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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Combined Contingency Management and Peer Navigation
* Behavioral: Contingency Management
* Behavioral: Peer Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contingency Management only<br>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<br> <br> |
| Active Comparator: Peer Navigation only<br>Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care | Behavioral: Peer Navigation<br> <br> |
| Experimental: Combined Contingency Management and Peer Navigation<br>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<br> <br> |
| No Intervention: Usual care<br>Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness | A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care | 5 years |