NCT04263441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2021

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

February 4, 2020

Last Update Submit

November 14, 2022

Conditions

HIV/AIDS

Keywords

Pre-Exposure Prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • Linkage

    365 Days

  • Retention

    365 Days

  • Viral Load Reduction

    91 days

  • Viral Suppression

    365 days

  • Maintained Status

    365 days

  • +5 more secondary outcomes

Study Arms (2)

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.

Behavioral: NICE Intervention

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.

Interventions

NICE InterventionBEHAVIORAL

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.

NICE Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Howard Brown Health

Chicago, Illinois, 60613, United States

Location

Chicago House and Social Service Agency, Inc.

Chicago, Illinois, 60614, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (9)

  • 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.

    PMID: 17694429BACKGROUND

  • 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.

    PMID: 22819656BACKGROUND

  • 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.

    PMID: 25911980BACKGROUND

  • 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.

    PMID: 22136012BACKGROUND

  • 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.

    PMID: 25874753BACKGROUND

  • 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.

    PMID: 3203524BACKGROUND

  • 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.

    PMID: 22247422BACKGROUND

  • 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.

    PMID: 20859193BACKGROUND

  • 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.

    PMID: 23253752BACKGROUND

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 10, 2020

Study Start

October 18, 2018

Primary Completion

March 16, 2020

Study Completion

May 14, 2021

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)