Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2023-04-27
2024-05-31
Brief Summary
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Detailed Description
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The program involves supporting Medicaid members 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.
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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Care
Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV.
No Intervention/Usual care
Participants in the usual care arm will receive standard state-level care for late ART prescription refill(s) for Virginia Medicaid enrollees living with HIV.
AIMS program - patient
Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community.
Experimental: AIMS program - patient
Patient-level support will be offered to eligible Virginia Medicaid enrollees who have a late ART prescription refill(s) by \>30 days. Support will come from the provider, pharmacy, managed care organization or the community. Patient-level support will involve direct linkages and referrals for participants with a late ART prescription refill(s) \>30-60 days. Support will intensify as the gap in ART prescription(s) fills increases. For those with a late ART prescription refill(s) for \>60 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.
Interventions
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Experimental: AIMS program - patient
Patient-level support will be offered to eligible Virginia Medicaid enrollees who have a late ART prescription refill(s) by \>30 days. Support will come from the provider, pharmacy, managed care organization or the community. Patient-level support will involve direct linkages and referrals for participants with a late ART prescription refill(s) \>30-60 days. Support will intensify as the gap in ART prescription(s) fills increases. For those with a late ART prescription refill(s) for \>60 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.
No Intervention/Usual care
Participants in the usual care arm will receive standard state-level care for late ART prescription refill(s) for Virginia Medicaid enrollees living with HIV.
Eligibility Criteria
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Inclusion Criteria
* Continuous Virginia Medicaid enrollment for the preceding 9 or more months;
* Current age 19-64 years;
* Identified as living with HIV according to an HIV case identification algorithm;
* Non-dual eligible for Medicare;
* History of ART prescription claim(s) within the past 12 months;
* Prior ART prescription claim, with claims for the most recent ART prescription refill(s) \>30 days late.
Exclusion Criteria
* New prescription claim(s) within 30 days for within-class ART drug(s) not previously prescribed;
* Service claim(s) for resistance testing and other ART prescription claim(s) within 30 days of most recent late ART prescription(s) for ART drug(s) not previously prescribed;
* Enrollee's linked HIV provider practices at a healthcare facility offering PositiveLinks;
* No record in the Virginia HIV surveillance data;
* Non-English speaking.
19 Years
64 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
National Institute of Mental Health (NIMH)
NIH
Virginia Department of Medical Assistance Services - Virginia Medicaid
UNKNOWN
Virginia Department of Health
OTHER_GOV
University of Virginia
OTHER
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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April D Kimmel, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Kimmel AD, Byrd KK, Stirratt M, Harris D, Stallings R, Bono RS, Mitchell A, Dillingham R, Palmer C, Popoff E, Pan Z, Ingersoll K, Dahman B; AIMS study team. Study Protocol(s) for Antiretroviral Improvement among Medicaid EnrolleeS (AIMS): A Cluster-Randomized Controlled Trial Leveraging Real-time Administrative Claims to Support Antiretroviral Prescription Adherence. Contemp Clin Trials. 2025 Jul;154:107959. doi: 10.1016/j.cct.2025.107959. Epub 2025 May 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HM20018229
Identifier Type: -
Identifier Source: org_study_id
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