MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT GENDER,
ELDERLY AND CHILDREN
MASWA CLINICAL OFFICERS TRAININGCENTRE
ORDINARY DIPLOMA IN CLINICAL MEDICINE
RESEARCH PROPOSAL
TITLE
TO DETERMINE THE PRIVALENCE OF NON ADHERERANCE TO
ANTIRETROVIRAL THERAPY AMONG CHILDREN OF LESS THAN 18 YEAR WHO
ATTENDING CARE AND TRETMENT CENTRE AT MASWA DISTRICT HOSPITAL
FROM SEPTEMBER UP TO NOVEMBER 2019
AUTHOR: LUCAS J. MARWA
NACTE NUMBER: NS4310/0018/2015
SUPERVISOR: DR. NELSON.
DR. MLEKWA
A proposal submitted to Maswa Clinical Officer Training Center in partial fulfillment of the requirement
of the award of Ordinary diploma in Clinical Medicine.
Contents
01. PRELIMINARY PAGES ....................................................................................................... 1
(i). ACKNOWLEDGEMENTS ................................................................................................................ 1
(ii). ABBREVIATIONS ........................................................................................................................... 2
(iii). OPERATIONAL DEFINITIONS ...........................................Ошибка! Закладка не определена.
(iv). ABSTRACT ..................................................................................................................................... 3
CHAPTER ONE ........................................................................................................................... 4
1.1 INTRODUCTION.................................................................................................................. 4
1.2 Background ......................................................................................................................................... 4
1.3 Problem statement .............................................................................................................................. 5
1.4.1 Objectives of study ......................................................................................................................... 6
1.4.2 Broad objective ............................................................................................................................... 6
1.5 Specific objective .............................................................................................................................. 7
1.6 Research question ....................................................................Ошибка! Закладка не определена.
1.7 Limitation of study ..................................................................Ошибка! Закладка не определена.
2.7 Rationale and significance of the study ...................................Ошибка! Закладка не определена.
CHAPTER TWO ........................................................................................................................ 12
02. LITERATURE REVIEW ................................................................................................... 12
2.1 Introduction...........................................................................................................................................1
2.2 Definition of key terms.........................................................................................................................2
2.3 Theoritical literature review.................................................................................................................3
2.4 Review empirical evidence..................................................................................................................4
CHAPTER THREE ...................................................................................................................... 3
03. METHODOLOGY (MATERIALS AND METODS).......................................................... 3
3.1 Introduction..........................................................................................................................................1
3.2 Research design.....................................................................................................................................2
3.3 Area of the study.................................................................................................................................3
3.4 Target population..................................................................................................................................4
3.5 Sample and sampling techique.............................................................................................................5
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3.6 Data analysis.......................................................................................................................................6
3.7 Work-plan (implementation plan).............................................Ошибка! Закладка не определена.
ii
01. PRELIMINARY PAGES
1.1 ACKNOWLEDGEMENTS
With an indebt gratitude to the Lord God Almighty, I dedicate this thesis to the Ministry of
Health, community development, gender, elderly, and children.
This study has been possible through the contributions of many people and I give my sincere
thanks to them all I am particularly grateful to my responsible Parents Mr.
I will also like to express my appreciation to the tutors Dr Aneth principal of Maswa COTC, Dr
wisiko, Dr Mlekwa, Dr Nelson, Mr, Masige jumanne, Mr, kaguo
and others who sacrifice their time to teach us
However, I will like to convey my deepest gratitude to my supervisor, Dr. Mlekwa and Dr
Nelson for his invaluable guidance and constructive comments throughout the study.
I say thank you to my collegians for the friendship, support and the sharing of ideas throughout
the period that we have known each other.
1
1.2 ABBREVIATIONS
AIDS……………………...............Acquired Immunodeficiency Syndrome
ART……………………………………Antiretroviral therapy
ARV………………………………….. Ant Retro Viral Drug
CTC…………………………………..Care and treatment centre
HAART……………………………….Highly Active Antiretroviral Therapy
HIV………………..………………….Human Immunodeficiency Syndrome
MDH …………………………Maswa District Hospital
IDC…………………………………… Infectious Disease Control
NGO…………………………………. Non-Government Organization
PLWHA……………………………. People Living With HIV/AIDS
WHO………………………………… World Health Organization
2
1.4 ABSTRACT
Objective The rapid scale up of antiretroviral treatment (ART) in Tanzania particularly Maswa
district has resulted in an increased focus on patient adherence. Non-adherence can lead to drugresistant HIV caused by failure to attain maximal viral suppression. The aim of this study is to
assess factors leading to non-adherence to ART among HIV-positive children attending CTC at
Maswa District' Hospital.
