Medication Optimization Intervention for HIV/AIDS

(HIV-MOI Trial)

Recruiting at 2 trial locations

Overseen By Marc L Fleming, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Texas Health Science Center

Disqualifiers: Pregnancy, Life expectancy < 2 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 2 years

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the medication optimization intervention for HIV/AIDS generally safe for humans?

The medication optimization intervention for HIV/AIDS involves antiretroviral therapy, which can cause adverse events like skin issues, mood changes, and stomach problems. These side effects are common and can lead to changes in medication, but they are generally manageable with medical supervision. ^{1 2 3 4 5}

How does the medication optimization intervention differ from other HIV/AIDS treatments?

The medication optimization intervention for HIV/AIDS is unique because it focuses on reviewing and optimizing the entire medication regimen for people living with HIV, addressing issues like polypharmacy (use of multiple medications) and improving adherence. This approach is different from standard treatments that primarily focus on antiretroviral therapy (ART) alone, as it aims to enhance overall medication management and reduce drug-related problems. ^{4 6 7 8 9}

What data supports the effectiveness of the medication optimization intervention for HIV/AIDS?

Research shows that optimizing medication regimens, such as simplifying dosing schedules and addressing side effects, can improve adherence to HIV treatment. This leads to better health outcomes, like increased CD4 counts, which are important for a strong immune system. ^{8 10 11 12 13}

Who Is on the Research Team?

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?

Group I: Medication Optimization Intervention Experimental Treatment 1 Intervention

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

Group II: Medication Optimization Control Active Control 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

HIV pharmaceutical care in primary healthcare: Improvement in CD4 count and reduction in drug-related problems. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Optimizing Antiretroviral Therapy with Bictegravir/Emtricitabine/Tenofovir Alafenamide in virologically suppressed PLWH. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Application of CMO (capacity, motivation, and opportunity) methodology in pharmaceutical care to optimize the pharmacotherapy in older people living with HIV. DISPIMDINAC project. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Adherence and plasma drug concentrations are predictors of confirmed virologic response after 24-week salvage highly active antiretroviral therapy. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment-related factors and highly active antiretroviral therapy adherence. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study. [2022]

7. Singapore pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral medication. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events from drug therapy for human immunodeficiency virus disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Structured medicines reviews in HIV outpatients: a feasibility study (The MOR Study). [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Medication Therapy Issues, Resolutions, and Adherence Among Persons With HIV in the Pharmacist-Led Patient-Centered HIV Care Model. [2023]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment simplification in HIV-infected adults as a strategy to prevent toxicity, improve adherence, quality of life and decrease healthcare costs. [2022]

13. Spain pubmed.ncbi.nlm.nih.gov

Application of the CMO methodology to the improvement of primary adherence to concomitant medication in people living with-HIV. The PRICMO Project. [2021]