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Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care (CHAMPS)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Contingency Management and Peer Navigation
Contingency Management
Peer Navigation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed HIV+
  2. Age 18 years or older
  3. English or Spanish speaking
  4. Residence in Los Angeles County
  5. prescribed ART in prior 24 months
  6. < 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database

Exclusion Criteria:

Not meeting any of the criteria identified above

Sites / Locations

  • Center for Health Justice
  • Los Angeles Sheriff's Department
  • AltaMed Health Services Corporation
  • Oasis Clinic
  • Olive View Medical Center
  • Northeast Valley Health Corporation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

Contingency Management only

Peer Navigation only

Combined Contingency Management and Peer Navigation

Usual care

Arm Description

Participants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy

Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care

Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care and will be eligible to receive incentives for attending HIV care visits/refilling prescriptions.

Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study.

Outcomes

Primary Outcome Measures

Change in retention-in-care behaviors over 12 months
Using a 2x2 factorial design, to examine the effect of the three interventions -- peer navigation, contingency management, combined approach and usual care -- and evaluate how well they improve retention in HIV care
Change in HIV RNA viral load suppression and medication adherence over 12 months
Using the same design, to examine the effects of the PN, CM and, CA interventions on HIV RNA viral load suppression and self-reported adherence

Secondary Outcome Measures

Cost effectiveness
A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care

Full Information

First Posted
July 18, 2014
Last Updated
November 16, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02310893
Brief Title
Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
Acronym
CHAMPS
Official Title
Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
579 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management only
Arm Type
Active Comparator
Arm Description
Participants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy
Arm Title
Peer Navigation only
Arm Type
Active Comparator
Arm Description
Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care
Arm Title
Combined Contingency Management and Peer Navigation
Arm Type
Experimental
Arm Description
Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care and will be eligible to receive incentives for attending HIV care visits/refilling prescriptions.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study.
Intervention Type
Behavioral
Intervention Name(s)
Combined Contingency Management and Peer Navigation
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigation
Primary Outcome Measure Information:
Title
Change in retention-in-care behaviors over 12 months
Description
Using a 2x2 factorial design, to examine the effect of the three interventions -- peer navigation, contingency management, combined approach and usual care -- and evaluate how well they improve retention in HIV care
Time Frame
Basline, follow-ups at month 2, 6, 12
Title
Change in HIV RNA viral load suppression and medication adherence over 12 months
Description
Using the same design, to examine the effects of the PN, CM and, CA interventions on HIV RNA viral load suppression and self-reported adherence
Time Frame
Basline, follow-ups at month 2, and 12
Secondary Outcome Measure Information:
Title
Cost effectiveness
Description
A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed HIV+ Age 18 years or older English or Spanish speaking Residence in Los Angeles County prescribed ART in prior 24 months < 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database Exclusion Criteria: Not meeting any of the criteria identified above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Cunningham, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Justice
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Los Angeles Sheriff's Department
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
AltaMed Health Services Corporation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Oasis Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Olive View Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Northeast Valley Health Corporation
City
Van Nuys
State/Province
California
ZIP/Postal Code
91401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care

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