Design Review of adherence to ART in Maswa District Hospital (MDH) from January up to
March 2020, will be conducted with 204 participants attending at ART clinic for follow up.
Methods A cross sectional study will be performed and collected through questionnaires. Risk
of bias will be assessed.
Results will be will help impart knowledge on adherence of ART therefore decrease morbidity
and mortality resulted to poor adherence due to HV/AIDS.
3
CHAPTER ONE
02. INTRODUCTION
2.1 Background
Adherence is defined as "to stick, to remain loyal. Suggested that word "compliance", be
replaced by "adherence" in 1975 in medical terminology Blackwell. Previously, "compliance"
was used to define the obedience of the patient to a prescribed medical regimen.
The WHO provides a guide for estimating adherence: adherence is classified as either “good
adherence” (i.e., ≥ 95%), “fair adherence” (i.e., 85%–94%), and “poor adherence” (i.e., <85%)
(World Health Organization, 2010) (2).
The unforgiving nature of the virus requires that levels of adherence (˃95%) be higher and
more sustained than in most other areas of medicine. The linear relationship between numbers of
daily pills taken and viral suppression is so rigid that a 5% difference in the adherence rate
significantly decreases the rate of virology success. The UNAIDS global report around 3.3
million children worldwide are HIV infected and 2.9 million of them live in sub Saharan Africa
at the end of 2012(3,4) . In the same year of 2012, there were 230,000 HIV infected children (5).
And according to 2017 World Health Organization’s (WHO) report, 36.7 million people were
living with HIV/ AIDS (Human Immunodeficiency Virus/Acquired Immunodeficiency
Syndrome) around the globe, of which 2.1 million were children less than 15 years of age (6).
The World Health Organization (WHO) recommends regimens involving tablets and that
syrup or liquid formulation be prescribed for children depending on weight, however recognizing
that lack of refrigeration and the supply chain for syrup or liquid forms may bring some
challenges (7).
In Tanzania, studies on adherence have been primarily focused on adults and less information
is available on children and teenagers. As children form a special group due to lengthy expected
time on ART and challenges faced, more information is needed in order to design appropriate
interventions to improve or maintain sufficient ART adherence levels (5).
Adherence of ART is a complex behavior, which is influenced by several determinants,
majorly patient loss to follow-up and ensuring adherence to ART regimens remain major
challenges in Tanzania.
4
2.2 Problem statement
Instead using of ART drugs of children under 18 years the PRIVALENCE of Non adherance
of ART is increased ,according to shown below nad explained statements,
HIV-positive children and young people may face substantial social barriers to maintaining
appropriate levels of adherence to antiretroviral therapy (ART) during childhood and
adolescence (8). “Adherence is a serious challenge for those receiving ART especially children.
Unlike adults, young children rely upon their caregivers for their medicines.”(9).
Being recently introduced into the country in comparison with other developed country and
some developing countries such as Tanzania non-adherence of ARV`s should be anticipated.
Due to the fact that previous studies in Tanzania with other diseases have indicated that some
patients do not have enough knowledge and/or do not remember how to use various prescribed
and dispensed drugs contributing to irrational usage. .This has also observed in the settings where
ARVs are used and so favors emergence of resistant HIV strains, treatment failure and increased
treatment cost.
There is lack of proper documentation on ARV treatment adherence and possible factors
contributing to ARV non-adherence in Tanzania. However, Studies in other countries have
described a range of factors affecting ARV treatment adherence at various levels.
The importance of adhering to ART has been widely accepted as critical element in the
success of ART. There is limited data on adherence to antiretroviral therapy worldwide, few
studies of HIV infected children show adherence to antiretroviral drugs as a major problem in
children. Adherence to ART in children is a problem due to multiple factors which include high
pill burden, poor palatability, side effects, long term toxicity, forgetfulness and caretaker factors
(4,5,10,11).
Many factors can affect the ability of ART to suppress viral replication, including low
potency of one of the drugs in the combination, viral resistance, inadequate drug exposure and
inadequate adherence to therapy. The major factor determining the success of ART is sustained
and optimum adherence to therapy, as poor adherence increases the risk of virology failure and
viral resistance (6).
Establishing and maintaining adherence to medication is a difficult goal for individuals with
5
chronic illness, even when the treatment regimen is simple and the patient is clearly
symptomatic. Antiretroviral therapy for HIV disease often highly demands requiring multiple
medications and frequent dosing with significant negative adverse effects (9). Children and
adolescents with HIV infection may face additional and unique obstacles to achieving adherence,
such as cognitive deficits, parental illness, depression, or behavioral problems (5)(11).
Adherence in children is especially challenging because of factors relating to children,
caregivers, medications and the interrelationships of these factors. The lack pediatrics
formulations, poor palatability, high pill burden or liquid volume, frequent dosing requirements,
dietary restriction, and side effects may affect the regular intake of required medications. Thus,
the successful treatment of a child requires the commitment and involvement of responsible
caregivers. This may be particularly complicated if the family unit is disrupted as a consequence
of adverse health or economic condition (12,13).
Sustaining adherence represents a significant challenge for children getting the treatment, their
caregivers as well as health care providers (14). It is critical to focus on maximizing adherence in
order to ensure the durability of effect of antiretroviral regimes and to minimize the emergency
of drug resistance. So far, very few studies exist concerning the adherence of ART in the
pediatrics population in Africa. In Ethiopia, there is a lack of studies that address pediatrics
adherence in the era of antiretroviral therapy. In order to facilitate adherence to ART and to
improve outcome of ART in HIV infected children, it is necessary to a deep understanding of the
factors influencing adherence and to determine the possible interventions that can improve
adherence in children.
Consequence of non-adherence to ART include increase in viral load, decrease of CD4 cell
count, disease progression, antiretroviral drug resistance, risk of transmitting resistant viruses
and limitation of future treatment option (4,5). Therefore, high level of adherence is very crucial
to maximize the usefulness of antiretroviral therapy. That is why the study designed to assessing
level of non-adherence to ART and it is associated factors among children.
2.4 Objectives of study
2.4.1 Broad objective
To determine prevalence of ART non adherence among under 18 year children living
6
with HIV/ AIDS who attending CTC at MDH
2.4.2 Specific objective
1. To identify factors leading to ART non adherence among children attending ART clinic
at Maswa District Hospital.
2. To determine the level of non adherence to ART among children attending CTC at
Maswa District Hospital.
Questionnaire- (English version)
I am a clinical officer student at Maswa clinical officer training center. Am conducting a
research concerning factors associated with non adherence to ART among the under 18 children
who attending CTC at MDH. The research results will help to alleviate the problem in the
society. I am requesting for your co-cooperation by answering the questions listed below.
Confidentiality of information is considered.
Answer the questions correct by writing the correct number in the space provided on each
particular question
NOTE; on attempting question number 14, if no correct answer among the answers provided you
should answer question number 16 below, but if the correct answer is in among to the provided
ones attempt as other question and there is no need to answer question number 16.
[
2. Age of the patient
1. patient code number
3. sex of the patient
4. Marital status
5.level of education
]
[
Male
Female
Married
Single
Divorced
Widowed
Primary
Secondary
University
None
]
[
]
[
]
[
]
7
6. occupation
Employed
Unemployed
1 .Biological parent
2. Brother/sister
3. Uncle/anti
4. Gland mother/parent
5. Other relatives
[
[
]
Yes
No
In months
[
]
Yes
No
[
]
Yes
No
Yes
No
[
]
[
]
13.Substance abuse e.g
alcohol, smoking
1. Yes
2. No
[
]
14. Reasons for missing
ART medications
Too busy doing other things
Traveling so could not keep the routine
Did not want anyone to know
Forgetting
Alcohol drinking
Others – Refer to question no 15
[
]
15. Side effects of ART
reported by patient
Fatigue or loss of energy
Pain, numbness
Headache
Fever, chills, or sweats
Dizziness
Loss of appetite
Nausea and vomiting
Felt nervous and anxious
[
]
7.Relation between patient
and caregiver living with
8. Substance abuse like
alcohol and/smoking
9. Duration on using the
ARV`s?
