Clinical trial NCT01406626: Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Official title: Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/Aids
Keywords: HIV
AIDS
Peer navigation
Viral load
Corrections
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
First posted: 2011-08-01
Enrollment: 356
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Linkage to HIV Care
timeFrame: 12 months
measure: Retention in Treatment
timeFrame: 12 months
measure: Adherence to Treatment
timeFrame: 12 months
measure: Viral Load
timeFrame: 12 months
Secondary outcomes:
measure: Costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County Jail
state: California
Study officials:
affiliation: University of California, Los Angeles
name: William E Cunningham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.