Research Topics: Highly Active Antiretroviral Therapy

Statement of the Problem……..……………………………….……….……………5 Significance of the Study………………………………….………………….………6 Need for the Study..………………………………….…………………………..……7 Conceptual Framework……………………………….………………………………8 Purpose of the Study ……………………………………………………….………14 Research Questions…………………………………………………………………14 Hypotheses……………………………………………………………………………14 Basic Assumptions of the IMB Model………………………………………………15 Definition of Terms …………………………………………………………………16 Limitations of the Study ………………………………………..……………….…18 Summary……………………………………………………………………………..18 CHAPTER2: LITERATURE REVIEW…………………………………………………19 Introduction to HAART………………….………. ………………………………………………19 Patient Specific Factors…………………….…………………………………………………….21 Culture, Religion and Ethnicity…………………….………………………………………….24 Literacy skills and educational level…………………….……………………………………24 Patient-Provider Relationship………………………………………………………..26 Motivational Interventions…………………………………………………………..28 Socioeconomic Factors…..…………………………………………………………..29 Social Support………………………………………………………………………..30 Drug use………………………………………………………………………………32 Summary…………………………………………………………………….……….33   CHAPTER 3: RESEARCH METHOD       Introduction……………………………………………………………….…………34 Research Design ……………………………………………………………………34 Recruitment and Enrollment………………………………………….……………37 Instrumentation Measures and Materials…………………………………………….39                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Motivation Subscale…………………………………………………………………40 Motivational Subscale ………………………………………………………………40 Scoring Plan…………….……………………………………………………………42 Data Collection Procedures……………………….…………………………………42 Data Analysis…………………………………………………………………………43 Confidentiality and protection of participants……………………………………….44 REFERENCES…………………………………………………………………………..45 APPENDIX A: THE LIFEWINDOWS IMB QUESTIONNAIRE……………………………58 APPENDIX B: PERMISSION NOTIFICATION FROM DR. FISHER………………64 APPENDIX C: DEMOGRAPHIC DATA SHEET………………………………………66 LIST OF TABLES Table 1. A Sample Showing Data Analysis Approach…………………………………..66     LIST OF FIGURES Figure 1. The IBM Model………………………………………………………………..12      Figure 2. The IBM Model – Adapted……………………………………………………13   CHAPTER 1 INTRODUCTION TO THE STUDY Since their initial discoveries in the United States in June 1981, human immunodeficiency virus (HIV), and acquired immunodeficiency, syndrome (AIDS) pandemics have proven to be public health challenges. The initial phase of the epidemic principally involved White, sexually active, homosexual men, but the pattern soon expanded to include other populations, such as women and children, other races, and adult African Americans of various sexual preferences and social lifestyles (  2006, 2006). HIV/AIDS is a potentially lethal, infectious disease that destroys the body’s defenses and renders it vulnerable to various opportunistic infections (, 2001). Numerous health agencies have predicted that by 2010, Ethiopia, Nigeria, China, India, and Russia, as a whole, will have contributed over 65 million new cases to the pandemic; in turn, these new cases will have increased the global HIV/AIDS-induced orphan population from the current figure of 14 million, to a predicted figure of 25 million ( 2006). These countries will contribute to the trend. In a  response to revised case definition criterion, to include cluster of differentiation 4   CD4 cell counts of less than 200 cells/mm3, the health organization found that HIV/AIDS prevalence rates in the United States peaked in 1993 (, 2001;  2004) and, by 2003, morbidity and mortality rates were estimated at 1.7 million and 550,000, respectively. Though CDC (2006) surveillance data showed that global AIDS mortality rates had declined by the end of 2005, prevalence and mortality rates had surpassed 39.5 million and 2.8 million cases, respectively. The following year, HIV/AIDS prevalence rates among adults and children under 15 years of age were 3.8 million and 530, 000, respectively. Throughout the epidemic, estimated annual HIV infection rates have consistently amounted to roughly 40,000 people ( 2007b). According to  (2008) estimates, in 2006, there were over 56,300 new cases of HIV, over half of which (53%) were contracted by gay and bisexual men. These figures serve to highlight the profound impact of the disease on society, but also that of the skewed racial toll on certain sectors of the U.S. population. African American adolescents, young adults, and middle- aged men and women sustain the harshest impact of the epidemic (2006, 2006); these groups, as a whole, are seven times more likely to contract the disease than their White counterparts are. According to the  (2008), in 2005, African Americans accounted for 18,121 (49%) of the estimated 37,331 new cases of HIV/AIDS in the 33 collaborating states (done via long-term, confidential name-based HIV reporting). Furthermore, AIDS severity is harshest in geographical locations with greater concentrations of multiethnic populations. For instance, New York State occupies the most multiethnic HIV population and correspondingly, the consistently highest HIV infection rates nationwide. Between 2004 and 2005, HIV incidence had reached 2,781, with the highest proportion occurring among men aged 20-29 and 40-55 years. Male homosexually acquired incidence rate increased in both African American and White males from 1,111 to 1,113 during the same period, though neither group has been found to be more genetically susceptible to HIV (2004; , 2006;  2004;  2004). By the end of 2005, the state of New York had the highest rate of AIDS diagnoses of all racial and ethnic groups, with over 189,000 HIV/AIDS cases and over 93,748 deaths (, 2006). In 2006, there were 5,495 new cases reported (, 2008). A significant proportion of New York State’s African American population dies within one year of being diagnosed with AIDS. The main contributing factors include late diagnosis, large rates of abrupt dosage termination, suboptimal adherence, and no adherence with treatment recommendations (, 2006). also found that African Americans are less likely to verify their HIV status, less likely to notice and seek treatment for symptoms of AIDS, and are less likely to acquire health insurance coverage necessary for fighting AIDS (2006). Other studies have also shown that suboptimal adherence to prescribed prophylacticand therapeutic treatment, including highly active antiretroviral therapy [HAART] predisposes HIV infected persons to other infections ( 2007; ., 2003). To this point, in the HIV/AIDS research era there is no scientific evidence of African Americans’ genetic predisposition to HIV infections. Prior to the introduction of [HAART] in 1996, diagnoses of HIV-positive portended eminent death (WHO, 2006). This was secondary to the fact that former public health interventions were (a) primarily focused on controlling HIV transmission, and (b) providing prophylactic medications to help the immune system defend the body against opportunistic infections. At that time, those diagnosed with AIDS were considered terminally ill ( 2001). Today, because of HAART’s capacity to increase CD4 counts to clinically adequate rates and to decrease HIV-1 RNA below assay detection levels, AIDS has been transformed into a manageable chronic condition for many Americans ( 2002). However, African American transmission and infection rates remain high, even though HIV/AIDS related mortality rates have declined significantly among the general population (2006;  2003). Problem Statement             Research findings from various observational, population-based, epidemiological, and clinical studies have verified HAART’s effectiveness in significantly reducing the harsh consequences of HIV/AIDS among humans (Moorman et al., 2002). However, studies and epidemiological data show that, in comparison to their racial counterparts, African Americans are most reluctant to be tested for HIV or adhere to their HAART regimen and dosage schedule, even when the clinical symptoms of AIDS are obvious. By 2003, there were 20 different varieties of HAART (, 2003); however, African Americans have not shown to benefit from any of these more than any of their racial counterparts. Because of belated testing for HIV and inconsistent adherence to prescribed HAART HIV/AIDS, exact a more severe toll on African Americans. Thus, African Americans constitute both the most likely racial group to die within the first year of AIDS diagnosis and the least likely racial group to benefit from this life-sustaining treatment (, 2005;  2002; , 2006;, 2003). African Americans have thus earned the reputation of being the racial/ethnic group to which modern HIV management is least effective ( 2003). For instance, the mortality rate among African Americans declined by only 7% even though HIV/AIDS related mortality declined by almost 20% in the period 2000 -2004 in the general population (, 2006). This illustrates yet another reason that African Americans’ quality of life is generally considered inferior to those of their White counterparts, even within similar socioeconomic and associated demographics.                Significance of the Study             The purpose of this study is to explore and generate an understanding of HIV/AIDS medicinal-adherence and motivational factors for antiretroviral therapy among inner city African Americans – specifically, New York. The significance of this study is in the potential life-saving information or methods that, as a result of this work, may be crafted and implemented. This research is being conducted in response to common rationalizations that African Americans disproportionate burden of HIV/AIDS are the direct consequences of socioeconomic factors or society’s attitude towards minorities ( 2006). Though the majority of HIV/AIDS related literature seems focused on social and environmental factors ( 2006;  2002), several studies have shown however, that the difficulties that African Americans experience in their pursuit of HIV related treatment are more likely behavior-oriented, as opposed to socially induced, such as inadequate health insurance and socio-economic background/immigration status (, 2006). However, recent research findings have found a closer association between HIV/AIDS mortality rates and African Americans’ nonconformity with HAART, which characteristically improves the prognosis of HIV infection from acute health problem or immediate death to at least, a chronic condition (2005). This suggests that irrespective of variations in ethnic and socioeconomic circumstances among African Americans, there may be unexplored motivational factors among African Americans for their underutilization of HAART (, 2006;  , 2002; , 1994). Thus, the researcher will gather, by first-hand report, the true motivational factors that deter or facilitate HAART adherence among African Americans. The results will fill the gap in scholarly research that explains the key motivational factors of HAART adherence among African Americans; enhance HIV/AIDS clinical practice; focus on interventions that are most critically needed contribute to the formulation of comprehensive approaches to improve HIV prevention behaviors and, and ultimately to increase HAART utilization rates among African Americans.              From a personal perspective, this researcher will generate a greater knowledge of the factors that deter African Americans from proactively seeking, managing, and maintaining HAART at optimal adherence rates of 95%. The findings of this study will be of significant interest to researchers involved in identifying the reasons that African Americans are more likely to delay being tested for HIV or accepting treatment for HIV infection. The result of this study will be vital to national, state, and local-based public health practitioners and entities involved in addressing the disproportionate burden of HIV/AIDS among African-Americans. Need for the Study This study is necessary because of the disproportionate impact of HIV/AIDS on New York’s inner-city African American women, youth, and men who have sex with men (, 2007). Epidemiologic evidence indicates that while some ethnic/racial groups in New York are essentially living with HIV, African Americans are essentially dying to it. For instance, New York States’ statistics show that, although HIV infection rates have stabilized among most racial and ethic groups in recent years, African Americans have consistently experienced greater number of HIV related illnesses, decreased life expectancy rates, and greater mortality rates, irrespective of age, gender and socioeconomic status (, 2005).             To illustrate, in 2005, about half (49%) of the people diagnosed with HIV/AIDS were African Americans. By the close of 2005, 189,165 New Yorkers were diagnosed with HIV/AIDS of which 93,748 (50%) were fatal ( 2006). One explanation for the disproportionate impact of HIV/AIDS among this population is the finding that inner-city African Americans generally delay in getting testing for HIV and, when they do, already present with advanced symptoms and complications from the disease (2006). To further complicate the issue, specific African American cultural beliefs and attitudes, concerning medication, have shown to facilitate viral replication and depreciation of quality of life (, 2006;   2003). As a result, a positive diagnosis of HIV portends inevitable death from AIDS. Theoretical Basis of the Study Several theory-based models of medication adherence have been used to guide efforts to explore the critical moderators of HAART adherence behaviors among subpopulations. These theory-driven approaches have been based on earlier models, such as the health belief model, the Tran theoretical model, the AIDS risk-reduction models, and, more recently, the information-motivation- behavioral skills model IMB. The IMB model was initially developed in response to the HIV epidemic for understanding, explaining, and promoting HIV risk reduction behaviors.   Figure 1 shows a flow diagram of the IMB model, which explains the interactions between constructs in performing HIV preventive behaviors. Figure 1.                                             From( January 19, 2004).   Figure 2 shows The IBM Model and its adaptation to HAART adherence behaviors. Figure 2.                             From: M. Gillespie (Personal communication, January 19, 2004). The model proposes that the three major constructs—information, motivation, and behavioral skills—are the primary predictors of HAART regimen adherence behavioral skills among HIV-infected individuals ( 2005;  2006). The constructs have gained increased usage in the research studies identifying, evaluating, and addressing the informational, motivational, and behavioral skills deficit among sub optimally adherent HAART recipients. Essentially, the IMB model posits two cognitive and one behavioral construct as important predictors of HAART adherence behavior: Information or knowledge about HAART; Motivation to take HAART; and behavioral skills to take HAART ( 2005;  2001). These constructs, when viewed in the context of HAART adherence, rationalize that specific individual-related factors, including one’s awareness of HAART benefits or perception of information necessary to promote therapy adherence, motivation to translate information into action, and possession of relevant behavior skills work through HAART adherence behavioral skills to achieve HAART adherence behaviors ( 2006). Adherence Information               According to the IMB model, explicit adherence instructions information about HAART adherence is fundamental to optimal adherence. Such information generally entails HAART adherence instructions and benefits, the implications of suboptimal adherence, related nutritional instructions, ideal adherence levels of ≥95% adherence, potential HAART side effects, synergistic effects of   co morbid drug abuse, and appropriate procedures in making up for missed doses ( 1992). The IMB model also assumes that an individual’s misinformation and misconceptions about medication (for example, “if I am not experiencing the clinical signs of HIV infection, I am OK with suboptimal dosages”) frequently undermine HAART adherence ( 1992. ). Equally, implicit theories, faulty heuristics, and supernaturalism (e.g., abrupt interruption of prescribed dosage administration in observance of ‘drug holiday’, ‘medication fasting’, or self-imposed controlled study) have also shown to undermine HAART adherence (  1992). Adherence Motivation               The IMB model proposes that personal and social factors generally motivate individuals to act upon HAART regimen information and that motivation is a key determinant of HAART-adherence behaviors. Thus, the IMB model posits that unmotivated individuals are more likely to perform suboptimal levels of medication adherence. Personal motivational factors involve the individual’s beliefs and perceptions about the significance of medication adherence (i.e. “If I take my medication as prescribed, I will have positive health outcomes”) implications of non adherence (i.e., “If I fail to take my medications as prescribed, I will have negative health outcomes”), and/or positively perceived consequences of HAART adherence-related health outcomes (i.e., “An improvement in my health would be good”; Adapted from 2006). More specifically, IMB-based HAART adherence studies have shown that particular factors, such as individuals’ personal/cultural attitudes and health beliefs (concerning dosage instructions, perceived medication efficacy and costs/benefits/side affects analyses, and perceived barriers or facilitators to treatment/medication access) have shown to influence HAART acceptance. Similarly, social motivational factors have been found to affect HAART acceptance, which generally include an individual’s perception of and existing social support to foster optimal adherence, quality of patient-clinician relationship, and situational circumstances – such as homelessness and drug use ( 2003). Adherence Behavioral Skills               The third element of the IMB model comprises the individuals’ actual or perceived skills that may influence HAART adherence. It proposes that there is a direct link between HAART adherence behavioral skills and HAART adherence related health outcomes, especially when patients closely follow the drug regimen. It also asserts that HAART specific adherence behavior skills represent important channels of HAART information and motivation in deriving the behavioral skills required for adherence behaviors. These behavioral skills can also determine correlation between HAART information and motivation with HAART medication adherence. The model has been evaluated with several HAART adherence studies, both nationally and internationally, using mixed variable approaches ( 2005; 2007;  , 2006) in a variety of subpopulations; however, African American were apparently excluded. Thus, it seems the most appropriate theoretical guide for this study because it affords a cohesive explanation of information, motivation, and behavioral skills among HIV+ individuals concerning achieving health outcomes ( 2007;  2000 ,1992; 2003;  and  2002;, 2003). Purpose of the Study             The purpose of this study is to assess the motivational factors that influence African Americans in inner city New York  to adhere to professionally prescribed HIV Highly Active Antiretroviral Therapy (HAART) treatment. The results of the study will be vital to the planning and delivery of culturally sensitive and ethnic-specific HIV/AIDS intervention strategies, and greater utilization of HAART among African Americans. Research Questions   The research questions are as follows: <li class="MsoNormal" style="line-height: 200%; margin-bottom: .0001pt"> What are the interrelationships among HAART adherence information, motivation, and behavioral skills?                                                                                    </li> <li class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt"> Are those interrelations related to the demographic factors?                                                       </li>     Hypotheses Based on the review of the literature and the conceptual framework of the study, the hypotheses for the study will be as follows: <li class="MsoNormal" style="line-height: 200%; text-autospace: none; vertical-align: baseline; margin-bottom: .0001pt"> HAART adherence information, motivation, and behavioral skills have direct effects on AIDS related prevalence rates.                                                                </li> <li class="MsoNormal" style="line-height: 200%; text-autospace: none; vertical-align: baseline; margin-bottom: .0001pt"> HAART adherence information, motivation, and behavioral skills have direct effects on HIV/AIDS mortality rates.</li> <li class="MsoNormal" style="line-height: 200%; text-autospace: none; vertical-align: baseline; margin-bottom: .0001pt"> HAART adherence behavioral skills have direct effects on HAART adherence behavior.