care and treatment [5, 6]. PLWHA are at increased risk of physiologic injury such as liver disease from alcohol [7].

Heavy episodic drinking is common in sub-Saharan Africa, the epicentre of the HIV pandemic [8]. The quantity of alcohol consumed is more closely related to HIV infection than the frequency although some studies have indicated that the drinking context is as important [9]. In addition to alcohol and other drug abuse, depression, anxiety and psychosis, are linked to non-adherence to HAART and to treatment interruptions [10‐12]. In order to achieve adequate viral suppression and improve adherence to HAART, AUDs and other psychiatric disorders need to be appropriately treated. Wu et al., after controlling for adherence, showed that daily consumption of alcohol was associated with a viral load increase, while reduction of alcohol intake to once weekly intake was associated with a reduction in viral load [13].

There is evidence that alcohol affects the functioning of the human immune system negatively [14]. Alcohol has been shown to increase the concentration of HIV RNA in semen and the vagina [15]. There is also some evidence that vaginal shedding of viral RNA is increased by alcohol which is associated with increased infectiousness [16].

AUDs and low adherence to HAART are associated with poor health outcomes and quality of life [17, 18], while simplification of HAART has been associated with improved adherence and quality life [19, 20]. Alcohol consumption has implications for HIV treatment through direct toxic effects on the liver and the interactions with HAART [21, 22].

Despite the high prevalence of alcohol use disorders among people living with HIV/AIDS (PLWHA) and the potential for adverse health consequences, there is not enough contextual evidence for behavioural interventions for AUDs in African settings. Motivational interviewing (MI), cognitive behavioural therapy (CBT), problem solving, and risk reduction are some of the evidence-based treatments that have been used to treat alcohol use disorders [23]. MI and CBT have been used both in combination and separately [24].

Sub-Saharan Africa suffers from the world’s most pronounced crisis in terms of human resources for health [25]. A streamlined and rationalized chain of care that relieves pressure on individual workers is needed. However this chain of care for patients, while increasing access to and uptake of interventions, must be quality assured [26]. Up skilling various cadres of staff to provide services that are normally delivered by highly skilled workers is recommended [27]. Task sharing has been proposed as an approach to provide services that are normally provided by highly skilled staff by the lesser skilled through training and provision of treatment manuals. For task-sharing to work, attention needs to be paid to the selection of staff, their current workload, the adequacy of training, and the availability of manualised interventions [28]. Supervision and support visits are essential for quality control and maintaining fidelity [29]. Task-sharing has the potential to build capacity and integrate HIV care, thereby also addressing the gap that results from health worker attrition due to immigration and HIV [30].

Most studies on HIV in Zimbabwe have focused on behavioural change with particular emphasis on risk reduction and adherence to HAART. There have been no studies of the management of AUDs among PLWHA in Zimbabwe. This is to our knowledge, the first intervention study that specifically targets AUDs in PLWHA. This intervention for AUDs intervention will be compared with the mhGAP intervention guide alcohol use management module which is a part of the WHO Mental Health Gap Action Programme (WHO mhGAP) [31]. The mhGAP intervention guide was developed for primary care settings and has been used in developing countries for the identification and management of various mental and neurological and substance use disorders (MNS).

In this study it is hypothesized that an adapted MI/CBT intervention will lead to a significant reduction in alcohol use in PLWHA. It is further hypothesized that reduction in alcohol use will lead to improved function as measured by the WHODAS 2.0, improved quality of life as measured by the WHOQoL HIV, and improved adherence to HAART as measured by the CD4 and viral load. This study further seeks to establish whether registered general nurses in primary health care facilities in Zimbabwe will be effective in providing the MI/CBT intervention to reduce alcohol use and improve patient engagement with treatment.

We will test the effectiveness of an MI/CBT intervention that can be used by RGNs for alcohol reduction in PLWHA. If successful, the intervention will be implemented in HIV clinics in Zimbabwe and other settings where general nurses oversee HIV treatment. We hypothesize that patients may view their ability to return to work as important and this may motivate them to adhere to the treatment. Improved quality of life has been shown to improve adherence in other studies.

Given that most behavioural interventions for alcohol use have been developed within a Western framework, the use of an adapted intervention in this study will inform us about its effectiveness in reducing alcohol use in PLWHA in a resource limited setting. In resource rich environments, inpatient and outpatient services for addictions are usually widely available. However, in Zimbabwe, as in many other resource-limited settings, inpatient management of AUDs may be unaffordable for the majority. Outpatient care, if available, is the rule rather than the exception.

To the authors’ knowledge, no published study from Zimbabwe has examined functioning and quality of life in PLWHA with AUDs. Improvement in functioning and quality of life are key aspects to address in this population. Quality of life has been shown to improve upon initiation of HAART (http://​www.​stata.​com) and studies in other countries have documented an improvement in adherence with an improvement in quality of life [61]. Over a quarter of 15–49 year olds in sub-Saharan Africa are living with AIDS [62]. Given that this is the most productive age group in the community, improving functioning will likely have positive socio-economic impacts on the community.

There are few limitations that warrant mention. Firstly, we will use a self-report screening measure of drinking. Self-report may not accurately reveal drinking quantity and behaviour. That said, the AUDIT has excellent sensitivity and specificity and cross-cultural applicability and can be used in remote areas where sampling for alcohol biomarkers may be challenging. Secondly, brief interventions have been shown to be more useful when provided at community level although the lack training often hampers provision at community level. Thirdly, viral suppression may not correlate well with adherence; even in resource rich settings viral suppression can be low despite an adherence of 80–95%. In this study viral load will be a proxy measure of adherence. CD4 count in addition to the viral load will be used as a measure of adherence.

This is a task-sharing intervention study. It is hoped that, upon successful completion of this study, RGNs from district hospitals and municipal health facilities will be trained in recognising and managing AUDs in HIV infected patients.