COVID-19, COVID-19 Testing
Conditions
Keywords
multiphase optimization strategy (MOST), COVID-19 testing, Black and Latino, frontline essential workers
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
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.
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.
Sponsors
Study design
Intervention model description
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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Testing at Follow-up Assessment | by the 12-week FU | COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance) |
Countries
United States
Participant flow
Recruitment details
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,
Participants by arm
| Arm | Count |
|---|---|
| Condition 1 Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation | 24 |
| Condition 2 Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit | 28 |
| Condition 3 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation | 28 |
| Condition 4 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit | 27 |
| Condition 5 Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation | 26 |
| Condition 6 Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit | 28 |
| Condition 7 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation | 28 |
| Condition 8 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit | 28 |
| Condition 9 Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation | 27 |
| Condition 10 Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit | 28 |
| Condition 11 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation | 28 |
| Condition 12 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit | 28 |
| Condition 13 Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation | 27 |
| Condition 14 Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit | 28 |
| Condition 15 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation | 28 |
| Condition 16 Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit | 27 |
| Total | 438 |
Baseline characteristics
| Characteristic | Condition 1 | Condition 2 | Condition 3 | Condition 4 | Condition 5 | Condition 6 | Condition 7 | Condition 8 | Condition 9 | Condition 10 | Condition 11 | Condition 12 | Condition 13 | Condition 14 | Condition 15 | Condition 16 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 37.46 years STANDARD_DEVIATION 10.56 | 36.07 years STANDARD_DEVIATION 8.73 | 33.54 years STANDARD_DEVIATION 10.12 | 39.44 years STANDARD_DEVIATION 12.07 | 35.19 years STANDARD_DEVIATION 11.18 | 35.29 years STANDARD_DEVIATION 9.56 | 33.82 years STANDARD_DEVIATION 9 | 31.82 years STANDARD_DEVIATION 8.46 | 35.37 years STANDARD_DEVIATION 7.75 | 36.04 years STANDARD_DEVIATION 11.44 | 35.64 years STANDARD_DEVIATION 9.19 | 35.54 years STANDARD_DEVIATION 10.07 | 32.59 years STANDARD_DEVIATION 8.66 | 33.89 years STANDARD_DEVIATION 9.32 | 34.75 years STANDARD_DEVIATION 9.16 | 32.41 years STANDARD_DEVIATION 9.11 | 34.93 years STANDARD_DEVIATION 9.65 |
| Race/Ethnicity, Customized African American/Black or bi- or multi-racial | 11 Participants | 11 Participants | 15 Participants | 13 Participants | 15 Participants | 12 Participants | 15 Participants | 18 Participants | 10 Participants | 16 Participants | 12 Participants | 12 Participants | 13 Participants | 11 Participants | 17 Participants | 13 Participants | 214 Participants |
| Race/Ethnicity, Customized Latino/Hispanic (yes) | 13 Participants | 17 Participants | 13 Participants | 14 Participants | 11 Participants | 16 Participants | 13 Participants | 10 Participants | 17 Participants | 12 Participants | 16 Participants | 16 Participants | 14 Participants | 17 Participants | 11 Participants | 14 Participants | 224 Participants |
| Race/Ethnicity, Customized Other race | 13 Participants | 17 Participants | 13 Participants | 14 Participants | 11 Participants | 16 Participants | 13 Participants | 10 Participants | 17 Participants | 12 Participants | 16 Participants | 16 Participants | 14 Participants | 17 Participants | 11 Participants | 14 Participants | 224 Participants |
| Sex/Gender, Customized Female/woman or gender minority | 16 Participants | 16 Participants | 8 Participants | 12 Participants | 11 Participants | 12 Participants | 16 Participants | 12 Participants | 15 Participants | 14 Participants | 14 Participants | 9 Participants | 14 Participants | 12 Participants | 15 Participants | 13 Participants | 209 Participants |
| Sex/Gender, Customized Man/male gender | 8 Participants | 12 Participants | 20 Participants | 15 Participants | 15 Participants | 16 Participants | 12 Participants | 16 Participants | 12 Participants | 14 Participants | 14 Participants | 19 Participants | 13 Participants | 16 Participants | 13 Participants | 14 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 26 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 26 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 26 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 | 0 / 27 |
Outcome results
COVID-19 Testing at Follow-up Assessment
COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance)
Time frame: by the 12-week FU
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition 1 | COVID-19 Testing at Follow-up Assessment | 0.85 proportion of those tested at least once | Standard Deviation 0.37 |
| Condition 2 | COVID-19 Testing at Follow-up Assessment | 0.61 proportion of those tested at least once | Standard Deviation 0.5 |
| Condition 3 | COVID-19 Testing at Follow-up Assessment | 0.63 proportion of those tested at least once | Standard Deviation 0.49 |
| Condition 4 | COVID-19 Testing at Follow-up Assessment | 0.81 proportion of those tested at least once | Standard Deviation 0.4 |
| Condition 5 | COVID-19 Testing at Follow-up Assessment | 0.68 proportion of those tested at least once | Standard Deviation 0.48 |
| Condition 6 | COVID-19 Testing at Follow-up Assessment | 0.59 proportion of those tested at least once | Standard Deviation 0.5 |
| Condition 7 | COVID-19 Testing at Follow-up Assessment | 0.54 proportion of those tested at least once | Standard Deviation 0.51 |
| Condition 8 | COVID-19 Testing at Follow-up Assessment | 0.64 proportion of those tested at least once | Standard Deviation 0.49 |
| Condition 9 | COVID-19 Testing at Follow-up Assessment | 0.64 proportion of those tested at least once | Standard Deviation 0.49 |
| Condition 10 | COVID-19 Testing at Follow-up Assessment | 0.79 proportion of those tested at least once | Standard Deviation 0.41 |
| Condition 11 | COVID-19 Testing at Follow-up Assessment | 0.69 proportion of those tested at least once | Standard Deviation 0.47 |
| Condition 12 | COVID-19 Testing at Follow-up Assessment | 0.68 proportion of those tested at least once | Standard Deviation 0.48 |
| Condition 13 | COVID-19 Testing at Follow-up Assessment | 0.54 proportion of those tested at least once | Standard Deviation 0.51 |
| Condition 14 | COVID-19 Testing at Follow-up Assessment | 0.81 proportion of those tested at least once | Standard Deviation 0.4 |
| Condition 15 | COVID-19 Testing at Follow-up Assessment | 0.56 proportion of those tested at least once | Standard Deviation 0.51 |
| Condition 16 | COVID-19 Testing at Follow-up Assessment | 0.71 proportion of those tested at least once | Standard Deviation 0.46 |