CHAPTER ONE

Introduction

1 .1     Background to the Study

The World Health Organization (WHO) recommendations on the use of antiretroviral therapy in the treatment of Human immune-virus positive patients recognize the critical role of adherence in order to achieve clinical and programmatic success (Machtinger & Bangsberg, 2006). Adherence is an extent to which a patient consumes an agreed treatment plan (Hornby, 2001). The term adherence has been defined as the extent to which a person’s behavior in terms of taking medications, following diets or executing life style changes coincides with medical or health advice (Haynes, Taylor & Sackett, 1979). Jani (2002) defined adherence to HIV medication as the ability of the person living with HIV and AIDS to be involved in choosing, starting, managing and maintaining a given therapeutic combination medication regimen to control viral replication and improve immune function.

Adherence to the highly active antiretroviral treatment regimen appears to be the single most important factor that predicts a patient’s ability to achieve and maintain suppression of HIV viraemia to below the level of detection (Paterson, Swindles & Mohr, 2000). According to Garcia, Schooley and Badaro (2003), adherence is the extent to which a patient’s behavior coincides with prescribed regimen as agreed upon through a shared decision making process between the client and its health care provider.  Here the patient takes an active part in this collaborative process by understanding and implementing the treatment plan. This is a result of a complex interaction between the patient, a prescribed medication and the health system. Medication adherence is crucial for successful treatment, that is, clinically significant viral load reduction (Lopez, Jones, Ishii, Tobin & Weiss, 2007).   According to Cooper, Gellartry Hankins, Fisher and Horne (2009) maintaining optimal levels of adherence over a lifetime is difficult.  Hence obtaining the full benefits of ART is a complex individual behavioural process determined by many broader factors including patient attributes and healthcare systems.

Therefore strict adherence to antiretroviral therapy is the key to sustained HIV suppression, reduced risk of drug resistance, improved overall health, quality of life and survival, as well as decreased risk of HIV transmission (WHO 2003; Chesney, 2006; & Cohen, Chen & McCauley, 2011). Conversely, poor adherence is the major cause of therapeutic failure.

Achieving adherence to ART is a critical determinant of long-term outcome in HIV infected patient. The loss of virology control as a consequence leads to emergence of drug resistance and loss of future treatment options.  Many patients initiating ART or already on therapy are able to maintain consistent levels of adherence with resultant viral suppression, CD4+ T-lymphocyte (CD4) count recovery, and improved clinical outcomes. Others however, have poor adherence from the outset of ART and or experience periodic lapses in adherence over lifelong course of treatment.

Human Immunodeficiency Virus (HIV) and Acquired Immuno Deficiency Syndrome (AIDS) is an epidemic that affects every part of the world. HIV, the virus that causes AIDS, is one of the world’s most serious health and development challenges. According to World Health Organization (WHO, 2014) there were approximately 35 million people worldwide living with HIV and AIDS in 2013.  Of these 3.2 million were children less than 15 years old.An estimated 2.1 million individuals worldwide became newly infected with HIV in 2013.  This includes over 240,000 children. Most of these children live in sub-Saharan Africa and were infected by their HIV positive mothers during pregnancy childbirth or breastfeeding. The WHO report further indicated that 1.5 million people died of AIDS related illnesses worldwide in 2013.At the end of 2013, 11.7 million people had access to antiretroviral therapy in low and middle income countries while over 28 million people are eligible for antiretroviral under WHO 2013 consolidated guidelines.

Today despite advances in our scientific understanding of HIV and its prevention and treatment as well as years of significant effort by the global health and leading government and civil society organizations, most people living with HIV or at risk for HIV do not have access to prevention, care and treatment, and there is still no cure.  However, effective treatment with antiretroviral drugs can control the virus so that people with HIV can enjoy healthy lives and reduce the risk of transmitting the virus to others. The UNIAIDS (1999) submitted that HIV epidemic not only affects the health of individuals, it impacts households, community and the development and economic growth of nations.  Many of the countries hardest hit by HIV also suffer from other infectious diseases, food insecurity, and other serious problem.Furthermore, almost 22 million other people living with HIV, or three of five people living with HIV, are still not accessing anti retroviral therapy (ART).

