Navigating Insurance Coverage Expansion (NICE)

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: NICE Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICE Intervention<br>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<br>* 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.<br>|
| No Intervention: Control Intervention<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage | Median length of time between baseline HIV test and first completed HIV-related care visit | 365 Days | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Enrolled in Insurance | Proportion of intervention arm participants who are successfully enrolled in health insurance | At study enrollment | 
| Changed Insurance | Proportion of currently insured intervention arm participants who change their insurance plan and reasons why | At study enrollment | 
| Medicaid Enrollment | Proportion of newly enrolled intervention arm participants who enroll in Medicaid | At study enrollment | 
| Private Insurance Enrollment | Proportion of newly enrolled intervention arm participants who enroll in private health insurance | At study enrollment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Exposure Prophylaxis (PrEP)