The SINCERE Intervention to Address COVID-19 Health Disparities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Community Services Navigation to Advance Health Equity in Breast Cancer Screening

NCT06305312

Breast Cancer

RECRUITING NA

SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Vaccination Rates Among Utah Community Health Centers

NCT04939519

Covid19

COMPLETED NA

SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Testing Among Utah Community Health Centers

NCT04939532

Covid19

COMPLETED NA

COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement

NCT05582746

COVID-19 Pandemic

COMPLETED NA

Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva

NCT06085547

SARS-CoV2 Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Vulnerable Populations Social Determinants of Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Call + Resources

Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.

Call + Resources + Scheduled Follow-Up

Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.

Group Type EXPERIMENTAL

Scheduled Follow-Up

Intervention Type BEHAVIORAL

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.

Call + Resources + SINCERE

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).

Group Type EXPERIMENTAL

SINCERE

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SINCERE

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.

Intervention Type BEHAVIORAL

Scheduled Follow-Up

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.

Intervention Type BEHAVIORAL

Standard of Care

211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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