Administrative information
Title {1} | Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community |
Trial registration {2a and 2b}. | ClinicalTrials.gov, NCT04757298 |
Protocol version {3} | This manuscript reflects the original study protocol, version 1.0, which was accepted by the NJCRI IRB on February 16, 2021 (IRB Protocol number: UIUC-NJCRI 102497-18274-267805). |
Funding {4} | 3R01MD010629-04S2 (U.S. NIH Grant/Contract, National Institute on Minority Health and Health Disparities) |
Author details {5a} | Liliane Windsor, Ph.D.University of Illinois Urbana Champaign Ellen Benoit, Ph.D.North Jersey Community Research Initiative Rogério M. Pinto, Ph.D.University of Michigan Jesus Sarol, Ph.D.University of Illinois Urbana Champaign |
Name and contact information for the trial sponsor {5b} | National Institute of Minority Health and Health Disparities (Nathaniel Stinson: stinsonn@mail.nih.gov |
Role of sponsor {5c} | The sponsor had no participation in the study design; collection, management, analysis, and interpretation of the data; writing of this manuscript; or decision to submit this manuscript for publication. |
Introduction
Background and rationale {6a}
Integrated framework and design overview
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
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Over 18 years of age
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Having a high risk to contract COVID or develop related complications
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Able to speak English
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Able and willing to provide informed consent
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Under 18 years of age
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Not at a high risk to contract COVID or develop related complications
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Unable to speak English
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Unable or unwilling to provide informed consent
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Study arm | Intervention 1 | Tested for COVID-19 up to 7 days post-baseline | Intervention 2 |
---|---|---|---|
1 | NS | Yes | NS |
2 | NS | Yes | BC |
3 | Brochure | Yes | Brochure |
4 | Brochure | Yes | BC |
5 | NS | No | NS |
6 | NS | No | CD |
7 | Brochure | No | Brochure |
8 | Brochure | No | CD |
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Recruitment | Baseline | Allocation1 | Fu1 | Allocation2 | Fu2 | |
---|---|---|---|---|---|---|
Time point** | t1 | t2 | t3 | t4 | t5 | t6 |
Enrollment | ||||||
Outreach | X | |||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Interventions | ||||||
NS | X | |||||
Brochure | X | |||||
BC | X | |||||
CD | X | |||||
Assessments | ||||||
COVID-19 knowledge (CDUHR) [34] | X | X | X | |||
Attitudes about COVID-19 vaccine (CDEs) [33] | X | X | X | |||
Attitudes about COVID-19 testing (CDEs) | X | X | X | |||
Confidence in government and the healthcare system (CDUHR) | X | X | X | |||
Comorbidities (CDEs) | X | X | X | |||
HIV (CDEs) | X | X | X | |||
COVID symptoms (CDEs) | X | X | X | |||
Demographics (name, address, phone, email, social media, locator information, age, race, gender, sexual preference, marital status, income, education, disabilities) | X | X | X | |||
Services accessed (TSR) [35] | X | X | X | |||
Housing (TSR and CDEs) | X | X | X | |||
Food access (PhenX Toolkit) [32] | X | X | X | |||
Health care access (CDEs) | X | X | X | |||
Use of technology (CDEs) | X | X | X | |||
X | X | X | ||||
Pandemic impact (PhenX Toolkit) | X | X | X | |||
Adherence to prevention guidelines (PhenX Toolkit) | X | X | X | |||
Adherence to treatment guidelines (CDEs) | X | X | X | |||
First COVID-19 test completion date | X | |||||
Second COVID-19 test completion date | X | |||||
COVID-19 test 1 result; COVID-19 test 2 result | X | |||||
General mental health (CDEs) | X | X | X | |||
X | X | X | ||||
Alcohol and nicotine use (CDEs) | X | X | X | |||
Treatment fidelity | X | X | ||||
Client satisfaction | X | X |
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a} Table 3
Area of assessment | Variable measured | Measure source |
---|---|---|
Demographics | Name, address, phone, email, social media, locator info, Age, race, gender, sexual orientation, marital status, income, education, employment, housing, health insurance, language | CDEs [33] |
COVID risk | Exposure to SARS-CoV-2 | CDEs |
Comorbidities | ||
Disabilities | ||
COVID symptoms | ||
COVID-19 attitudes/beliefs/knowledge | COVID-19 knowledge | NIH PhenX Toolkit [32] |
Attitudes about COVID-19 vaccine | CDEs | |
Attitudes about COVID-19 testing | ||
Confidence in government and the healthcare system | PhenX Toolkit | |
Social determinants of health | Services accessed in the past 30 days/week/2 weeks | Treatment Service Review (TSR) [35] |
Housing | Added from TSR and CDEs | |
Food access | PhenX Toolkit | |
Health care access | CDEs | |
Use of technology (including telehealth) | PhenX Toolkit/CDEs | |
Social support | MOS Social Support [36] | |
Pandemic impact | PhenX Toolkit | |
COVID-19 outcomes | Adherence to prevention guidelines | PhenX Toolkit |
Adherence to treatment guidelines | CDEs | |
First COVID-19 test completion date | – | |
Second COVID-19 test completion date | ||
COVID-19 test 1 result | ||
COVID-19 test 2 result | ||
First stage intervention completion date | ||
Second stage intervention completion date | ||
Mental health and drug use | Overall mental health | CDEs |
Trauma | CDEs and PTSD Checklist [37] | |
Self-efficacy | General Self-Efficacy Scale (GSE-6) [38] | |
Substance misuse | CDEs | |
Client satisfaction | End of treatment questionnaire | Developed by us |
IRB | Anticipated adverse events | |
Serious adverse events |