According to the UHPAB Academic Research Guidelines (Section 9.4.3), Chapter Three (3) shall be structured as follows:

• 3.0 Introduction: It should introduce the summary of this Chapter in one paragraph.
• 3.1 Study Design: which must include the rationale;
• 3.2 Study Setting: which must include the rationale;
• 3.3 Study Population;
• 3.4 Sample Size Determination and its Justification: (Use simple scientific methods);
• 3.5 Sampling Method/Procedure: which must include the rationale;
• 3.6 Inclusion and Exclusion Criteria;
• 3.7 Study Variables;
• 3.8 Research Instruments/Tools;
• 3.9 Data Collection Method/Procedure;
• 3.10 Data Management and Analysis;
• 3.11 Data Presentation;
• 3.12 Quality Control: Validity and Reliability;
• 3.13 Ethical Considerations;
• 3.14 Limitations to the Study;
• 3.15 Dissemination of Study Findings;

3.1 Study Design

Study or Research design defines the approaches, methods, and the rationale of picking that appropriate research design.

• Example: descriptive cross-sectional design.
• Approaches can be Quantitative/qualitative or both. Note that qualitative and quantitative are research approaches, not study designs.
• The design is the framework for the methodology to be applied while collecting data, sampling, analyzing data, etc.
• You should always state the reason/rationale for using that particular design (why that particular design).

Example: “The study will use a descriptive cross-sectional study design which enables the researcher to collect data from many participants at a single point in time, saving both time and resources.”

3.2 Study Setting

Also called the study area.

• It helps the reader to locate where your study is to be done from.
• Direct the reader in terms of location and setting (school, community, factory, health facility, etc.).
• State the reason/rationale for choosing that specific setting.

Example: “The study will be carried out at the ART clinic of Kayunga Hospital in Kayunga district, which is located in the central part of Uganda. The ART clinic operates daily from Monday to Friday from 8 am to 4 pm. It has a total of 10 nurses, 2 laboratory technicians, 2 clinical officers, and 1 medical officer. This clinic receives on average a number of 150 patients on every clinic day. This study setting was chosen because the ART clinic serves a large population of about 4,500 HIV-infected clients, providing an accessible pool of respondents.”

3.3 Study Population

Explain the population from which your sample will be collected.

• This is the target population that the results will be generalized to.
• Provide the rationale for the selected population.
• The population should be clearly defined before deciding on how to sample it.

Example: “This study will be carried out among HIV-infected clients attending Kayunga ART clinic who are on first-line ART regimens for at least three years. Kayunga ART clinic has a total of 4,791 clients, of whom 2,728 are on first-line ART regimens. The clinic usually receives about 50 clients on first-line ART per day, which provides a highly suitable study population to address the research objectives.”

3.4 Sample Size Determination and its Justification

Sampling is the process of selecting a subset (sample) from a larger group of people (population).

• Use simple scientific methods showing how you determined the sample size.
• State the standardized method or table used to estimate the sample size.

Example: “Using Krejcie and Morgan (1970)’s table, when a population is 250, a total sample size of 150 respondents is required and justified to maintain a 95% confidence level.”

3.5 Sampling Method/Procedure

This refers to the way you select your participants. It includes simple scientific rationale for why a particular method was chosen.

• Probability sampling involves: Simple random sampling, systematic sampling, stratified sampling, and cluster sampling.
• Non-probability sampling involves: Convenience sampling, purposive/judgmental sampling, snowball sampling, and quota sampling.

Example: “A simple random sampling method will be used to select clients on the different first-line ART regimens to give every eligible client an equal chance of participating and avoid selection bias.”

3.6 Inclusion and Exclusion Criteria

This defines which people among the selected population qualify to participate in the study and who is excluded.

• Inclusion criteria: Characteristics that participants must have if they are to be eligible (e.g., age, disease stage).
• Exclusion criteria: Specific factors/illnesses that exclude potential subjects (do not include "everyone who is not in the inclusion list").

Example: “Clients must be on first-line ART regimens for at least 3 years and present at the ART clinic during data collection. They must be 18 years or older. Excluded from the study are eligible clients who are critically ill and cannot converse.”

3.7 Study Variables

A variable is a measurable characteristic that assumes different values among subjects.

• Clearly identify both your Dependent and Independent variables.
• It is best to present variables and their measurements in a table format.

Example: “The dependent variable of this study is the level of viral load (virological outcome) measured in copies/ml, where virological failure is defined as >1000 copies/ml. The independent variables include age, sex, adherence level, and duration on ART.”

3.8 Research Instruments/Tools

This refers to the tools you will use to gather evidence. They include questionnaires, interviews, checklists, and standardized tests.

Example: “The researcher will use a structured questionnaire containing both open and closed-ended questions. The questionnaire will be translated into the local language and pretested to adjust for any ambiguity or formatting errors.”

I. Questionnaires

Involves predetermined questions. Can be Self-administered or Researcher-administered.

Comparison of Questionnaire Types

Self-Administered Questionnaires	Researcher-Administered Questionnaires
Advantages: Convenience: Participants can complete at their own pace. Privacy: Respondents have privacy for sensitive questions. Time Flexibility: Participants can choose when to complete. Cost-Effective: No researcher presence reduces data collection costs. Large Sample Size: Suitable for reaching a larger, spread sample. Reduced Researcher Bias: Participants may provide candid responses.	Advantages: Clarity: Researchers can clarify questions for better understanding. Motivation: Higher motivation can lead to improved response rates. Probing: Allows probing to ensure thorough and accurate responses. Control: Researchers can control the survey environment. Data Quality: Offers control over data quality and completeness. Clarification: Offers the ability to probe and clarify ambiguous answers.
Disadvantages: Non-Response Bias: Response rates might be lower, potentially biased. Misinterpretation: Participants might misunderstand questions. Incomplete Responses: Respondents may skip or provide incomplete answers. Low Control: Researchers have limited control over survey environment. Limited Probing: Researchers cannot probe further for clarification.	Disadvantages: Time-Consuming: Due to researcher presence. Researcher Influence: Presence of a researcher can influence responses. Costly: Due to resources needed for administration. Limited Anonymity: Might affect the honesty of responses. Geographical Constraints: Limit participant availability.

II. Interviews

These are mainly used to get responses for qualitative data. They could be used as:

• Interview guides.
• Focus Group discussion interviews - of 5 to 10 members.

III. Checklists

Also called observation forms. Researcher ticks responses on observation of what has been done or not. In many studies, rating is done thereafter.

IV. Standardized tests

These are tools used to score all populations across the board. For example, when scoring IQ levels of children, cognitive tests.

3.9 Data Collection Method/Procedure

This outlines the step-by-step physical procedure of gathering information from study participants.

Example: “Upon gaining approval, permission will be presented to the ART clinic in-charge. One nurse will be trained as a research assistant. Eligible clients will be approached, and informed consent will be obtained. Questionnaires will then be administered in a private room to ensure confidentiality.”

3.10 Data Management and Analysis

Describe how you will clean and manage data (data entry, software packages) followed by statistical methods used to analyze each objective.

Example: “Completed questionnaires will be checked daily for missing data and errors. Data will then be entered into SPSS version 26. Descriptive statistics (frequencies, means, and percentages) will be calculated to analyze each study objective.”

3.11 Data Presentation

This outlines how findings will be displayed so that the reader can easily interpret them.

Example: “Analyzed data will be presented using a combination of descriptive narratives, statistical tables, pie charts, and bar graphs.”

3.12 Quality Control

This addresses the measures taken to ensure validity (accuracy of the tools) and reliability (consistency of findings).

Example: “Quality control will be maintained through pretesting 10% of the tools at a neighboring hospital, training research assistants, and strictly adhering to Standard Operating Procedures (SOPs).”

3.13 Ethical Considerations

Focuses on protecting human subjects (Informed consent, Confidentiality, Privacy, and IRC Approval).

• Informed consent
• Confidentiality
• Ethics committees
• Privacy
• Explain how you will meet the ethical guidelines of research.

Example: “This research proposal will be submitted to the Institutional Research Committee (IRC) for approval. Written consent will be obtained from each participant, and no names will be written on questionnaires to maintain anonymity.”

3.14 Limitations to the Study

Anticipated constraints over which the researcher has no control (e.g., language barriers, work schedules) and how you will mitigate them.

• The researcher may not have control over them and therefore the need to identify them so that possible solutions can be planned before beginning the study.
• They also help in predicting the necessary help needed and the feasibility of the research.
• Explain the constraints you are likely to meet and how you will overcome them.

Example: “Potential language barriers with participants who do not speak English will be mitigated by translating the questionnaire into the local Luganda language.”

3.15 Dissemination of Study Findings

Describe how results will be shared with relevant stakeholders.

• It can also be published as reports, journals, CMEs, posters in conferences, etc.
• Dissemination helps other scholars know what has been done.
• List how and where you will communicate your results.

Example: “The final research report will be compiled, and bound copies will be distributed to UHPAB, the hospital library, and the clinic management to help inform future policy.”