NCT Number: NCT04263441
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Chicago House and Social Service Agency, Inc., Chicago, Illinois, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed
Time frame: 90 days
Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed
Time frame: 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.
Time frame: 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.
Time frame: 365 Days
Median length of time between baseline HIV test and first completed HIV-related care visit
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At study enrollment
Proportion of intervention arm participants who are successfully enrolled in health insurance
Time frame: At study enrollment
Proportion of currently insured intervention arm participants who change their insurance plan and reasons why
Time frame: At study enrollment
Proportion of newly enrolled intervention arm participants who enroll in Medicaid
Time frame: At study enrollment
Proportion of newly enrolled intervention arm participants who enroll in private health insurance
Time frame: 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
University of Chicago
Other
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
Acronym: NICE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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