This trial is active, not recruiting.

Condition hiv-infection/aids
Treatment health navigator
Sponsor University of California, Los Angeles
Collaborator Los Angeles County Department of Public Health
Start date December 2012
End date January 2016
Trial size 360 participants
Trial identifier NCT01406626, R01DA030781


This study will implement a health navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Subjects will receive the following health 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 health navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge things that make it hard or easy for him to get regular HIV care 2b) Optional health navigator accompaniment sessions: If the participant requests, the health navigator will provide accompaniment to supportive HIV care appointments (one per month max) 3) 14 Health navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care.
health navigator
Health navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
(No Intervention)
Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail

Primary Outcomes

Linkage to HIV Care
time frame: 12 months (baseline, 2, 6, and 12 month follow ups)
Retention in Treatment
time frame: 12 months total (baseline, 2, 6, and 12 month follow ups)
Adherence to Treatment
time frame: 12 months (baseline, 2, 6, and 12 month follow ups)
Viral Load
time frame: 12 months total (Baseline, 2 and 12 month follow ups)

Secondary Outcomes

time frame: Assessed at one point only toward the end of the study period

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Age: 18 years or older 2. Male or male-to-female transgender 3. Fluency in English 4. Residing in LA County upon release Exclusion Criteria: 1. Inability to give informed consent 2. stays in jail <5 days 3. Lack of English fluency

Additional Information

Official title Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
Principal investigator William E Cunningham, MD, MPH
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 health 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; We hypothesize that the intervention will result in more rapid 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. We hypothesize that active substance abuse will moderate the effect of the intervention, so the intervention will be less effective among participants who report substance use.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.