Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care (LINK LA)

November 16, 2020 updated by: University of California, Los Angeles
This study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study has two Primary Specific Aims:

  1. To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
  2. Using a two-group experimental RCT design, to test the adapted peer navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;

The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.

Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.

Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90012
        • LA County Jail

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Age 18 or older
  • Men or TGW diagnosed HIV-positive
  • English or bilingual Spanish speaking
  • Selected for the TCM program (control condition) prior to LINK LA enrollment
  • Residing in LA County upon release
  • Eligible for ART or incarcerated on ART.

Exclusion criteria:

  • Inability to give informed consent
  • Parole hold or planned transfer to prison
  • Stay in jail <5 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Navigation Intervention Arm

Subjects will receive the following peer navigation services:

1) 10 Navigator meetings: Navigators will meet with participants in person to teach linkage/retention skills and knowledge

2a) 2 Navigator accompaniment sessions: the peer navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge and things that make it hard or easy for him/her to get regular HIV care

2b) Optional peer navigator accompaniment sessions: If the participant requests, the peer navigator will provide accompaniment to supportive HIV care appointments (one per month max)

3) 14 peer navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care.
Behavioral: Peer Navigator
Peer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
No Intervention: Usual Care
Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage to HIV Care
Time Frame: 12 months
Number of HIV+ ex jail inmates accessing HIV care
12 months
Retention in Treatment
Time Frame: 12 months
This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
12 months
Adherence to Treatment
Time Frame: 12 months
How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.
12 months
Viral Load
Time Frame: 12 months
HIV+ ex jail inmates' viral load
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs
Time Frame: 12 months
Cost of the intervention and HIV care
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Los Angeles County Department of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA030781 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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