Back to resultsVirological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol
Primary Purpose
Hiv
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Service of care
Sponsored by
About this trial
This is an interventional other trial for Hiv
Eligibility Criteria
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
Sites / Locations
- One Community Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pharmacy
Case management
Arm Description
service of care: pharmacy
service of care: case management
Outcomes
Primary Outcome Measures
Percentage of virological suppression
Secondary Outcome Measures
Full Information
NCT ID
NCT03517358
First Posted
April 10, 2018
Last Updated
July 30, 2020
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03517358
Brief Title
Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol
Official Title
Virological Suppression in HIV Positive Patients Involved in a Novel, Standardized Adherence Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacy
Arm Type
Active Comparator
Arm Description
service of care: pharmacy
Arm Title
Case management
Arm Type
Active Comparator
Arm Description
service of care: case management
Intervention Type
Other
Intervention Name(s)
Service of care
Intervention Description
Subjects will be receiving care from case management or clinical pharmacy.
Primary Outcome Measure Information:
Title
Percentage of virological suppression
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
One Community Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol
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