Trial Outcomes & Findings for Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO (NCT NCT04878328)
NCT ID: NCT04878328
Last Updated: 2026-06-25
Results Overview
Testing uptake will be defined as the number and percentage of participants who had tests performed and will be determined using program logs and healthcare record extraction. To measure testing uptake, a dichotomous outcome of having at least one complete SARS-CoV-2 test over the 12-month study period, defined as having a test performed with results received by participants within two weeks of the test being conducted, was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2026-06-25
Participant Flow
572 participants were screened and 250 were randomized into the study. Of the 322 participants who were not enrolled into the study, 247 participants did not meet all of the eligibility criteria, 75 did not show up for the enrollment visit.
Participant milestones
| Measure |
Onsite Point-of-care (o-POC)
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
72
|
62
|
|
Overall Study
NOT COMPLETED
|
53
|
63
|
Reasons for withdrawal
| Measure |
Onsite Point-of-care (o-POC)
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
50
|
|
Overall Study
Incarcerated
|
11
|
9
|
|
Overall Study
Withdrawn from study
|
4
|
4
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
Baseline characteristics by cohort
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 12.2 • n=20 Participants
|
41.2 years
STANDARD_DEVIATION 11.3 • n=20 Participants
|
42.0 years
STANDARD_DEVIATION 11.8 • n=40 Participants
|
|
Sex/Gender, Customized
Cisgender men
|
106 Participants
n=20 Participants
|
110 Participants
n=20 Participants
|
216 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Cisgender women
|
17 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Transgender women
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Non-binary/None of these describe me
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
69 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
120 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
39 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
12 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsTesting uptake will be defined as the number and percentage of participants who had tests performed and will be determined using program logs and healthcare record extraction. To measure testing uptake, a dichotomous outcome of having at least one complete SARS-CoV-2 test over the 12-month study period, defined as having a test performed with results received by participants within two weeks of the test being conducted, was used.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Testing Uptake
|
109 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsThe number/percentage of participants who completed at least one SARS-CoV-2 test for the whole 12-month study period (up to 5 tests available) is summarized by study arm.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Number of Participants Who Completed SARS-CoV-2 Tests
|
125 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: 12 months post-enrollmentMasking adherence behavior was measured using a composite weighted variable estimating how frequently participants engaged in activities with potential COVID-19 exposure and how often they wore a mask during those activities in the previous two weeks. Initial response options were 1=Always, 2=Most of the time, 3=Sometimes, 4=Rarely or 5=Never. Responses were combined and standardized to a scale of 1 to 100 with higher scores indicating greater masking adherence. Results are summarized by study arm using descriptive statistics.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Masking Adherence
|
45.1 score on a scale
Standard Deviation 35.8
|
37.0 score on a scale
Standard Deviation 35.3
|
SECONDARY outcome
Timeframe: 12 months post-enrollmentSocial distancing measured the participants' social distancing behavior by their responses to the following question: "Overall, on a scale of 1-100, how often did you stay greater than 6 feet away from others when you were not masked in the past 2 weeks? Higher scores were indicative of more frequent social distancing. Results are summarized by study arm using descriptive statistics.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Social Distancing Behavior
|
55.3 score on a scale
Standard Deviation 35.3
|
49.6 score on a scale
Standard Deviation 35.4
|
SECONDARY outcome
Timeframe: 12 months post-enrollmentParticipants' hand washing behavior was measured by the following question: Overall, on a scale of 1-100, how often did you wash hands after shaking hands with or touching surfaces that were touched by someone else in the past two weeks? Higher scores were indicative of more frequent hand washing behavior. Results are summarized by study arm using descriptive statistics.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Hand Washing Adherence
|
73.8 score on a scale
Standard Deviation 29.9
|
70.3 score on a scale
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: 12 months post-enrollmentThe number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.
Outcome measures
| Measure |
Onsite Point-of-care (o-POC)
n=125 Participants
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 Participants
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Mitigation Measures
|
115 Participants
|
114 Participants
|
Adverse Events
Onsite Point-of-care (o-POC)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 1 deaths
Standard of Care (SOC)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Onsite Point-of-care (o-POC)
n=125 participants at risk
CHWs will reach out to participants to schedule O-PoC visits. At O-PoC visits, CHWs will provide: 1. COVID-19 education; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR tests; 3. Needs assessments and facilitated access to masks and hygiene supplies; 4. Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5. Supportive counseling. Due to SCT's emphasis on social influence, external and internal social reinforcement, we propose our O-PoC intervention delivered by CHWs onsite at Fortune locations over a 12-month period will lead to increased uptake of mitigation behaviors.
|
Standard of Care (SOC)
n=125 participants at risk
The current standard of care (SoC) for SARS-CoV-2 testing for Fortune clients is referral to offsite community testing sites and informal, unstructured education. In the SoC arm, Fortune staff will provide clients with a list of offsite SARS-CoV-2 testing locations, which are published online and available to all NYC residents. Those without insurance are not subject to a copay. Participants in SoC will continue to receive Fortune's suite of services as they are delivered (remote and/or in-person) at the time of study participation.
|
|---|---|---|
|
Social circumstances
Incarceration
|
8.8%
11/125 • enrollment through end of follow up, up to 12 months
|
7.2%
9/125 • enrollment through end of follow up, up to 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
1.6%
2/125 • enrollment through end of follow up, up to 12 months
|
|
Social circumstances
Banned from Fortune Society
|
2.4%
3/125 • enrollment through end of follow up, up to 12 months
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
|
Social circumstances
Disenrolled (behavior)
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
|
Social circumstances
Disenrolled (relocated)
|
0.00%
0/125 • enrollment through end of follow up, up to 12 months
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
|
Social circumstances
Withdrew self
|
0.00%
0/125 • enrollment through end of follow up, up to 12 months
|
0.80%
1/125 • enrollment through end of follow up, up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place