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Not Yet Recruiting NCT05614388

A Study on Voluntary Routine COVID-19 Self-testing in Mizoram, India.

Conditions: COVID-19

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 646
Sponsor: PATH

Summary

This interventional study aims to evaluate the utilization, adherence, and acceptability of voluntary, free, routine self-testing for COVID-19 (Corona Virus (19) Disease) and related information, education and communication (IEC) messages in two institutional settings in Mizoram, India. In addition, it will assess and measure preferences for assisted vs unassisted and observed vs unobserved self-testing, assess adherence and measure dropout rate and describe dropout characteristics.The research questions it aims to address are -What is the uptake and adherence of voluntary, free, routine self-testing for COVID-19 and related IEC messages vy students, employees, and healthcare workers in two institutional settings in India? Are there any dropouts from routine self-testing and what are the factors related to dropouts?What is the preferred mode of self-testing- observed or unobserved, assisted or unassisted? Do these preferences change over time? The researchers will be measuring - Utilization rate, Adherence rate, Proportion of preference to assisted vs unassisted self-testing, Proportion of preference to observed vs unobserved self-testing, Time to dropout and Acceptability of COVID-19 self-testing kits.

Eligibility Criteria

Inclusion Criteria:Above the age of 18 years, irrespective of gender and past COVID-19 statusRegistered with participating institutionsAble and willing to provide informed consentOwns a smartphone capable of downloading the SURE STATUS app for uploading resultsAble to read the instructions in the Mizo or English or HindiExclusion Criteria:Does not consent.Has any contraindication to nasal sample collection, including recent nasal injury, nasal surgeries.Personnel who are directly involved in the conduct of the study, e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05614388). StuddyBuddy aggregates publicly available trial information.