CHAPTER THREE: - RESEARCH METHODOLOGY
3.1 Study Design
This is a cross-sectional study profiling the NRTI drug resistance and susceptibility patterns
of treatment naïve HIV patients in Machakos level IV hospital.
3.2 Study Site
The study samples were collected from Machakos Level 5 hospital, located in Machakos
town, Machakos County, about 63km from Nairobi City. Machakos County borders Nairobi
and Kiambu counties to the West, Embu to the North, Kitui to the East, Makueni to the
South, Kajiado to the South West, and Murang’a and Kirinyaga to the North West. It serves
the Eastern region of Kenya. Machakos Level 5 hospital was established in Kenya by the
Ministry of Health and entrusted with the responsibility with other medical facilities of
managing most of the medical cases in Kenya.
3.3 Scope of the study
This study was done at Kenya Medical Research Institute for the samples collected from
Machakos Level 5 hospital, with the population target being both male and female HIV
patients. Machakos Level 5 hospital is the most advanced facility in Machakos County. The
study obtained blood samples of the 30 patients, which were then used in the DNA
extraction.
3.3 Study Population
The population of this study was both male and female HIV-positive patients aged 16–64
years who are enrolled at Machakos Level 5 hospital. The HIV-positive status of participants
was based on hospital clinical records. Machakos County has a population of 1 155 957
people (49% male population and 51% female population). The overall prevalence of HIV or
AIDS is 5%, with the prevalence among women being higher (6.8%) than among men
(2.9%). About 73% of people had never been tested for HIV. About 25% of the adults are
enrolled for care. Most HIV or AIDS patients use Machakos level five comprehensive care
clinic for treatment refill, care, and testing. Some supportive care is provided through six
community units and support groups. The Aids Health Foundation and other partners provide
HIV/AIDS and ARVs support.
1
, 3.4 Study criteria
3.4.1 Inclusion criteria
The study included HIV-positive patients aged 16 to 64 years who were enrolled at Machakos
Level 5 hospital between the year 2016 and 2018.
3.4.2 Exclusion criteria
This study excluded seriously ill patients.
3.5 Sample size calculation
Yamane (1967) provides a formula to calculate sample sizes for finite populations. The
sample size was determined based on confidence interval and confidence level. The
researcher adopted a confidence interval of 5% and a confidence level of 95%.
n= N
1+N(e)^2
Where:
n= desired sample size
N= Population
e = margin of error at 5% (standard value of 0.05)
The sample size for the study was:
n = 10
1+ 10(0.05) ^2
= 10
However, according to Lindemann (2019), the average response rate for the survey is 33%,
and it's necessary to adjust that number factor to cater to those that might not respond
(Saunders, Lewis & Thornhill 2009) hence the targeted sample will be 14.
3.6 Sample Collection
Plasma samples were collected from HIV-1-positive individuals enrolled at the Machakos
Level 5 hospital from 2016–to 2018. Basic epidemiological data such as gender, transmission
route, CD4 cell count, viral load, and HIV-1/AIDS-related symptoms were recorded upon
enrollment; samples without clear treatment history were excluded.
2
3.1 Study Design
This is a cross-sectional study profiling the NRTI drug resistance and susceptibility patterns
of treatment naïve HIV patients in Machakos level IV hospital.
3.2 Study Site
The study samples were collected from Machakos Level 5 hospital, located in Machakos
town, Machakos County, about 63km from Nairobi City. Machakos County borders Nairobi
and Kiambu counties to the West, Embu to the North, Kitui to the East, Makueni to the
South, Kajiado to the South West, and Murang’a and Kirinyaga to the North West. It serves
the Eastern region of Kenya. Machakos Level 5 hospital was established in Kenya by the
Ministry of Health and entrusted with the responsibility with other medical facilities of
managing most of the medical cases in Kenya.
3.3 Scope of the study
This study was done at Kenya Medical Research Institute for the samples collected from
Machakos Level 5 hospital, with the population target being both male and female HIV
patients. Machakos Level 5 hospital is the most advanced facility in Machakos County. The
study obtained blood samples of the 30 patients, which were then used in the DNA
extraction.
3.3 Study Population
The population of this study was both male and female HIV-positive patients aged 16–64
years who are enrolled at Machakos Level 5 hospital. The HIV-positive status of participants
was based on hospital clinical records. Machakos County has a population of 1 155 957
people (49% male population and 51% female population). The overall prevalence of HIV or
AIDS is 5%, with the prevalence among women being higher (6.8%) than among men
(2.9%). About 73% of people had never been tested for HIV. About 25% of the adults are
enrolled for care. Most HIV or AIDS patients use Machakos level five comprehensive care
clinic for treatment refill, care, and testing. Some supportive care is provided through six
community units and support groups. The Aids Health Foundation and other partners provide
HIV/AIDS and ARVs support.
1
, 3.4 Study criteria
3.4.1 Inclusion criteria
The study included HIV-positive patients aged 16 to 64 years who were enrolled at Machakos
Level 5 hospital between the year 2016 and 2018.
3.4.2 Exclusion criteria
This study excluded seriously ill patients.
3.5 Sample size calculation
Yamane (1967) provides a formula to calculate sample sizes for finite populations. The
sample size was determined based on confidence interval and confidence level. The
researcher adopted a confidence interval of 5% and a confidence level of 95%.
n= N
1+N(e)^2
Where:
n= desired sample size
N= Population
e = margin of error at 5% (standard value of 0.05)
The sample size for the study was:
n = 10
1+ 10(0.05) ^2
= 10
However, according to Lindemann (2019), the average response rate for the survey is 33%,
and it's necessary to adjust that number factor to cater to those that might not respond
(Saunders, Lewis & Thornhill 2009) hence the targeted sample will be 14.
3.6 Sample Collection
Plasma samples were collected from HIV-1-positive individuals enrolled at the Machakos
Level 5 hospital from 2016–to 2018. Basic epidemiological data such as gender, transmission
route, CD4 cell count, viral load, and HIV-1/AIDS-related symptoms were recorded upon
enrollment; samples without clear treatment history were excluded.
2
