Research Design and methodology:
Research is defined by Oliver (2010) as a process to systematically collect information. In order to design a research study that relate to HIV Self-Testing the researchers’ plan is to incorporate the “HUIT” acronym. This stands for “Hypothesis, Unit of analysis, Intervention and Timing of measure” (Bailey and Handu 2013) p. 32. In this perspective, although “Intervention” for HIV Self-Testing is embedded in clinical settings in randomised control studies however, in order to examine the spread of HIV among IDU and to analyse the history trend of HIV, the intervention is designed in a community setting in order to answer the hypotheses question mentioned in the background information.
Randomised Control Study:
According to Stewart (2002) p.119, “randomised control study is applied in an approach to examine the effectiveness of an intervention”. Manson and Dale (2011) p.9 went on to define it as a tool for self-management of health. However, the definition is simplified by Kendall (2013) as it is referred to as a trial that random assign either one or two groups to receive an intervention to test and to give a comparison.
In randomised studies, errors are predictable when measuring prevalence randomly from a population such as HIV and this is likely in all epidemiological studies (Jekel et al 2001). In order to minimise sampling error, a 95% confidence probability will be used in this interventional study. Stewart (2002) p. 39, points that this formula will represent a “true population value” in almost 95% of the cases.
In epidemiology, a population is “every subject” in a group of study (Stewart 2012). This meets the inclusion criteria for the proposed study. Population group also include organisations that we will be working with.
In this study, the population criteria are planned to apply basic demographic factors because this is important at the analysis stage as it is the stage that will show if the confounding variables were equally distributed (Kendall 2012). Confounding relates to other influential risk factors and the following are the confounding variables within this study:
• Alcohol misuser and
• Other drug abusers.
• The IDU community which has been represented in the background information.
• A population that can give informed consent as this is ethical.
The approach to deal with confounding is that, we will ensure that our sample study is selected randomly and to apply stratified analysis. The stratified analysis is explained by Jekell et al (2007) as a process to assign the subjects in groups basing with baseline variables such as alcohol misuse that can contribute to a risk of practising safer sex and HIV.
• A population that cannot give consent and this is unethical.
In a research proposal, a sampling strategy must be representative of the study population (Kendall 2013). The planned approach is to collaborate with Liverpool Scheme in order to recruit the population group that is projected to apply the results. This approach of collaborating with an organisation that holds information of patients is recommended by (Stewart 2002) as effective in avoiding recording bias. Furthermore, the study population is accessible and this will help to generalise the findings from the study sample effectively and reduce follow-up bias. With the recruitment, the focus will be given to the inclusion and exclusion criteria identified above.
Bias is defined as the systematic difference of results between the association of the exposure and the outcome risk (Stewart 2002). Therefore, it is intended to incorporate a computed approach to recruit the sample randomly in this study. The recruitment plan will be concealed from the targeted population until the time of the study to ensure that bias is not introduced especially at this stage of subject assigning. Hence – the selection bias is reduced. Two groups will be assigned for this study randomly. By doing so, subjects will have the chance to be distributed evenly and this will be a plan to reduce recall bias in a way that one group is planned to be a control and the other group a case study. According to Spieth, et al (2016), assigning of two or more groups is evidenced to increase efficiency thereby reducing bias.
Pandis et al (2011) stress that a proper sample size in a study gives precision and power for the study findings as it is scientifically and justified ethically and holds credibility unlike studies with insufficient size. Therefore, the sample size of 30 will be recruited randomly to ensure validity and efficiency. Pieth et, al (2016) considered effective randomisation as efficient in constituting intervention evidence.
The tool for data collection will be a questionnaire. With this tool, the group intend to give patients the questionnaires for data collection while at the Liverpool Scheme. These will be then collected for analysis by using a computer system.
The designed questionnaire will apply the variables important in the study such as asking age not date of birth. Questions will be specific, short, clear with simply language and presented in a methodically manner. With this target group, yes and no answer will be appropriate.
It is lawful to give maintain confidentiality when working or studying in health. This is in accordance with Data Protection Act 2018 (https://www.gov.uk/data-protection). The act requires sensitive information to be kept secure.
The findings of the project evaluation will be published on DrugWise website and in the project newsletter. The newsletter will be available in Liverpool council libraries around the borough and Liverpool John Moore University.
The monitoring plan strategy will commence at the end of the first month of operation to ensure effectiveness and efficiency of the initiative. According to Courtney (2002), many strategies plan fails because of no framework put in place at the beginning to monitor progress against the plan. The project evaluator will be responsible will the process. The evaluation strategy will be conducted using the formative as well as the quantitative procedures for effective results. The system of evaluation is planned based on a protocol guide of Specific, Measurable, Agreed, Realistic and Timely records (SMART).