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STUDY DESIGN

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HIV/AIDS Needle Exchange  In your essay, you must include information describing the disease, a section presenting the details of your study design, and a section discussing potential negative impacts on data quality and study design. 2-Next, your paper should present and discuss your study design. This is the methods section of your paper. For this paper, you will use only one study design and it must be a randomized trial. This section should indicate how you will collect the information (i.e. methods for data collection) about the event and the outcome, as well as clearly stating how you will determine what individuals will be included and excluded from the study, and how you will categorize study participants into specific groups (i.e. control or treatment, exposed and unexposed, or cases and controls). Tables and/or figures may be appropriate in this section. Please include them at the end of the paper and refer to them in the text of your paper as (Figure 1) or (Table 2).  Figures and tables will not count against your page limit.  Finally, please predict what your data would look like if your hypothesis is supported and what the data would look like if the hypothesis was not supported. Randomized Trial Who will be the study population? How will you recruit the volunteers? How will you ensure randomization? How will you treat both groups (i.e. will the controls receive a therapy as well or not)? How is the outcome defined? How will you collect information on the outcome? POPULATION WASHIGTON DC Needle exchange program  3-The third section of your paper should focus on potential problems in data collection and analysis, as well as how specific details of your study design will mitigate these issues.  You will also likely need to note that some potential issues cannot be controlled for.  Be sure to indicate why this is the case J  Finally, be sure to discuss what population your study is relevant for (ie external validity). POPULATION WASHIGTON DC Needle exchange program  Include a hypothesis or purpose for the study Chose a study design and justified your choice. What are the advantages of the study design in general? What are the advantages of the study you have designed for answering your hypothesis? What are the disadvantages of your study design in general? What are the disadvantages of the study you have designed for answering your hypothesis? What population does this study represent (external validity)? Hypothesis: Implementation of a needle exchange program in Washington, DC will lead to a decrease in HIV rates across the district.  Randomized Trial The advantages of a randomized  Compliance & Willingness to participate Loss-to-follow up or Non-response bias Generalizability (external validity) Confounders Selection Bias Information Bias Recall Bias Bias in outcome assessment

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Phyllis Mugure

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