AMBO UNIVERSITY

SCHOOL OF MEDICINE AND HEALTH SCIENCE

DEPARTMENT OF HEALTH OFFICER

Research Proposal on :

Measuring the Quality Of Life (QOL) of People Living With

HIV/AIDS (PLWHA) With Highly Active Antiretroviral Therapy
L(HAART) in Ambo General Hospital

BY 4th Year medical student 1. Abdisa Geleta

2. Ararso Tolesa

3. Mindaye Abera
Abstract
The AIDS epidemic has affected much of Sub-Saharan Africa, Ethiopia not being an exception.
HIV/AIDS was a highly stigmatized and fatal disease and although the presence of stigma is
widely acknowledged, practical methods of intervention are rarely documented or analyzed for
outcome and effectiveness.

The development of antiretroviral drugs has significantly changed the perception

of HIV/AIDS from a very fatal to a chronic and potentially manageable disease, and the
availability and administration of antiretroviral therapy (ART) has significantly reduced
mortality and morbidity associated with HIV and AIDS.

There is a relationship between ART and quality of life of people living with HIV and AIDS, and
several studies have reported a strong positive association between ART and improved quality of
life in different domains among people living with HIV and AIDS in both developed and
developing countries. ART increases the length, quality of life, and productivity of the people
living with HIV (PLWH). But such data are lacking in the study area. However, some studies
have reported on the negative effects of ART, which directly or indirectly relate to the quality of
life and longevity of HIV-infected persons. In this study Measuring the Quality Of Life (QOL) of
People Living With HIV/AIDS (PLWHA) With Highly Active Antiretroviral Therapy (HAART)
in Ambo General Hospital based on studies done in developed and developing countries is
examined .This project will address three main questions:

1) What is the general understanding of HIV/AIDS and its associated QOL of PLWHA With
HAART in Ambo General Hospital?

2) What factors contribute to determining the quality of life of PLWHA on ART as compared to
their neighbors?
3) To assess the Quality of Life (QoL) of People Living With HIV/AIDS (PLWHA) on
Highly Active Antiretroviral Therapy (HAART) as determined by clinical variables.

The data collection will include both qualitative and quantitative methods encompassing
structured interviews and surveys. In conducting the research, in-country support will be
provided by the Stand for Vulnerable Organization (SVO), whose aims are empowering
vulnerable community members (especially women, children, and the elderly) by providing
different forms of grassroots support, including HIV prevention and family economic
development. The proposed outcome of this project is to gather and analyze data, producing an
informative report for SVO to address issues of QOL associated with HIV in PLWHA on ART.
Moreover, the findings will be integrated in an educational curriculum that will be piloted in
tandem with the data collection.
INTRODUCTION

The Human Immunodeficiency Virus (HIV) attacks CD4+ T-cells compromising its host’s immune system
and leaving it vulnerable to opportunistic infections (1). HIV is contracted through the transfer of body
fluids (blood, breast milk, semen, vaginal fluids, rectal mucous) with an infected person (4). As the
disease progresses, individuals not receiving effective treatment will eventually develop Acquired
Immune Deficiency Syndrome (AIDS) (1). The human immunodeficiency virus (HIV) continues to
take a tremendous toll on human health,having claimed more than 35 million lives so far. In
2015, 1.1 million people died from HIV-related causes globally. There were approximately 36.7
million people living with HIV at the end of 2015 with 2.1 million people becoming newly
infected with HIV. Sub-Saharan Africa is the most affected region, with 25.6 million people
living with HIV and accounts for two-thirds of the global total of new HIV infections (9).

Currently the data source for HIV prevalence estimations in Ethiopia are ANC sentinel
surveillances and national demographic and health surveys (DHS). From these data sources
estimated prevalence and other indicators of HIV/AIDS of the country are synthesized.
According to EPHI HIV Related Estimates and Projections for Ethiopia for 2017, the national
HIV prevalence is 1.16%.There are a total of 718,500 people living with HIV, of which 60 % are
female. Besides, there were an estimated 27,288 people newly infected during 2016, of whom
59% are young females. Annual AIDS deaths during the same period are 19,743(9)

While the AIDS epidemic is globally recognized and measures are being taken to encourage prevention
and increase universal access to treatment, AIDS-related deaths have fallen
by 28% with some 8 million lives saved. This achievement was the result of great efforts by
national
HIV program supported by civil society and a range of development partners.
Expanding ART to all people living with HIV and expanding prevention choices can help avert
21
million AIDS-related deaths and 28 million new infections by 2030. the matter of HIV/AIDS stigma
and discrimination has largely remained unresolved for over 25 years (5). What research has been done
has found that HIV-related stigma impedes measures like 
universal access (treatment), HIV testing, and
the effectiveness of national responses programs (5). HIV/AIDS is so highly stigmatized in some regions
that it hinders many from acknowledging their status or seeking treatment. Even with the influence of
stigma on HIV/AIDS prevention and control, it continues to be at the bottom of AIDS program
priorities(6).

