Antiretroviral Improvement Among Medicaid Enrollees

NCT ID: NCT05477485

Last Updated: 2025-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2024-05-31

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 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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Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type OTHER

No Intervention/Usual care

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Experimental: AIMS program - patient

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Current enrollment in Virginia Medicaid;
* 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

* Record of non-Medicaid health insurance or other health care service payer in past 3 months;
* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Virginia Department of Medical Assistance Services - Virginia Medicaid

UNKNOWN

Sponsor Role collaborator

Virginia Department of Health

OTHER_GOV

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 40393614 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U01PS005192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20018229

Identifier Type: -

Identifier Source: org_study_id

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