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

HIV/AIDS Clinical Trial

— CHAMPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310893
• Other study ID #: 1R01MH103076-01A1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Combined Contingency Management and Peer Navigation

• Contingency Management

• Peer Navigation

Locations

Country	Name	City	State
United States	AltaMed Health Services Corporation	Los Angeles	California
United States	Center for Health Justice	Los Angeles	California
United States	Los Angeles Sheriff's Department	Los Angeles	California
United States	Oasis Clinic	Los Angeles	California
United States	Olive View Medical Center	Sylmar	California
United States	Northeast Valley Health Corporation	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cost effectiveness	A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care	5 years