Trial results for a study investigating a patient-centered, community pharmacy-based care model for HIV, Type 2 Diabetes, and Hypertension were posted on ClinicalTrials.gov on 2025-07-18. The trial, which was terminated, reported that the intervention arm had an average A1c of 7.45% and average systolic blood pressure of 134.6 mmHg, which were higher than the control arm.
Background
Type 2 Diabetes, Hypertension, and HIV/AIDS are chronic conditions requiring ongoing management, often involving multiple healthcare providers and complex medication regimens. Effective management of Type 2 Diabetes focuses on glycemic control, typically monitored by HbA1c levels, to prevent long-term complications. Hypertension management aims to control blood pressure to reduce cardiovascular risks. For individuals living with HIV, co-morbidities like diabetes and hypertension are increasingly common, adding layers of complexity to their care. Integrating care across different healthcare settings, such as community pharmacies, is an area of interest for improving patient outcomes, especially by enhancing information sharing among providers. This trial explored whether providing community pharmacists with patient medical records could lead to better health outcomes for a specific population managing these conditions.
Trial design
This study, identified as "Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)", was listed as Phase "NA" and was ultimately "TERMINATED". The trial enrolled 129 participants, focusing on adult, African-American individuals with HIV/AIDS who also had either Diabetes Mellitus, Type 2, Hypertension, or both. The purpose was to assess if participants experienced better health outcomes when their pharmacist had access to their medical records. The intervention involved providing study pharmacists with medical records for half of the participants, implying a control arm where pharmacists did not receive these records. The trial was primarily conducted in Fort Worth and Dallas, Texas. No primary outcomes were listed in the available data.
Key results
The trial reported key measurements for average A1c and average systolic blood pressure for both the intervention and control arms:
- Average A1c (% glycosylated hemoglobin):
- Intervention Arm: Mean of 7.45 (Standard Deviation 1.84)
- Control Arm: Mean of 6.66 (Standard Deviation 2.26)
- Average Systolic Blood Pressure (mmHg):
- Intervention Arm: Mean of 134.6 (Standard Deviation 13.1)
- Control Arm: Mean of 129.2 (Standard Deviation 14.9)
No key analyses or adverse event summaries were provided in the posted results.
What this means
The results from this terminated trial suggest that providing community pharmacists with patient medical records, as implemented in this specific care model, did not lead to improved glycemic control or blood pressure management in the studied population. The intervention arm exhibited numerically higher average A1c levels (7.45% vs. 6.66%) and higher average systolic blood pressure (134.6 mmHg vs. 129.2 mmHg) compared to the control arm. These findings indicate that simply providing record access may not be sufficient to improve health outcomes for patients with HIV, Type 2 Diabetes, and Hypertension, or that other factors within the trial design or population may have influenced these results. The termination of the trial further implies that the study did not achieve its intended goals or encountered issues that prevented its completion.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03437694, titled "Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)", were posted on 2025-07-18 on clinicaltrials.gov.
