Chapter Three: Methodology

Chapter 3 covers the following key aspects:

1. Study Design
2. Study Setting
3. Study Population
4. Sample Size Determination
5. Sampling Procedure
6. Inclusion Criteria
7. Definition of Variables
8. Data Collection Instruments
9. Reliability and Validity of Research
10. Data Collection Procedure
11. Data Management
12. Statistical/Data Analysis
13. Ethical Considerations
14. Collecting and Processing Data
15. Limitations
16. Dissemination of Results

This chapter details the methods the researcher will follow while collecting and processing data. It serves as a practical guide that explains how the research will be carried out, ensuring that the study is both rigorous and transparent. This section is crucial as it lays out the specific procedures that will be used to gather, analyze, and interpret data.

Key Components of the Methodology Chapter:

• Study Design

  • The design is the structure or framework of the study and provides the basis for the methodology applied during data collection and analysis.
  • It ensures the evidence obtained can answer the initial research questions as unambiguously as possible.
  • The design should be clearly stated and appropriate for the research objectives.
  • For example, “This study will be a cross-sectional study”.

• Study Setting

  • This section directs the reader to the location where the study will be conducted and provides the rationale for selecting that particular setting.
  • It should detail the specific location and explain why it is relevant to the study.
  • For instance, “Study will be carried out at ART clinic of Kayunga Hospital in Kayunga district which is located in central part of Uganda.”
  • “The ART clinic operates daily from Monday to Friday and has a total of 10 clinicians”.

• Study Population

  • The study population is the entire group of individuals that the researcher is interested in investigating.
  • This section defines the population and explains how a sample will be drawn from it.
  • For example, “This study will be carried out among HIV-infected clients attending Kayunga ART clinic and who are on first-line ART regimens for at least three years”.
  • “Kayunga ART clinic has a total of 4791 clients, of which 2728 are on 1st line ART regimen”.

• Sample Size Determination

  • This section explains how the sample size was calculated and justifies the chosen sample size.
  • It should state the method used to estimate the sample size.
  • For example, “Using Krejcie and Morgan (1970)’s table, when a population is-250, a total of sample size of 150 respondent is supposed to be sampled”.

• Sampling Procedure

  • This section explains how the subjects will be selected during sampling.
  • It details the specific sampling method and why it was chosen.
  • For example, “A proportionate quota sampling method will be used to sample representative clients on the different first -line ART regimens”.
  • The rationale for the chosen procedure should be stated.

• Inclusion Criteria:

  • These are the characteristics that prospective subjects must possess to be included in the study.
  • Factors like age, sex, race, ethnicity, stage of disease, and past treatment history are typical inclusion criteria.
  • For instance, “For participants to be included in this study, they have to be clients on 1st line-ART regimen for at least 3 years and are attending ART clinic at Kayunga Hospital during the time of data collection.”
  • “They must also be of 18 years of age and above, which is the consent age according to the Ugandan constitution”.

• Definition of Variables:

  • This section defines the dependent and independent variables of the study.
  • For instance, “the dependent variable of this study is the virological outcome (level of viral load)”.
  • “In this study the level of viral load means the amount (measure) of Plasma HIV-1 RNA and is measured in ml/copies”.
  • “A viral load of >5000 copies/ml at 12 months of antiretroviral treatment will be taken as indication for virological failure”.

• Data Collection Instruments

  • This details the instruments that will be used to collect data.
  • It should explain the type of instrument used and the rationale for using them.
  • For example, “The researcher will use a questionnaire which consists of both open and close ended questions written in simple language and will be filled by the researcher himself and his assistant by use of patient’s record”.
  • “The questionnaire will be pre-tested on six clients from Mulago National Referral Hospital ART clinic to check out any ambiguous questions and errors”.

• Data Collection Procedure:

  • This outlines the entire process of data collection, from start to finish.
  • For example, “A letter obtained from research committee will be taken to the management of Kayunga Hospital and to the ART clinic to allow the researcher carry out data collection among HIV- infected clients on 1st line ART regimens”.
  • “A verbal and written consent will be obtained from respondents before data collection”.

• Data Management

  • This section explains how data will be managed after collection.
  • For instance, “After data collection, every questionnaire will be checked for completeness, and any gaps will be filled immediately before the client leaves the clinic”.
  • “The questionnaires will be kept under key and lock, accessible only to the researcher and his assistant on request; then it will be directly entered into SPSS software package for social science version”.

• Data Analysis:

  • This part explains how the data will be analyzed.
  • For example, “Data will be entered directly into SPSS 17 for data analysis and will be analyzed starting with the demographic data and then the other objectives”.
  • “The analyzed data will then be presented in form of percentages and frequencies in tables, pie charts, and graphs”.

• Ethical Considerations

  • This section describes how ethical guidelines of research will be met.
  • For example, “Research proposal will be submitted to the Research and Ethical Committee at Makerere University for approval.”
  • “A letter from the Committee will be taken to Mulago Hospital management and ART clinic to seek permission to pre-test the Questionnaire”.
  • “The same letter will be taken to Kayunga District hospital management and ART clinic where data collection will be done to seek permission to carry on data collection among HIV-infected clients on 1st —line ART regimens”.

• Study Limitations:

  • This part discusses the constraints that the researcher expects to encounter and how to overcome them.
  • For instance, “The researcher expects to encounter time constraints in the course of study, balancing the research study and other demanding work.”
  • “The researcher will overcome this limitation by drawing up a time table that will be strictly followed”.

• Dissemination of Results

  • This section lists how and where the research results will be communicated.
  • For example, “Information from the study will be compiled into a research report and four copies of research report will be made”.
  • “A copy will be submitted to; Makerere University, Kayunga Hospital ART clinic, Research Supervisor and the Researcher”.

In summary, Chapter Three is a comprehensive and systematic description of the research methodology, covering all essential elements for a thorough and well-executed study.