Clinical trial NCT05614388: A Study on Voluntary Routine COVID-19 Self-testing in Mizoram, India.
Official title: A Study on Utilization, Adherence, and Acceptability of Voluntary Routine COVID-19 Self-testing Among Students, Staff and Health Workers at Two Institutions in Mizoram, India.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID 19
Self-Test
Pandemic Preparedness
Infectious diseases
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: UNITAID
name: Zoram Medical College (ZMC)
name: Pacchunga University College
name: Association for Leprosy Education Rehabilitation & Treatment India (ALERT India)
name: Government of Mizoram
First posted: 2022-11-14
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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. 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Does not consent.
2. Has any contraindication to nasal sample collection, including recent nasal injury, nasal surgeries.
3. 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.

Primary outcomes:
measure: Utilization rate
timeFrame: 5 Months
measure: Adherence Rate
timeFrame: 5 Months
measure: Preferences of participants on self testing
timeFrame: 5 Months
measure: Observation proportions of participants on self testing
timeFrame: 5 Months
measure: Time to dropout
timeFrame: 5 Months
measure: Acceptability of COVID-19 self-testing kits
timeFrame: 5 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zoram Medical College
name: Jane Ralte, MD
role: PRINCIPAL_INVESTIGATOR
References: