HIV/AIDS
Conditions
Keywords
Pre-Exposure Prophylaxis (PrEP)
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).
Interventions
BEHAVIORALNICE 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.
Sponsors
Howard Brown Health Center
Chicago House and Social Service Agency
Centers for Disease Control and Prevention
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Enrolled in Insurance | At study enrollment | Proportion of intervention arm participants who are successfully enrolled in 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 |
| 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 |
| Changed Insurance | At study enrollment | Proportion of currently insured intervention arm participants who change their insurance plan and reasons why |
| Linkage | 365 Days | Median length of time between baseline HIV test and first completed HIV-related care visit |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed