Navigating Insurance Coverage Expansion (NICE)
- Conditions
- HIV/AIDS
- Interventions
- Behavioral: NICE Intervention
- Registration Number
- NCT04263441
- Lead Sponsor
- University of Chicago
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 630
- Black or Hispanic men who have sex with men (MSM) or transgender persons
- 18 or older
- Cisgender women
- Cisgender men who have not had anal or oral sex with a man in last 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NICE Intervention 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.
- Primary Outcome Measures
Name Time Method 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
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
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.
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
Name Time Method 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
Enrolled in Insurance At study enrollment Proportion of intervention arm participants who are successfully enrolled in health insurance
Changed Insurance At study enrollment Proportion of currently insured intervention arm participants who change their insurance plan and reasons why
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
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.
Linkage 365 Days Median length of time between baseline HIV test and first completed HIV-related care visit
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.
Medicaid Enrollment At study enrollment Proportion of newly enrolled intervention arm participants who enroll in Medicaid
Private Insurance Enrollment At study enrollment Proportion of newly enrolled intervention arm participants who enroll in private health insurance
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
Trial Locations
- Locations (3)
Howard Brown Health
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Chicago House and Social Service Agency, Inc.
🇺🇸Chicago, Illinois, United States