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COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission chains and reduce community transmission. However, Black and Latino/Hispanic populations in lower status frontline essential occupations such as food preparation, retail, building maintenance, personal services, and in-home health care have serious barriers to COVID-19 testing and, therefore, insufficient testing rates. The proposed study will use the multiphase optimization strategy framework to address the problem of low COVID-19 testing rates for this population: We will test the effects of four distinct candidate intervention components and then create an efficient multicomponent made up of the most effective combination of the components that can be rapidly scaled up in community settings to boost COVID-19 testing rates.
The proposed study responds to RFA-OD-21-008 which calls for community-engaged interventions to support COVID-19 testing in underserved and vulnerable populations. Among those at highest risk for exposure to COVID-19 is the large population of frontline essential workers (FEW) in lower status occupations (e.g., retail, in-home health care), among whom Black and Latino/Hispanic (BLH) persons are over-represented. The CDC recommends testing for all those experiencing symptoms of COVID-19. For those not vaccinated, testing is recommended after exposure to individuals with a COVID-19 diagnosis, and regular COVID-19 screening testing is recommended even when asymptomatic for those with frequent close contact with others in indoor settings such as FEW. However, BLH-FEW experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines, distrust), social- (e.g., social norms), and structural-levels of influence (e.g., poor access to testing). Indeed, testing rates are lower among BLH than White populations and only 25-50% of BLH-FEW are currently vaccinated. The proposed community-engaged study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation (NMIC). Its main goal is to optimize a behavioral intervention to boost COVID-19 testing rates for BLH-FEW. Consistent with RFA-OD-21-008, the proposed study uses the multiphase optimization strategy (MOST) framework to test four candidate intervention components grounded in our past research. The candidate components are informed by critical race theory and guided by the theory of triadic influence, are brief or do not require substantial staff time, and will be tested in a highly efficient factorial experimental design. They are A) motivational interview counseling, B) a text message component grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to a test appointment vs. a self-test kit). All participants receive the standard of care, namely, health education on COVID-19 testing, and referrals. The specific aims of the study are to: identify which of four candidate components contribute meaningfully to improvement in the primary outcome, COVID-19 testing with medical confirmation; the most effective combination of components will comprise the "optimized" intervention (Aim 1), identify mediators (e.g., distrust, access) and moderators (e.g., sociodemographic characteristics) of the effects of each component (Aim 2), and use a mixed-methods approach to explore relationships among barriers to, facilitators of, and uptake of COVID-19 testing and COVID-19 vaccination (Aim 3). Participants will be N=448 BLH-FEW who have not been tested for COVID-19 in the past three months and have not been vaccinated for COVID-19 in the past 12 months, randomly assigned to an intervention condition, and assessed at 6- and 12-weeks post-baseline; N=50 participants will engage in qualitative in-depth interviews. We will also uncover, describe, and plan for implementation issues so the optimized intervention can be rapidly scaled up by NMIC and other community-based organizations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation |
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| Condition 2 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
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| Condition 3 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation |
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| Condition 4 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing (MI) counseling | Behavioral | Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes. The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances. |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Testing at Follow-up Assessment | COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance) | by the 12-week FU |
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INCLUSION CRITERIA: 1) age 18-70 years; 2) can engage in study activities in English or Spanish; 3) Black or African American (including Caribbean, African, or multi-ethnic Black) and/or Latino or Hispanic race/ethnicity; 4) resides in NYC; 5) in the past month, was employed as a frontline worker in a lower status essential occupation in one or more of the domains listed above; 6) has a phone that can be used for study participation and can receive TMs; 7) has not received any doses of a COVID-19 vaccination in the past 12 months; 8) has not been tested for COVID-19 in the past three months; 9) if previously diagnosed with COVID-19, has not been symptomatic in the past two weeks or 90 days has passed since treatment with monoclonal antibodies or convalescent plasma98; 10) has not been educated/interviewed as a peer for Component C; 11) willing to engage in a core session and be randomly assigned to receive 1-4 components.
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| Name | Affiliation | Role |
|---|---|---|
| Marya Gwadz, PhD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Silver School of Social Work | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35729622 | Derived | Gwadz M, Cleland CM, Lizardo M, Hawkins RL, Bangser G, Parameswaran L, Stanhope V, Robinson JA, Karim S, Hollaway T, Ramirez PG, Filippone PL, Ritchie AS, Banfield A, Silverman E. Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol. BMC Public Health. 2022 Jun 21;22(1):1235. doi: 10.1186/s12889-022-13576-0. |
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The optimization randomized controlled trial described here was conducted in New York City between July 2022 and February 2024. The trial was a collaboration between New York University and the Northern Manhattan Improvement Corporation. Study activities were conducted at a research field site in lower Manhattan. Persons could participate there in-person or engage in the study virtually. Recruitment took place in the community,
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| ID | Title | Description |
|---|---|---|
| FG000 | Condition 1 | Component A: MIC - ON Component B: TM - ON Component C: PE- ON Component D: Navigation |
| FG001 | Condition 2 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2023 |
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Full factorial experiment testing 4 behavioral intervention components. There are 16 conditions needed to test the effects of the 4 components. Each condition comprises a combination of components. In the sections that follow, we describe the 16 conditions.
