Vitamin A Deficiency may be Associated with Increased Mortality n HIV - Research Proposal Example

Observational studies suggest vitamin A deficiency may be associated with increased mortality in HIV 0 Introduction 1 Background Information and Significance of Study Since its inception, HIV and AIDS has remained a thorny force for scientist and health researchers to reckon. Though prevalence rates are not as high as they used to be decades back, rate of infection continues to be very alarming. In 2009 for instance, new data in the AIDS epidemic update reported that new HIV infections have reduced by nearly 17% over the past eight years with some parts of the world such as East Asia, recording as high as 25% reduction rate (UNAIDS, 2010). As new rates of infection reduce, the new line of focus and attention for stakeholders should be remain on how to reduce mortality rate among infected people (Gardner, 2011). Global facts and figures from the World Health Organisation HIV/AIDS in 2009 states that “Since the beginning of the epidemic, almost 60 million people have been infected with HIV and 25 million people have died of HIV-related causes” (WHO, 2009). What the figure of number of people who have died out of the epidemic means is that more than 3 nations have entirely been wiped out if the average population of each of the nations is made equivalent to the population of Switzerland, which is 7,639,961 (CIA, July 2011 est.). Such is the threat that high mortability rate of AIDS poses to the world; considering the fact that the rate of reproduction that the dead people would have accounted for the world’s human resource growth have not even been estimated. This research work is therefore of primary importance in saving ‘nations from being wiped away’. This research is meant to save lives and make people live longer enough to contribute their human resource abilities to the development of the globe. 2.0 Methodology 2.1 Study Design The study design to be adopted is going to be randomized controlled trials. It has been explained that “the randomized controlled trial is a study in which people are allocated at random to receive one of several clinical interventions” (Stolberg, Norman and Trop, 2004). This explanation expresses two major ideas that are very relevant for this study. These ideas are the fact that there will be a random sampling method to select participants and the fact that there will be an intervention in place. Explaining further, Stolberg, Norman and Trop (2004) assert that the intervention “should be used in a much wider sense to include any clinical manoeuvre offered to study participants that may have an effect on their health status.” In this research, the clinical manoeuvre to be adopted shall be the use of vitamin A supplements to access the rate of improvement in health conditions of HIV AIDS patients. 2.2 Participants The population of the study shall be based in Kenya in Eastern Africa. AVERT (2011) reports that “An estimated 1.5 million people are living with HIV; around 1.2 million children have been orphaned by AIDS; and in 2009 80,000 people died from AIDS-related illnesses.” This represents very high mortality rate among HIV AIDS patients in Kenya. The delimitation of population shall be AIDS patients in a specific hospital of the country. The justification of selecting Kenya is in its high mortality rate in terms of AIDS. The justification in selecting a specific hospital is for the need to allow for closer monitoring of participants. 2.2.1 Inclusion Criteria Though there exist as many HIV/AIDS patients in Kenya and for that matter the selected hospital, not all patients will be included in the data collection process. Inclusion criteria will be designed to accommodate few patients among whom a sample size will be built. The inclusion criteria is justifiable as the University of Oklahoma College of Medicine (2011) notes that “inclusion criteria are the criteria for including a patient in the study, and it is important that these criteria be clearly defined in an objective manner, so that anyone involved in the study can reproduce patient inclusion decisions precisely.” To this end, the following inclusion criteria are to be used. Patients on the use of antiretroviral drugs Patients whose diagnosis is in the third year Patients who have not received alternative treatment outside the orthodox medical system Patients who are receiving intensive and exclusive care from the hospital Patients who are not at risk or have not been diagnosed with other diseases that require the dependence on vitamin A such as diabetes and cardiovascular diseases. Patients who are less than 50 years 2.2.2 Exclusion Criteria Patients may be excluded from the study based on the following exclusion criteria. Patients who have lived with AIDS for more than 3 years Patients who have undergone radiographic evidence to be with pulmonary blebs Patients who are already receiving treatment that includes vitamin A supplications A patient who’s HIV/AIDS cannot be traced or ascertained by the hospital upon which they are on admission. Patients above the age of 50 Patients with uncontrolled psychiatric disorders like psychosis Patients with profound history of noncompliance. The inclusion and exclusion criteria will be beneficial to the research in the sense that it will help in creating a variable base, upon which the researcher can be assured that all participants will belong to an even criterion. 2.3 Recruitment Strategy Having identified the inclusion and exclusion criteria above, it is just right that the researcher makes bare, how the actual recruitment of participants to be included will be done. In other to ensure accuracy in the recruitment procedure, the researcher shall embark on a collaborative recruitment strategy. This is to say that the researcher shall include other health experts, who are in a position to providing every needed authentic diagnosis and review to HIV/AIDS patients at the hospital. The recruitment team shall be led by the chief paramedic in-charge of HIV/AIDS at the hospital. As part of the strategy, the recruitment team shall make use of both existing and post-diagnostic records. With the existing records, the team shall easily exclude patients on the basis of age, year of disease contraction, history of noncompliance and reception of vitamin A related interventions. The post-diagnostic records would however be used to exclude patients on the basis of the presence of other diseases that will be found to be a hindrance to the present research work. 2.4 Sample size After the recruitment strategy has gone through and the required participants have been selected, a random sampling technique shall be used to raise a sample size. As a principle of randomized controlled trial, there shall be a random assignment method to select the controlled group. As explained by Trochim (2006), “Random assignment is how you assign the sample that you draw to different groups or treatments in your study.” For this reason, the researcher shall cut pieces of papers that are as many as the number of AIDS patients as there are in the hospital. Out of the pieces of papers, twenty (20) of the pieces of papers shall bear the inscription ‘-do-’. All pieces of papers including those with the inscription shall be mixed thoroughly in bowl. All the members in the population permitted to be part of the research shall be made to pick one of the papers at random and without looking into the bowl. The twenty (20) patients to select papers with the inscription ‘-do-’ shall be made part of the sample size. 2.5 Intervention / Control treatment The researcher shall adopt an efficacy or effectiveness trials. This efficacy and effectiveness trail shall help in realising the dream of the researcher in finding the efficacy or effectiveness of vitamin A supply in AIDS patients in relation to their mortality rate. It is in this direction that Stolberg, Norman and Trop (2004) explains that “efficacy refers to interventions carried out under ideal circumstances, whereas effectiveness evaluates the effects of an intervention under circumstances similar to those found in daily practice.” The intervention to use will be a close monitoring and administration of vitamin A supplement and vitamin A enhanced meal. Levels of improvement in control group shall be compared to the experimental group to ascertain the effectiveness or efficacy of administration of vitamin A to HIV AIDS patients. 2.6 Outcomes There is expected to be both primary and secondary outcome with results. The primary results shall be based on the trend of improvement of health records received from medical officers. This will be a roadmap to determining the actual mortality rate among the AIDS patients. This also means that the research timeframe would span for very long time. As long as all people in the sample group will be deceased. Secondary outcomes will be based on interpretations given to primary research from existing literature. Some of the existing researches that will be used in the secondary data collection are as follows: Of 271 women who received multivitamins, 67 had progression to World Health Organization (WHO) stage 4 disease or died — the primary outcome — as compared with 83 of 267 women who received placebo (24.7 percent vs. 31.1 percent; relative risk, 0.71; 95 percent confidence interval, 0.51 to 0.98; P=0.04). – Wafaie et al (2004) Mortality at 24 months was 2.3 per 1000 person-years and 38.3 per 1000 person-years in HIV-negative and HIV-positive women, respectively. Vitamin A had no effect on mortality. Tuberculosis was the most common cause of death, and nearly all tuberculosis-associated deaths were among HIV-positive women. – Zvandasara et al (2006) Among HIV-infected individuals, many nutritional factors that influence disease progress, mortality, and transmission are not well understood. Of particular interest is the role of vitamin A. The benefits of vitamin A have been recognized since ancient times by Egyptian physicians who successfully treated night blindness with vitamin A. – Kuhn et al. (2000) 2.7 Statistical methods The selected statistical method for the study is selected primarily based on the fact that a random or probability sampling method would be used in the creation of the sample size. The statistical method is the multivariate method. Multivariate methods work best in situations where there is a probability sampling technique and in a situation, where different variables will be used. In this research, the creation of a control and experimental group would lead to the researcher having to deal with two variables thus patients under vitamin A intervention and those without vitamin A intervention. With the multivariate method, the researcher shall use inference for various parameters such as variances and means based on normal distribution. This will lead to the use of principal component analysis. The aim of the use of the principal component analysis is primarily to “make each successive component account for as much as possible of the remaining variability uncorrelated with previously determined components” (Delorme, 2002). Simply put, there should be a conclusion