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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • 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
Other: Service of care
Subjects will be receiving care from case management or clinical pharmacy.
Active Comparator: Case management
service of care: case management
Other: Service of care
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

University of California, Davis

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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