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| Condition 5 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation |
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| Condition 6 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit |
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| Condition 7 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation |
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| Condition 8 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit |
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| Condition 9 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
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| Condition 10 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
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| Condition 11 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
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| Condition 12 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
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| Condition 13 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
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| Condition 14 | Experimental | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
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| Condition 15 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
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| Condition 16 | Experimental | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
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| Text messages (TMs) and quiz questions (QQs) | Behavioral | This intervention lasts 6 weeks. This component is grounded in principles of behavioral economics. Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed. Participants first receive a brief orientation to the component (15 min.), and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent. TMs and QQs are programmed into the Telerivet program and sent automatically. Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer. Participants earn modest prizes based on their points. |
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| Peer education | Behavioral | This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min. training). Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages. These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study. |
|
| Access to COVID testing | Behavioral | Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed. Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19. Level 2: 1 month after enrollment, participants will be contacted by phone. If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them. |
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| FG002 | Condition 3 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation |
| FG003 | Condition 4 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
| FG004 | Condition 5 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation |
| FG005 | Condition 6 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit |
| FG006 | Condition 7 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation Peer education: This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min. training). Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages. These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study. Access to COVID testing: Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed. Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19. Level 2: 1 month after enrollment, participants will be contacted by phone. If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them. |
| FG007 | Condition 8 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit Peer education: This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min. training). Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages. These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study. Access to COVID testing: Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed. Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19. Level 2: 1 month after enrollment, participants will be contacted by phone. If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them. |
| FG008 | Condition 9 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
| FG009 | Condition 10 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
| FG010 | Condition 11 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
| FG011 | Condition 12 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
| FG012 | Condition 13 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
| FG013 | Condition 14 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
| FG014 | Condition 15 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
| FG015 | Condition 16 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
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| NOT COMPLETED |
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Information is the same
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| ID | Title | Description |
|---|---|---|
| BG000 | Condition 1 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation |
| BG001 | Condition 2 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
| BG002 | Condition 3 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation |
| BG003 | Condition 4 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit |
| BG004 | Condition 5 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation |
| BG005 | Condition 6 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit |
| BG006 | Condition 7 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation |
| BG007 | Condition 8 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit |
| BG008 | Condition 9 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
| BG009 | Condition 10 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
| BG010 | Condition 11 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation |
| BG011 | Condition 12 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit |
| BG012 | Condition 13 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
| BG013 | Condition 14 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
| BG014 | Condition 15 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation |
| BG015 | Condition 16 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit |
| BG016 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Self report: What terms best express how you describe your gender identity? (SELECT ONE) Responses: woman, man, non-binary, transgender man, transgender woman, none, other Note that we had missing data on sex assigned at birth so we relied on gender for this study. In most cases, sex and gender are the same. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | COVID-19 Testing at Follow-up Assessment | COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance) | participants | Posted | Mean | Standard Deviation | proportion of those tested at least once | by the 12-week FU |
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12-week follow-up
Several mechanisms were put in place to monitor potential adverse events that participants may experience throughout the study, whether related to project participation or not. Events were classified as Reportable, Adverse, or Not Harmful/Expectable and reported to the IRB and Program Official as required. No adverse events were observed during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Condition 1 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Condition 2 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Condition 3 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Condition 4 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit | 0 | 27 | 0 | 27 | 0 | 27 |
| EG004 | Condition 5 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation | 0 | 26 | 0 | 26 | 0 | 26 |
| EG005 | Condition 6 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG006 | Condition 7 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation | 0 | 28 | 0 | 28 | 0 | 28 |
| EG007 | Condition 8 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG008 | Condition 9 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation | 0 | 27 | 0 | 27 | 0 | 27 |
| EG009 | Condition 10 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG010 | Condition 11 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation | 0 | 28 | 0 | 28 | 0 | 28 |
| EG011 | Condition 12 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG012 | Condition 13 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation | 0 | 27 | 0 | 27 | 0 | 27 |
| EG013 | Condition 14 | Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit | 0 | 28 | 0 | 28 | 0 | 28 |
| EG014 | Condition 15 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation | 0 | 28 | 0 | 28 | 0 | 28 |
| EG015 | Condition 16 | Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit | 0 | 27 | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marya Gwadz, PhD | NYU | 917-863-2125 | mg2890@nyu.edu |
| Apr 30, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2023 | Sep 17, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003153 | Community Health Services |
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| Female/woman or gender minority |
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| Other race |
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| Latino/Hispanic (yes) |
|