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Antiretroviral Improvement Among Medicaid Enrollees (AIMS)

Primary Purpose

Human Immunodeficiency Virus

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antiretroviral Improvement among Medicaid enrolleeS (patient)
Antiretroviral Improvement among Medicaid enrolleeS (provider)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus

Eligibility Criteria

19 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for patients:

  • Current enrollment in Virginia Medicaid;
  • Continuous Virginia Medicaid enrollment for the preceding 12 or more months;
  • Current age 19-63 years;
  • Identified as living with HIV according to an HIV case identification algorithm;
  • Non-dual eligible for Medicare;
  • Prior ART prescription claim, with claims for the most recent ART prescription refill(s) >30-90 days late OR no history of ART prescription.

Exclusion criteria for patients:

  • Record of non-Medicaid health insurance or other health care service payer in past 12 months;
  • New prescription claim(s) in past >30-90 days for within-class ART drug(s) not previously prescribed (indicating an ART prescription was discontinued due to ART toxicity (within-class switch));
  • Service claim(s) for resistance testing and other ART prescription claim(s) in past >30-90 days for ART drug(s) not previously prescribed (indicating the previous ART prescription was discontinued due to ART resistance);
  • Service address of the enrollee's most frequent HIV provider for a healthcare facility currently offering PositiveLinks;
  • No record in the Virginia HIV surveillance data;
  • Non-English speaking.

Inclusion criteria for providers:

• Identified primary HIV provider for eligible patient participant meeting all selection criteria and with no record of prior ART prescription

Exclusion criteria for providers:

• None

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care

AIMS program - patient

AIMS program - provider

Arm Description

Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants who are patients of providers assigned to the usual care arm will receive standard state-level care for missing or late ART prescription refill(s) for Virginia Medicaid enrollees living with HIV.

Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants who are patients of providers assigned to the AIMS program arm will receive patient-level support.

Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants assigned to the AIMS program arm will receive provider-level support.

Outcomes

Primary Outcome Measures

HIV viral load
Participant HIV viral load will be obtained from surveillance data

Secondary Outcome Measures

Antiretroviral Therapy (ART) adherence
Proportion of participants with ART prescription claims covering >90% of enrolled coverage days

Full Information

First Posted
July 26, 2022
Last Updated
May 1, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Centers for Disease Control and Prevention, National Institute of Mental Health (NIMH), Virginia Department of Medical Assistance Services - Virginia Medicaid, Virginia Department of Health, University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05477485
Brief Title
Antiretroviral Improvement Among Medicaid Enrollees
Acronym
AIMS
Official Title
Antiretroviral Improvement Among Medicaid Enrollees (AIMS): An Insurance-based Data to Care Initiative for Medicaid Enrollees in Virginia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Centers for Disease Control and Prevention, National Institute of Mental Health (NIMH), Virginia Department of Medical Assistance Services - Virginia Medicaid, Virginia Department of Health, University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate whether a new program will affect how often human immunodeficiency virus (HIV) antiretroviral therapy (ART) prescriptions are filled and whether the program improves the health of people living with HIV.
Detailed Description
Virginia Commonwealth University and study collaborators are working together to learn about challenges that Virginia Medicaid members have in taking their prescribed medication. To do this, the researchers are implementing and evaluating a program called Antiretroviral Improvement among Medicaid enrolleeS (AIMS). This program is designed to support members to fill ART prescriptions. The program involves two components: Supporting Medicaid members living with HIV directly by talking to them about challenges with filling their ART prescriptions and linking them to resources that can help with those challenges. Some members will be offered access to warm health technology support. Supporting the clinicians of Medicaid members living with HIV through one-on-one consultations with peers who are experts in HIV care. The researchers think this support may increase how often ART prescriptions are filled and hope that the AIMS program can improve individuals' health and increase HIV viral suppression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants who are patients of providers assigned to the usual care arm will receive standard state-level care for missing or late ART prescription refill(s) for Virginia Medicaid enrollees living with HIV.
Arm Title
AIMS program - patient
Arm Type
Experimental
Arm Description
Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants who are patients of providers assigned to the AIMS program arm will receive patient-level support.
Arm Title
AIMS program - provider
Arm Type
Experimental
Arm Description
Providers will be cluster-randomized by provider characteristics (HIV patient volume) and patient characteristics (distribution of providers' patients by age, gender, race/ethnicity, and urbanicity). Participants assigned to the AIMS program arm will receive provider-level support.
Intervention Type
Behavioral
Intervention Name(s)
Antiretroviral Improvement among Medicaid enrolleeS (patient)
Other Intervention Name(s)
AIMS
Intervention Description
Patient-level support will be offered to eligible Virginia Medicaid enrollees who have a late ART prescription refill(s) by >30-90 days. Patient-level support will involve direct linkages and referrals for participants with a late ART prescription refill(s) >30-60 days. Interventions will intensify as the gap in ART prescription(s) fills increases. For those with a late ART prescription refill(s) for >60-90 days, added patient-level support will include warm health technology via PositiveLinks, a mobile app program promoting better health through self-monitoring tools, educational resources, direct messaging with program staff, and a confidential user community board.
Intervention Type
Behavioral
Intervention Name(s)
Antiretroviral Improvement among Medicaid enrolleeS (provider)
Other Intervention Name(s)
AIMS
Intervention Description
Provider-level support will involve peer-to-peer provider consultations, which will be offered to providers of eligible Virginia Medicaid enrollees who have no record of a prior filled ART prescription.
Primary Outcome Measure Information:
Title
HIV viral load
Description
Participant HIV viral load will be obtained from surveillance data
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Antiretroviral Therapy (ART) adherence
Description
Proportion of participants with ART prescription claims covering >90% of enrolled coverage days
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for patients: Current enrollment in Virginia Medicaid; Continuous Virginia Medicaid enrollment for the preceding 12 or more months; Current age 19-63 years; Identified as living with HIV according to an HIV case identification algorithm; Non-dual eligible for Medicare; Prior ART prescription claim, with claims for the most recent ART prescription refill(s) >30-90 days late OR no history of ART prescription. Exclusion criteria for patients: Record of non-Medicaid health insurance or other health care service payer in past 12 months; New prescription claim(s) in past >30-90 days for within-class ART drug(s) not previously prescribed (indicating an ART prescription was discontinued due to ART toxicity (within-class switch)); Service claim(s) for resistance testing and other ART prescription claim(s) in past >30-90 days for ART drug(s) not previously prescribed (indicating the previous ART prescription was discontinued due to ART resistance); Service address of the enrollee's most frequent HIV provider for a healthcare facility currently offering PositiveLinks; No record in the Virginia HIV surveillance data; Non-English speaking. Inclusion criteria for providers: • Identified primary HIV provider for eligible patient participant meeting all selection criteria and with no record of prior ART prescription Exclusion criteria for providers: • None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April D Kimmel, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Antiretroviral Improvement Among Medicaid Enrollees

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