B. P. Koirala Institute of Health Sciences, Dharan Nepal

APPLICATION FORMAT FOR RESEARCH GRANT

Section–A

1. Title of the research project:

Nutritional Status of the People Living with AIDS Receiving ART at BPKIHS

2. Name and designation of:

a. Principal investigator:

Name:

Designation: Nursing Officer, Medical-Surgical Nursing Department, CON

Name Designation Department

3. Expected duration of the proposal: 1 Year

4. Amount of grant in – aid asked RS. = 25,000/-

5. This is new project: Yes.

Declaration

1. I/we have read the terms and the terms and conditions of BPKIHS research grants, and agree to abide by them.

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2. I/we agree to submit, within three months from the date of termination of the project, a report on the work done.

3. I/we agree to maintain a stock book for purchases made for he project. I/we shall submit the complete statement of account within three months of the termination of the project, and at any other time as required by the accounts section.

4. I/we agree to acknowledge the grant in any publication resulting from the project if it is approved for financial assistance.

5. I/we declare that no research grant is already available for the research project from any other source.

6. I/we declare that the project will be conducted as per the highest ethical standards applicable to animal/human experiments.

Signatures (with seal and date):

Principal Investigator Signature Date

Co-investigator Signature Date

Remarks form the HoD of the Principal Investigator:

Date: Signature & Seal of the HoD

Remarks for the HoD of the Co-investigator:

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Section-C

Details of the research project

1. Title of the research project

Nutritional Status of the People Living with AIDS Receiving ART at BPKIHS

2. Objectives: To assess the nutritional status of the People Living with AIDS receiving ART at BPKIHS

3. Summary of the research project. Weight loss is associated with adverse outcomes in HIV. In assessment of nutritional status, serial weight measurement has been used by the Centers for Disease Control and Prevention (CDC) as a way to identify the wasting syndrome. Serial measurements of body mass index (BMI; the weight in kilograms divided by the square of the height in meters) predicted the development of AIDS. Measurements of body compartments are crucial in identifying persons with HIV who are at risk for serious consequences of malnutrition. Other measures of nutritional status also predict outcome with HIV infection. Studies by Chlebowski et al. and others showed that serum albumin levels predicted survival. Micronutrient deficiencies are common in HIV infection. Deficiencies in serum vitamin A, vitamin B12, selenium, and zinc, in particular, have been associated with progression of HIV infection. Thus, measurements of serum proteins and micronutrients can predict outcome and may identify correctable deficiencies. Lipodystrophy, or the syndrome of fat redistribution, has been described in HIV infection and may be related to antiretroviral therapy. Regional measures of fat must be made both to detect changes in fat distribution and to plan intervention strategies. Nutritional assessment in HIV-infected persons can identify those at risk for adverse outcomes, including death, from nutritional deficiencies. Minimally invasive, proven, and acceptable methods exist for accurate nutritional assessment. National guidelines for adults and children with HIV are needed to provide the information and impetus for appropriate nutritional screening and intervention in persons with HIV infection. It is hospital based descriptive cross-sectional study conducted among the PLWA receiving ART at BPKIHS. All the PLWA (about 200PLWA) receiving ART at BPKIHS ART center will be included in the study.

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4. Review of the literature pertaining to the project. Malnutrition is a frequent complication of human immunodeficiency virus (HIV) infection and is associated with a poor prognosis. To compare different measures of nutritional status in HIV-infected patients, we prospectively studied 88 outpatients seen at a Paris AIDS outpatient clinic for routine follow-up examinations. Nutritional status was assessed according to body weight loss (BWL, 4 classes), anthropometry, bioelectric impedance analysis (BIA), and subjective global assessment of nutritional status (SGA). Malnutrition was diagnosed in 22.4% of subjects using SGA, and 37.1% by BWL. SGA rapidly detected a worsening of nutritional status, while BWL detected malnutrition at an earlier stage. A good correlation was found between SGA class and body composition assessed by anthropometry and BIA. Deteriorating nutritional status diagnosed by SGA correlated with the CDC HIV disease class. SGA, a simple nutritional assessment, can serve as a basis for prescribing artificial nutrition, while BWL detects malnutrition at an earlier stage.1 Globally, acquired immunodeficiency syndrome (AIDS) is an epidemic, severe and fatal disease. Along with the etiological factors of human immunodeficiency virus infection (HIV+) and decreased immunity, there are a number of other risk factors including opportunistic infection, malnutrition, wasting syndrome, and oxidative stress. The nutritional problems have been shown to be significant and contribute to health and death in HIV+/AIDS patients. Weight loss, lean tissue depletion, lipoatrophy, loss of appetite, diarrhea, and the hypermetabolic state each increase risk of death. The role of nutrition and how oxidative stress is involved in the pathogenesis of HIV+ leading to AIDS is reviewed. Studies consistently show that serum antioxidant vitamins and minerals decrease while oxidative stress increases during AIDS progression.2 The optimization of nutritional status, intervention with foods and supplements, including nutrients and other bio-active food components, are needed to maintain the immune system. Various food components may be recommended to reduce the incidence and severity of infectious illnesses by forms of bio-protection which include reduced oxidative stress due to reactive oxygen species which stimulate HIV replication and AIDS progression. Probiotics or lactic acid bacteria and prebiotics are sometimes given on the presumed basis that they help maintain integrity of mucosal surfaces, improve antibody responses and increase white blood cell production. People with HIV+/AIDS can be informed about the basic concepts of optimal nutrition by identifying key foods and nutrients, along with lifestyle changes, that contribute to a strengthened immune system. Moreover, nutritional management, counseling and education should be beneficial to the quality and extension of life in AIDS.3 Adults who are HIV-positive are more likely to be undernourished than those whose status is not established, as there is a significant difference (P = 0.000) between the nutritional status (BMI) of PLWHA and those whose HIV/AIDS status is not established. PLWHA consume foods that are low in nutrients to promote their nutritional well-being and health.4 This study, which evaluated HIV infected patients with no clinical signs of AIDS, found that majority of them had some degree of malnutrition. Malnutrition, which is often seen at an advanced stage of HIV-infection, was a prominent feature in the early stages of HIV infection

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because of the poor nutritional status of a significant percentage of individuals in our environment. In general, the nutritional status of the normal Nigerian population is lower compared to that of other countries. For example, a previous study states that in Nigeria, 14% of normal females and 15% of males are underweight , which contrasts the situation in Brazil, where 4.8% (men) and 11.7% (women) were found to be obese . The inability of individual HIV-infected patients to meet the daily recommended dietary allowance is more likely due to socioeconomic factors. More than a third of the HIV-infected patients in this study belonged to the lower socioeconomic status, a group classified as “food insecure,” which is defined as not having access at all times to enough food for an active and healthy lifestyle.5 Families affected by HIV experience the death of partner, divorce or separation and increased household expenses due to increased health costs incurred by laboratory tests that they must pay for themselves. The end result is more poverty and more food insecurity. Unfortunately, these conditions may continue for some time as international donor agencies such as the US Presidential Emergency Program for AIDS Relief (PEPFAR) and AIDS Relief place more emphasis on the treatment of HIV with potent antiretroviral therapy rather than on providing food supplements in addition to antiretroviral drugs to the detriment of the nutritional status of the HIV patients. World Health Organization (WHO) nutritional recommendations for HIV-infected individuals emphasize the critical role of adequate nutrition for the health and survival of all subjects regardless of their HIV stage. 6 In conclusion, malnutrition is common among HIV-infected patients. Nutritional status has been shown to predict survival rate in adult with HIV after adjusting for CD4 count and other secondary events. Optimal nutrition no doubt helps boost immune function and maximize the effectiveness of antiretroviral therapy. This study will find the nutritional status of the people receiving ART at BPKIHS and help in planning needful strategies. 5. Rational of the study. This study will find out the nutritional status of the people living AIDS receiving ART at BPKIHS ART centre, as nutritional problem is very common among these group of population. Appropriate nutritional management will be beneficial for the quality of life of the patient receiving ART.

6. Research design and methodology.

A. Research design: it will be descriptive cross sectional research design.

B. Research Setting/Sample Area: The study will be conducted at ART center of BPKIHS

C. Target population: All the people living with AIDS receiving ART at BPKIHS ART

center constitute the population of the study.

D. Sample and sample size:

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Sample: The PLWA receiving ART at BPKIHS ART center who fulfill the set selection

criteria constitute the sample of the study.

Sample size: All the PLWA (About 200 subject) will be included in the study.

E. Criteria for sample selection/Procedure: All the PLWA on ART who give the

consent

F. Criteria for sample exclusion: Those PLWA who refuses to participate in the study will

be excluded.

G. Sampling technique: Total enumerative sampling technique will be used to collect the

data.

H. Research instrument:

Interview schedule and measurement tools will be used to collect the data. I. Validity of the tool:

Content and face validity of the tool will be again established with the experts of concerned field. Pre-testing of the tool will be done among 3-4 subjects. Nepali version of the tool will be prepared and again it will be translated to English for validity.

J. Methods of data collection/Data collection Procedure:

• A detailed list of all the cases will be prepared before starting the data collection. • Ethical clearance from concerned authorities (BPKIHS ethical review board) will be

obtained. • Permission from concerned authorities i.e. HODs, In-charges etc. • Informed written consent from each subject will be obtained prior to interview.

K. Statistical Analysis of data: a. Descriptive data analysis: Percentage, Mean and SD will be used for describing

demographic Profile. b. Inferential data Analysis: Chi-squire and Correlation will be used to find out

association and draw the conclusions. L. Limitations of the study: The study is limited to the PLWA receiving ART at BPKIHS.

M. Ethical Issues for the Research: i. Written permission will be obtained from the concerned authority. ii. Anonymity of the subjects will be maintained. iii. The informed written permission will be obtained from subjects. iv. The subjects will be assured of the confidentiality of the information. v. Ensure privacy and confidentiality and to hide the patient’s diagnosis from extended

family members. Interview conducted in caregiver in alone, not with patients and other family members.

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5. Results and Discussion: The collected data will be entered in SPSS-12.5 software package and will be analyzed. The findings will be presented in table and graphs. Inferential statistics will be used to analyze and draw the conclusion. The results will be compared with the findings of study conducted by various investigators on related fields.

6. ORGANIZATION OF THE STUDY: (TIME SCHEDULE)

SN Activities Duration/Time

1. Literature review and finalization of the project 2 Months 2. Pre-testing and finalization of tool 1 Months 3. Data collection 6 Months 4. Analysis of Data 1 Months 5. Report writing and Submission 2 Months ……………………….

1 Year

Section-D

Details of the Budget:

SN Item/Particular Amount (In NP Rs.) 1 Data Collection 3,000 2 Tool: Preparation, Printing & Testing. 2,500 3 Refreshment for Participants 3000 4 Data Processing: coding and entry 2000 5 Report preparation and Typing 4000 6 Data Analysis 3000 7 Photocopy, Printing and Binding 6000 8 Miscellaneous 1500 9 Grand Total 25,000 /-

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References

1. Chlebowski RT, Grosvenor MB, Barnhard NH, Morales LS, Bulcavage LM. Nutritional

status, gastrointestinal dysfunction, and survival in patients with AIDS. Am J Gastroenterol 1989; 84:1288–93.

2. Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab 1996; 81:4051–8.

3. Ott M, Fischer H, Polat H, et al. Bioelectrical impedance analysis as a predictor of survival in patients with human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol 1995; 9:20–5.

4. Palenicek J, Graham N, He Y, et al. Weight loss prior to clinical AIDS as a predictor of survival. J Acquir Immune Defic Syndr Hum Retrovirol 1995; 10:366–73.

5. Suttmann U, Ockenga J, Selberg O, Hoogestraat L, Deicher H, Muller MJ. Incidence and prognostic value of malnutrition and wasting in human immunodeficiency virus–infected outpatients. J Acquir Immune Defic Syndr Hum Retrovirol 1995; 8:239–46.

6. Kotler DP, Tierney AR, Wang J, Pierson RN. Magnitude of body-cellmass depletion and the timing of death from wasting in AIDS. Am J Clin Nutr 1989; 50:444–7.

7. Wheeler DA, Gibert CL, Launer CA, et al. Weight loss as a predictor of survival and disease progression in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr 1998; 18:80–5.

8. Guenter P, Muurahainen N, Simons G, et al. Relationships among nutritional status, disease progression, and survival in HIV infection. J Acquir Immune Defic Syndr 1993; 6:1130–8.

9. Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Morb Mortal Wkly Rep 1992; 41(RR-17):1–19.

10. Maas JJ, Dukers N, Krol A, et al. Body mass index course in asymptomatic HIV-infected homosexual men and the predictive value of a decrease of body mass index for progression to AIDS. J Acquir Immune Defic Syndr 1998; 19:254–9.

11. Paton NI, Castello-Branco LR, Jennings G, et al. Impact of tuberculosis on the body composition of HIV-infected men in Brazil. J Acquir Immune Defic Syndr Hum Retrovirol 1999; 20:265–71.

12. Semba RD, Caiaffa WT, Graham NM, Cohn S, Vlahov D. Vitamin A deficiency and wasting as predictors of mortality in human immunodeficiency virus–infected injection drug users. J Infect Dis 1995; 171: 1196–202.

13. Tang AM, Graham NM, Chandra RK, Saah AJ. Low serum vitamin B-12 concentrations are associated with faster human immunodeficiency virus type 1 (HIV-1) disease progression. J Nutr 1997; 127:345–51.

14. Baum MK, Shor-Posner G, Lai S, et al. High risk of HIV-related mortality is associated with selenium deficiency. J Acquir Immune Defic Syndr Hum Retrovirol 1997; 15:370–4.

15. Baum MK, Shor-Posner G, Campa A. Zinc status in human immunodeficiency virus infection. J Nutr 2000; 130:1421S–3S.