</li> <li class="MsoNormal" style="line-height: 200%; text-autospace: none; vertical-align: baseline; margin-bottom: .0001pt"> The IMB behavioral skills model is an empirically adequate model for predicting motivation to perform HAART adherence behaviors among adult African Americans living in New York City. </li> <li class="MsoNormal" style="line-height: 200%; text-autospace: none; vertical-align: baseline; margin-bottom: .0001pt"> There is direct relationship between HAART information and motivation to perform HAART adherence behavior. </li> Basic Assumptions of the IMB Model               The IMB proposes that specific health related information, personal and social motivation, and behavioral skills represent fundamental determinants of HAART adherence ( 2000). It also asserts that an individual’s adoption of HAART related behaviors is the direct result of him receiving information about HAART benefits, being motivated to initiate or maintain HIV/AIDS health promotion practices, and possessing the necessary behavioral skills for performing the specific acts required for HAART adherence (, 2000). According to the approach individuals who are (a) well informed about the potential health benefits, (b) positively motivated to respond to the health benefits information, and (c) capable of performing the requisite behavioral skills, are inclined to adopt and maintain new, health promoting behaviors (under conditional circumstances). Conversely, under specific circumstances, when individuals are (d) inadequately informed, (e) unmotivated to act upon the new health changing information, and (f) incapable of performing specific behavioral skills to effect the behavior changes—they are disinclined to engage in positive health promoting behaviors ( 2002; , 2006).   Operational Definition of Terms   Adherence: The extent that the HIV-positive individual complies with medication dosage instructions. Adherence barriers: (a) Systems barriers that inhibit consistent access and optimal adherence to HAART; (b) personal barriers that deter HAART adherence even when the medication is available. Adherence behavior: Computation, usually in terms of percentage rate, of the number of HAART pills taken versus number of pills prescribed to be taken over a course of time to achieve intended health outcomes. Adherence behavioral skills: The HIV-positive individual’s objective and perceived abilities to access and take professionally prescribed HAART medication as directed. Adherence information: Knowledge, data, facts, explaining significance of adherence/non-adherence benefits and consequences, optimal dosage requirements, procedures for missed doses, potential drug interactions, and side effects. Adherence motivation: (Personal): The HIV-positive individual’s attitudes and, or beliefs concerning his or her HAART regimen.                                                         Adherence motivation: (Social): (a) Perception of available social supports from significant others to facilitate HAART adherence, and (b) The individual’s interest to work with support network to increase adherence.                                                        AIDS: (Acquired Immune Deficiency Syndrome/Human Deficiency Virus): Cumulative opportunistic infections that befall an individual subsequent to being infected with HIV. African American: Citizens or residents of the United States who have origins in any of the black racial groups of Africa. CD4 cell (count): A periodical blood test performed on HIV+ individuals to determine level of functionality of their immune system in fighting a variety of infections. Ecological skills: Cues and strategies for pill taking, often discreetly, in otherwise inconvenient settings. Health beliefs/ cultural background: Spiritual/religious orientation in respect to HIV diagnosis, prognosis, medications, benefits/consequences in reference to one’s life and health goals. Health outcomes: Increased regeneration of CD4, decreased viral load and viral resistance, improvement in quality of life, and decreased HIV related mortalities. HIV/AIDS: Combined diagnoses of HIV infection (not AIDS), (b) HIV infection, and subsequent development of AIDS, and (c) coexisting diagnoses of HIV infection and AIDS. Moderating factors: Specific circumstances or personal characteristics that influence the relationship between the IMB model constructs and adherence behavior. Optimal adherence: HAART adherence rates of 95% or greater. Perceived social support: Perception of available support for facilitate HAART adherence. Social Support: Existing social network support for taking and or adhering medication regimen.                                                                         Suboptimal adherence/Non-adherence: HAART adherence rates, usually ranging from 30% to 75% of ideal adherence rates. Viral load: A biological marker of HIV virus within an HIV-positive person.   Limitations of the Study Participants will be drafted in the study based on self-identification as African Americans who are currently prescribed a HAART regimen. Generalization of the study results may be limited because adherence assessment will be based on self-reports of all participants; however, inclusion/exclusion criteria do not affect African-Americans with limited periods of residence in the state of New York. This broad categorization does not preclude the participation of specific subgroups, such as the financially destitute or cognitively and behaviorally disturbed drug users and the mentally/emotionally unstable who, at the time of the questionnaire’s completion, may give erroneous responses. There is also high probability for selection bias, since more motivated participants might be more likely to participate and thus be overrepresented in the study population. Summary This chapter presented an overview of the overall impact of suboptimal HAART adherence on adult African Americans living with HIV/AIDS in New York City. Consistent adherence to prescribed antiretroviral therapy has been shown to dramatically decrease opportunistic infections rates, improve the quality of life among infected individuals, and decrease related mortality rates. Relevant New York State data indicated that although HIV incidence rates remain virtually unchanged across all racial groups, AIDS related morbidities and mortalities occur more prominently among African Americans, due to high incidence of suboptimal HAART adherence. African Americans experience greater rates of therapeutic failure and deterioration of health status, which precipitates development of multidrug-resistant strains of HIV that are easily transmitted to zero-negative others. Research conducted in the preparation of this chapter suggested that a plausible explanation for ethnic disproportionate morbidity and mortality rates are associated with African Americans reluctance to get tested for HIV or aggressively access and adhere to prescribed HAART regimen ( 2006; 2002; ). Various theories have been used to identify empirical explanation for this disparity; however, the IMB theoretical framework seems to explore possible social and psychological bases for the observed underutilization of HAART. The choice of questions, hypotheses, proposed study population, and research methodology are appropriate complement of the IMB construct, as well. These constructs will adequately verify whether the availability or lack thereof, of information, motivation, and behavioral skills available to African Americans control regulate HAART adherence rates among them. Reducing mortality commences with initially identifying and addressing the function of motivational factors in moderating HAART adherence among an already predisposed population. In chapter 2, the available research literature will be examined to identify causal relationship between and the IMB, HAART adherence and consequential health outcomes. In chapter 3, the methodology component will explain the series of steps that the study will follow. It will focus primarily on participants, measures, and data analysis.   Chapter 2   LITERATURE REVIEW A consistent HAART regimen is proven to significantly delay clinical manifestations of AIDS and its associated mortalities among HIV-infected individuals ( 2004;  2002; , 2005; , 2005). Alternatively, deviations from the prescribed regimen result in reverse benefits, including increased morbidity and mortality rates, therapeutic failure, depreciated quality of life, the manifestation of multidrug-resistant strains of HIV, and other adverse public health consequences. While this method is effective in treating the disease, research is still silent on why, exactly, the regimen is less effective in treating AIDS in African Americans. For instance, some studies show that, even after controlling for recognized influences of racial/ethnic health disparities among minorities, African Americans generally derive the least of HAART’s intended benefits to humans (, 2006). Electronic database indexes were used to identify relevant articles, including    and . The  search engine, manuscripts, and biomedical literature databases and its associated anecdotes, bibliographies, dissertations, reference lists, and related citations, were also used to examine previous work related to HAART adherence-factors. The search terms African American, inner city, and HIV medication compliance/adherence factors, medication adherence, medication adherence motivational factors, medication adherence behavioral skills, barriers to medication adherence, HAART adherence study, antiretroviral therapy, HAART, antiretroviral drugs, and health disparity were used in order to survey the literature field. These attempts yielded few results. Additionally, a thorough review of several peer-reviewed journal articles published post 2000 was conducted; again though, the research attempts further highlighted the dearth of current research regarding HAART adherence among African Americans. Most adherence studies were unrelated to both HAART and African Americans. Of those that were related, only studies published after 2000 were included; those published before this year were only included if their theoretical and historical significance to the current study was evident. Emphasis was placed on empirical studies with data-based conclusions that were relevant to the problem statement, purpose, research questions, hypothesis, and study methodology; more specifically, influential-articles examined (a) the relationship between medication adherence and motivation, (b) historical and medical content (e.g. studies related to the origin of HAART and HIV/AIDS prognosis), (c) factors that help or obstruct adherence to an antiretroviral treatment regimen, and (d) adherence outcomes.  