According to International Association of Providers of AIDS Care (IAPAC) (2014), antiretroviral therapies are medications that treat HIV.  The drugs do not kill or cure the virus.  However, when taken in combination with others they can prevent the growth of the virus.  When the virus is slowed down, so is HIV opportunistic infections. The introduction of highly active antiretroviral treatment (HAART) in 1996 was a turning point for millions of people who are living with HIV and AIDS. Palella, Delaney and Moorman(1998) stated that the use of combined antiretroviral agents has had an important effect on the natural evolution of HIV disease resulting in a reduction in complications from immune deficiency and an important reduction in morbidity and mortality.  This therapy provides relief to HIV infected individuals by reducing the likelihood of opportunistic infection rather than curing the disease; making the lifespan and quality of life for people living with HIV and AIDS to greatly improved (Amico, Toro Alfonso & Fisher, 2005).

Simony, Frick, Pantalone and Turner (2003) stated that to achieve optimal viral suppression it is necessary to attain a high level of adherence for an indefinite time period.Adherence is the main factor health services act in order to enhance the effectiveness of the treatment as well as decrease the chance of the emergence of HIV resistance to antiretroviral drugs.  For this reason Osterberg and Blaschke (2005) maintained that institutional and non institutional guidelines have been produced.

Ickovics and Meade (2002) described the factors associated with medication adherence under five intersecting categories.  These factors are patient’s variables which include socio demographic factors of (age, gender, income, education literacy level, HIV risk factors) and psychosocial factors of (mental health, substance use, social climate and support, knowledge and attitude about HIV and its treatment).

The second variable that predicts adherence is the treatment regimens which include the number of pills prescribed, the complexity of regimen, the specific type of antiretroviral drugs and the short and long term medication side effects.  In addition to the above variables are the disease characteristics which include the stage and duration of HIV infection, associated opportunistic infections and HIV-related symptoms.

The fourth variable has to do with patient-provider relationship that may affect adherence which include the patient’s overall satisfaction and trust in the provider and clinic staff, the patient’s opinion of the provider’s competence, the provider’s willingness to include the patient in the decision-making process, the effective tone of the relationship, and the adequacy of referrals. The fifth variable has to do with the clinical setting that may influence adherence include access to ongoing primary care, involvement in a dedicated adherence programme, availability of transportation and care, pleasantness of the appointments, perceived confidentiality and satisfaction with past experiences in health care system.The American Public Health Association (2004) also enumerated the factors influencing patient adherence to include social and economic factors, Healthcare team and health system related factors, condition-related and patient-related factors.Clinician working with patient needs an accurate and relatively simple method of assessing adherence in order to support its vital role in treatment outcomes.

In measuring adherence, there are a number of methods either alone or in combination. This reflects the fact that there is no gold standard by which to measure adherence.  Wagner (2002) and other researchers submitted that the objective measures used in research, although impractical for most clinical settings, are more sensitive than patient’s self-report for detecting medication non adherence.  The common adherence measures used in research studies are:

A MEM cap which utilizes a computer chip embedded in a specially designed pill bottle cap to record the time and duration of each bottle opening.

Pill counts, biological markers, and pharmacy - refill data, therapeutic drug monitoring and physician assessment (Monjok, Smesny, Okokon, Mgbere & Essen, 2010).  However, the most common method used in resource-limited settings is self report or pharmacy refill records (Chesney, 2006).

