Antiretroviral Improvement Among Medicaid Enrollees

Human Immunodeficiency Virus Clinical Trial

— AIMS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05477485
• Other study ID #: HM20018229
• Secondary ID: U01PS005192
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Centers for Disease Control and Prevention, National Institute of Mental Health (NIMH), University of Virginia, Virginia Department of Health, Virginia Department of Medical Assistance Services - Virginia Medicaid

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of participants reinitiating late antiretroviral therapy (ART) prescription	Prescription claim(s) for ART prescription(s)	3 months
Secondary	Antiretroviral therapy (ART) adherence	ART prescription claim(s) covering >90% of enrolled coverage days.	3 months
Secondary	Number and percentage of participants virally suppressed	HIV viral load	3 months