Navigating Insurance Coverage Expansion (NICE)

HIV/AIDS Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263441
• Other study ID #: IRB16-1260
• Secondary ID: CDC
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: May 14, 2021

Study information

• Verified date: November 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: May 14, 2021
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
United States	Chicago House and Social Service Agency, Inc.	Chicago	Illinois
United States	Howard Brown Health	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	Centers for Disease Control and Prevention, Chicago House and Social Service Agency, Howard Brown Health Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. Epub 2007 Aug 13. Review. — View 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. Review. — View 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. — View Citation

Matts JP, Lachin JM. Properties of permuted-block randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):327-44. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage	Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed	30 days
Primary	Delayed Linkage	Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed	90 days
Primary	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.	365 days
Primary	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.	183 days
Secondary	Linkage	Median length of time between baseline HIV test and first completed HIV-related care visit	365 Days
Secondary	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	365 Days
Secondary	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.	91 days
Secondary	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	365 days
Secondary	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.	365 days
Secondary	Enrolled in Insurance	Proportion of intervention arm participants who are successfully enrolled in health insurance	At study enrollment
Secondary	Changed Insurance	Proportion of currently insured intervention arm participants who change their insurance plan and reasons why	At study enrollment
Secondary	Medicaid Enrollment	Proportion of newly enrolled intervention arm participants who enroll in Medicaid	At study enrollment
Secondary	Private Insurance Enrollment	Proportion of newly enrolled intervention arm participants who enroll in private health insurance	At study enrollment
Secondary	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	At study enrollment

External Links

•   Chicago Department of Public Health. HIV/STI Surveillance Report 2016
•   HIV Among Gay and Bisexual Men
•   HIV Risk and Prevention Behaviors Among Men Who Have Sex With Men, Chicago, 2008 and 2011
•   In-Person Assistance in the Health Insurance Marketplaces
•   Injustice at Every Turn: A Report of the National Transgender Discrimination Survey
•   Moving Black MSM Along the HIV Care Continuum
•   The 10 largest Hispanic origin groups: Characteristics, rankings, top Counties
•   The Role of Application Assistance and Information in College Decisions: Results from the H&R Block Fafsa Experiment