Antiretroviral Improvement Among Medicaid Enrollees (AIMS)

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Experimental: AIMS program - patient; Other: No Intervention/Usual care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT05477485

HM20018229

U01PS005192 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Usual Care

Other group

Description:

Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV.

Treatment:

Other: No Intervention/Usual care

AIMS program - patient

Experimental group

Description:

Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community.

Treatment:

Behavioral: Experimental: AIMS program - patient