Moreso, the clinical efficacy of antiretroviral therapies in suppressing the HIV and improving survival rates for those living with HIV has been well documented (Kredo, Walt Vander, Siegfried & Cohen, 2009). However successful antiretroviral treatment is dependent on sustaining high rates of compliance that is correct dose, taken on time and in the correct way, either with or without food.  The optimal compliance required for ARVs medication to work effectively is 95% (Lima, Harrigan, Murray, Moore, Wood & Hogg, 2008). Anything less will result in the development of viral resistance and earlier treatment failure (Bangsberg, 2006). 

            Compliance describes the degree to which a patient  correctly follows medical advice. Worldwide, non compliance is a major obstacle to the effective delivery of health care.  WHO (2003) indicated that only about 50% of patient with chronic diseases living in developed countries follow treatment recommendations.  Compliance rates may be overestimated in the medical literature, as compliance is often high in the setting of a formal clinical trial but drops off in a real world setting.

            According to Elliotand Marriot (2009) efforts to improve compliance have been aimed at simplifying medication packaging, providing effective medication reminders, improving patient education and limiting the number of medications prescribed simultaneously.It is too critical that each patient receives and understands information about HIV disease including the goals of therapy (achieving and maintaining viral suppression, decreasing HIV-related morbidity and mortality, and preventing sexual transmission of HIV), the prescribed regimen (including dosing of strict adherence to ART, and the potential for the development of drug resistance as a consequence of suboptimal adherence. This research will focus on patient demographic variables, psychosocial variables, economic variable and the health care system determinants.

1.2       Statement of the Problem

            In Akwa Ibom State, the prevalence of HIV rate had been fluctuating between 12.5% in 1999, 10.7% in 2001, 7.2% in 2003, 8.0% in 2005 and 10.9% in 2010.   It is a welcome development that the Federal Ministry of Health National HIV and AIDS Reproductive Health Survey (NHARHS) (2014) in population based survey declared that Akwa Ibom State stands at 6.5% prevalence rate. Despite this, ensuring adherence to HIV treatment remains challenging in the state.  Therefore it is pertinent to assess the determinant factors in adherence to antiretroviral therapy.

In medical practice, non-adherence to medication is widespread among patients with chronic diseases including HIV and AIDS. Poor adherence to antiretroviral medications accelerates development of drug-resistant HIV. Without adequate adherence, antiretroviral are not maintained at sufficient concentration to suppress HIV replication in the infected cells and to lower the plasma viral load.  A lot of interventions have been developed for improving adherence which includes tailoring the choice of drug regimen to patient’s life style, frequent follow up, rapid viral load feedback, use of reminder calls and alarm and many others.  Few studies in San Diego revealed that poor adherence correlated with clinical and virology failure at a 3-month of follow up.  The report suggested that a high degree of adherence is necessary for maintenance of drug efficacy. Despite the importance of adherence as the fulcrum of the success of any HIV treatment initiates, it has some challenges for many patients in the different domains. Adherence to ART and barriers to compliance have been reported to vary from one country to another even within the same country (Mills, Nachega, Buchean, Orbinski, Athran, Singh, Rachilis, Wu, & Cooper, 2006).Non-compliance with ART has been cited as one of the major problems in other sub Saharan countries (Kagee, 2004), resulting in high rate of relapse, re-hospitalization, morbidity and mortality. Achieving and maintaining the health benefit of this regimen requires near perfect adherence which most patients do not achieve.

The researcher has witnessed many cases of defaults in antiretroviral therapy and the effects it has on the defaulters.  As treatment of HIV infection with antiretroviral medications becomes a reality in the developing countries, adherence to the treatment regimen also becomes a bigger issue that needs to be addressed. Perfect adherence of at least 95 percent is needed for patients on anti retroviral  therapy (ART) to keep the viral load at detectable levels for as long as possible and to maintain the functionality of the immune system. Hence several patients and regimen related issues still need to be overcome to achieve optimal adherence. It is on this note that this study tries to find out the determinants of adherence to antiretroviral therapy and the strategies for compliance among people living with HIV and AIDS in Akwa Ibom State.