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| ID | Type | Description | Link |
|---|---|---|---|
| CDC | Other Grant/Funding Number | RFA-PS-16-004 |
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| Name | Class |
|---|---|
| Howard Brown Health Center | OTHER |
| Chicago House and Social Service Agency | UNKNOWN |
| Centers for Disease Control and Prevention | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NICE Intervention | Experimental | 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. |
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| Control Intervention | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICE Intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard Brown Health | Chicago | Illinois | 60613 | United States | ||
| Chicago House and Social Service Agency, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17694429 | Background | Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13. | |
| 22819656 | Background |
| Label | URL |
|---|---|
| HIV Among Gay and Bisexual Men | View source |
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Not provided
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 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 |
| Chicago |
| Illinois |
| 60614 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Millett GA, Peterson JL, Flores SA, Hart TA, Jeffries WL 4th, Wilson PA, Rourke SB, Heilig CM, Elford J, Fenton KA, Remis RS. Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis. Lancet. 2012 Jul 28;380(9839):341-8. doi: 10.1016/S0140-6736(12)60899-X. Epub 2012 Jul 20. |
| 25911980 | Background | Sullivan PS, Rosenberg ES, Sanchez TH, Kelley CF, Luisi N, Cooper HL, Diclemente RJ, Wingood GM, Frew PM, Salazar LF, Del Rio C, Mulligan MJ, Peterson JL. Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study. Ann Epidemiol. 2015 Jun;25(6):445-54. doi: 10.1016/j.annepidem.2015.03.006. Epub 2015 Mar 24. |
| 22136012 | Background | Khan L. Transgender health at the crossroads: legal norms, insurance markets, and the threat of healthcare reform. Yale J Health Policy Law Ethics. 2011 Summer;11(2):375-418. No abstract available. |
| 25874753 | Background | Hall G, Li K, Wilton L, Wheeler D, Fogel J, Wang L, Koblin B. A Comparison of Referred Sexual Partners to Their Community Recruited Counterparts in The BROTHERS Project (HPTN 061). AIDS Behav. 2015 Dec;19(12):2214-23. doi: 10.1007/s10461-015-1005-2. |
| 3203524 | Background | 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. |
| 22247422 | Background | 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. |
| 20859193 | Background | 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. |
| 23253752 | Background | Horberg M, Raymond B. Financial policy issues for HIV pre-exposure prophylaxis: cost and access to insurance. Am J Prev Med. 2013 Jan;44(1 Suppl 2):S125-8. doi: 10.1016/j.amepre.2012.09.039. No abstract available. |
| 41181883 | Derived | Umutoni V, Eavou R, Almirol E, Neumann MS, Rivera J, Schneider JA. A Community Located Insurance Navigation Intervention to Link Sexual and Gender Minorities in Status Neutral Care: Results From the Navigating Insurance Coverage Expansion Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2026 Jul 1;101(7):709-716. doi: 10.1097/QAI.0000000000003788. |
| The 10 largest Hispanic origin groups: Characteristics, rankings, top Counties | View source |
| Injustice at Every Turn: A Report of the National Transgender Discrimination Survey | View source |
| Moving Black MSM Along the HIV Care Continuum | View source |
| In-Person Assistance in the Health Insurance Marketplaces | View source |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |