Human Immunodeficiency Virus
Conditions
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.
Interventions
BEHAVIORALExperimental: 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.
OTHERNo 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.
Sponsors
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
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Virally Suppressed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription | 3 months | 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. |
| Antiretroviral Therapy (ART) Adherence | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
Baseline characteristics
| Characteristic | AIMS program - patient | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 10.6 | 45 years STANDARD_DEVIATION 10.6 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | — |
| Region of Enrollment United States | 4 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | — |
| Sex: Female, Male Male | 2 Participants | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 4 |
| other Total, other adverse events | 0 / 0 | 0 / 4 |
| serious Total, serious adverse events | 0 / 0 | 0 / 4 |
Outcome results
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number and Percentage of Participants Virally Suppressed | 0 Participants |
| AIMS program - patient | Number and Percentage of Participants Virally Suppressed | 0 Participants |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Antiretroviral Therapy (ART) Adherence | 0 Participants |
| AIMS program - patient | Antiretroviral Therapy (ART) Adherence | 3 Participants |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription | 0 Participants |
| AIMS program - patient | Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription | 4 Participants |