Antiretroviral Improvement Among Medicaid Enrollees (AIMS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Other: No Intervention/Usual care; Behavioral: Experimental: AIMS program - patient

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 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV.	Other: 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.
Experimental: AIMS program - patient; Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Participants Virally Suppressed	HIV viral load data come from Virginia Department of Health (VDH) routine surveillance. Viral load data indicate whether or not an individual was virally suppressed, i.e., the level of HIV in a blood sample was less than the detectable limit.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription	Data source is prescription claim(s) for antiretroviral therapy (ART) prescription(s) made available through Virginia Medicaid. Participants will be considered as reinitiating if they have a filled ART prescription after study enrollment.	3 months
Antiretroviral Therapy (ART) Adherence	Data source is prescription claim(s) for antiretroviral therapy (ART) made available through Virginia Medicaid. Participants will be considered adherent if their ART prescription claim(s) cover >90% of enrolled coverage days.	3 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Mental Health (NIMH); Centers for Disease Control and Prevention; University of Virginia; Virginia Department of Health; Virginia Department of Medical Assistance Services - Virginia Medicaid
• Investigators: Principal Investigator: April D Kimmel, PhD, Virginia Commonwealth University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: HM20018229; U01PS005192 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No