- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03517358
Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol
July 30, 2020 updated by: University of California, Davis
Virological Suppression in HIV Positive Patients Involved in a Novel, Standardized Adherence Protocol
This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95831
- One Community Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with a baseline viral load > 200 copies/ml
- Patients who agree to program enrollment
- Patients ≥ 18 years of age
Exclusion Criteria:
- Pregnant women
- Adults unable to consent
- Prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pharmacy
service of care: pharmacy
|
Subjects will be receiving care from case management or clinical pharmacy.
|
Active Comparator: Case management
service of care: case management
|
Subjects will be receiving care from case management or clinical pharmacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of virological suppression
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 7, 2018
Study Record Updates
Last Update Posted (Actual)
July 31, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1150661
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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