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

HIV-infection/Aids Clinical Trial

— LINK LA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406626
• Other study ID #: R01DA030781
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-infection/Aids

Intervention

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

Locations

Country	Name	City	State
United States	LA County Jail	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Los Angeles County Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to HIV Care	Number of HIV+ ex jail inmates accessing HIV care	12 months
Primary	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
Primary	Adherence to Treatment	How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.	12 months
Primary	Viral Load	HIV+ ex jail inmates' viral load	12 months
Secondary	Costs	Cost of the intervention and HIV care	12 months