Trial Outcomes & Findings for Optimization of a New Adaptive Intervention to Increase COVID-19 Testing (NCT NCT04757298)
NCT ID: NCT04757298
Last Updated: 2024-02-15
Results Overview
For the first stage intervention, the primary outcome is coming to the agency and completing the COVID-19 antigen test one week after completing the baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
668 participants
Primary outcome timeframe
Stage 1: Within one week of completing baseline.
Results posted on
2024-02-15
Participant Flow
Participants were recruited into the study at the North Jersey Community Research Initiative (NJCRI), one of New Jersey's largest and most comprehensive HIV/AIDS community-based organization.
Participant milestones
| Measure |
Stage 1: Navigation
Participants in this arm were randomized to receive Navigation Services for Stage 1
|
Stage 2 Navigation Followed by Navigation
Participants in this arm were first randomized to receive Navigation Services in Stage 1 and then were randomized again to receive Navigation Services in Stage 2
Navigation Services: Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
|
Stage 2: Navigation Followed by Brief Counseling
Participants in this arm were randomized into Navigation Services in Stage 1 then randomized into Brief Counseling in Stage 2.
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Stage 2: Navigation Followed by Critical Dialogue
Participants in this arm were first randomized to receive Navigation Services in Stage 1 then randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
|
Stage 1: Brochure
Participants in this group were randomized to receive a digital brochure in Stage 1.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Stage 2: Brochure Followed by Brochure
Participants in this group were randomized to receive a brochure in Stage 1 and randomized to receive a brochure in Stage 2.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Stage 2: Brochure Followed by Brief Counseling
Participants in this group were randomized to receive a brochure in Stage 1 and randomized to receive Brief Counseling in Stage 2
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Stage 2: Brochure Followed by Critical Dialogue
Participants in this group were randomized to receive a Brochure in Stage 1 and randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: First Intervention
STARTED
|
328
|
0
|
0
|
0
|
340
|
0
|
0
|
0
|
|
Stage 1: First Intervention
COMPLETED
|
160
|
0
|
0
|
0
|
165
|
0
|
0
|
0
|
|
Stage 1: First Intervention
NOT COMPLETED
|
168
|
0
|
0
|
0
|
175
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
0
|
160
|
36
|
126
|
0
|
165
|
32
|
137
|
|
Second Intervention
COMPLETED
|
0
|
96
|
16
|
16
|
0
|
164
|
19
|
19
|
|
Second Intervention
NOT COMPLETED
|
0
|
64
|
20
|
110
|
0
|
1
|
13
|
118
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimization of a New Adaptive Intervention to Increase COVID-19 Testing
Baseline characteristics by cohort
| Measure |
Navigation (1)+ Navigation (2)
n=160 Participants
Participants in this group were randomized in Stage 1 to receive Navigation Services and randomized to receive Navigation Services in Stage 2.
Navigation Services: Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
|
Navigation (1) + Brief Counseling (2)
n=36 Participants
Participants in this Group were randomized to receive Navigation services in Stage 1 and randomized to receive Brief Counseling in Stage 2.
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Navigation (1) + Critical Dialogue (2)
n=126 Participants
Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities
|
Brochure (1) + Brochure (2)
n=165 Participants
Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Brochure (1)+ Brief Counseling (2)
n=32 Participants
Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2.
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Brochure (1) + Critical Dialogue (2)
n=137 Participants
Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
|
Total
n=656 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
153 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
630 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
76 Participants
n=10 Participants
|
364 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Female
|
72 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
271 Participants
n=115 Participants
|
|
Sex/Gender, Customized
none of these describe me (includes those identifying as non-binary, transgender, and bi-gender)
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Gender Missing/Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
96 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
105 Participants
n=10 Participants
|
529 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
127 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
99 Participants
n=10 Participants
|
509 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
64 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
55 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Missing/Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
36 participants
n=7 Participants
|
126 participants
n=5 Participants
|
165 participants
n=4 Participants
|
32 participants
n=21 Participants
|
137 participants
n=10 Participants
|
656 participants
n=115 Participants
|
|
COVID tested within previous 30 days
|
40 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
165 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Stage 1: Within one week of completing baseline.Population: Population for Stage 1
For the first stage intervention, the primary outcome is coming to the agency and completing the COVID-19 antigen test one week after completing the baseline.
Outcome measures
| Measure |
Navigation (1)
n=328 Participants
Participants in this group are randomized to receive Navigation Services in Stage 1.
Navigation Services: Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
|
Brochure Only
n=340 Participants
After initial randomization, some participants will be assigned to receive standard referral services. Those who complete the COVID-19 testing will again be randomized and some will receive a digital brochure.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Navigation (1) + Critical Dialogue (2)
Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities
|
Brochure (1) + Brochure (2)
Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Brochure (1)+ Brief Counseling (2)
Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2.
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Brochure (1) + Critical Dialogue (2)
Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
|
|---|---|---|---|---|---|---|
|
Stage 1: Completion of COVID-19 Test After First Randomization
Stage 1 COVID tested
|
78 participants
|
71 participants
|
—
|
—
|
—
|
—
|
|
Stage 1: Completion of COVID-19 Test After First Randomization
Missing/Unknown
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 2: 6 months post baseline (4th follow up visit)Population: Population includes baseline at Stage 2.
For the second stage intervention, the primary outcome is self-reported completion of COVID-19 test in the past 30 days at the follow up completed 6 months after baseline. Study participants were asked whether they had completed a COVID-19 test in the past 30 days.
Outcome measures
| Measure |
Navigation (1)
n=160 Participants
Participants in this group are randomized to receive Navigation Services in Stage 1.
Navigation Services: Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
|
Brochure Only
n=36 Participants
After initial randomization, some participants will be assigned to receive standard referral services. Those who complete the COVID-19 testing will again be randomized and some will receive a digital brochure.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Navigation (1) + Critical Dialogue (2)
n=126 Participants
Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities
|
Brochure (1) + Brochure (2)
n=165 Participants
Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2.
Referral and Digital Brochure: Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
|
Brochure (1)+ Brief Counseling (2)
n=32 Participants
Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2.
Brief Counseling: Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
|
Brochure (1) + Critical Dialogue (2)
n=137 Participants
Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2.
Critical Dialogue: Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
|
|---|---|---|---|---|---|---|
|
Stage 2: Reported COVID Test in Last 30 Days at 6 Months Post Baseline
Reported COVID tested in prior 30 days
|
40 participants
|
12 participants
|
26 participants
|
40 participants
|
8 participants
|
39 participants
|
|
Stage 2: Reported COVID Test in Last 30 Days at 6 Months Post Baseline
Missing
|
0 participants
|
18 participants
|
57 participants
|
78 participants
|
16 participants
|
53 participants
|
Adverse Events
Stage 1: Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Navigation Followed by Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Navigation Followed by Brief Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Navigation Followed by Critical Dialogue
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 1: Brochure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Brochure Followed by Brochure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Brochure Followed by Brief Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Brochure Followed by Critical Dialogue
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Liliane Windsor
University of Illinois Urbana Champaign
Phone: 217-300-1782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place