A study conducted in Ethiopia evaluated basic knowledge of HIV/AIDS across the population, measuring
quality of people living with HIV/AIDS on ART (7). Although the article brings forth evidence for the
existence of Poor quality of life living with HIV/AIDS on ART in Ethiopia, it acknowledges that more
needs to be done to document and study quality related intervention.

Our research questions will encompass similar questions evaluated in previous studies to reconfirm their
outcomes and create a background for the development of an educational program.

Working closely with our faculty mentors and community partner, our general aim is to assess the
quality of life of people living with HIV/AIDS on highly active antiretroviral
therapy in Ambo.

Our project will focus on three types of information categories.

1) Evaluate the general level of HIV/AIDS knowledge and assess associated perceptions, barriers, and
justifications for the quality of life of people living with HIV/AIDS of those on highly active
antiretroviral therapy.

2) Examine the factors contribute to determining the quality of life of PLWHA on ART as
compared to their neighbors.

3) Assess the Quality of Life (QoL) of People Living With HIV/AIDS (PLWHA) on
Highly Active Antiretroviral Therapy (HAART) as determined by clinical variables.Information
gained from investigating these questions will be used to develop an educational program targeting
HIV/AIDS stigma and barriers for employment—influenced by stigma—that exacerbate spirals into
poverty.

My inspiration for this project stems from working with Dr. Sumedha Ariely and Dr. Kathryn Whetten on
an extension of the Positive Outcomes for Orphans (POFO) study. Through my involvement with POFO I
was introduced to Stand for Vulnerable Organization (SVO). SVO is an organization that aspires to
promote self-reliance through the promotion of education in sound health and finance practices. The
organization has been in partnership with POFO for nearly two years and the director, Mr. Misganaw
Eticha is a knowledgeable, well connected, and respected member of the NGO and Ethiopian
community.
The ideal outcome of the project would be to present SVO an analysis of the data in a report, while also
having run one or two pilot tests for the stigma education program. The curriculum may be further
developed and fully implemented when it reaches that stage. The curriculum will be malleable, so it may
be adapted as circumstances change. The issue of employment in conjunction with stigma can be
addressed by the analysis of the beneficial resources cited by interviewees. This may be transferred into
a resource guide for members of the community seeking employment.

OBJECTIVES
General:
To assess the quality of life of people living with HIV/AIDS on highly active antiretroviral
therapy.
Specific:
A) To assess the Quality of Life (QoL) of People Living With HIV/AIDS (PLWHA) on
Highly Active Antiretroviral Therapy (HAART) as determined by clinical variables.
B)To identify factors determining the quality of life of PLWHA on ART as compared to their
neighbors.
C)To identify the most affected quality of life dimension in PLWHA on HAART as compared to their neighboring comparison group.
D)To evaluate the performance ability of the Amharic Medical Outcomes Study-HIV(MOSHIV)
survey instrument that has been translated from the standard MOS-HIV English
version

METHODOLOGY

Description of the study area and subjects.

