Antiretroviral Improvement Among Medicaid Enrollees

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antiretroviral Improvement Among Medicaid Enrollees (AIMS): An Insurance-based Data to Care Initiative for Medicaid Enrollees in Virginia

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Antiretroviral Improvement among Medicaid enrolleeS (patient)
* Behavioral: Antiretroviral Improvement among Medicaid enrolleeS (provider)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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. | |
| Experimental: AIMS program - patient<br>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. | Behavioral: Antiretroviral Improvement among Medicaid enrolleeS (patient)<br>* 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.<br>* Other names: AIMS;|
| Experimental: AIMS program - provider<br>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. | Behavioral: Antiretroviral Improvement among Medicaid enrolleeS (provider)<br>* 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.<br>* Other names: AIMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load | Participant HIV viral load will be obtained from surveillance data | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Therapy (ART) adherence | Proportion of participants with ART prescription claims covering >90% of enrolled coverage days | 12 months |