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

NCT05614388 | Unknown

• 1 other identifier: RES-376
• Study Type: interventional
• Target: 646
• Locations: 0 countries
• Sites: N/A

Brief 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 -

1. 1.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?
2. 2.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.

Conditions

COVID-19

Keywords

COVID 19; Self-Test; Pandemic Preparedness; Infectious diseases

Outcome Measures

Primary Outcomes (6)

• Utilization rate

  Individual level: the proportion of tests each individual uses till the end of the follow-up period from the minimum number of tests allocated to them. Sample-level: mean and standard deviations calculated based on the individual utilisation rates

  5 Months

• Adherence Rate

  Individual level: the proportion of tests an individual performs according to the testing schedule over the total number of tests they perform. Sample-level: mean and standard deviations calculated based on the individual adherence rates

  5 Months

• Preferences of participants on self testing

  Proportion of preference to assisted vs unassisted self-testing

  5 Months

• Observation proportions of participants on self testing

  Proportion of preference to observed vs unobserved self-testing

  5 Months

• Time to dropout

  The time to drop out will be the time from enrolment of the participant till drop-out

  5 Months

• Acceptability of COVID-19 self-testing kits

  A composite indicator based on ease of use of COVID-19 self-testing kits, ease of interpretation of test results, and recommendation to others

  5 Months

Study Arms (1)

Study participants

EXPERIMENTAL

The study procedure is universal to all the participants from both the institutes. There are no control arms defined separately. The groups within the participants include - include health care workers, non-medical hospital staff and medical students at ZMC; and faculty, students and supporting staff at the Pacchunga University College.

Diagnostic Test: COVID-19 Self testing and related messaging

Interventions

COVID-19 Self testing and related messaging DIAGNOSTIC_TEST

Provisioning of voluntary, free self-testing for COVID-19 (approved and validated in the country) and related Information, Education and Communication (IEC) messages

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 18 years, irrespective of gender and past COVID-19 status
• Registered with participating institutions
• Able and willing to provide informed consent
• Owns a smartphone capable of downloading the SURE STATUS app for uploading results
• Able to read the instructions in the Mizo or English or Hindi

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• UNITAID: collaborator
• Zoram Medical College (ZMC): collaborator
• Pacchunga University College: collaborator
• Association for Leprosy Education Rehabilitation & Treatment India (ALERT India): collaborator
• Government of Mizoram: collaborator

MeSH Terms

Conditions

COVID-19; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Ralte, MD

  Zoram Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muneer Kutty, MPH

CONTACT

+919999798283; mkutty@path.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants include health care workers, non-medical hospital staff and medical students at ZMC; and faculty, students and supporting staff at the Pacchunga University College. All these groups will be participating in the study simultaneously. The study results will be compared for all these 6 groups.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share