Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
CHAMPS
1 other identifier
interventional
579
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 17, 2020
November 1, 2020
3.9 years
July 18, 2014
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Cost effectiveness
5 years
Study Arms (4)
Contingency Management only
ACTIVE COMPARATORParticipants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy
Peer Navigation only
ACTIVE COMPARATORParticipants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care
Combined Contingency Management and Peer Navigation
EXPERIMENTALParticipants 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.
Usual care
NO INTERVENTIONParticipants in this arm will receive the care that they would usually get in their clinic in the absence of this study.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not meeting any of the criteria identified above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Center for Health Justice
Los Angeles, California, 90012, United States
Los Angeles Sheriff's Department
Los Angeles, California, 90012, United States
AltaMed Health Services Corporation
Los Angeles, California, 90022, United States
Oasis Clinic
Los Angeles, California, 90059, United States
Olive View Medical Center
Sylmar, California, 91342, United States
Northeast Valley Health Corporation
Van Nuys, California, 91401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Cunningham, MD, MPH
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2014
First Posted
December 8, 2014
Study Start
January 1, 2016
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
November 17, 2020
Record last verified: 2020-11