An interventional study of Medication optimization intervention in HIV/AIDS, Diabetes Mellitus, Type 2 and Hypertension, sponsored by University of North Texas Health Science Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by University of North Texas Health Science Center · Not applicable, Interventional, and Health services research
This is a clinical trial. The purpose of this clinical trial is to see if study participants have better health outcomes if their pharmacist has access to their medical records. The study will take place primarily in Fort Worth and Dallas, Texas. The trial will enroll adult, African-Americans with HIV. Study participants must also have either diabetes, high blood pressure or they may have both. Study participants will agree to have their medical records from all of their health providers released to UNTHSC. UNTHSC will provide the study pharmacist the medical records for half of the participants. Using the medical records, the study pharmacist will provide 'enhanced' patient counseling services to half of the participants. This enhanced service is called 'medication optimization'. For half of the participants that the study pharmacist does not see the medical records, they will receive usual and customary patient counseling. Not seeing the medical records is considered standard of care. In both groups, the counseling frequency will be based on the participant's needs but the study pharmacist will contact every participant to check on them at least every 90 days. These visits will happen for 2 years. The two groups will be compared to see if those participants having medical information supported medication optimization have better health than those getting routine, the standard of care medication optimization.
This study examines HIV medication optimization (HIV-MOI) in a prospective, randomized (1:1 HIV-MOI: standard of care), clinical trial, comparing disease-specific clinical and humanistic outcomes in up to 200 adult African-Americans with HIV (1:1 men: women) and either diabetes mellitus type 2 (DM) and/or hypertension (HTN). Data will be collected from individual participants for a 2 year period. Once properly screened, consented and enrolled, medical records from participant's medical provider(s) will be obtained. Upon receipt of the medical records, research team personnel (working closely with the project biostatistician) will provide medical information only for those participants randomized to receive HIV-MOI to the study pharmacist. The study pharmacist then assesses the information to determine the clinical effectiveness and appropriateness of the current medical plan's medications. Upon completion, the study pharmacist will develop a prioritized medication problem list, create a plan, discuss/collaborate with the medical provider/healthcare team member as needed and then conduct the initial HIV-MOI visit with the patient. At the initial visit, an individualized care plan would be finalized with study participant input. Also at the initial HIV-MOI visit, the patient should receive an accurate (and reconciled with medical providers) personal medication record (PMR). Participants should also receive an individualized care plan called a medication action plan (MAP). The MAP can include non-pharmacological instructions and education. This may be guided in part by qualitative survey data obtained as part of the study visit. Follow-up visits will occur (ideally) not less than quarterly. Follow-up visits may occur face-to-face or using telecommunication methods.
The study pharmacist will only be provided the medical information for the intervention group. Standard of care for pharmacists is not having access to medical information when providing HIV-MOI. Extracted data and study obtained data will be entered into the study database for analyses.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 129 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will represent those participants whose medical records have been provided to the pharmacist.
Other: Medication optimization intervention
This group will represent those participants whose medical records have not been provided to the pharmacist.
Other: Medication optimization intervention
Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).
Also known as: medication therapy management
Average A1c
The average A1c in study participants with Diabetes mellitus at the end of their study participation
Time frame: Through study completion, up to 3 years
Average Systolic Blood Pressure
The average SBP in study participants with hypertension at the end of their study participation
Time frame: Through study completion, up to 3 years
| Milestone | Intervention Arm | Control Arm |
|---|---|---|
| Started | 64 | 65 |
| Completed | 25 | 26 |
| Not completed | 39 | 39 |
The average A1c in study participants with Diabetes mellitus at the end of their study participation
| Average A1c (% glyosylated hemoglobin) | Intervention Arm | Control Arm |
|---|---|---|
| Average A1c | 7.45 ± 1.84 | 6.66 ± 2.26 |
The average SBP in study participants with hypertension at the end of their study participation
| mmHg | Intervention Arm | Control Arm |
|---|---|---|
| Average Systolic Blood Pressure | 134.6 ± 13.1 | 129.2 ± 14.9 |
Collected over Through study completion, up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 1/64 (1.6%) | 8/64 (12.5%) | — |
| Control Arm | 1/65 (1.5%) | 9/65 (13.8%) | — |
| Event | Intervention Arm | Control Arm |
|---|---|---|
| Hospitalization unscheduledGeneral disorders | 7/64 | 5/65 |
| Hospitalization due to procedure or surgerySurgical and medical procedures | 1/64 | 2/65 |
| ED visitGeneral disorders | 0/64 | 2/65 |
| Age, Continuous(years) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 54.01 ± 10.6 | 52.38 ± 10.96 | 53.19 ± 10.76 |
| Sex: Female, Male(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 27 | 24 | 51 |
| Male | 37 | 41 | 78 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 64 | 65 | 129 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| HIV Viral Load(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| VL < LLOQ | 18 | 29 | 47 |
| Detectable VL | 46 | 36 | 82 |
| Comorbidities(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Hypertension | 43 | 34 | 77 |
| Diabetes mellitus | 21 | 31 | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Jan 2024, 65 months.
Results were first posted in Jul 2025, 1 year 5 months after primary completion.
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This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
University of North Texas Health Science Center