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HIV/AIDSNICENCT04263441

Navigating Insurance Coverage Expansion (NICE)

A study testing NICE Intervention in people with HIV/AIDS, run by University of Chicago at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
NICE Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
3 sitesUnited States
Study dates
18 Oct 2018to 14 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Black or Hispanic men who have sex with men (MSM) or transgender persons
  • 18 or older

Who cannot join

  • Cisgender women
  • Cisgender men who have not had anal or oral sex with a man in last 2 years

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Howard Brown Health

    Chicago, Illinois, 60613

  • Chicago House and Social Service Agency, Inc.

    Chicago, Illinois, 60614

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: 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

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.

Read the 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).

Conditions
HIV/AIDS
Being tested
NICE Intervention
Keywords
Pre-Exposure Prophylaxis (PrEP)
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NICE InterventionBehavioural

    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.

Study groups in NCT04263441
Study groupRoleWhat they receive
NICE InterventionExperimentalThe 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.
Receives: Behavioral: NICE Intervention
Control InterventionNo interventionSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Linkage

    Proportion of participants who completed at least one HIV-related medical visit within 30 days after their baseline HIV test was performed

    Measured: 30 days

  2. Delayed Linkage

    Proportion of participants who completed at least one HIV-related medical visit within 90 days after their baseline HIV test was performed

    Measured: 90 days

  3. 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.

    Measured: 365 days

  4. 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.

    Measured: 183 days

Secondary outcomes (10)

  1. Linkage

    Median length of time between baseline HIV test and first completed HIV-related care visit

    Measured: 365 Days

  2. 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

    Measured: 365 Days

  3. 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.

    Measured: 91 days

  4. 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

    Measured: 365 days

  5. 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.

    Measured: 365 days

  6. Enrolled in Insurance

    Proportion of intervention arm participants who are successfully enrolled in health insurance

    Measured: At study enrollment

  7. Changed Insurance

    Proportion of currently insured intervention arm participants who change their insurance plan and reasons why

    Measured: At study enrollment

  8. Medicaid Enrollment

    Proportion of newly enrolled intervention arm participants who enroll in Medicaid

    Measured: At study enrollment

  9. Private Insurance Enrollment

    Proportion of newly enrolled intervention arm participants who enroll in private health insurance

    Measured: At study enrollment

  10. 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

    Measured: At study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start18 Oct 2018
  3. Primary completion16 Mar 2020
  4. Study completion14 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04263441
Sponsor's protocol ID
IRB16-1260
Other IDs
CDC
Acronym
NICE
Status last verified
Nov 2022
First submitted
4 Feb 2020
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17694429

  • 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.

    PubMed 22819656

  • 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.

    PubMed 25911980

  • 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.

    PubMed 22136012

  • 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.

    PubMed 25874753

  • 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.

    PubMed 3203524

  • 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.

    PubMed 22247422

  • 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.

    PubMed 20859193

  • 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.

    PubMed 23253752

  • 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.

    PubMed 41181883

Questions about this trial

What is this clinical trial studying?

A study testing NICE Intervention in people with HIV/AIDS, run by University of Chicago at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Linkage (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04263441, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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