Trial Outcomes & Findings for Antiretroviral Improvement Among Medicaid Enrollees (NCT NCT05477485)

Last Updated: 2025-10-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

3 months

Results posted on

2025-10-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	0	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	0	4

Baseline Characteristics

Antiretroviral Improvement Among Medicaid Enrollees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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.	AIMS program - patient n=4 Participants 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.	Total n=4 Participants Total of all reporting groups
Age, Continuous	—	45 years STANDARD_DEVIATION 10.6 • n=7 Participants	45 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	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.
Number and Percentage of Participants Virally Suppressed	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	AIMS program - patient n=4 Participants 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.
Number and Percentage of Participants Reinitiating Late Antiretroviral Therapy (ART) Prescription	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	AIMS program - patient n=4 Participants 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.
Antiretroviral Therapy (ART) Adherence	0 Participants	3 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AIMS program - patient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. April D. Kimmel

Virginia Commonwealth University

Phone: (804) 628-6273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place