that either confirms a correlation between the mortality and health wellness rate among HIV/AIDS patients and the intake of vitamin A or denies it. Mathematically, the principal component analysis should be given as: With random vector population Z, Z = (z1….,zn)T Mean will be given as µz = E {z} Then co-variance matrix of same set of data will be Cz = E{(z - µz) (z - µz) T} Given the components of Cz as Cab, the co-variance between the random variable component will be given as Za and Zb. This means that the components of Caa will be the variance of the Za. Mathematically, the Aalto University Department of Information and Computer Science (2001) explain that the variance of a component indicates the spread of the component values around its mean value. To this effect, if two components Za and Zb of the data are uncorrelated, their covariance is zero; implying that (Cab = Cba = 0). The covariance matrix is, by definition, always symmetric. 2.8 Data Analysis Plan Quantitative data analysis shall be employed in the examination, interpretation and analysis of results. This means that there shall be the need to use statistical methods of data handling. To this effect, the researcher shall employ the use of simple percentage changes in rate of progression of improvement in health status as given by medical records of participants. This shall also call for the use of graphs and tables where the need be. 2.9 Adverse event monitoring and trial stopping Because all forms of monitoring shall be based and backed by professional medical results, it will be very easy to identify and forms of adverse events and effects on participants. In cases of this nature and per professional medical advice, trail and treatment of any form shall be stopped immediately. Depending on the time of research span, new participants may be recruited. 3.0 Feasibility and ethical issues Hope of the feasibility of the research is based on the fact that similar researches have been conducted in other parts of Africa including Zimbabwe and Egypt (Zvandasara et al, 2006; Kuhn et al., 2000). This not withstanding, the researcher shall conduct personal feasibility studies on the study. This shall include financial cost, availability of resources and all forms of legal and professional ethical issues relating to the study. For example permission shall be sought from senior health officers in targeted hospitals in Kenya. Where it becomes extremely difficult to have permission granted, replaceable options shall be used. In the actual conduct of the research also, the researcher shall comply strictly by any instructions given by supervisors and senior health officers, under whose supervision the research shall be conducted. Finally, basic research ethical issues such as anonymity of participants and confidentiality of results obtained shall be observed. 4.0 Lay statement This is a study that seeks to find out whether the absence of vitamin A in the diet or medicine of an HIV AIDS patient can cause the patient to die earlier than expected. The same bases shall be used to determine if HIV/AIDS patients may die earlier if the take vitamin A in fewer quantities. The need for the research is against the backdrop that existing researches do not have any convincing conclusions as to whether or not vitamin A has a role to play in the life expectancy of HIV/AIDS patients. By and large, the study will be very important in saving lives especially if the findings turn out to favour the idea that vitamin A helps in increasing the life expectancy of HIV/AIDS patients. Even if the research proofs otherwise, room shall be created for finding other convincing conclusions on how to help increase the life span of HIV/AIDS patients. REFERENCE LIST AVERT, 2011, ‘HIV and AIDS in Kenya’, accessed October 12, 2011 CIA, 2011, ‘Switzerland’, World Fact Book, accessed October 14, 2011 Gardner, A. E., 2011, ‘New Approach to HIV/AIDS Combating’, Universal Printing Press: Toronto Hani G., 2009, ‘Sample Group – A Subset of Population’, Experiment Resources, accessed October 13, 2011 Kuhn et al. 2000, ‘Vitamin A and HIV infection: disease progression, mortality, and transmission’, Nutr Rev. 2000 Oct;58(10):291-303.. available on line at http://www.ncbi.nlm.nih.gov/pubmed/11127968 McCutcheon, G. & Jung, B. 1990, ‘Action Research’, accessed October 14, 2011 Stolberg H. O, Norman G and Trop I. 2004, ‘Randomized Controlled Trials’, American Journal of Roentgenology. Accessed October 1 2011 Trochim M. W. K. 2006, ‘Random Selection & Assignment’ accessed October 17, 2011 UNAIDS, 2010, ‘2009 AIDS Epidemic Update’, accessed October 13, 2011 Wafaie et al 2004, ‘A Randomized Trial of Multivitamin Supplements and HIV Disease Progression and Mortality’, accessed October 12, 2011 World Health Organisation, 2009, ‘Global Facts and Figures on AIDS’ accessed October 13, 2011 Zvandasara et al. 2006, ‘Mortality and morbidity among postpartum HIV-positive and HIV-negative women in Zimbabwe: risk factors, causes, and impact of single-dose postpartum vitamin A supplementation’, J Acquir Immune Defic Syndr. 2006 Sep;43(1):107-16. Available on line at http://www.ncbi.nlm.nih.gov/pubmed/16885772 Aalto University Department of Information and Computer Science, 2001, ‘Principal component analysis’, accessed October 25, 2011 Delorme A, 2002, ‘Statistical Methods’ Swartz Center for Computational Neuroscience, CA92093-0961, La Jolla. Available online at http://sccn.ucsd.edu/~arno/mypapers/statistics.pdf University of Oklahoma College of Medicine, 2011, ‘Inclusion and Exclusion Criteria’, Accessed October 24, 2011 Read More