Chapter 1 Introduction Background Since the beginning of the HIV pandemic

Chapter 1
Introduction

Background

Since the beginning of the HIV pandemic, HIV has caused 35 million deaths, 37 million are living with the infection, 1.9 million were infected in 2016, 20.9 million were on antiretroviral therapy as at June 2017, and by 2020 US$ 26.2 billion will be required to address HIV/AIDS in low and middle income countries(UNAIDS, 2017). Although the first infection was documented among injection drug users and gay men in the USA (Center), in Sub-Saharan Africa the main mode of infection is through heterosexual contact (Bulletin, 2001). Sub Saharan Africa has two thirds of all infections(2018, 2018), while in Zimbabwe 1.6 million individuals are infected with 75% knowing their HIV status, HIV and 75% of those infected on antiretroviral treatment and 64% virally suppressed(Organization, 2017; phia.icap.columbia.edu/wp-content/uploads/2016/…/ZIMBABWE-Factsheet.FIN_.pdf).

Mental illness has been shown to be associated with poor HIV disease treatment outcomes(Mayston, Kinyanda, Chishinga, Prince, & Patel, 2012). People with HIV infection are at increased risk of mental illness with more than twice the risk of depression, alcohol and substance use and anxiety disorders(Ezeamama et al., 2016; Galvan et al., 2002; Kinyanda, Hoskins, Nakku, Nawaz, & Patel, 2011). Psychiatric disorders have been shown to negatively impact adherence(Heestermans, Browne, Aitken, Vervoort, & Klipstein-Grobusch, 2016). Alcohol and substance use disorders have been especially implicated in non-adherence and other mental health problems related to poor HIV treatment outcomes(Palepu, Horton, Tibbetts, Meli, & Samet, 2004).

Alcohol use disorders (AUDs), as defined by the American Psychiatric Association Diagnostic Statistical Manual Version 5 (DSM-5) are characterized by excessive consumption of alcohol leading to specific syndromes such as intoxication, withdrawals and tolerance((2013). 2013).

AUDs and HIV transmission

Alcohol users are at increased risk of HIV infection(Kalichman, 2010).(Fisher, Bang, & Kapiga, 2007; Hurley et al., 2017) The increased risk of infection with HIV is related to both behavioural and biological factors(better, Coates, & The Lancet ). Alcohol consumption leads to risky behaviour that includes increased unprotected sex, transactional sex and multiple partners (Pitpitan et al., 2014; Watt et al., 2012). Alcohol-serving venues are frequently visited by individuals who have multiple sex partners and who engage in transactional sex(Kalichman, Simbayi, Vermaak, Jooste, & Cain, 2008; Staras, Maldonado-Molina, Livingston, & Komro, 2012). Alcohol use has been associated with sexually transmitted infections due to risky sex(Morojele et al., 2006). This is important as HIV infection requires a breach in the vaginal epithelium which is facilitated by sexually transmitted infection(Sales, Brown, Vissman, & DiClemente, 2012). Besides, alcohol use increases risk of bacterial vaginosis increasing the risk of acquiring sexually transmitted infection(Francis et al., 2016). Research has shown an increased infectiousness in women who drink with underlying biological factors such as inflammation and accumulation of monocytic phagocytes and T-cells processes which facilitate HIV infection are believed to be involved(Rassjo, Mirembe, & Darj, 2006; Theall, Amedee, Clark, Dumestre, & Kissinger, 2008).

AUDs and the HIV treatment cascade

Studies have shown that individuals who drink alcohol are less likely to present for HIV testing or delay in HIV testing, and delay in the commencement antiretroviral therapy (ART)(Vagenas et al., 2015). As a result, by the time that individuals test for HIV they are at an advanced stage of HIV disease and are likely to have poor treatment outcomes(Marshall et al., 2017). Alcohol, HIV and hepatitis C often co-occur and negatively affect the metabolism of antiretroviral drugs(Puoti, Moioli, Travi, & Rossotti, 2012). The resulting liver disease can lead to increased antiretroviral drug toxicity and reduced effectiveness of ART(Marshall et al., 2017).

AUDs and adherence

The association between poor adherence to HIV treatment and alcohol consumption has been well established(Amin & Douaihy, 2018; Braithwaite & Bryant, 2010; Gordon et al., 2017; Heestermans et al., 2016; Shubber et al., 2016). Both the frequency of drinking and quantity of drinking results in poor adherence to HIV treatment (). AUDs often co-occur with depression and both have been associated with poor adherence to ART (). Alcohol consumption is associated with cognitive impairment and memory loss that often cause patients to forget taking antiretroviral drugs (). Studies have also shown that some PLWH, through inappropriate HIV treatment education and messaging, believe that ARVs and alcohol should not be taken together as the combination could be poisonous(Kalichman et al., 2012). Further, many patients take their medications ‘out of time’ on drinking days and this may lead to suboptimal effects of ARVs and hence non-suppression(Kalichman et al., 2013).

