Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI) (HIV-MOI)

Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Diabetes Mellitus, Type 2; HIV/AIDS
• Intervention / Treatment: Other: Medication optimization intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center
    • Fort Worth, Texas, United States, 76107
      • Crystal Hodge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• African-American
• HIV positive
• At least one of the following: hypertension or diabetes type 2

Exclusion Criteria:

• Pregnant (at screening, may enroll 6 months post-delivery)
• Have a life expectancy < 2 years
• Refusal to provide medical record release

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication Optimization Intervention; This group will represent those participants whose medical records have 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).; Other Names: medication therapy management
Active Comparator: Medication Optimization Control; 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).; Other Names: medication therapy management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average A1c	The average A1c in study participants with Diabetes mellitus at the end of their study participation	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	Through study completion, up to 3 years

Collaborators and Investigators

• Sponsor: University of North Texas Health Science Center
• Collaborators: University of California, San Francisco; University of Minnesota; Walgreens Boots Alliance
• Investigators: Principal Investigator: Crystal K Hodge, PharmD, UNTHSC

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Hypertension; AIDS; Medication Therapy Management; Pharmacist; MTM; Medication optimization; Diabetes Melllitus, Type 2
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: U54Proj2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No