Human Immunodeficiency VirusAIMSNCT05477485

Antiretroviral Improvement Among Medicaid Enrollees

A study testing Experimental: AIMS program - patient in people with Human Immunodeficiency Virus, run by Virginia Commonwealth University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 19 to 64 years
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Experimental: AIMS program - patient
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 27 Apr 2023to 31 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

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

Read the 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.

Conditions: Human Immunodeficiency Virus
Being tested: Experimental: AIMS program - patient, No Intervention/Usual care
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: AIMS program - patientBehavioural
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.
No Intervention/Usual careOther
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.

Study groups in NCT05477485
Study group	Role	What they receive
Usual Care	Other	Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV. Receives: 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. Receives: Behavioral: Experimental: AIMS program - patient

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (2)

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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 202331 May 2024

First posted28 Jul 2022
Study start27 Apr 2023
Primary completion31 May 2024
Study completion31 May 2024

Why it stopped: Insufficient rate of accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05477485
Sponsor's protocol ID: HM20018229
Other IDs: U01PS005192
Acronym: AIMS
Status last verified: Oct 2025
First submitted: 26 Jul 2022
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kimmel AD, Stirratt M, Byrd KK, Bono RS, Mitchell A, Popoff E, Palmer C, Stallings R, Harris D, Dillingham R, Higginson R, Eichholz T, Pan Z, Ingersoll K, Dahman B; Antiretroviral Improvement of Medicaid EnrolleeS (AIMS) Team. Brief Report: The Trials of Insurance-Based Data to Care-Rx: Low Enrollment in the Antiretroviral Improvement Among Medicaid EnrolleeS (AIMS) Study. J Acquir Immune Defic Syndr. 2026 May 1;101(5):520-525. doi: 10.1097/QAI.0000000000003830.
PubMed 41511388
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.
PubMed 40393614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antiretroviral Improvement Among Medicaid Enrollees (AIMS): An Insurance-based Data to Care Initiative for Medicaid Enrollees in Virginia
ClinicalTrials.gov ID: NCT05477485
Acronym / sponsor ID: AIMS / HM20018229
Conditions: Human Immunodeficiency Virus
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient rate of accrual
Enrolment: 4 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, National Institute of Mental Health (NIMH), Virginia Department of Medical Assistance Services - Virginia Medicaid, Virginia Department of Health, University of Virginia
Study start: 27 Apr 2023 (actual)
Primary completion: 31 May 2024 (actual)
Study completion: 31 May 2024 (actual)
First posted: 28 Jul 2022 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care	Other	Other: No Intervention/Usual careUsual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV.
AIMS program - patient	Experimental	Behavioral: Experimental: AIMS program - patientParticipants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community.

Who may qualify

Ages: 19 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: AIMS program - patientPatient-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.	Behavioural	AIMS program - patient
No Intervention/Usual careParticipants in the usual care arm will receive standard state-level care for late ART prescription refill(s) for Virginia Medicaid enrollees living with HIV.	Other	Usual Care

Primary outcome

Number and Percentage of Participants Virally Suppressed
Time frame: 3 months
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.

2 secondary outcomes

Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription
Time frame: 3 months
Antiretroviral Therapy (ART) Adherence
Time frame: 3 months

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	0	0
AIMS program - patient	4	0

Primary outcome: Number and Percentage of Participants Virally Suppressed

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Usual Care n = 0	AIMS program - patient n = 0
Value	0	0

Population analysed: Data for this outcome measure would have been obtained through data reports made available through the Virginia Department of Health (VDH). At the time of this outcome measure, when data would have been collected, there were no reports from VDH. Therefore, no primary outcome data were available to be collected for all enrolled participants in this study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 0	0 of 0	0
AIMS program - patient	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41511388Kimmel AD, Stirratt M, Byrd KK, Bono RS, Mitchell A, Popoff E, Palmer C, Stallings R, Harris D, Dillingham R, Higginson R, Eichholz T, Pan Z, Ingersoll K, Dahman B; Antiretroviral Improvement of Medicaid EnrolleeS (AIMS) Team. Brief Report: The Trials of Insurance-Based Data to Care-Rx: Low Enrollment in the Antiretroviral Improvement Among Medicaid EnrolleeS (AIMS) Study. J Acquir Immune Defic Syndr. 2026 May 1;101(5):520-525. doi: 10.1097/QAI.0000000000003830.
Derived from this study: PubMed 40393614Kimmel 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

April D Kimmel, PhD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: AIMS program - patient in people with Human Immunodeficiency Virus, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Participants Virally Suppressed (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477485, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.