Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05614388 |
| Other study ID # |
RES-376 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2022 |
| Est. completion date |
May 2023 |
Study information
| Verified date |
November 2022 |
| Source |
PATH |
| Contact |
Muneer Kutty, MPH |
| Phone |
+919999798283 |
| Email |
mkutty[@]path.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. 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. 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.
Description:
Testing is a critical component of the pandemic response. It serves two purposes; for
clinical purposes, it focuses on identifying disease in symptomatic patients, while testing
for epidemiological purposes, spread in the population is also assessed. India uses a mix of
both Reverse Transcriptase Polymerase Chain Reaction (RT PCR) and Antigen Rapid Diagnostic
Tests (Ag RDTs) for COVID-19 testing. RT PCR is the reference standard test for detection of
the virus. However, not all facilities have RT PCR, and many communities have poor access.
This leads to a long turn-around time (TAT) for the results to be obtained and a high load on
RT PCR facilities. Hence, to prevent the spread of the virus, cases must get detected early.
At the peak of the first wave of the pandemic in the country, Ag RDTs constituted close to
50% of all the tests conducted in the country. Self-testing for COVID-19 has emerged as a
viable complementary testing modality. The use of self-testing kits while ensuring the
availability of other COVID-19 tests at the nearest point of care addresses many of the usual
barriers to uptake of services, leading to timely testing of individuals, diagnosis, and
access to care. It can also reduce the burden on existing testing infrastructure especially
during a surge in the cases. It also reduces overcrowding at testing facilities thereby
reducing the risk of disease transmission. To improve access to testing and prevent
overreliance on RT PCR laboratories, the Indian Council of Medical Research (ICMR) approved
and validated the use of COVID-19 self-testing kits. As of March 2022, sixteen self-testing
kits have been validated in India of which 10 are found to be satisfactory. While there are
many benefits to self-testing, it is also essential to understand the utilization of the
self-testing strategy, including whether or not the community can follow the steps for
self-testing and what support, if any, the community may require to use self-test kits.
The present study proposes the demonstration of ICMR and US-FDA (United States Food & Drug
Administration) approved SURE STATUS self-testing kit in the healthcare workers and
educational institution setting in Mizoram for a period of 5 months. With the ease of
lockdown and movement restrictions, workplaces and educational institutes are gradually
opening up. However, with the threat of the pandemic still looming large, it is prudent to
put in place systems for regular screening within these settings to promote early diagnosis
and care and prevent outbreaks. COVID-19 self-test has been identified as one way any
institution can scale up COVID-19 testing to improve COVID-19 status awareness by reaching
out to as many people as possible at a given point of time.
While COVID-19 self-tests are available and widely used in India, these kits are largely used
within the confines of individual homes. It is learnt that the reporting of the results of
the self-test is poor as compared to the utilization of the self-test kits. To the
investigator's knowledge, no study has been conducted in India to assess the utilization of
self-testing as a routine procedure in places of mass indoor gathering, like workplaces and
educational institutions. To address this gap, the investigators will conduct a study to
evaluate the utilization, adherence, and acceptability of routine COVID-19 self-testing among
students, employees and healthcare workers in two congregate settings: one University College
and one Medical College and Hospital in Mizoram, India. The proposed study will document
challenges, if any, in reporting of self-test results and document the key processes in
operationalizing routine COVID-19 self-testing among students, employees and healthcare
workers and provide learning and recommendations for systematic use of self-tests for future
models of institution based COVID-19 self-testing in congregate settings.
