Medication Optimization Intervention for HIV/AIDS

(HIV-MOI Trial)

No longer recruiting at 2 trial locations
ML
Overseen ByMarc L Fleming, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Texas Health Science Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether people with HIV experience better health outcomes when their pharmacist accesses their full medical records. It focuses on African-Americans with HIV who also have diabetes or high blood pressure. Participants are divided into two groups: one receives standard care, while the other receives enhanced counseling based on their full medical history. This enhanced counseling is part of the medication optimization intervention. The study aims to determine if more information leads to better health results.

As an unphased trial, this study allows participants to contribute to research that could enhance personalized healthcare strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems the focus is on optimizing your medication management rather than changing your existing medications.

What prior data suggests that this medication optimization intervention is safe?

Research has shown that pharmacists can safely and effectively assist people living with HIV in managing their medications. In one study with 143 patients, pharmacist involvement reduced medication-related issues by 38.43%. This demonstrates that pharmacists can improve medication use without causing harm.

In this trial, pharmacists will access medical records to provide better counseling. The trial does not test new drugs; instead, it focuses on improving the use of current medications. This approach makes it a low-risk trial compared to those testing new drugs.

Overall, research supports that having pharmacists lead this approach is well-tolerated and can effectively aid in managing medications.12345

Why are researchers excited about this trial?

Researchers are excited about the medication optimization intervention for HIV/AIDS because it focuses on a personalized approach to managing the condition. Unlike traditional treatments that strictly rely on prescribed medication regimens, this intervention involves providing pharmacists with access to patients' medical records. This allows for tailored adjustments to medication plans based on individual needs and responses. By enhancing communication between pharmacists and patients, the intervention aims to improve adherence to medication and overall health outcomes, offering a potentially more effective way to manage HIV/AIDS.

What evidence suggests that this medication optimization intervention is effective for improving health outcomes in African-Americans with HIV?

Research has shown that when pharmacists access patients' medical records, they can help improve the health of people with HIV. In this trial, participants in the Medication Optimization Intervention arm will have their medical records provided to the pharmacist, allowing for more personalized care. Studies have found that involving pharmacists leads to better medication habits and more effective control of the virus. Specifically, when pharmacists have more information, patients are more likely to take their medication correctly and manage their HIV better. One study found that when pharmacists are actively involved, people with HIV use their medications more effectively. These findings suggest that allowing pharmacists full access to medical records could help patients achieve better health outcomes.678910

Who Is on the Research Team?

CK

Crystal K Hodge, PharmD

Principal Investigator

UNTHSC

Are You a Good Fit for This Trial?

This trial is for adult African-Americans with HIV who also have high blood pressure, type 2 diabetes, or both. Participants must be willing to share their medical records and not be pregnant or have a life expectancy of less than 2 years.

Inclusion Criteria

I have either high blood pressure or type 2 diabetes.
This criterion does not provide enough context to accurately summarize it. Can you please provide more details or specify what the criterion is referring to?
You have HIV.

Exclusion Criteria

I refuse to allow access to my medical records.
You are expected to live for less than 2 years.
Pregnant (at screening, may enroll 6 months post-delivery)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Enrollment

Participants' medical records are obtained and assessed; initial HIV-MOI visit conducted with individualized care plan development

4 weeks
1 visit (in-person)

Treatment

Participants receive either enhanced medication optimization or standard of care; follow-up visits occur at least quarterly

2 years
8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Medication optimization intervention
Trial Overview The study tests if pharmacists improve health outcomes by accessing patients' medical records. Half will receive 'medication optimization' based on full records, while the other half gets standard counseling without record access.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Medication Optimization InterventionExperimental Treatment1 Intervention
Group II: Medication Optimization ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Texas Health Science Center

Lead Sponsor

Trials
41
Recruited
20,800+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Walgreens, A Boots Alliance

Collaborator

Trials
1
Recruited
130+

Walgreens Boots Alliance

Collaborator

Trials
2
Recruited
610+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Published Research Related to This Trial

In a study of 143 HIV-infected outpatients, pharmacist interventions significantly reduced drug-related problems (DRPs) by 38.43%, highlighting the importance of medication safety in managing HAART.
The intervention group experienced an 84% increase in CD4 counts compared to the control group, suggesting that pharmacist support improves adherence and the effectiveness of antiretroviral therapy.
HIV pharmaceutical care in primary healthcare: Improvement in CD4 count and reduction in drug-related problems.Molino, CGRC., Carnevale, RC., Rodrigues, AT., et al.[2020]
In a study of 235 AIDS patients on antiretroviral therapy (ART) over 6 months, a staggering 90.6% experienced adverse drug reactions (ADRs), primarily affecting the gastrointestinal (42.39%) and central nervous systems (25.57%).
Severe ADRs were reported in 17.4% of patients, leading to drug withdrawal in some cases, and 28.9% of patients reported non-compliance due to these reactions, highlighting the need for careful monitoring and management of ART.
Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study.Nagpal, M., Tayal, V., Kumar, S., et al.[2022]
In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.
The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.
Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS.Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

Citations

The Latest Trends and Evolution of HIV Medication ...For instance, combination antiretroviral therapy (ART) has been effective in significantly reducing the viral load to undetectable levels (<50 ...
Effectiveness of a Web-Based Intervention to Support ...This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV.
Effect of mobile health intervention on medication time ...This study aimed to assess the impact of Mobile health (M-health) on medication time adherence among people living with HIV/AIDS (PLWHA).
The Effects of Medication Therapy Management on ...Conclusions. Medicare MTM programs effectively improved medication utilization among people living with HIV/AIDS. Future studies should explore the long-term ...
Analysis of Systematic Reviews of Medication Adherence ...A qualitative review36 of pharmacist-related interventions examined the pharmacist's role in HIV care: ART adherence and viral load improved.
Optimizing HIV prevention and treatment outcomes for ...A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled ...
Study Details | NCT00537394 | Optimizing Treatment for ...Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside ...
Medication Optimization Intervention for HIV/AIDS ...In a study of 143 HIV-infected outpatients, pharmacist interventions significantly reduced drug-related problems (DRPs) by 38.43%, highlighting the importance ...
Optimization Models for HIV/AIDS Resource AllocationThis study reviews optimization models for human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) resource allocation.
Adherence to the Continuum of Care | NIHBased on 2022 data, about 82% of individuals were linked to care within 30 days of receiving an HIV diagnosis.5,6 However, only 54% of people ...
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