HIV/AIDSHIV-MOINCT03437694
Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)
A study testing Medication optimization intervention in people with HIV/AIDS and Diabetes Mellitus, Type 2, run by University of North Texas Health Science Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Medication optimization intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2018to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- African-American
- HIV positive
- At least one of the following: hypertension or diabetes type 2
Who cannot join
- Pregnant (at screening, may enroll 6 months post-delivery)
- Have a life expectancy < 2 years
- Refusal to provide medical record release
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Crystal Hodge
Fort Worth, Texas, 76107
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV/AIDS, Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Medication optimization intervention
- Keywords
- HIV, AIDS, Diabetes Melllitus, Type 2, Hypertension, Pharmacist, Medication optimization, Medication Therapy Management, MTM
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication optimization interventionOther
Also called medication therapy management
Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).
| Study group | Role | What they receive |
|---|---|---|
| Medication Optimization Intervention | Experimental | This group will represent those participants whose medical records have been provided to the pharmacist. Receives: 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. Receives: Other: Medication optimization intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average A1c
The average A1c in study participants with Diabetes mellitus at the end of their study participation
Measured: 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
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start3 Aug 2018
- Primary completion31 Jan 2024
- Study completion27 Feb 2025
Why it stopped: Recruitment and funding challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either the intervention or control group.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of Minnesota, Walgreens Boots Alliance
- Responsible party
- Sponsor
- Investigators
- Crystal K Hodge, PharmD, Principal investigator, UNTHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437694
- Sponsor's protocol ID
- U54Proj2
- Acronym
- HIV-MOI
- Status last verified
- Jul 2025
- First submitted
- 12 Feb 2018
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model
- ClinicalTrials.gov ID
- NCT03437694
- Acronym / sponsor ID
- HIV-MOI / U54Proj2
- Conditions
- HIV/AIDS, Diabetes Mellitus, Type 2, Hypertension
- Keywords
- HIV, AIDS, Diabetes Melllitus, Type 2, Hypertension, Pharmacist, Medication optimization, Medication Therapy Management, MTM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and funding challenges
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Minnesota, Walgreens Boots Alliance
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Medication Optimization Intervention | Experimental | Other: Medication optimization interventionThis group will represent those participants whose medical records have been provided to the pharmacist. |
| Medication Optimization Control | Active comparator | Other: Medication optimization interventionThis group will represent those participants whose medical records have not been provided to the pharmacist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- African-American
- HIV positive
- At least one of the following: hypertension or diabetes type 2
Key exclusion criteria (3 listed)
- Pregnant (at screening, may enroll 6 months post-delivery)
- Have a life expectancy < 2 years
- Refusal to provide medical record release
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication optimization interventionAlso: medication therapy managementPharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control). | Other | Medication Optimization Control, Medication Optimization Intervention |
Primary outcome
Average A1c
Time frame: Through study completion, up to 3 years
The average A1c in study participants with Diabetes mellitus at the end of their study participation
Average Systolic Blood Pressure
Time frame: Through study completion, up to 3 years
The average SBP in study participants with hypertension at the end of their study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal K Hodge, PharmD principal investigator
UNTHSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication optimization intervention in people with HIV/AIDS and Diabetes Mellitus, Type 2, run by University of North Texas Health Science Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average A1c (time frame: Through study completion, up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.