Antiretroviral Improvement Among Medicaid Enrollees

NCT05477485 | Terminated Results

• 2 other identifiers: HM20018229U01PS005192
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription

  3 months

• Antiretroviral Therapy (ART) Adherence

  3 months

Study Arms (2)

Usual Care

OTHER

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

AIMS program - patient

EXPERIMENTAL

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

Interventions

Experimental: AIMS program - patient 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.

AIMS program - patient

No Intervention/Usual care 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.

Usual Care

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Centers for Disease Control and Prevention: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Virginia Department of Medical Assistance Services - Virginia Medicaid: collaborator
• Virginia Department of Health: collaborator
• University of Virginia: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 40393614 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Four participants enrolled in the intervention (AIMS program - patient arm, n=4). For the primary outcome, all enrolled participants were lost to follow-up. Primary outcome data were not available. No participants were enrolled in the usual care arm (n=0), and therefore, no data were collected for the outcome measures for that arm.

Results Point of Contact

• Title: Dr. April D. Kimmel
• Organization: Virginia Commonwealth University

adkimmel@vcu.edu

(804) 628-6273

Study Officials

• April D Kimmel, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: April 27, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)