Clinical trial NCT05477485: Antiretroviral Improvement Among Medicaid Enrollees
Official title: Antiretroviral Improvement Among Medicaid Enrollees (AIMS): An Insurance-based Data to Care Initiative for Medicaid Enrollees in Virginia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: National Institute of Mental Health (NIMH)
name: Virginia Department of Medical Assistance Services - Virginia Medicaid
name: Virginia Department of Health
name: University of Virginia
First posted: 2022-07-28
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and percentage of participants reinitiating late antiretroviral therapy (ART) prescription
timeFrame: 3 months
Secondary outcomes:
measure: Antiretroviral therapy (ART) adherence
timeFrame: 3 months
measure: Number and percentage of participants virally suppressed
timeFrame: 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: April D Kimmel, PhD
role: PRINCIPAL_INVESTIGATOR
References: