Clinical trial NCT04263441: Navigating Insurance Coverage Expansion (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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Pre-Exposure Prophylaxis (PrEP)
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Howard Brown Health Center
name: Chicago House and Social Service Agency
name: Centers for Disease Control and Prevention
First posted: 2020-02-10
Enrollment: 630
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Linkage
timeFrame: 30 days
measure: Delayed Linkage
timeFrame: 90 days
measure: Retention
timeFrame: 365 days
measure: Early Retention
timeFrame: 183 days
Secondary outcomes:
measure: Linkage
timeFrame: 365 Days
measure: Retention
timeFrame: 365 Days
measure: Viral Load Reduction
timeFrame: 91 days
measure: Viral Suppression
timeFrame: 365 days
measure: Maintained Status
timeFrame: 365 days
measure: Enrolled in Insurance
timeFrame: At study enrollment
measure: Changed Insurance
timeFrame: At study enrollment
measure: Medicaid Enrollment
timeFrame: At study enrollment
measure: Private Insurance Enrollment
timeFrame: At study enrollment
measure: Market place enrollment
timeFrame: At study enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Health
state: Illinois
city: Chicago
country: United States
facility: Chicago House and Social Service Agency, Inc.
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
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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.
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.
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.
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