The study was carried out in ALERT (All African Leprosy Eradication and Rehabilitation
Training Center) or Zenebework hospital; a Non Governmental Organization providing
Tuberculosis (TB) and Leprosy treatment and rehabilitation services. More over ALERT has
commenced free ART since 2004.The non equivalent controls were selected from Kolfe keranio
and Nifasilk-Lafto subcities where the study participants are residing.
The Study population consisted two groups: the source population for the ALERT (Study group)
included PLWHA on HAART and; that of the comparison group were nearest households or
neighbors of the HAART participants residing in Kolfe Keranio and Nifasilk-lafto subcities.
All subjects provided verbal informed consent before participating in the study.
PLWHA on HAART were excluded from participating in the study if they were under 18 years
of age, have been on treatment for less than 3 months, had incomplete patient chart, and/or
did
not provide verbal consent.
Instrument and sample size
This study was a cross-sectional comparative study. For both cases and nonequivalent controls
data on demographic and socio-economic variables were collected using a pre tested
questionnaire while, clinical variables of HAART group was collected from their hospital charts.
In addition, information on health related quality of life variables was also collected by the
13
standard - Medical Outcome Study-HIV (MOS-HIV) questionnaire. Overveiw of the MOS-HIV
scales is presented in table 4.
Sample size for the HAART group was determined using the following eligibility criteria: age
>18 years, medical diagnosis of a chronic illness particular to the subject concerned must be not
less than 3 months (24,25); as it is assumed that QoL scores for chronic disease patients on drug
treatment changes significantly after three months. The definition of a chronic condition
adapted
is a medical condition that has lasted or is expected to last more than 3 months (26), volunteer
(27), on free treatment, have no serious mental illness, currently on follow-up and, had
complete
patient chart.
As the study focus on measuring health related quality of life in both groups; the proportion of
PLWHA on HAART and neighborhood comparison group with good quality of life score in
developing countries are found to be between (33%-59.8%) and (49.4%-66.8%) respectively.
This study used the average of the two proportion to attain adequate number of participants.
And
a 1to2 ratio of the size of the two groups was used to decrease variability in some of the
independent variables.
Based on the above criteria, sample size was determined by the general formula that has been used by researchers in cross-sectional
comparative
studies.
The formula was: let P= P1 + rP2
14
1+r and
n1= [Zα/2 √(1+1/r) P (1-P) +Zβ √P1(1-P1) + P2 (1-P2)]
(P1-P2) ²
Where, P is proportion of outcome of interest in the general population (0.503)
P1: proportion of outcome of interest in neighborhood comparison group (0.581)
P2: proportion of outcome of interest in "HAART" group (0.462)
r: is ratio of the size of sample 2 to sample 1,in this case, 1:2
Z α ; value of standard normal deviate at level of significance, 1.96 at 95% CI, α=0.05
2
Zβ; power (1-β ),i.e; 80%.
With additional assumption of 20% non response rate the total sample size became 795; 265
for
the “HAART” and 530 for “neighborhood” comparison groups.
Sampling procedure
After obtaining the list of 1600 PLWHA on HAART form the hospital records, systematic
random sampling was employed to obtain 265 study subjects on ART. The first participant was
Identified using (k=6) a currency note, while the neighborhood participants were recruited
based
on the nearest neighbor to the study subject principle. Adult neighbor to the right and left of
study subjects were considered eligible. If there were more than one adult in the nearby
15
household; the individual that match the cases with regard to age and sex is selected. If there
were two or more individuals that match the cases, one of them is randomly selected..
Data collection Tools
Two senior nurses extracted the data on clinical characteristics of PLWHA on HAART
according to the selection criteria while, 4 grade 12 complete data collectors collected the
demographic and quality of life information of PLWHA and the comparison group (neighbors).
The principal investigator supervised the data collection process. Prior to beginning the day’s
work, every data collector obtained information about the address (Sub city, Keble, Home No
and special area (local names) of the study subjects so as to gain access to their right and left
neighbors. All data collectors and supervisors took two days training before starting the survey.
Data for both groups were collected in two ways:
1. Relevant clinical data such as CD4+ count, weight…etc. of HAART group were collected
from their medical charts.
2. MOS-HIV-QOL survey instrument was administered to PLWHA on HAART and their
neighbors.
3. Information on demographic and socioeconomic variables was collected using pre tested
interview questinnaires.
In this study selected clinical information has been planned to be extracted form the patient’s
chart using data extraction sheet. Unfortunately the clinical information registered in the
16
patient’s chart has left much to be desired as the data available are either incomplete or not
timely filled. As a result, analysis of certain selected clinical variables was excluded.
Quality of life questionnaire
The study questionnaires measure HRQoL socio-demographic and health information. To
measure HRQoL the medical Outcomes Study HIV health survey (MOS-HIV) instrument that
has shown good reliability and validity in a wide variety of settings was used. The 35-item
questionnaire included 11 dimensions of physical and mental functioning. These are perceived
health, bodily pain, QOL, role functioning social functioning ,vitality, mental heath, health
distress, cognitive functioning, physical functioning and health transition. Scoring of the
MOSHIV was done by summing and linearly transforming raw scores of the 35 individual items
into
11 dimension scores that range from 0 to 100, a higher score indicates better functioning. A
physical and mental scores was also calculated (4). The English version of MOS-HIV was
translated to Amharic language using standard methods. The intent is to retain conceptual
equivalence of questions rather than to perform literal translations. Two independent forward
translations and three independent backward translations was performed by Amharic speakers
fluent in English (4). Translation of the MOS-HIV into the Amharic language was done using the
standard two independent forward and three independent back ward translation (4) by
Amharic
speaking English language post graduate students of AAU. Questionnaire were administered
face
- to - face in private rooms for PLWHA and in the homes of comparison group respondents
during December-February 2006.
17
To evaluate responsiveness of Amharic translated MOS-HIV interview questionnaire a three day
pretest of 10% sample size was employed in PLWHA on HAART residing in the neighboring
Gulele sub city.

Variables for the study

Dependent variables (dimensions) -Vitality
- Perceived health
- Bodily pain - Mental health
- QOL - Health distress
- Cognitive
- Role functioning
functioning
- Physical
- Social functioning
functioning
-Health transition

Independent variables
- Clinical disease stage - Duration of treatment
- Viral load (CD4+count)
Confounding factors
- Age - Family size
- Marital status - Employment
- Income - Religious affiliation
Education
Ethical clearance
Ethical clearance was obtained from the ethical clearance committee of Addis Ababa
University's, Medical Faculty. All participants have given their verbal consent and all
information were kept strictly confidential and a code number was used instead of name .
20
Data entry processing and analysis
Data entry was performed by the principal investigator and data entry clerks. The principal
investigator has processed and analysed the data using SPSS 13

WORK PLAN
Dissemination and Utilization of Results

Budget
Budget Total: $ 4280.00

Travel:

Airfare Addis Ababa, Ethiopia roundtrip: $1800

Public transportation to and from community partner: $260 ($5/day)

Food Lodging:

Food: $8/day for 52 days for a total of $420.00.

Addis Ababa: $25/day for 52 days for a total of $1300.00

Supplies & Equipment:

$500 for interviewing documents, printouts, pilot implementation costs, and compensation for
participants.

Additional funding sources (applied):

Career Center Internship Funding 2500.00

Duke Global Health Institute 5000.00

Duke Center for Civic Engagement 3000.00

Duke Center for International 2500.00

Deans’ Summer Research Fellowship

References
1.Basic Information on HIV and AIDS. Center for Disease Control and Prevention. Center for Disease
Control and Prevention , 03AUG2011. Web. 14 Feb 2012.

2. Epidemiological Fact Sheet on HIV and AIDS. World Health Organization. World Health Organization,
OCT 2008. Web. 15 Feb 2012.
<http://apps.who.int/globalatlas/predefinedReports/EFS2008/full/EFS2008_ET.pdf>.

3.Global Summary of HIV/AIDS epidemic 2010. World Health Organization. World Health Organization,
01DEC2010. Web. 14 Feb 2012.

4. How do you get HIV or AIDS? AIDS.gov. AIDS.gov, 20JUN2011. Web. 17 Feb 2012.
<http://aids.gov/hiv-aids- basics/hiv-aids-101/overview/how-you-get-hiv-aids/index.html>.

5. MacQuarri, Kerry, and Traci Eckhaus. HIV-related Stigma and Discrimination: A Summary of Recent
Literature. United Nations AIDS. United Nations AIDS, AUG2009. Web. 15 Feb 2012. <http://data.unaids.
org/pub/Report/2009/20091130_stigmasummary_en.pdf>.

6. Mahaja, Anish. Stigma in the HIV/AIDS epidemic: A review of the literature and recommendations for
the way forward. National Institute of Health Public Access. (2008): 1,4,7. Web.16 Feb.
2012.<http://www.ncbi.nlm.nih. gov/pmc/articles/PMC2835402/pdf/nihms168647>

7. Nyblad, Laura, and Rohini Pande. Disentangling HIV and AIDS S T I G M A in Ethiopia, Tanzania and
Zambi. International Center for Research on Women. (2003): 10,23,44. Web. 17 Feb. 2012.
<http://www.icrw. org/files/publications/Disentagling-HIV-and-AIDS-Stigma-in-Ethiopia-Tanzania-and-
Zambia.pdf>.

8. Worldwide HIV and AIDS Statistics and Commentary.AVERT HIV and AIDS. AVERT HIV and AIDS,
DEC2010. Web. 15 Feb 2012. <http://www.avert.org/worlstatinfo.htm>

9. National
Comprehensive HIV Prevention, Care and
Treatment Training for Health care Providers(2017)

annex