Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care (LINK LA)
|ClinicalTrials.gov Identifier: NCT01406626|
Recruitment Status : Unknown
Verified January 2016 by William Cunningham, University of California, Los Angeles.
Recruitment status was: Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV-infection/Aids||Behavioral: Health Navigator||Not Applicable|
The proposed study has two Primary Specific Aims:
- 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);
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: Health Navigation Intervention Arm
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.
Behavioral: 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: Usual Care
Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail
- Linkage to HIV Care [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ]Linking HIV+ ex jail inmates to HIV care
- Retention in Treatment [ Time Frame: 12 months total (baseline, 2, 6, and 12 month follow ups) ]This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
- Adherence to Treatment [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ]This measures how adherent the HIV+ ex jail inmates are to their treatment regiment.
- Viral Load [ Time Frame: 12 months total (Baseline, 2 and 12 month follow ups) ]This measures the HIV+ ex jail inmates' viral load to see how effective their treatment adherence has been.
- Costs [ Time Frame: Assessed at one point only toward the end of the study period ]To examine whether the costs of the intervention and HIV care are offset by reductions in healthcare and recidivism costs from the perspective of LA County.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406626
|United States, California|
|LA County Jail|
|Los Angeles, California, United States, 90012|
|Principal Investigator:||William E Cunningham, MD, MPH||University of California, Los Angeles|