Virological Suppression in HIV Positive Patients Involved... | NCT03517358

Studies
Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol

NCT03517358

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Jul 31, 2020Actual

Enrollment

10Actual

Phase

Phase 3

Conditions

Interventions

Service of care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Apr 10, 2018

First Submission Date that Met QC Criteria

May 3, 2018

First Posted Date

May 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Jul 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmacy	Active Comparator	service of care: pharmacy	Other: Service of care
Case management	Active Comparator	service of care: case management	Other: Service of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Service of care	Other	Subjects will be receiving care from case management or clinical pharmacy.	Case management Pharmacy

Measure	Description	Time Frame
Percentage of virological suppression		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
One Community Health		Sacramento	California	95831	United States

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided