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

Primary Purpose

HIV-infection/Aids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Navigator
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-infection/Aids focused on measuring HIV, AIDS, Peer navigation, Viral load, Corrections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • LA County Jail

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Navigation Intervention Arm

Usual Care

Arm Description

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.

Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Costs
Cost of the intervention and HIV care

Full Information

First Posted
July 28, 2011
Last Updated
November 16, 2020
Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT01406626
Brief Title
Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Acronym
LINK LA
Official Title
Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The proposed study has two Primary Specific Aims: 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); 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids
Keywords
HIV, AIDS, Peer navigation, Viral load, Corrections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Navigation Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigator
Intervention Description
Peer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
Primary Outcome Measure Information:
Title
Linkage to HIV Care
Description
Number of HIV+ ex jail inmates accessing HIV care
Time Frame
12 months
Title
Retention in Treatment
Description
This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
Time Frame
12 months
Title
Adherence to Treatment
Description
How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.
Time Frame
12 months
Title
Viral Load
Description
HIV+ ex jail inmates' viral load
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Costs
Description
Cost of the intervention and HIV care
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-represented transgender women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Cunningham, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
LA County Jail
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29532059
Citation
Cunningham WE, Weiss RE, Nakazono T, Malek MA, Shoptaw SJ, Ettner SL, Harawa NT. Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):542-553. doi: 10.1001/jamainternmed.2018.0150.
Results Reference
derived

Learn more about this trial

Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care

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