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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01406626
Collaborator
Los Angeles County Department of Public Health (Other)
356
1
2
46
7.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Navigator
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
356 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Linkage to HIV Care [12 months]

    Number of HIV+ ex jail inmates accessing HIV care

  2. Retention in Treatment [12 months]

    This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.

  3. Adherence to Treatment [12 months]

    How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.

  4. Viral Load [12 months]

    HIV+ ex jail inmates' viral load

Secondary Outcome Measures

  1. Costs [12 months]

    Cost of the intervention and HIV care

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 LA County Jail Los Angeles California United States 90012

Sponsors and Collaborators

  • University of California, Los Angeles
  • Los Angeles County Department of Public Health

Investigators

  • Principal Investigator: William E Cunningham, MD, MPH, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01406626
Other Study ID Numbers:
  • R01DA030781
First Posted:
Aug 1, 2011
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Keywords provided by University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2020