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| ID | Type | Description | Link |
|---|---|---|---|
| U01PS005192 | U.S. NIH Grant/Contract | View source |
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Insufficient rate of accrual
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| National Institute of Mental Health (NIMH) | NIH |
| Virginia Department of Medical Assistance Services - Virginia Medicaid | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April D Kimmel, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41511388 | Derived | 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. | |
| 40393614 |
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Recruitment for the intervention (AIMS program-patient arm) occurred April 2023-May 2024, with n=4 enrolled in the intervention. Recruitment for the Usual Care arm does not apply. The study design was such that the Usual Care arm would be constructed after follow-up on the intervention. As the trial was terminated due to insufficient rate of accrual for the intervention, no such sample was constructed. No data were collected for the Usual Care arm (n=0); there are no data to analyze or report.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV. 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. Recruitment for the Usual Care group does not apply. The Usual Care group was a comparison group to be constructed from existing data. The trial ended with an insufficient rate of accrual for the AIMS program-patient (intervention) group, no sample was constructed. No data was collected for the usual care arm (n=0), there is no data to report. |
| FG001 | AIMS program - patient | Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Usual Care group was not constructed because the trial was terminated. The study design was such that the Usual Care arm would be constructed after follow-up on the intervention (AIMS program - patient arm). No data were collected for the Usual Care arm (n=0); there are no data to analyze or report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | 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. Recruitment for the Usual Care group does not apply. The Usual Care group was a comparison group to be constructed from existing data. The trial ended with an insufficient rate of accrual for the AIMS program-patient (intervention) group, no sample was constructed. No data was collected for the usual care arm (n=0), there is no data to report. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 3 months |
|
3 months
Medical adverse events do not apply.
Adverse events consist of emotional or psychological distress during the AIMS program-patient intervention phone call or during use of the optional PositiveLinks app.
Adverse events do not apply to the Usual Care group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual Care participants will receive standard state-level care for missing ART prescription refill(s) for Virginia Medicaid enrollees with HIV. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. April D. Kimmel | Virginia Commonwealth University | (804) 628-6273 | adkimmel@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2024 | Apr 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2024 | May 13, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Virginia Department of Health |
| OTHER_GOV |
| University of Virginia | OTHER |
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|
| 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. |
|
| 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. | 3 months |
| 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. |
| BG001 | AIMS program - patient | Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | AIMS program - patient | Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community. 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. |
|
|
| Secondary | 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. | 4 subjects enrolled in the intervention (AIMS program - pt arm, n=4). No participants were enrolled into the usual care arm, and therefore, no data were collected for this outcome measure for that arm. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | 4 subjects enrolled in the intervention (AIMS program - pt arm, n=4). No participants were enrolled into the usual care arm, and therefore, no data were collected for this outcome measure for that arm. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | AIMS program - patient | Participants will receive patient-level support. Support will come from the participant's provider, pharmacy, managed-care organization or the community. 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |