Navigating Insurance Coverage Expansion (NICE) (NICE)

November 14, 2022 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

630

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60613
        • Howard Brown Health
      • Chicago, Illinois, United States, 60614
        • Chicago House and Social Service Agency, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage
Time Frame: 30 days
Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed
30 days
Delayed Linkage
Time Frame: 90 days
Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed
90 days
Retention
Time Frame: 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.
365 days
Early Retention
Time Frame: 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.
183 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage
Time Frame: 365 Days
Median length of time between baseline HIV test and first completed HIV-related care visit
365 Days
Retention
Time Frame: 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
365 Days
Viral Load Reduction
Time Frame: 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.
91 days
Viral Suppression
Time Frame: 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
365 days
Maintained Status
Time Frame: 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.
365 days
Enrolled in Insurance
Time Frame: At study enrollment
Proportion of intervention arm participants who are successfully enrolled in health insurance
At study enrollment
Changed Insurance
Time Frame: At study enrollment
Proportion of currently insured intervention arm participants who change their insurance plan and reasons why
At study enrollment
Medicaid Enrollment
Time Frame: At study enrollment
Proportion of newly enrolled intervention arm participants who enroll in Medicaid
At study enrollment
Private Insurance Enrollment
Time Frame: At study enrollment
Proportion of newly enrolled intervention arm participants who enroll in private health insurance
At study enrollment
Market place enrollment
Time Frame: 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
At study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2018

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

May 14, 2021

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-1260
  • CDC (CDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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