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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310893
Other study ID # 1R01MH103076-01A1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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