NCT01406626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

July 28, 2011

Last Update Submit

November 16, 2020

Conditions

HIV-infection/Aids

Keywords

HIVAIDSPeer navigationViral loadCorrections

Outcome Measures

Primary Outcomes (4)

  • Linkage to HIV Care

    Number of HIV+ ex jail inmates accessing HIV care

    12 months

  • Retention in Treatment

    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

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

    12 months

  • Viral Load

    HIV+ ex jail inmates' viral load

    12 months

Secondary Outcomes (1)

  • Costs

    12 months

Study Arms (2)

Peer Navigation Intervention Arm

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Peer NavigatorBEHAVIORAL

Peer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles

Peer Navigation Intervention Arm

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-represented transgender women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LA County Jail

Los Angeles, California, 90012, United States

Location

Related Publications (1)

  • 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.

    PMID: 29532059DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • William E Cunningham, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

December 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

US(1)