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

NCT03437694 | Terminated Results DMC

• 1 other identifier: U54Proj2
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV/AIDS; Diabetes Mellitus, Type 2; Hypertension

Keywords

HIV; AIDS; Diabetes Melllitus, Type 2; Hypertension; Pharmacist; Medication optimization; Medication Therapy Management; MTM

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Medication Optimization Intervention

EXPERIMENTAL

This group will represent those participants whose medical records have been provided to the pharmacist.

Other: Medication optimization intervention

Medication Optimization Control

ACTIVE COMPARATOR

This group will represent those participants whose medical records have not been provided to the pharmacist.

Other: Medication optimization intervention

Interventions

Medication optimization intervention OTHER

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

Medication Optimization Control; Medication Optimization Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• University of California, San Francisco: collaborator
• University of Minnesota: collaborator
• Walgreens Boots Alliance: collaborator

Study Sites (2)

Crystal Hodge

Fort Worth, Texas, 76107, United States

Location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Diabetes Mellitus, Type 2; Hypertension

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

Challenges with recruitment during the COVID-19 pandemic limited study participant enrollment within the grant period. Due to funding and enrollment constraints, the study was terminated before all study participants were able to complete all expected study visits.

Results Point of Contact

• Title: Crystal Hodge
• Organization: University of North Texas Health Science Center

crystal.hodge@unthsc.edu

8177350131

Study Officials

• Crystal K Hodge, PharmD

  UNTHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to either the intervention or control group.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: August 3, 2018
• Primary Completion: January 31, 2024
• Study Completion: February 27, 2025
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)