10. Has the dose been
missed/skipped within a
month period?
11. Support from family
12. Disclosure of serostatus
[
]
] months
8
16. Reason for missing to take ART……………………...........................................
………………………………………………………………………………………
5.3 Questionnaire- (Swahili version)
DODOSO
Mimi ni mwanafunzi wa uwafsa tabibu katika chuo cha maafsatabibu Maswa. Ninafanya
utafiti kuhusiana na sababu zinazopelekea watoto wa umri chini ya miaka 18 wanaoishi na virusi
vya ukimwi kutotimiza matumizi sahihi ya dawa za ART katika utoaji uduma wa Hospitali ya
wilaya ya Maswa. Majibu ya utafiti huu yatasaidia kupunguza tatizo hili kwenye jamii. Naomba
ushirikiano wako katika ujibuji wa maswali hapo chini kwa usahihi, usiri wa taarifa
umezingatiwa.
Jibu maswali yote kwa ufasaha hapo chini kwa kuandika namba ya jibu sahihi kati yayote
katikanafasi zilizo wazi kwa kila swali
Zingatia; katikakulijibu swali la 14; kama hamna jibu sahii
Hi kati ya yaliopo utatakiwakujibu swali namba 16, ila kama swali hilo litajibika hapo hapo
hauto kuwa na haja yakujibu swali namba 16 bali acha wazi
1. Namba ya mgonjwa
2.Umri
3. Jinsia
4. Mahusiano
5.Elimu
6. Kazi
Me
Ke
Ameoa/ameolewa
Sijaoa/sijaolewa
Ameachika
Mjane/mgane
Elimu ya msingi
elimu ya sekondari
Chuo
Sijasoma
Ameajiriwa
Amejiajiri
Mkulima
[
[
[
]
]
]
[
[
]
]
9
7.Mahusiano kati ya
mgonjwa na mlezi anaeishi
nae
Mwanafunzi
Sina kazi
1 .Mzazi
2. Kaka au dada
3. Mjomba au shangazi
4. Babu au bibi
5. Ndugu mwingine
8. Utumiaji wa pombe na
sigara
9. Muda wa kutumia dawa
za ARV`s?
10. Dawa ziliwahi kuachwa
kutumiwa katika kipindi
cha mwezi mmoja?
11. unapata msaada kutoka
kwenye familia?
12. Hali inafahami kwa
watu
Ndiyo
Hapana
Kwa miezi
13.Unatumia kilevi pombe
au/ na sigara
1.ndiyo
2.Hapana
14. Ni sababu zipi zilifanya
au zinaweza kuchangia
kuacha kumeza dawa?
15. Madhara yatokanayo na
dawa
Ndiyo
Hapana
Ndio
Hapana
Ndiyo
Hapana
[
]
[
]
[
]
miezi
[
]
[
]
[
]
Kazi nyingi
Kusafiri
Kumeza dawa mbele za watu
Kusahau
Unywaji wa pombe
Nyingine – jibu swali la 15
[
]
Kuchoka au kukosa nguvu
Maumivu , ganzi
Kuumwa kichwa
Homa , baridi, au jasho
Kizunguzungu
kukosa hamu ya kula
kichechefu na kutapika
kujihisi mwenye hasira na hofu
[
]
16. Sababu zinazo pelekea kutomeza dawa za ART...................................................
.....................................................................................................................................
10
ASANTE KWA USHIRIKIANO.
Study limitations
Unwillingness of people living with HIV/AIDs (PLWHA) to participate in
the study and Time limit of the study activities
2.3 Rationale of the study
ART is lifelong treatment, it is important to assess level of adherence and look for factors
affecting it in children. This study identifies barriers of adherence which is used for designing
effective intervention to maximize adherence to ART among pediatrics. Identifying associated
factors of adherence in children will contribute to improve adherence to ART. Thus, this study
will be used as important literature for the future researchers who want under take similar study
11
CHAPTER TWO:
LITERATURE REVIEW
INTRODUCTION
The adherence literature has documented direct associations between poor adherence and the
complexity of drug regimens. In addition to the number of different medications in a drug
regimen, the number of daily pills, dietary limitations, interference with the patients' daily life
and serious adverse reactions that many patients experience are each associated with ARV
treatment failure. Patients are easily, self-motivated when the medication produces symptom
relief, while occurrence of side effects of medications leads to discontinuation of therapy and
acquisition of bad fears of that treatment. Unlike in other therapeutic fields, antimicrobial agents
do not tolerate frequent lapses in therapy since resistance mutations often emerge in the presence
of suboptimal concentrations of drug. Adherence to antiretroviral treatment has dramatically
improved the prognosis for HIV-positive patients, substantially reducing the rate of disease
progression and death(10).
The study done in Northeast Ethiopia, with 464 study participants, 440 children along
with their caregivers were included in the analysis, yielding a response rate of 94.8%. Obtain the
commonly mentioned reasons for missing these ART medications were: forgetfulness (28.4%),
child’s refusal to take the drugs (19.3%); and lack of transportation access to the facilities
(19.1%) (9).
The study done they look at the association between HIV-related knowledge and
adherence, hypothesizing that a better understanding of HIV and its treatment is associated with
better adherence. In analyses based on 997 participants, knowledge, as measured by five
true/false questions, was significantly associated with self-reported adherence. In multivariate
analysis, compared to persons with four or five items answered correctly, persons with fewer
correct answers were more likely to report missed doses (15).
The study done in England indicate Significant associations of less adherent behavior
identified by two or more self-report tools were the reported use of recreational drugs, living
alone, feeling depressed, being influenced by the media, and lack of a close confidant(12)
12
Other study describes the reasons got from the patients for missing doses were: simply
forgot to take the pills for 152(40.3%), change in their daily routine work for 215(57%)
participants. Other barriers fifteen (4%) they felt sleep. Two hundred two (53.6%) of participants
had felt sick or ill at that time. Five (1.3%) of the patients had too money pills to take at the same
time. Ninety three (27.7%) they felt the drug was too toxic (harmful) and want to avoid side
effects were the main problems to adhere ARV drugs for the patients (13).
Also the study identified eight common barriers to adherence to HAART. In descending
order, the barriers include: [1] frequency and severity of side effects, [2] conflicts with daily
routines, [3] dietary requirements, [4] frequency of taking medications, [5] number and dosage of
medications, [6] psychosocial factors (i.e., stress, feeling good, and bad news), [7] pharmacy
refills, and [8] physiological needs (i.e., sleep, hunger, or thirst). Many factors play a role in the
success or failure of HAART, including preexisting drug resistance, drug-drug interactions, and
the ability of PLWHIV/AIDS to adhere to a rigid and frequently changing therapy regimen (9).
A study done in Northern Tanzania concluded that, only 24.6 %of patients had good
adherence to ART when subjected to all three adherence measures which is lower than found in
many other studies. Statistically significant predictors of poor adherence based on multivariate
analysis included experiencing ARV drug side effects, having missed drugs doses in six months
prior to study period, affording transportation to the clinic and level of household monthly
income. To maximize adherence to ARV drugs: it is important to explain drug side-effects and
how to manage these side-effects to both caregivers and children. This study also found
empowering family members on income generating activities might raise household income and
hence improve adherence (16).
OPERATIONAL DEFINITIONS
Non-adherence ART: - is the condition of missing doses completely, not following
information given by a physician, as well as taking drugs inappropriately. Which means taking
doses two or more hours before, and/or two or more hours after the time of a doctor’s advice to
take doses or missing doses completely (less than 95% adherence = missing >2 doses of 30 doses
or >3 doses of 60 doses). OR
Patients and caregivers’ self-report of ever missing at least one dose
13
regardless of the length of time since the missed dose.
Adherence to ART: - is defined as taking one’s medicine as prescribed and agreed
between the patient and provider which is 95% or more adherence to ART. Which means taking
doses no more than two hours before or two hours after the time of a doctor’s advice to take
doses (95% or more adherence = missing ≤2 doses of 30 doses or ≤3 doses of 60 doses)(1) .
Primary caregiver: Any person who lives with the child and participates in the child’s
daily care, support and takes the responsibility of giving the child medication and bringing them
to clinic.
