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

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ClinicalTrials.gov Identifier: NCT02310893
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
William Cunningham, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Combined Contingency Management and Peer Navigation Behavioral: Contingency Management Behavioral: Peer Navigation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Change in retention-in-care behaviors over 12 months [ Time Frame: Basline, follow-ups at month 2, 6, 12 ]
    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

  2. Change in HIV RNA viral load suppression and medication adherence over 12 months [ Time Frame: Basline, follow-ups at month 2, and 12 ]
    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 :
  1. Cost effectiveness [ Time Frame: 5 years ]
    A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310893


Contacts
Contact: Danielle Seiden, MPP 310-794-3556 dseiden@mednet.ucla.edu
Contact: Jimmy Ngo 310-794-3556 jtngo@mednet.ucla.edu

Locations
United States, California
Center for Health Justice Recruiting
Los Angeles, California, United States, 90012
Contact: William Cunningham       wcunningham@mednet.ucla.edu   
Los Angeles Sheriff's Department Recruiting
Los Angeles, California, United States, 90012
Contact: William Cunningham         
AltaMed Health Services Corporation Recruiting
Los Angeles, California, United States, 90022
Contact: William Cunningham, MD, MPH    310-794-3556    wcunningham@mednet.ucla.edu   
Oasis Clinic Recruiting
Los Angeles, California, United States, 90059
Contact: William Cunningham       wcunningham@mednet.ucla.edu   
Olive View Medical Center Active, not recruiting
Sylmar, California, United States, 91342
Northeast Valley Health Corporation Recruiting
Van Nuys, California, United States, 91401
Contact: William Cunningham, MD, MPH    310-794-3556      
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: William Cunningham, MD, MPH University of California, Los Angeles

Responsible Party: William Cunningham, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02310893     History of Changes
Other Study ID Numbers: 1R01MH103076-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017