search
Back to results

Navigating Insurance Coverage Expansion (NICE) (NICE)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NICE Intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring Pre-Exposure Prophylaxis (PrEP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Howard Brown Health
  • Chicago House and Social Service Agency, Inc.
  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NICE Intervention

Control Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Linkage
Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed
Delayed Linkage
Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed
Retention
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.
Early Retention
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

Linkage
Median length of time between baseline HIV test and first completed HIV-related care visit
Retention
Median length of time between first completed HIV-related care visit and subsequent HIV-related care visits during the 12-month follow-up period
Viral Load Reduction
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.
Viral Suppression
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
Maintained Status
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.
Enrolled in Insurance
Proportion of intervention arm participants who are successfully enrolled in health insurance
Changed Insurance
Proportion of currently insured intervention arm participants who change their insurance plan and reasons why
Medicaid Enrollment
Proportion of newly enrolled intervention arm participants who enroll in Medicaid
Private Insurance Enrollment
Proportion of newly enrolled intervention arm participants who enroll in private health insurance
Market place 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

Full Information

First Posted
February 4, 2020
Last Updated
November 14, 2022
Sponsor
University of Chicago
Collaborators
Howard Brown Health Center, Chicago House and Social Service Agency, Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT04263441
Brief Title
Navigating Insurance Coverage Expansion (NICE)
Acronym
NICE
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Howard Brown Health Center, Chicago House and Social Service Agency, Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Pre-Exposure Prophylaxis (PrEP)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NICE Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NICE Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Linkage
Description
Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed
Time Frame
30 days
Title
Delayed Linkage
Description
Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed
Time Frame
90 days
Title
Retention
Description
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.
Time Frame
365 days
Title
Early Retention
Description
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.
Time Frame
183 days
Secondary Outcome Measure Information:
Title
Linkage
Description
Median length of time between baseline HIV test and first completed HIV-related care visit
Time Frame
365 Days
Title
Retention
Description
Median length of time between first completed HIV-related care visit and subsequent HIV-related care visits during the 12-month follow-up period
Time Frame
365 Days
Title
Viral Load Reduction
Description
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.
Time Frame
91 days
Title
Viral Suppression
Description
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
Time Frame
365 days
Title
Maintained Status
Description
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.
Time Frame
365 days
Title
Enrolled in Insurance
Description
Proportion of intervention arm participants who are successfully enrolled in health insurance
Time Frame
At study enrollment
Title
Changed Insurance
Description
Proportion of currently insured intervention arm participants who change their insurance plan and reasons why
Time Frame
At study enrollment
Title
Medicaid Enrollment
Description
Proportion of newly enrolled intervention arm participants who enroll in Medicaid
Time Frame
At study enrollment
Title
Private Insurance Enrollment
Description
Proportion of newly enrolled intervention arm participants who enroll in private health insurance
Time Frame
At study enrollment
Title
Market place enrollment
Description
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
Time Frame
At study enrollment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Howard Brown Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Chicago House and Social Service Agency, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17694429
Citation
Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13.
Results Reference
background
PubMed Identifier
22819656
Citation
Millett GA, Peterson JL, Flores SA, Hart TA, Jeffries WL 4th, Wilson PA, Rourke SB, Heilig CM, Elford J, Fenton KA, Remis RS. Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis. Lancet. 2012 Jul 28;380(9839):341-8. doi: 10.1016/S0140-6736(12)60899-X. Epub 2012 Jul 20.
Results Reference
background
PubMed Identifier
25911980
Citation
Sullivan PS, Rosenberg ES, Sanchez TH, Kelley CF, Luisi N, Cooper HL, Diclemente RJ, Wingood GM, Frew PM, Salazar LF, Del Rio C, Mulligan MJ, Peterson JL. Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study. Ann Epidemiol. 2015 Jun;25(6):445-54. doi: 10.1016/j.annepidem.2015.03.006. Epub 2015 Mar 24.
Results Reference
background
PubMed Identifier
22136012
Citation
Khan L. Transgender health at the crossroads: legal norms, insurance markets, and the threat of healthcare reform. Yale J Health Policy Law Ethics. 2011 Summer;11(2):375-418. No abstract available.
Results Reference
background
PubMed Identifier
25874753
Citation
Hall G, Li K, Wilton L, Wheeler D, Fogel J, Wang L, Koblin B. A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). AIDS Behav. 2015 Dec;19(12):2214-23. doi: 10.1007/s10461-015-1005-2.
Results Reference
background
PubMed Identifier
3203524
Citation
Matts JP, Lachin JM. Properties of permuted-block randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):327-44. doi: 10.1016/0197-2456(88)90047-5.
Results Reference
background
PubMed Identifier
22247422
Citation
Farnham PG, Sansom SL, Hutchinson AB. How much should we pay for a new HIV diagnosis? A mathematical model of HIV screening in US clinical settings. Med Decis Making. 2012 May-Jun;32(3):459-69. doi: 10.1177/0272989X11431609. Epub 2012 Jan 12.
Results Reference
background
PubMed Identifier
20859193
Citation
Gebo KA, Fleishman JA, Conviser R, Hellinger J, Hellinger FJ, Josephs JS, Keiser P, Gaist P, Moore RD; HIV Research Network. Contemporary costs of HIV healthcare in the HAART era. AIDS. 2010 Nov 13;24(17):2705-15. doi: 10.1097/QAD.0b013e32833f3c14.
Results Reference
background
PubMed Identifier
23253752
Citation
Horberg M, Raymond B. Financial policy issues for HIV pre-exposure prophylaxis: cost and access to insurance. Am J Prev Med. 2013 Jan;44(1 Suppl 2):S125-8. doi: 10.1016/j.amepre.2012.09.039. No abstract available.
Results Reference
background
Links:
URL
https://www.cdc.gov/hiv/group/msm/index.html
Description
HIV Among Gay and Bisexual Men
URL
https://www.pewresearch.org/hispanic/2012/06/27/the-10-largest-hispanic-origin-groups-characteristics-rankings-top-counties/
Description
The 10 largest Hispanic origin groups: Characteristics, rankings, top Counties
URL
https://www.thetaskforce.org/wp-content/uploads/2019/07/ntds_full.pdf
Description
Injustice at Every Turn: A Report of the National Transgender Discrimination Survey
URL
https://files.hiv.gov/s3fs-public/bmsm-webinar-06252014.pdf
Description
Moving Black MSM Along the HIV Care Continuum
URL
http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html
Description
In-Person Assistance in the Health Insurance Marketplaces
URL
https://academic.oup.com/qje/article-abstract/127/3/1205/1921970?redirectedFrom=fulltext
Description
The Role of Application Assistance and Information in College Decisions: Results from the H&R Block Fafsa Experiment
URL
https://www.chicago.gov/content/dam/city/depts/cdph/HIV_STI/World_AIDS_Day_Report_012717.pdf
Description
Chicago Department of Public Health. HIV/STI Surveillance Report 2016
URL
https://www.chicago.gov/content/dam/city/depts/cdph/infectious_disease/STI_HIV_AIDS/MSMReport2012.pdf
Description
HIV Risk and Prevention Behaviors Among Men Who Have Sex With Men, Chicago, 2008 and 2011

Learn more about this trial

Navigating Insurance Coverage Expansion (NICE)

We'll reach out to this number within 24 hrs