Trial Outcomes & Findings for Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI) (NCT NCT03437694)
NCT ID: NCT03437694
Last Updated: 2025-07-18
Results Overview
The average A1c in study participants with Diabetes mellitus at the end of their study participation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
Through study completion, up to 3 years
Results posted on
2025-07-18
Participant Flow
Participant milestones
| Measure |
Intervention Arm
The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.
|
Control Arm
The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
39
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=64 Participants
The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.
|
Control Arm
n=65 Participants
The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.01 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
52.38 years
STANDARD_DEVIATION 10.96 • n=7 Participants
|
53.19 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HIV Viral Load
VL < LLOQ
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
HIV Viral Load
Detectable VL
|
46 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
43 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Comorbidities
Diabetes mellitus
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 3 yearsPopulation: Only study participants with Diabetes mellitus
The average A1c in study participants with Diabetes mellitus at the end of their study participation
Outcome measures
| Measure |
Intervention Arm
n=21 Participants
The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.
|
Control Arm
n=31 Participants
The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).
|
|---|---|---|
|
Average A1c
|
7.45 Average A1c (% glyosylated hemoglobin)
Standard Deviation 1.84
|
6.66 Average A1c (% glyosylated hemoglobin)
Standard Deviation 2.26
|
PRIMARY outcome
Timeframe: Through study completion, up to 3 yearsPopulation: Only study participants with hypertension
The average SBP in study participants with hypertension at the end of their study participation
Outcome measures
| Measure |
Intervention Arm
n=43 Participants
The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.
|
Control Arm
n=34 Participants
The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).
|
|---|---|---|
|
Average Systolic Blood Pressure
|
134.6 mmHg
Standard Deviation 13.1
|
129.2 mmHg
Standard Deviation 14.9
|
Adverse Events
Intervention Arm
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Control Arm
Serious events: 9 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Arm
n=64 participants at risk
The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants.
|
Control Arm
n=65 participants at risk
The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided).
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization due to procedure or surgery
|
1.6%
1/64 • Number of events 1 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
3.1%
2/65 • Number of events 2 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
|
General disorders
Hospitalization unscheduled
|
10.9%
7/64 • Number of events 7 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
7.7%
5/65 • Number of events 5 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
|
General disorders
ED visit
|
0.00%
0/64 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
3.1%
2/65 • Number of events 2 • Through study completion, up to 3 years
Serious adverse events included any hospitalization for any cause including scheduled procedures or unrelated hospitalizations. Other adverse events were not monitored or assessed
|
Other adverse events
Adverse event data not reported
Additional Information
Crystal Hodge
University of North Texas Health Science Center
Phone: 8177350131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place