In addition, this study keenly examined articles that concentrated on HAART adherence among African Americans, including (a) risk factors for HAART adherence among African Americans, (b) demographic and socioeconomic information of African Americans, (c) factors potentially relevant to African Americans medication adherence behaviors, (d) research in HAART adherence information, adherence motivation, and adherence behavioral skills, and (e) public health implications of HAART no adherence. Patient-Specific Factors The world is facing different problems, specifically in terms of achieving optimum health. It can be said that one of the most significant world health issue is human immunodeficiency virus or HIV. It has been noted that HIV epidemic is a tragedy, a tragedy of unfathomable proportion, in the lives people in the global community. Millions of people throughout the world have died of AIDS in little more than ten years, and it is estimated that there were 32.8 million people who are living with HIV and 2.5 million have been newly infected with HIV at the end of 2007 ( 2008). One thinks of HIV disease first and foremost as a profound medical problem affecting a person’s health and longevity. A central consideration of people living with HIV disease and their demographic profiles, therefore, often concerns progress in the prevention, containment, and cure for this disease, as well as issues about their immediate health and health care. Over the 2 decades since HAART’s discovery, there remains a lack of social and psychological literature related to HAART adherence among minority populations, especially African Americans. Among this limited research, however, is a consensus that suggests individual factors play a significant role in moderating medication taking behaviors among minority groups, including social and cultural background, health beliefs, and related treatment practices. Many of these motivational factors, which have been socially and culturally constructed, have shaped African Americans’ notions of HIV and HAART medication. Furthermore, these specific culturally bound factors have been shown to be principal determinants of HAART adherence behaviors among African Americans. For example, (2003) examined a convenience sample of 62 multiethnic HAART recipients, in order to find correlations between personal notions of HIV/AIDS and HAART. The majority of the sample was African American and included other minority populations (21 African Americans, 7 Asian Americans, 2 Haitian Americans, 12 Latino Americans, 19 European Americans, and 11 Native Americans). The author found that, among the minority groups, especially that of African Americans, the principal barriers to HAART adherence among non-adherent subjects were a (a) perception of being healthy, and thus, justification for skipping doses, (b) suspicion/experiences of potential medication side effects, and (c) preference for alternate treatment, including holistic medicine, acupuncture, and herbal supplements. In addition, the study found a strong correlation between HAART adherence information and HAART adherence benefits among the HAART adherent subjects, a finding congruent with that of the IMB model. The study also found that many African Americans held specific, erroneous perceptions or misconceptions about HAART, each of which ultimately jeopardized their prognosis. For example, many African Americans in the study were unable to distinguish between HIV and AIDS, while others thought HAART adherence should be delayed until the onset of AIDS. Accordingly,(2003) further examined the health beliefs and practices of HIV-positive African Americans in relation to HIV/AIDS and treatment adherence. Study findings suggested that many African Americans did not possess adequate knowledge of the nature of HIV and AIDS, which, in turn, directly influenced their health-related behaviors and treatment adherence. For example, one African American female believed that HIV and AIDS were virtually unrelated and thought that being exposed to HIV meant she was insusceptible to AIDS. Furthermore, she believed that if she ceased her illicit drug use and reduced other high-risk behaviors while increasing positive health-related behaviors (such as taking vitamins and eating nutritiously); she would actually increase her risk of acquiring AIDS. Another participant in this study, an African American teenager, believed he was insusceptible to AIDS because his T-cell count had increased. He rationalized that proper nutrition and cessation from drug use were adequate steps to avert the progression of HIV to AIDS. In addition, his perception of ‘feeling healthy’ led him to discontinue HAART adherence, even though his condition worsened soon after. Conversely, an elderly African American male who experienced significant nausea believed that this symptom would lead to eventual death from malnutrition and, therefore, refused to take his medication, asserting that he was going to die anyway whether or not he was medication-compliant. In another case, an African American female drug user, who managed to survive with HIV, without HAART, for 9 years due to denial (even in the face of a positive diagnosis), admitted that she believed the decline of her T-cells meant dying from HIV related causes would be inevitable. She conceded that her initial impression of HIV infection was that death was eminent upon initial infection. She explained, “I thought that when you lose T-cells, you die” (, 2003); however, upon further clarification of the disease’s process—from initial infection through manifestation of typical clinical features of AIDS, she began to understand the importance of taking her HAART medication and ceased her drug use. These examples not only suggest that popular, misconstrued views and myths concerning the nature of HIV and AIDS, and HAART directly influence individuals’ health-related behaviors and treatment adherence, but also makes it difficult for infected individuals to distinguish between HIV, AIDS, HIV related mortalities, and susceptibility to HIV infection via drug use (F2005;, 2003). In a US Study, it has been found that specific factors associated with imperfect adherence to HAART and with the failure to enhance adherence. In this study, the investigators from the  aims to determine which factors were connected with the changes in the levels of adherence and to identify whether there are specific individual whose adherence is constantly and relatively poor.  is an ongoing cohort study which involved over 5000 HIV Positive gay men in the United States.   In this study, the researchers have found that the men included in the study were generally highly adherent. In this study, the factors associated with the reduction in adherence to less than 100% included no recent outpatient appointment of people less than 40 years, depression and lack of college education. Herein, the study concluded that the non-coherence to HAART medication can be considered as not a random events in the MACS and the participants who reported their non-adherence were more likely to continue being non-adherent. The IMB model purports that it is important to understand medication storage and dosing, which is often a particularly challenging aspect in HAART adherence ( 2006). Notably, voluntary HAART adherence, within confinement, is a less severe concern for African Americans. As indicated in the literature, many non-institutionalized African Americans encounter significant adherence challenges because of the stigma, embarrassing social aspects, and debilitating side effects/adverse events – such as nausea and vomiting (2005;  1998; 1999). In addition to these individual factors, there also exists a popular, publicly held fallacy that HIV can be reversed in a manner independent of medication therapy. As cited by  (2005) a popular example that supports this myth is that celebrities, such as  have not developed AIDS even after being infected for extented period of time.  However,  (2005) explained that the public fails to recognize the fact that Magic Johnson has been HAART compliant since his contracting HIV, thereby delaying onset of AIDS. Thus, socially constructed notions, based on public misinformation/misperception and inaccurate media reports, are influential in shaping HAART adherence among African Americans. Culture, Religion and Ethnicity There is rationale for studying associations between African Americans’ cultural, religious, social behavior, and ethnic background and HAART adherence. A vast percent of this diverse population rely on culturally based medications. for the relief of  even the most acute illness. For instance, cultural expressions, experiences, norms, customs, behaviors, morals, learned values, attitudes, and beliefs about prescribed medications have been studied and identified as important predictors of medication adherence behaviors among multiethnic populations (2004;  1999). The  (2004) also asserts that, although these traits are dominant influences on the way African Americans adhere to HAART treatment protocol, they vary in interpretation and intensity across cultural subsets within the African American population. Thus, according to the IMB model’s constructs, specific cultural considerations are necessary to foster optimal adherence to HAART ( 2006), a fact that has particular meaning to African Americans whose adherence levels have been compromised by perceived or actual discrimination and stigma (   2004).  (2007) investigated the influence of social and religious support variables on a mixed population of Whites, African American, and Hispanic HIV patients. The findings indicated that all three racial/ethnic groups were affected in distinct ways by each adherence-related variable. For instance, among Whites, the chief motivators of  HAART adherence were educational background, age, and, to a lesser extent, religiosity. However, among African Americans, religiosity was the main positive motivational factor of HAART adherence. Literacy skills and educational level Studies have shown that literacy is critical to understanding the HAART adherence instructions. Thus, according to the premise of IMB model, literacy is a correlated attribute in understanding information about HAART adherence.  (2004) explained that health literacy requires the ability to understand occasionally complex dosage instructions, the benefits of optimal adherence, and the risks associated with suboptimal or no adherence. However, to many African Americans, reading, understanding medical jargon, and complex medication administrations instructions and schedules represent significant challenges. For example, (1999a) studied correlations between health literacy and HAART adherence among a community sample of 282 HIV positive men and women of varying ages: 60% of the population was from minority groups and 73% had been diagnosed with AIDS. The Test of Health Literacy in Adults instrument was used for the investigation. Multiple regressions analysis showed that education and health literacy were significant predictors of HAART adherence. Further, the findings demonstrated that African Americans with poor literacy skills tended to feel demoralized or depressed to the point that these feelings compromise their medication adherence. The study showed that subjects with low literacy skills were more likely to be confused, depressed, and less inclined to attend to and/or maintain appropriate hygiene. In addition, the study found that pride was also a factor in determining whether or not African Americans sought HAART adherence-related assistance from individuals to whom they were not willing to disclose their level of literacy. Thus, as asserted by  (2001), where literacy is compromised, proper medication dosing and critical health decisions are also jeopardized. A study by  (1999) also supported the finding that poor literacy significantly affects critical health decisions and HAART adherence, but also enhances the disparity in treatment-related outcomes between African American and White populations. The study compiled a test group of 74 African American and White adult HIV-positive patients; it found that that, in comparison to their White counterparts, African-Americans were only 31% adherent with their regimen, 56.3 % knowledgeable of the significance of CD4 lymphocyte counts to AIDS prognosis and were 87% less likely to understand the meaning of HIV-viral load measurement. Among members of the sample with high literacy skills, 66.7% of African-Americans, in comparison to 83.3% of Whites were optimally adherent to HAART regimen, while only 34.1% of African-Americans (at or below 6th grade reading level) adhered to HAART regimen. Furthermore, additional research found that HAART adherence is significantly dependent on patient/provider relationships (1996) examined correlations between physicians’ instructions and medication adherence among a population of predominantly African American adults, using Bales interaction process analysis. Of interest to the study was the way patients understood their physicians’ teaching and motivational interventions to foster increased adherence to their medication regimen. The results suggested that most patients considered their physicians’ instructions to be too complex to understand. As a result, adherence was 29% versus 52 % no adherence among the population of 153 patients. This shows that linguistic barriers (as inherent in complex medical jargon) can compromise genuine efforts to disseminate critical HAART related information (  2007). This aspect highlights that l 23literacy does not rest exclusively on the patient – as proposed by the Institute of   (2004), and that poor communication can be the result of the providers’ skills as well. It further suggests that in addition to providing adequately trained and culturally -competent practitioners to staff health clinics, it is equally imperative to incorporate culturally relevant approaches of communicating HAART-related instructions to patients. Addressing this issue can enhance a patient’s motivation to listen to and conform to providers’ treatment recommendations about HAART. Patient-provider relationships/communication Successful medication adherence often reflects the level of trust and communication that exists between patients and their health-care providers. Several examples of this dynamic were identified among reports from African Americans HAART recipients, which included cases where providers’ HAART adherence information – instructions/teaching (e.g., food and dosing instructions), were too complex for patients and adherence levels were low ( 2004). However, when information is provided in simple and understandable language, in both oral and in written form, providing examples, greater adherence results. Similarly, strong patient/provider relationships and information exchanges increase adherence levels. Furthermore, . (2003) found that patients with significant trust and respect for their health providers were more willing to listen and conform to HAART related treatment recommendations. These findings showed that, even when controlling for similarities in cultural backgrounds, providers who treated their patients with greater respect were more successful in motivating patients to stick to their treatment. In the face of convincing evidence – that African Americans account for lower use of effective antiretroviral therapy,  (2004) investigated why this disparity exists. The investigators examined whether racial concordances between 1,241 adult subjects and 287 of their HAART treatment providers influenced the time at which a doctor would prescribe protease inhibitors. The results showed that White patients received protease inhibitors much earlier than African-American patients (median 277 days compared to 439 days). In addition, African-American patients with White providers received protease inhibitors significantly later than African-American patients with African-American providers (median 461 days vs. 342 days respectively). However, no difference was found between African-American patients with African-American providers vs. White patients with White providers (342 vs. 353 days respectively). Although these results did not point to distinct biases, there is suggestion that provider-patient relationship and racial similarities can influence the administration of HAART-related services among African Americans.  (2006) explored correlation between 611 (>70% African Americans) HIV positive patients’ trust and mistrust between their health providers and government and health services; the study evaluated patients attitude, and beliefs concerning AIDS etiology, perceptions of conspiracy theory (the notion that the government created HIV to obliterate the minority population), and trust of care providers. Trust in care providers was associated with increased HIV-related outpatient clinic visits, fewer emergency room visits, increased use of antiretroviral medications, and improved reported-physical and mental health. However, trusting the government yielded fewer emergency room visits and better mental and physical health. More than 25% of the population believed in a conspiracy theory, over 50% believed critical AIDS related information were being withheld from the public, and over 10% did not view their providers services were genuine. The results showed positive correlations between good patient–provider trust and increased HAART adherence levels. Motivational Interventions         Relative to the importance of motivation, as a part in shaping HAART adherence, study-results vary. ,  , (2005) studied correlations between personal motivation factors and HAART adherence by examining 76 HIV positive adults who were prescribed HAART treatment. Subjects were randomized into two different groups. Group A received treatment of HAART only accompanied by dosage administration teaching, while Group B received the same treatment as Group A; in addition, Group B received motivational interventions to adhere to medication schedules. Subsequent CD4 count analyses indicated significant changes in viral loads (or CD4 counts) in the presence of patient-interventions. Additionally, results from , (2001) randomized trial suggested that only single-session adherence-enhancement interventions could increase HAART adherence. Similarly,, (2000) conducted a study testing the efficacy of medication counseling and behavioral intervention in facilitating HAART adherence. The study population consisted of 73.8% African-Americans, 14.3% Hispanics, and 11.9% non-Hispanic, White veterans. During the study period, participants received monthly medication counseling and a weekly medication pill organizer. Participants were compared with 21 non-adherent, matched controls who received standard pharmacy care, including brief educational review of the medication and its purpose. Intervention and control participants were compared according to medication refill timeliness, appointment attendance, hospitalizations, and opportunistic infections. Participants of the matched control group demonstrated significant improvement in drop-in visits and fewer reports of opportunistic infections rates or hospitalizations. Such findings demonstrated significantly strong correlations between motivational interventions and HAART adherence. In addition, researchers have identified theoretical basis for personal adherence to HAART treatment regimen. This view asserts that individuals’ personal enthusiasm and willingness are critical ingredients in one’s regimen adherence. Thus, as asserted by  (2006) “an individual’s motivation to adhere to HAART is based on his or her personal and social motivation” and involves personal “attitudes toward adhering to his or her regimen and his or her beliefs about the outcomes of HAART adherence and evaluations of these outcomes”. To demonstrate this concept, Fisher and colleagues studied motivation to HAART adherence among 100 participants of varied demographic characteristics and risks for HIV. Seventy-four percent or fewer obtained high school education, 34% were male, 38% were married, 46% had children, and 39% were employed. The study used the 10 item, Adult AIDS (., 2000) self-administered questionnaire to elicit factors that motivated participants to adherence to their HAART regimen. Based upon responses to the questionnaire,  (2006) concluded that personal, unaided motivation was more likely to mediate HAART medication-taking behavior. Socio-economic factors There is increasing evidence that socioeconomic factors play a significant role in the influence of HAART adherence among African Americans. (2005) for instance, found that socio economic variables, including welfare, age, race, educational background, financial status, perceived social support, disabilities, employment status, and living situation, had positive correlation with HAART adherence. The author further observed that economic disparities frequently impeded access to and conformity with HAART regimen. For example, the author found that individuals living in suburban communities encountered greater financial barriers in gaining initial access to HIV diagnoses and care, fulfilling scheduled follow up appointments, and obtaining HAART prescription refills. Similar to other studies, (2006) and  (2005) found that missed workdays, dietary and fluid intake requirements, elder, and or childcare during medical appointments, health services co-payments, and immigration status affected motivation to access and adherence to HAART regimen. In addition, to many HAART recipients, economic instability translates to inadequate housing/homelessness, malnutrition, and greater dependence on public assistance. Persistence of these economic variables among African Americans has been found to be intricately associated with suboptimal HAART adherence ( 2006;  2005). It is not surprising, therefore, that poorer HAART recipients, especially African Americans, experience greater HIV related morbidity and mortality rates (, 2005).  (1999) landmark HIV Cost and Utilization Study found that the availability of adequate and affordable transportation or the lack thereof was an important predictor of HAART medication adherence. Greater than one third of the population of over 83,000 subjects reported that they had to postpone at least one appointment over the course of the 6-month study. The study also revealed that over 17,000 subjects, who prioritized receipts of HARRT-related care, had the occasional cause to sacrifice a variety of daily necessities.  (2000) studied the difficulties experienced by minority groups in gaining access to adequate HAART over a 6-month period. The sample population was comprised of 2,776 minority nationals, including African Americans. Data were extracted from the baseline and six-month follow-up surveys, the findings of which suggested that economic factors were universal in determining access to HAART treatment; however, the barriers were more pronounced among the poorer African Americans in the sample. This finding not only highlights the seriousness of inequitable access to HAART, but also underscores the need for relevant bodies and officials to work together to provide more affordable and unencumbered access to HIV-related treatment.                                                             Social Support             The presence of social support has been long believed to have moderating effects on African Americans’ level of medication adherence.  (2007) conducted a randomized study to identify the relationship between type and quality of social support and HAART adherence among 98 people living with HIV/AIDS. The study showed that perceived social support from partners, family members, and health care providers could have either a positive or a negative influence on medication adherence. For instance, individuals who received higher levels of support from their spouses were more motivated to take their medications. Conversely, those receiving higher levels of social support from family members who had negative notions about HAART were less were less inclined to adhere to their pill-taking regimen.  (2003) examined the role of family as a source of social support among African American women living with HIV/AIDS in two urban cities in New Jersey. Many subjects had common African American women’s attributes: (a) heads of single income households, (b) uneducated, (c) underemployed, (d) unemployed, (e) experience severe transportation difficulties, and (f) lack of health insurance options. The majority of the subjects family as their main source of emotional support, love and affection, sympathy and compassion, acceptance, housing, domestic, elders and childcare needs. Literature also shows that these types of assistance generally provide important relief from the HIV-related fears, depressions, and stress that may further compromise HAART adherence (2005). However, Owens found that a major hindrance to HAART adherence among people with high family-support was due to miscommunication between family members and the family’s denial of the severity of HIV and its potential to progress to AIDS. These results suggested that subjects that encountered communication barriers with even close family members were less likely to adhere to their HIV treatment regimen due to misconceptions of the disease’s impact. Young et al., (2004) conducted a prospective study to investigate the association between stable relationships and progression to AIDS among 3,736 HAART recipients. The results showed that persons with steady relationships achieved higher rates of CD4 cell increases, viral suppression, and AIDS symptomatology. The findings of this study support the views of (2004) – that having dependable social support can both aid in the relief of HIV related depression and motivate individuals to take their medication.                                                             Drug use             There are salient reasons to explore the associations between drug use and HAART adherence among African Americans. One important reason, according to (2005), is that drugs have claimed an historic reputation for influencing the health status, health decision behaviors, and health decision-making skills of its users. She further suggests that this behavior often distorts users’ perceptions of their medical, social, and emotional needs. As a result, patients fail to recognize and utilize resources that are available to improve their quality of life while living with HIV. Similarly, (2004) found that drug users often fail to take their medication within prescribed times and miss important medical appointments because of competing efforts to locate and use drugs. This problem is pervasive throughout the literature. For example,  (2002) assessed HAART adherence levels among 85 persons characterized by HIV zeropositivity and history of illicit drug use. Over the six-month study period, 262 electronic monitors were used to measure interrelations between active drug use and poor HAART adherence levels. The results showed only 27% of the active drug users of the population was optimally HAART adherent, compared to 68% who were not using. Further analyses showed only 13% of active drug users’ sustained viral suppression, compared to 46% of individuals without history of drug use. Summary This chapter has provided a review of HAART adherence literature, with particular focus on HIV positive African Americans. It also examined fundamental predictors of HAART adherence behaviors, including (a) socioeconomic status, (b) history of substance abuse, (c) perceived health care provider support, (d) therapy-related factors, (e) personal characteristics (including attitudes and beliefs concerning medications), (f) social support, and (g) religiousness, culture and ethnicity, and cultural theories. The review demonstrated that adherence was a multifaceted phenomenon and that no adherence appeared in a variety of forms, exclusive of purposeful neglect and delinquency. By recognizing and addressing important predictors of no adherence to HAART, adherence can be improved with appropriate health promotion measures. In the next chapter, 3, the methods and procedures that will guide this study’s investigation will be presented.       Chapter 3 METHODOLOGY Research shows that HAART adherence can significantly reduce HIV associated mortality and morbidity rates and improve quality of life (CDC, 2006). To maximize the benefits of HAART, an adherence rate of 95% or higher is required ( 2000). However, the national average among people living with HIV/AIDS [PLW HIV/AIDS] is approximately 70% ( 2002). This is because various subsets of the PLW HIV/AIDS population demonstrate different levels of adherence to HAART, each,  due to varying factors. For example, New York State’s HIV surveillance data shows that adult African Americans, particularly those living in urban areas, are the least likely ethnic group to maintain optimal adherence levels and to achieve the full benefits of HAART due to poor motivation (, 2006;  2006). This chapter presents the methods and approaches used in this study to explore the role motivational factors play in HAART adherence among adult, inner city African Americans. It also details the research setting and sample characteristics, instrumentation, measures and materials, data collection, and analysis procedures used to analyze the phenomenon. Finally, survey data, and privacy measures are also discussed. Research Design and Approach              According to the IMB of HAART adherence ( 1992), [p2] individual [p3]  knowledge of HAART adherence benefits, [p4]   his motivation for adherence, and behavioral skills related to adherence, are the fundamental factors determining the [p5]  individual [p6]   HAART adherence level. The IMB skills model asserts that these core constructs combine to achieve medication adherence. This model is designed specifically to explore the role that social and personal motivational factors influence and determine HAART adherence levels ( 2006). The IMB model of HAART adherence further states that adherence related information and [p7]   motivation is associated with adherence related behavioral skills which also[p8]  directly predict adherence to HAART.                                                 This quantitative   cross-sectional survey will utilize the IMB model theoretical framework to examine the relationship between the core constructs of the IMB model of HAART adherence, and the HAART adherence levels among a sample population of New York inner-city African American men and women. The instrument will be a multiple item, pencil and paper, self-administered questionnaire. [p9]  Singleton and Straits (1999), maintain that data derived from a cross-sectional design best represents a particular target population given at one point in time. They also assert that cross-sectional designs are specifically useful in identifying association between two variables, but are less effective in determining causality ( 1999 ). This study will utilize  an existing 33-item self-administered instrument –  the ) which was originally developed by the ), and validated for similar studies ( 2006).  The LW-AIM-AAQ will be used to assess to the relationship between the study participants’ knowledge of HAART adherence information and adherence, and between motivations (personal and social) and adherence.  In contrast to other survey approaches, self-administered questionnaires have shown to be more effective in eliciting information on behaviors that are critical to the study objectives ( 1999). The survey approach, in combination with descriptive statistics, will allow for a quantitative analysis of the data ( 2001;  1999). Included among important benefits of using a self-administered questionnaire to this population is the greater potential control of the researcher to control or eliminate interview biases and reducing administration time, and costs (2001;  1999). On the other hand, because participant non-responses to items on a questionnaire may compromise the validity of the research data, the researcher will be able to ensure that participants respond to every item in the instrument, irrespective of the sensitive nature of questions asked. Setting and Sample                         As mentioned earlier in this chapter, ]  research has demonstrated that adult African Americans, particularly those living in urban communities,   are the least likely ethnic group to maintain optimal HAART adherence levels (e, 2006). Furthermore, in  comparison to other ]  racial/ethnic groups, morbidity and mortality rates are highest among adult African Americans living with HIV/AIDS ( 2001; 2006; 2005;, 2002). In this context, this study will exclusively target those individuals who both self-identify as African Americans and had been  [  prescribed HAART. It would not be feasible for the researcher to elicit responses from a population as large as the total number of HIV-positive African Americans who have been prescribed HAART. Instead, the researcher will utilize [  a random sample approach to select [African American men and women, aged 18 -55 years, residents of inner-city New York, who self-reported being diagnosed with HIV/AIDS and had been prescribed HAART regimens. Additional inclusion-criteria for the sample population include the ability to participate in the study and give informed consent, self-report knowledge of HAART, or   presently utilizes HAART, and can   ] read and write English. Exclusion criteria for the sample population include participants who are below 18 years of age, do not self-identify themselves as African Americans, and cannot read and write English. The population of interest age range of 18-55 years was selected in order to best represent the adult population who are prescribed HAART regimens. Participants’ ability to read, write, and understand English will be necessary in order to give proper informed consent, and to complete the self-administered questionnaire. The researcher will use the random number generator (RAND) function in Microsoft Excel to derive a random sample of 230 participants based on the following information: (a) Target Population: 120; (b) Desired error level: 5%; and (c) Confidence interval: 95%. The 120 subjects will be arbitrarily assigned ID numbers from 1 to 120. The series of 120 elements will be placed in the first column on an Excel worksheet (e.g. Column A). In each corresponding cell in the adjoining column (column B), the random generator function (fx) will generate a random number to be attached to each participant. Both columns will then be sorted by column B, and the first 230 persons selected will form the overall sample for the study. Variables will be separately defined and measured independently. Demographic information, including age, gender, race/ethnicity, sexual orientation, educational levels, current employment status, level of income, history of substance abuse, and religious affiliation will also be obtained through the questionnaire. Recruitment and enrollment plan African Americans living in New York City with diagnosis of HIV/AIDS will be targeted for this study. The following are some of the participants’ recruitment strategies for the study: Sample recruitment and outreach services efforts will be carried out at the n residential complexes, including in the Bronx, and , in Harlem. These facilities are home to over one hundred multiracial/multiethnic residents of which, over eighty percent are African Americans whose health conditions meet the medical criteria for this study. Letters and announcements about the study will be sent to religious and social organizations where African American men and women congregate. Community and church leaders will also be requested to announce the research project and invite participation from their respective communities and congregations during their weekly services, to participate in the research. The researcher will perform outreach to various community-based organizations such as drop-in centers (), homeless shelters, grocery stores, restaurants, and nightclubs in the New York metropolitan area.[]  Educational and vocational institutions, social entitlement offices, including offices, and check-cashing offices will also be targeted. In addition, the researcher will set up information desks at each housing facility to explain the study. Due to the high prevalence of HIV/AIDS in most of these targeted areas, obtaining a sample of optimal adherence (OA :> 95% or higher adherence rates) and suboptimal (SA :< 95% adherence rates) participants of one hundred twenty (120) will be feasible. Potential participants will be approached and asked if they are currently using HAART, and, if so (irrespective of their adherence level), asked if they would be willing to complete a 45 minute survey on HAART adherence. Participants will receive certificates of appreciation, ten dollars () remuneration, and a CDC pamphlet and information sheet on the benefits of HAART adherence. Participating facilities and organizations will also receive tokens of appreciation and the option to receive a summary of the research findings at the end of the study. Instrumentation, Measures and Materials Participants will be administered the LW-IMB-AAQ (Appendix A), a self-administered questionnaire designed to measure the constructs identified in the IMB model of adherence and to elicit critical information concerning the barriers and facilitators to HAART adherence ( 2006). The LW-IMB-AAQ will be used to assess HAART-related information, motivation, and/or behavioral strengths and weaknesses, as well as signals that specific IMB adherence-related deficits should be addressed in order to improve or effectively maintain HAART adherence (,  2006).                         The LW-IMB-AAQ consists of 35 items and 3 subscales, which are designed to measure the core constructs of the IMB model and identify the potential barriers to HAART adherence. For example, items I1-I9 measure informational barriers, items M1-M10 measure motivational barriers, and items B1-B11 measure behavioral-skill barriers. Each question is answered on a 5-point rating scale using the following: (a) responses for the Information and Motivation subscales (I) range from ‘strongly disagree’ (1) to strongly agree (5); (b) responses for the Behavioral-skill subscale range from ‘very hard’ (1) to “very easy’ (5). The LW-IMB-AAQ was initially developed to measure HAART adherence barriers but has found relevance in evaluating levels of adherence motivation ( 2006). It follows the constructs identified in the Information—Motivation—Behavioral Skills (IMB) model of adherence (n, 2006) and has been effectively used to elicit critical information concerning HAART recipients’ behaviors. The information drawn by the LW-IMB-AAQ has been found useful for tailoring cultural-specific health promotion interventions. This instrument has the reputation for (a) eliciting and measuring information, motivation, and/or behavioral skills strengths and deficits in practical or real-world settings and (b) evaluating motivation for adherence behaviors among HIV+ men and women (2006).The LW-IMB-AAQ is appropriate for this study because of its ability to quickly identify potential adherence related barriers and to specifically quantify motivational levels related to HAART adherence.  Questions in the Information subscale of the instrument will reflect the influence of HAART adherence information in achieving HAART adherence behaviors. For accuracy scores, ‘Strongly Agree’ will be given a value of 1 for all I items, except I3 and I5, which will be given a value of N/A or ‘0’. Responses to all items will be tallied for a ‘total correct’ score. Responses to items in the motivations section will be used to quantify the motivation construct. These items are rated on 5-point scales. Responses to Information and Motivation subscales will range from ‘strongly disagree’, ‘somewhat disagree’, ‘neither agree nor disagree’, ‘somewhat agree’, and ‘strongly agree’. Responses for behavioral skills questions will range from ‘very hard’, ‘hard’, ‘sometimes hard’, ‘sometimes easy’, ‘easy’, and ‘very easy’ (For example, item B1 asks, “How hard is it for you to stay informed about HIV treatment ?” (Adapted from m, 2006). Motivation Subscale:                         The researcher is particularly interested in participants’ responses related to HAART adherence motivational factors. Therefore, data derived from the Motivation subscale on the LW-IMB-AAQ will be evaluated in the context of personal and social motivation ( 2007). The former motivation reflects an individual’s attitudes and beliefs about HAART adherence or nonadherence, which includes the perceived physical consequences or benefits of taking medication ( 2007). This is  represented by questionnaire  items M8, M9, and M10 while the burden and/or impact adherence has on daily life is represented by items M1, M2, M3, and M7. The latter is related to an individual perception of social support for performing HAART adherence behaviors, that is whether the support is [p21]  from friends/family aware of the individual’s HIV/AIDS diagnosis, represented by questionnaire item M5 or from a healthcare provider, represented by items M4 and M6 (al., 2007).     Initial reviews of the  project data indicated an intern item-consistency of 0.70 for attitudes/beliefs regarding the burden of adherence (M9, M10, and M8) and 0.75 for attitudes/beliefs about the negative effects of ART medications (M1, M2, M3 and M7) (, 2006). Consistent with the  (2006), items M4 and M5 will be summed to represent social motivation as a single-item indicator. The personal motivation sub-scale will consist of 4 measured variables. Similar to (2007) approach, that demonstrated internal consistency (a = .74), responses to the three items related to negative beliefs about HAART: (M1) I am worried that other people might realize that I am HIV positive if they see me taking my HIV medications (M10) ‘It upsets me that the HIV medications I have been prescribed can affect the way I look (M9)’ ‘It upsets me that the HIV medications I have been prescribed can cause side effects will be summed and considered one variable. (M2) ‘It frustrates me that I have to plan my life around my medications (M3) and ‘I don’t like taking my HIV medications because they remind me that I am HIV positive’ (M7) ‘It frustrates me that I have to take these medications for the rest of my life (M8) ‘I am worried that the HIV medications I have been prescribed will hurt my health’ will be summed Responses to items related to the personal motivation sub-construct will be summed because of high level of correlation found by . (2007) in a similar study. The ‘negative beliefs about medications’ scale demonstrated adequate internal consistency (a = .74). Scoring approach:                          Following the original scoring approach of  the instrument, scores `will range from 1 point for  strongly  disagree to strongly agree After  reverse scoring of  items I3 and I5, all items will be summed-up in order to create a total score.  Responses of ‘Strongly Agree’ will be given a value of 1 for all items except I3 and I5,whereby ‘strongly Agree’ responses will be given a value of 0, and other response values for items I3 and I5 will be given a value of 0. ‘Strongly Disagree’ responses will be given a value of 5 for all items except I3 and I5 whereby ‘Strongly Disagree’ responses for items I3 and I5 will be given a value of 1, and other response values for items I3 and I5 will be given a value of 0. Accuracy score will be represented a summed total score.[p22]  Data collection procedures                         Before conducting this study, the dissertation proposal will be prepared and presented for approval from Walden University’s Institutional Review Board (IRB). Upon approval, the researcher will visit various recruitment locations (refer to recruitment section) to approach groups of potential participants in person. For those individuals who respond to the researcher using contact information provided through flyers, bulletins, and/or community announcements, the researcher will arrange a convenient time,  safe, comfortable location to meet with the participant. After brief introductory remarks, the researcher will  explain to  potential participant the purpose of the study, including the time required for questionnaire completion. The researcher will then screen each potential participant for eligibility and determine each participant’s interest in study participation. All participants for this study will be treated equally and those individuals who do not meet study eligibility criteria will be provided the reason’s) for ineligibility by this researcher. Those individuals who meet eligibility requirements and express interest in the study will be given a more detailed description of the study using a script, and debriefed by the researcher on participant confidentiality and the required procedures for informed consent. Each participant will be handed a study packet that includes a cover letter entitled “implied consent” which explains the definition and procedures for informed consent and requires the participant to initial and return to the researcher, a signed disclosure statement by the researcher, the LW-IMB-AAQ, and a pencil and eraser. An information sheet will be attached to the front of the questionnaire explaining the study and its objectives. Participants will be explained the voluntary nature of the study and no identifying information will be requested. The second page of the questionnaire will be a brief demographic information elicitation sheet, which will require participants’ demographic data. All data collected will be placed  on  an Excel spreadsheet in preparation for analysis. To ensure participants’ confidentiality and to protect the integrity of the process, all data will be secured in a locked cabinet, whose access is limited to the researcher. Data Analysis Plan             Multiple logistic regressions will be used to examine the relationship of HAART adherence information, HAART adherence motivation, and HAART adherence behavioral skills compared with participants’ HAART adherence levels. The main focus will be to identify motivation-related items, which might be related to poor adherence. Pearson correlation analysis will be used to assess multivariable associations between medication beliefs and non-adherence. Table 1 shows the data analysis approach.   Table 1 Data Analysis Approach                                                                                                           Research Questions                      Operational  Definitions________ Statistical Approach 1. What are the interrelationships among HAART adherence information, motivation, and behavioral skills   Adherence (Items I1 to I9) Motivation (Items M1 to M10) Behavioral Skills (Items B1 to B14) Pearson correlations 2. Are those interrelations related to the demographic factors? Same as above   Demographics (age, marital status, gender, education) Multiple regression ________________________________________________________________________     Descriptive and inferential statistics, generated in response to the research questions, will be computed using the latest version of SPSS. Cronbach Alpha will be used to evaluate the internal consistency reliability of summated scales and the LW-IMB-AAQ.  Confidentiality and Protection of Participants’ Rights                         Research ethical approval will be requested from participating residential and clinical facilities. Recruitment and enrollment procedures will be configured to protect participants’ confidentiality. Each study participant will be debriefed on confidentiality and the procedures by which their privacy and well-being will be ensured. Participants will be  made aware that the questionnaires are anonymous and that each participant’s questionnaire is assigned a numerical ID, pursuant to each participant‘s coding information. Participants are required to give informed consent by signing a consent form provided by the researcher prior to completing the LW-IMB-AAQ. Questionnaire enumeration will be for tracking purposes only, and will have no personal identifiers, as all responses will be strictly voluntary and anonymous. Each questionnaire will include written explanation for completing the survey, including the right to choose to participate or not. Study records will be kept private and no aspect of participants’ identity will be revealed in any probable publication of dissertation results. All records will be kept in a locked file, whereby only the researcher will have access. In addition, all coding information will remain completely secure. Each questionnaire will be numbered for tracking purposes only, and will have no personal identifiers; and responses will be strictly voluntary and anonymous.                                                                         Summary                                                                                              This chapter outlines the methodology and procedures of this study, which  examines HAART adherence motivational factors among African Americans using the IMB skills model as a theoretical foundation. In addition, special attention will be paid to the specific individual motivational factors found related to HAART adherence, including participants opinions and experience regarding HAART.Further, the project will include standard procedures for conducting empirical quantitative studies, such as coding, editing, data entry, cleaning and data modification ( 1999,), as well as methodology from various studies that have been successful in researching samples of HIV population on HAART regimens in other geographical locations. The significance of this quantitative study lies in the importance of generating a causal understanding of suboptimal HAART adherence by analyzing statistical data and a behavioral theory ( 199) in order to suggest specific interventions, which may  enhance overall HAART adherence rates among all HIV/AIDS patients. This study is   applicable only to African American population in an urban community. .             </div>   APPENDIX B  Permissions for Use and Reproduction of The Lifewindows study questionnaire from   Re: []                                                      Monday, August 25, 2008 8:18 PM                                                                                                                                                               Add sender to Contacts                                                                                               ok    —– Original Message —–                                                                                                       From:                                                                                                                               To:                          Sent: Monday, August 25, 2008 4:17 PM                                                                            Subject: Re:   Dear Dr. Thank you very much for allowing me permission to use the questionnaire in my study. I hereby also formally request your permission to reproduce the instrument in my dissertation. Most respectfully,  (Doctoral Candidate) =====================================================================   Sent from my   From:  To:  Sent: Sat May 03 02:31:49 2008  Subject: The lifewindows study questionnaire   50 Mercer Street Stratford, CT  06614   Dr.  Principal Investigator  Lifewindowsprogram  Center for Health, Intervention, and Prevention,     Dear                                                                                                                         Good day.  Please allow me to introduce myself and to express my appreciation for your global efforts to address various issues related to HIV/AIDS. My name is  and a doctoral student in public health epidemiology at My research interest is in correlation factors of HAART adherence among African Americans. Your investigations and publications have been pivotal sources of education in my current doctoral studies. I have taken the liberty to use IMB model to guide my dissertation. Upon reviewing the application of the LW-IMB-AAQ in the Lifewindows Project, I am persuaded that it is the most suited for my research. I respectfully request your permission to use same as the major methodological tool in my research. Sincerely,       APPENDIX C: SCREENING QUESTIONS 1.      Are you an African American living in New York? ____________________ 2.      Are you between of 18-55 years? ____________________ 3.      Dou you have a positive diagnosis for HIV/AIDS? ____________________ 4.      Are you currently taking prescribed medications (Highly Active Antiretroviral Therapy) because of your diagnosis? ____________________ 5.      Are you able to participate in the study and give informed consent? ____________________ 6.      Have you received any teaching about the medication that you were told to take for HIV? ____________________ 7.      Are you able to read and write English at about the sixth grade level? ____________________ 8.      Are you willing to complete a 35-item questionnaire about the way you take your medication? ____________________   Table 1 Data Analysis Approach Research Questions                                 Operational Definitions           Statistical Approach 1. What are the interrelationships among HAART adherence information, motivation, and behavioral skills   Adherence (Items I1 to I9) Motivation (Items M1 to M10) Behavioral Skills (Items B1 to B14) Pearson correlations 2. Are those interrelations related to the demographic factors? Same as above Demographics (age, marital status, gender, education) Multiple regression ________________________________________________________________________         </div> Credit:ivythesis.typepad.com

Adherence Motivational Factors of HIV Highly Active Antiretroviral Therapy among African Americans Living in Inner-City New York

Statement of the Problem……..……………………………….……….……………5 Significance of the Study………………………………….………………….………6 Need for the...