NCT03517358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 hiv

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

April 10, 2018

Last Update Submit

July 30, 2020

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

  • Percentage of virological suppression

    6 months

Study Arms (2)

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

Service of careOTHER

Subjects will be receiving care from case management or clinical pharmacy.

Case managementPharmacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a baseline viral load \> 200 copies/ml
  • Patients who agree to program enrollment
  • Patients ≥ 18 years of age

You may not qualify if:

  • Pregnant women
  • Adults unable to consent
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

One Community Health

Sacramento, California, 95831, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2018

First Posted

May 7, 2018

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

US(1)