This document provides details of a proposed research study on the nutritional status of people living with AIDS receiving antiretroviral therapy (ART) at B.P. Koirala Institute of Health Sciences in Dharan, Nepal. The principal investigator is a nursing officer in the medical-surgical nursing department. The study will use a descriptive cross-sectional design to assess the nutritional status of approximately 200 ART patients through measurements of weight, BMI, serum proteins, micronutrients, and fat distribution over the course of one year with a budget of 25,000 Nepali rupees. A literature review establishes that malnutrition is common in HIV/AIDS and predicts health outcomes, so this study aims to identify nutritional deficiencies and

1. 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.

2. 2. I/we agree to submit, within three months from the date of termination
2
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:

3. 3
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.

4. 4
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

5. 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
5
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:

6. 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
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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.

7. 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.
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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 /-

8. 8
References
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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
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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.