Clincosm LogoSign in Get a demo

Navigating Insurance Coverage Expansion (NICE)

Sponsor
University of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04263441
Collaborator
Howard Brown Health Center (Other), Chicago House and Social Service Agency (Other), Centers for Disease Control and Prevention (U.S. Fed)
630
Enrollment
3
Locations
2
Arms
42.4
Anticipated Duration (Months)
210
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care, referrals to other HIV-associated health services, and health outcomes. The study population is Black and Hispanic men who have sex with men (MSM) and transgender persons who are at higher risk for HIV.

The study team will be testing the hypotheses that in-person health insurance enrollment assistance results in positive outcomes with regard to linkage to and retention in HIV-related health care. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NICE Intervention
 N/A

Detailed Description

The overall goal of this study is to test whether providing in-person assistance in enrolling in private health insurance or Medicaid for the first time, changing to a different insurance plan, or understanding how to use current insurance policies following HIV testing will (1) increase the proportion of participants who obtain health insurance; (2) result in better health outcomes among participants; (3) improve the linkage and retention rates of participants, especially those diagnosed with HIV; and (4) increase linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

Study Design

Study Type:
Interventional
Actual Enrollment :
630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Navigating Insurance Coverage Expansion (NICE): A Collaboration to Increase Access to Care for Black and Hispanic Men Who Have Sex With Men and Transgender Persons
Actual Study Start Date :
Oct 18, 2018
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NICE Intervention

The proposed intervention will engage clients in the health care enrollment and navigation process in-person, at the time of the HIV testing event. Subjects will be asked to share thoughts on the satisfaction survey.

Behavioral: NICE Intervention
Subjects enrolled in the intervention arm will be offered assistance in enrolling in healthcare coverage and provided assistance on where they can go for care immediately. Subjects will be followed for 1 year and information including lab tests and insurance coverage status will be collected. This information will be collected from medical record review.
No Intervention: Control Intervention

Subjects will be offered a handout on how to enroll in healthcare coverage This group will be provided with the site's standard healthcare enrollment and linkage to care, which is specific to the health care clinic they are visiting. Subjects will be followed for 1 year and information including lab tests and insurance coverage status will be collected. This information will be collected from medical record review. Subjects will be asked to share thoughts on the satisfaction survey.

Outcome Measures

Primary Outcome Measures

  1. Linkage [30 days]

    Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed

  2. Delayed Linkage [90 days]

    Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed

  3. Retention [365 days]

    Proportion of HIV positive participants who completed at least 2 HIV-related medical visits within 12 months after their baseline HIV test was performed. Visits must be separated by at least 3 months.

  4. Early Retention [183 days]

    Proportion of HIV negative participants who completed at least 2 medical visits within 6 months after their baseline HIV test was performed, regardless of whether they enrolled in PrEP.

Secondary Outcome Measures

  1. Linkage [365 Days]

    Median length of time between baseline HIV test and first completed HIV-related care visit

  2. Retention [365 Days]

    Median length of time between first completed HIV-related care visit and subsequent HIV-related care visits during the 12-month follow-up period

  3. Viral Load Reduction [91 days]

    Proportion of HIV positive participants who are retained and achieved reduced viral load at their first visit at least 3 months post-linkage. Reduced viral load is considered to be fewer RNA copies/mL than the participant's viral load test result on their previous medical care visit.

  4. Viral Suppression [365 days]

    Proportion of HIV positive participants who are retained and achieved viral suppression (<200 RNA copies/mL) at their last visit within 12 months after enrollment

  5. Maintained Status [365 days]

    Proportion of HIV negative participants who are retained and remained HIV negative at their last visit within 12 months after enrollment, regardless of whether they enrolled in PrEP.

  6. Enrolled in Insurance [At study enrollment]

    Proportion of intervention arm participants who are successfully enrolled in health insurance

  7. Changed Insurance [At study enrollment]

    Proportion of currently insured intervention arm participants who change their insurance plan and reasons why

  8. Medicaid Enrollment [At study enrollment]

    Proportion of newly enrolled intervention arm participants who enroll in Medicaid

  9. Private Insurance Enrollment [At study enrollment]

    Proportion of newly enrolled intervention arm participants who enroll in private health insurance

  10. Market place enrollment [At study enrollment]

    Proportion of intervention arm participants who enroll in the bronze level of coverage, who enroll in the silver level of coverage, and who enroll in gold or platinum levels of coverage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Black or Hispanic men who have sex with men (MSM) or transgender persons

  • 18 or older

Exclusion Criteria:

  • Cisgender women

  • Cisgender men who have not had anal or oral sex with a man in last 2 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Howard Brown Health Chicago Illinois United States 60613
2 Chicago House and Social Service Agency, Inc. Chicago Illinois United States 60614
3 University of Chicago Medical Center Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago
  • Howard Brown Health Center
  • Chicago House and Social Service Agency
  • Centers for Disease Control and Prevention

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04263441
Other Study ID Numbers:
  • IRB16-1260
  • CDC
First Posted:
Feb 10, 2020
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Chicago
Pre-Exposure Prophylaxis (PrEP)
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

Study Results

No Results Posted as of Mar 4, 2022