The level of non adherence to ART among children
The study suggests that near-perfect adherence, such as higher than 95%, is necessary to
achieve suppression of HIV replication (HIV-RNA <400 copies/ml). Inadequate viral
suppression resulting from failure to adhere closely to treatment causes a worsening of
immunological and clinical states and leads to emergence of drug-resistant HIV strains(13)
The study done in Lao PDR ( is a Southeast Asian country), Show the Level of nonadherence to ART as follows. Non adherence to the prescribed medication and dosage was
reported by 39.1% PLHIV. The major reasons given for non-compliance were being too busy
and forgetfulness (97.0% vs 62.2% respectively). Forty three (12.4%) of the respondents
reported having missed at least one medical appointment. The reasons for this were given as
being too busy (41.9%), lack of money to travel to the health center (32.6%) or because the
center was too far from their home (27.9%). One hundred and eighty one (52.3%) patients
reported having had experienced side effects due to their treatment. Of these, the most common
symptom was a rash (42%), followed by headache or dizziness (34.3%) and numbness (32.6%).
In order to examine factors associated with adherence, two groups were created. One consisted
of those with an adherence score of ≥ 95% (n=206, 59.5%). Participants with adherence scores of
≤ 95% (n=140, 40.5%) were allocated to a non-adherence group (17).
On the same study done in Northeast Ethiopia, report Adherence to ART among children
14
Based on the caregivers’ report, a total of 78.6% children were reported to have an adherence
rate of ≥95% in the month prior to interview. The adherence rates to ART among children in the
past three and seven days of the interview date were 95.9% and 89.8%, respectively. 78.6% in
the past one month caregivers’ reports. This finding is comparable to similar studies conducted
in Ethiopia (80.9%), Nigeria (80%), Togo (80%), and Vietnam (75.1%). This finding is also
comparable with a systematic review of pediatric ART adherence studies in middle- and lowincome countries (75%). Nevertheless, it was lower than studies conducted in the United States
(84%), Jamaica (87.5%), New Delhi (91.4%) but higher than studies conducted in Brazil
(50.5%), and Kenya (44.2%) (9).
A study done in Soweto, South Africa revealed that of 105 HIV clinic patients
evaluated,70% of whom were not on ART, 89% had good knowledge about the cause of HIV
infection and 83% knew about the modes of transmission. 59% reported they were not worried
about ART side effects. 65% agreed that missing ART doses can lead to disease progression.
90% had disclosed their HIV sero status to 1 or more persons but only 62% of those with a
current sexual partner reported having told that partner. Approximately 80% reported that if they
were taking ART they would not worry about their friends, family or friends.(7)
The prevalence of non adherence and non readiness to HAART and their determinants
among patients attending the antiretroviral clinics in Gondar and Felege Hiwot Hospitals in
Northwest Ethiopia were the focuses of this study. Of all study subjects, 87 (17.3%) respondents
had less than 95% adherence and 70 (13.9%) of the respondents had not been ready to HAART.
The level of non adherence in this study was comparable with those reported in Addis Ababa
(capital city of Ethiopia) where adherence rates were 81.2% and 82.8%, but it was lower than in
most developed countries, where adherence rates ranged from 50% to 70%. The low level of non
adherence in this study compared to in most developed countries might be due to the infancy
stage of HAART program in the study areas (18).
Also another study show Caregiver reported level of ART adherence. According to the
caregivers’ report, 93% and 94% of the children adhered to their prescribed ARV regimen in the
first seven days and during the first month of treatment, respectively. In terms of missing doses,
19% of children missed at least one or more doses during the first month after treatment
15
initiation. The major reason reported by caregivers for missing an ARV dose during the first
month of the child’s treatment was forgetfulness, as reported by 46% (14).
The study done in Uganda, show the Level of adherence to ART as follow; 79.1% (121/153)
of the children did not miss any ART doses over the 7 days. Thirty-five children (20.9%) missed
at least one dose within a period of 7 days. The commonest reasons for missing doses were
forgetfulness, 34% (13/35), transportation costs to the health facilities, 17% (6/35) and children
sitting for examinations at school, 17% (6/35). Seventeen caregivers reported various side effects
of ART including dizziness, 23% (4/17), vomiting, 18% (3/17), stomach pain, 11% (2/17),
rashes, 18% (3/17), headaches, 18% (3/17) and fever, 11% (2/17) (19).
And also in Tanzania a study done at Kilimanjaro Christian Medical Centre (KCMC), for
the Adherence to antiretroviral therapy among HIV-infected children, Adherence level was
assessed by three methods. Good adherence was found by two- day self-report in 148 (80.9%),
by visual analogue scale in 136 (73.4%), and by pill count in 64 (35%) patients. Only 45 (24.6%)
patients had good adherence when subjected to all three measurement (16).
Through research
done in various areas in the world still the problem does not controlled and especially in Simiyu
region at Maswa district hospital research does not done but the problem is presents
16
CHAPTER THREE
04. METHODOLOGY (MATERIALS AND METODS)
INTRODUCTION
This is the research which is going to be conducted at Maswa district hospital which comprises the
followings
4.01 Study design and study duration
A descriptive hospital based cross sectional study will be used for this study from Jan- Feb
2020
4.02 Study area
The study will be conducted at Maswa District Hospital found, in Maswa District council
in Simiyu region in Lake zone.
Tribes found in Maswa district are sukuma. Economic activities of the people in Maswa are
agriculture and livestock keeping, business.
4.03 Target Population
The study included all children who were on ART at Maswa District Hospital fulfilling the
inclusion criteria. Information about a child’s ART adherence status was collected from their
caregivers or guardians.
4.04 Inclusion and exclusion criteria
Inclusion criteria: Children and adolescent of age less than 18 years. The ones who will be
available at specified period for data collection
Exclusion criteria: HIV/AIDS positive child who is on regular follow up but did not start ART.
17
4.05 Sample size and sampling technique.
4.05.1 Sampling procedure
Random sampling will be used to select the information from Mtuha books register of CTC
which satisfy the inclusion criteria to be included in the study and exclusion criteria. All children
who were attending ART clinic at Maswa District Hospital were consecutively recruited to the
study during the period of data collection.
ART registers was used to identify the total number of children who were being actively
followed up.
4.05.2 Sample size
Sample size will be calculated as follows
N= Z2×P×Q/e2
Where
N= sample size
Z= standard normal deviation of 1.96 corresponding to 95% confidence interval
P= is the prevalence rate which was 84.2% in one of the study done in Tanzania (5).
This prevalence is further supported by a study done in Northwest Ethiopia (13) which a
prevalence of ART adherence was 82.7%, and also relate with study done in Zambia that shows
60.1% of adherence global and 83.9% of adherence in Africa (20).
Q=percentage of no adherent
e=margin of error which is 5%
N= 1.96. ×1.96×0.842×0.158/0.05×0.05
Sample size in this study will be N=204
4.06 Data collection method
The study will involve the use simple questionnaires target on objectives of the study to
collect data and interview. The data was collected using structured questionnaires which contain
four main parts; socio-demographic characteristics of the child and caregiver, clinical marker of
the child, access to care, and medication taking behaviour of the child through face to face
interview of the caregivers. The interview was conducted in a private room to create an
18
atmosphere of empathy and confidence with in a secure environment. Data was collected by two
clinical nurses who are currently working at Maswa District Hospital at ART clinic. The data
collection process was supervised by the principal investigator.
4.07 Data analysis procedures and statistical analysis
To assure the quality of data, the following measures under: most of the questions will be
adapted from previously conducted studies with some changes based on the local context. Data
will collected by health care providers. There was continuous supervision to control the data
collection procedure. All the data was checked for completeness, clarity, and consistency. Data
will be intensively cleaned before analysis. The data will be entered and analyzed using
descriptive data is generated and placed in terms of frequency and percentage analysis will be
used to estimate association between dependent and independent variables.
Work-plan
TASK TO BE PERFORMED
M O N T H S
January 2020
February 2020
March 2020
WEEKS
WEEKS
WEEKS
1
2
3
4
1
2
3
4
1
2
3
4
Ethical maters clearance and
proposal writing
Starting a Research by collecting
data by using questionnaires and
basic data collection from CTC
Data analysis
Compilation of information and
Research report writing
Research report printing and
presentation
Dissemination of research results
to Maswa COTC Staff, DMO &
MOI of MDH
19
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