COVID-19SINCERENCT05228886
The SINCERE Intervention to Address COVID-19 Health Disparities
A study testing SINCERE and Scheduled Follow-Up in people with COVID-19 and Vulnerable Populations, run by Andrea Wallace at 1 site in United States.
Trial summary
The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vulnerable Populations, Social Determinants of Health
- What is being tested?
- SINCERE and Scheduled Follow-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (> 17 years)
- English or Spanish speaking
- Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
- Able to be reached by phone during the intervention OR able to complete surveys sent by text or email
Who cannot join
- Those unable to communicate verbally
- Those living in nursing facilities, or those who are not otherwise responsible for self-care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities
The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.
- Being tested
- SINCERE, Scheduled Follow-Up, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SINCEREBehavioural
Each goal setting session will involve templated prompts in 211's ServicePoint to guide the creation of a patient-centered "action plan" specifying what, when, how much, and how often patients will engage in a behavior (e.g., "I will work on filling out eligibility paperwork for 30 minutes on Wednesday evening"). Again, following clear prompts, ISs negotiate the "action plan" with patients until patients can rate their level of confidence for achieving this behavior a 7 on a scale from 0 to 10.
Scheduled Follow-UpBehavioural
Adding to the standard Call + Resources protocol, those assigned to scheduled follow-up will receive a proactive call from 211 every 2 weeks for 3 months to explore additional service needs. These calls will be unstructured, guided by participant requests and 211 IS prompts.
Standard of CareOther
211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.
| Study group | Role | What they receive |
|---|---|---|
| Call + Resources | Active comparator | Participants receive standard care typically provided to 211 callers, including ad hoc follow-up. Receives: Other: Standard of Care |
| Call + Resources + Scheduled Follow-Up | Experimental | Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description. Receives: Behavioral: Scheduled Follow-Up |
| Call + Resources + SINCERE | Experimental | Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting). Receives: Behavioral: SINCERE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Health over 12-week time period
Standardized PROMIS v1.2 Global Health. 10 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating lower severity. The outcome variable will be PROMIS v1.2 Global Health with Time included as a variable in the model.
Measured: Baseline, 2-week, 4-week and 12-week surveys
Change in Depression over 12-week time period
Standardized PROMIS Depression - Short Form 8b. 8 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Measured: Baseline, 2-week, 4-week and 12-week surveys
Change in Anxiety over 12-week time period
Standardized PROMIS Anxiety- Short Form 7a. 7 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Measured: Baseline, 2-week, 4-week and 12-week surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start27 Sep 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Wallace
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Andrea Wallace, University of Utah
- Investigators
- Andrea Wallace, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228886
- Sponsor's protocol ID
- 00140301
- Other IDs
- 1R01NR019944-01
- Acronym
- SINCERE
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In agreement with the investigative team, the PI will share de-identified data to other investigators for study. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the Aims. De-identified data will be available directly from the PI after consulting with the investigative team on relevant requests. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities
- ClinicalTrials.gov ID
- NCT05228886
- Acronym / sponsor ID
- SINCERE / 00140301
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Andrea WallaceUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Call + Resources | Active comparator | Other: Standard of CareParticipants receive standard care typically provided to 211 callers, including ad hoc follow-up. |
| Call + Resources + Scheduled Follow-Up | Experimental | Behavioral: Scheduled Follow-UpParticipants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description. |
| Call + Resources + SINCERE | Experimental | Behavioral: SINCEREParticipants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (> 17 years)
- English or Spanish speaking
- Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
- Able to be reached by phone during the intervention OR able to complete surveys sent by text or email
Key exclusion criteria (2 listed)
- Those unable to communicate verbally
- Those living in nursing facilities, or those who are not otherwise responsible for self-care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SINCEREEach goal setting session will involve templated prompts in 211's ServicePoint to guide the creation of a patient-centered "action plan" specifying what, when, how much, and how often patients will engage in a behavior (e.g., "I will work on filling out eligibility paperwork for 30 minutes on Wednesday evening"). Again, following clear prompts, ISs negotiate the "action plan" with patients until patients can rate their level of confidence for achieving this behavior a 7 on a scale from 0 to 10. | Behavioural | Call + Resources + SINCERE |
| Scheduled Follow-UpAdding to the standard Call + Resources protocol, those assigned to scheduled follow-up will receive a proactive call from 211 every 2 weeks for 3 months to explore additional service needs. These calls will be unstructured, guided by participant requests and 211 IS prompts. | Behavioural | Call + Resources + Scheduled Follow-Up |
| Standard of Care211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner. | Other | Call + Resources |
Primary outcome
Change in Global Health over 12-week time period
Time frame: Baseline, 2-week, 4-week and 12-week surveys
Standardized PROMIS v1.2 Global Health. 10 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating lower severity. The outcome variable will be PROMIS v1.2 Global Health with Time included as a variable in the model.
Change in Depression over 12-week time period
Time frame: Baseline, 2-week, 4-week and 12-week surveys
Standardized PROMIS Depression - Short Form 8b. 8 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Change in Anxiety over 12-week time period
Time frame: Baseline, 2-week, 4-week and 12-week surveys
Standardized PROMIS Anxiety- Short Form 7a. 7 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. In agreement with the investigative team, the PI will share de-identified data to other investigators for study. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the Aims. De-identified data will be available directly from the PI after consulting with the investigative team on relevant requests. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Wallace, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SINCERE and Scheduled Follow-Up in people with COVID-19 and Vulnerable Populations, run by Andrea Wallace at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Health over 12-week time period (time frame: Baseline, 2-week, 4-week and 12-week surveys). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.