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Clinical Trials/NCT02310893
NCT02310893CompletedNot Applicable

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

University of California, Los Angeles6 sites in 1 country579 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
579
Locations
6
Primary Endpoint
Change in HIV RNA viral load suppression and medication adherence over 12 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not meeting any of the criteria identified above

Arms & Interventions

Contingency Management only

Active Comparator

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

Intervention: Contingency Management (Behavioral)

Peer Navigation only

Active Comparator

Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care

Intervention: Peer Navigation (Behavioral)

Combined Contingency Management and Peer Navigation

Experimental

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.

Intervention: Combined Contingency Management and Peer Navigation (Behavioral)

Usual care

No Intervention

Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Cost effectiveness(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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