AUDs and viral suppression and CD4

AUDs are often associated with poor viral suppression(Chander, Lau, & Moore, 2006). In as far as CD4 counts are concerned, AUDs have been shown to be associated with low CD4, especially in dependent drinkers (). However, unhealthy users and recent commencement on ART has not been shown to lead to a rapid increase of CD4(). The failure to suppress the HIV virus is mainly due to poor adherence (). Apart from poor adherence, drinking leads to poor nutritional habits, poor absorption of nutrients (). Although non-suppression may be related to poor adherence, other factors such as concurrent mental health problems and nutrition may be contributory (Kalichman et al., 2014). Given the importance of viral suppression that results from HIV treatment in new HIV infections prevention, it is important to attain viral suppression ().

Safe Drinking and HIV

World Health Organisation recommend safe drinking of 14 units per week for females and 21 units per week for males (). The safe drinking limits are however different for pregnant women and the elderly (). However, the population most affected by HIV are the 15-49-year age-groups, who will qualify for the safe drinking limits above (). However, safe drinking that applies to HIV negative individuals may not be applicable to individuals who are HIV positive, as studies have shown that HIV infected individuals need less alcohol to experience a ‘buzz’ or to feel intoxicated(R. Scott Braithwaite et al., 2008).

Research has shown that compared with HIV negative individuals, HIV positive individuals suffer more physiological harm from alcohol(Justice et al., 2016). The effects of alcohol on the brain is affected by the levels of viral suppression. HIV positive individuals who are virally unsuppressed need much less quantities of alcohol to get drunk compared with those who have achieved viral suppression (R. S. Braithwaite et al., 2008; McGinnis et al., 2016).

Alcohol consumption has been shown to increase inflammatory activities in the vaginal canal (). As a result, females who are HIV positive who consume alcohol have also been shown to be at increased risk of passing on the HIV virus compared to those who do not drink(Theall et al., 2008).

Assessment of AUDs

Alcohol consumption has been assessed using surrogate measures such as liver transaminases and mean corpuscular volume and self-report assessments such as the Alcohol use disorders identification test (AUDIT). AUDIT-consumption and the CAGE. The self-report questionnaires that are often used have social desirability bias as the main disadvantage (). Changes in liver enzymes can be caused by a range of liver pathologies and the same with the red blood cell changes (). Phosphotidylethanol has been shown to be robust in assessing alcohol use and treatment effectiveness(Viel et al., 2012). These markers are, however, expensive and may be unaffordable in low and middle income contexts(Freyer, Morley, & Haber, 2016). Screening for alcohol use is an important component of Screening and Brief Interventions (SBI), which has the most evidence for effectiveness and found in many guidelines for treatment of AUDs in general population (Kaner et al., 2009).

AUD Interventions in PLWH

Alcohol use has been recognized as a modifiable risk factor in HIV prevention and treatment failure.(Gordon et al., 2017) Despite the availability of many intervention modalities, few have proven effective in reducing alcohol use(Brown, DeMartini, Sales, Swartzendruber, & DiClemente, 2013). Some of the reasons may have to do with multiple morbidities in HIV, the extent of alcohol use, the differences in the levels of experience in intervention staff and dose of the interventions(Brown et al., 2013). As patients with AUDs differ in the severity of their disorder, patients with heavy alcohol use and dependence may benefit from a stepped up model of care(Jaehne et al., 2012). As such, pharmacological interventions may be needed to complement psychotherapeutic and psychosocial modalities(Addolorato et al., 2002).

Evidence based treatments for AUDs are motivational therapies and cognitive behaviour therapies (Brown et al., 2013). The individual studies have been too heterogenous to allow for pooled effects in meta-analyses to allow recommendations of particular treatment modality (). Some interventions have used a combination of both(Parsons, Golub, Rosof, & Holder, 2007). Data on the effectiveness of these interventions have not been consistent(Brown et al., 2013; Samet & Walley, 2010). High levels of alcohol use may require more intensive interventions(Saitz, 2010). The interventions may require a combination of psychological and pharmacological approaches in a stepped care design(Edelman et al., 2017). However, again due to the multiple comorbidities, pharmacological treatments for AUDs may be faced with similar adherence challenges as with ART.

Task sharing in AUDs and HIV Care

Many countries that have a high burden of HIV infection also face severe staff shortages (). As a result, additional staff to deliver these interventions for AUDs may not be available (). A task-sharing has been touted as the solution, though it may require additional training and necessary funding (). Indeed, WHO recommends task sharing as the approach of choice ().

