Comparison of Self-Taken Extragenital Samples for Gonorrhoea and Chlamydia
In this study, the sensitivity and specificity of self-taken swabs from rectum and pharynx are compared with clinician-taken swabs for the diagnosis of gonorrhoea and chlamydia in women and MSM. The background, objective, study population, exclusion criteria, and power calculation for the systematic trial are detailed, aiming to address gaps in published evidence and improve specimen collection processes. The study aims to recruit 1500 women and 850 MSM to achieve 50 cases of each infection at each site.
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Project title, investigators & related information Reference Number: Title: PI s Name PI s Dept : Collaborator (s), if any With Dept. & Name of Organization (if outside SGPGI): Duration and Budget (in Lakhs): Two years (can t exceed 10 lakh) 1
Proposal Overview Rationale (with references, use different font colour for the references): --------------- Aim : Primary Secondary: 2
Proposal Overview Sample size calculation (if needed) Statistical analysis plan 4
Budget (in Lakhs) Budget (in Lakhs) 1. Proposed budget (can t exceed 10 lakh) Heads First Year Second Year Total (INR) Remarks/Justification Non-Recurring (e.g. equipments, accessories, etc.) Consumables and contingency Others Others Total 5
Proposal Overview Intramural Project status (if available): Regulatory requirements & Status (if identified): Experience of the PI & Team Members (relevant to proposal): 6
Outcome of previous intramural projects by the PI Project name Year sanctioned Year completed Completion report submitted (Y/N) Publication (in Vancouver style) Any related extramural project? 7
Outcome of previous intramural projects by the PI Project name Year sanctioned Current status Annual report submitted (Y/N) Any additional remark? 8