Trial record 5 of 34 for: " July 27, 2011":" August 26, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care (LINK LA)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Los Angeles County Department of Public Health

Information provided by (Responsible Party):

William Cunningham, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01406626

First received: July 28, 2011

Last updated: January 15, 2016

Last verified: January 2016

History of Changes

Purpose

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.

Condition	Intervention
HIV-infection/Aids	Behavioral: Health Navigator


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Linkage to HIV Care [ Time Frame: 12 months (baseline, 2, 6, and 12 month follow ups) ] [ Designated as safety issue: No ]
Linking HIV+ ex jail inmates to HIV care
Retention in Treatment [ Time Frame: 12 months total (baseline, 2, 6, and 12 month follow ups) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
This measures the HIV+ ex jail inmates' viral load to see how effective their treatment adherence has been.

Secondary Outcome Measures:

Costs [ Time Frame: Assessed at one point only toward the end of the study period ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	360
Study Start Date:	December 2012
Estimated Study Completion Date:	June 2016
Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age: 18 years or older
Male or male-to-female transgender
Fluency in English
Residing in LA County upon release

Exclusion Criteria:

Inability to give informed consent
stays in jail <5 days
Lack of English fluency

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406626

Locations


United States, California
LA County Jail
Los Angeles, California, United States, 90012

Sponsors and Collaborators

University of California, Los Angeles

Los Angeles County Department of Public Health

Investigators


Principal Investigator:	William E Cunningham, MD, MPH	University of California, Los Angeles

More Information


Responsible Party:	William Cunningham, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01406626 History of Changes
Other Study ID Numbers:	R01DA030781
Study First Received:	July 28, 2011
Last Updated:	January 15, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:


HIV AIDS Health navigation Viral load Corrections

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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