The HIV/AUD situation in Zimbabwe

Zimbabwe has a per capita consumption of about 6litres of alcohol according to World Health Organisation(Organisation, 2014). With a large burden of HIV and substantial levels of alcohol consumption, a huge proportion of the people living with HIV (PLWH) in Zimbabwe are suspected to have unhealthy alcohol consumption. People living with HIV have high prevalence of alcohol use according to research from the US(Galvan et al., 2002). AUDs are associated with risky sexual behaviour, delayed testing of HIV, delayed commencement of HIV treatment, and high levels of unplanned treatment interruptions(Monroe et al., 2016; Morrison, DiClemente, Wingood, & Collins, 1998). WHO initiated the ‘test and treat’ policy, as defined in current HIV management guidelines, which has led to many more people now on treatment(WHO, 2016). The focus currently is on achieving the 90-90-90 targets, asset by the UNAIDS, which means that by 2020, 90% of people infected with HIV will know their status, 90% will receive HIV treatment and 90% will be virally suppressed with a view to eliminating HIV by 2030(UNAIDS, 2018).

Research question

Does a behavioural intervention for alcohol use disorder in PLWH, as offered by registered general nurses in a resource limited setting, lead to a reduction in alcohol use (as measured by the AUDIT), and an improvement in functional capacity, quality of life and adherence to HAART (as measured by the viral load and CD4)?

Hypothesis

1. An adapted MI-CBT intervention will lead to reduction in AUDs among PLWA.
2. An adapted MI-CBT intervention to reduce AUDs in PLWA compared to World Health Organisation mental health GAP Intervention Guide( mh GAP IG) will lead to reduction in alcohol use, adherence to HAART and significantly greater improvement in functional capacity and quality of life.

Specific aims

1. To evaluate the effect of an adapted Motivational Interviewing and Cognitive Behavioural Therapy (MI-CBT) intervention in people living with AIDS (PLWA) on alcohol use outcomes.
2. To assess whether an adapted MI-CBT intervention for Alcohol Use Disorders (AUDs) in PLWA compared with the World Health Organisation mental health GAP Intervention Guide( mh GAP IG) as delivered by Registered General Nurses (RGN) improves their functional ability and quality of life.
3. To establish whether an adapted MI-CBT intervention for AUD in PLWA compared with mhGAP IG as delivered by RGN can lead to better treatment adherence in Zimbabwe as measured by viral loads and CD4.

General methods

A full description of the study methodology is included in the accompanying manuscripts.

Ethical considerations

The Health Research Ethics Committee (SI14/10/222) of Stellenbosch University, Cape Town, and the Medical Research Council of Zimbabwe (A/1936), Harare, Zimbabwe approved the study.

To inform the development of the intervention, a systematic review of evidence for the psychological evidence-based therapies for AUDs in general and AUDs in PLWH in particular was done. A qualitative study to assess the perceptions of drinking in the context of HIV was undertaken among 39 PLWH and in-depth interviews with 5 experts in mental health and HIV care. Further, a pilot and feasibility study were done at a central Zimbabwean hospital in 40 people living with HIV. In order to answer our research question, a cluster randomised controlled trial involving 16 HIV care clinics was done. Results of these studies are in the accompanying manuscripts.

Systematic review of psychological interventions for alcohol use disorders in PLWH

In this manuscript we followed PRISMA guidelines to systematically review the literature on interventions designed to test empirically proven psychological interventions for AUDs in PLWH. See methods section of the review manuscript.

Development of the intervention protocol

The aim was to develop a framework for the study, outline the process of developing the MI/CBT and control interventions, provide background to the assessment measures used in the study and incorporate quantitative findings from a pilot and feasibility study, as well as the findings from a qualitative study.

Qualitative study to understand knowledge and perceptions of the effects of drinking in the context of HIV infection

The study aimed to describe and understand the perceptions and impact of alcohol use in a sample of HIV positive individuals. The methods are fully described in the article.

Pilot and feasibility study of an alcohol use disorder intervention

The aim of the study was to assess the feasibility of doing a cluster randomised controlled trial on the effectiveness of motivational interviewing/Cognitive behavioural therapy (MI/CBT) intervention for AUDs compared to an WHO mh GAP IG in PLWH in Zimbabwe. The aims and methods are discussed in the manuscript below.

Alcohol use disorders intervention in PLWH in Zimbabwe: a cluster randomised controlled trial (RCT)

The overall aim of the RCT was to compare the effectiveness of an MI/CBT compared to mh GAP IG on a number of primary and secondary outcome parameters as well as the effectiveness of using trained registered general nurses in delivering manualised interventions. The methods used in this study are outlined in the manuscript.

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