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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Contingency Management; Behavioral: Peer Navigation; Behavioral: Combined Contingency Management and Peer Navigation

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • OASIS Clinic
    • Los Angeles, California, United States, 90012
      • Center for Health Justice
    • Los Angeles, California, United States, 90012
      • Los Angeles Sheriff's Department
    • Los Angeles, California, United States, 90022
      • AltaMed Health Services Corporation
    • Sylmar, California, United States, 91342
      • Olive View Medical Center
    • Van Nuys, California, United States, 91401
      • Northeast Valley Health Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Contingency Management only; 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	Behavioral: Contingency Management
Active Comparator: Peer Navigation only; Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care	Behavioral: Peer Navigation
Experimental: Combined Contingency Management and Peer Navigation; 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.	Behavioral: Combined Contingency Management and Peer Navigation
No Intervention: Usual care; Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Basline, follow-ups at month 2, 6, 12
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	Basline, follow-ups at month 2, and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care	5 years

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: William Cunningham, MD, MPH, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 1R01MH103076-01A1 (U.S. NIH Grant/Contract)