CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC) (CARE+)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by George Washington University
Sponsor:
Collaborators:
The Miriam Hospital
New York University
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01721226
First received: October 16, 2012
Last updated: May 23, 2014
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether an intervention (CARE+ Corrections) delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and recently -released ex-detainees in the community can improve linkage to community HIV care and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral suppression following community re-entry.


Condition Intervention
Human Immunodeficiency Virus
Device: Intervention Arm (computer-based CARE+ Corrections tool)
Other: Educational video on opiate overdose prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Plasma Viral Load Suppression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Study participants' Plasma Viral Load will be obtained by GWU study staff at baseline by either a chart review within the jail or as blood draw at post-release. In addition, Plasma Viral Load will be obtained by GWU study staff at 12 and 24 weeks.


Secondary Outcome Measures:
  • Linkage to community care [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    During the two follow-up visits after enrollment(12 week and 24 week), study participants will self-report their linkage to HIV care. GW staff will then validate linkage to care by reviewing medical records.


Estimated Enrollment: 320
Study Start Date: August 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Arm
Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
Other: Educational video on opiate overdose prevention
Participants in the Control Arm will view an educational video on opiate overdose prevention in jail prior to release. Control arm participants will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
Experimental: CARE tool and cell phone/text messaging
The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
Device: Intervention Arm (computer-based CARE+ Corrections tool)
Study participants in the intervention arm will complete the computer-based CARE+ Corrections tool at baseline. The CARE tool provides tailored feedback based on the participants' responses to a series of questions included in the counseling session. Participants in this arm of the study recruited inside the DC DOC will receive typical discharge planning services as conducted by the correctional facility. Participants will be followed for six months after release/study enrollment. At the post-release baseline visit, participants in the intervention arm will receive a cell phone/SMS text messaging intervention consisting of using cell phone-delivered SMS text messages with the intent of improving linkage to community HIV care and adherence to ART (if prescribed.)

Detailed Description:

The intervention is modeled after CARE, a technology based HIV-counseling tool used in other settings. The investigators have adapted CARE to create CARE+ Corrections, a tool designed specifically for incarcerated and recently-released populations. New and innovative information communication tools (ICT), including a cell phone/text messaging component delivered in the community after release from jail, will be included in the intervention.

The study is a randomized controlled trial. One half of the participants will receive the intervention either inside the jail, in addition to standard discharge planning services, or in the community right after release. The other half of the participants will view an educational video related to the prevention of drug overdose following release, in addition to standard discharge planning services, or in the community right after release. The investigators will follow all participants for 6 months post release/study enrollment and determine if the linkage to community care and adherence to HIV medications was higher in the intervention arm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently detained in jail or released from the jail/prison 6 months ago or less
  • 18 years of age or older
  • English speaking
  • Able to provide informed consent for research participation
  • Anticipated release from the DOC to the community (or living in the community if recently released ex-detainee)
  • Confirmed to be HIV-infected by self-report
  • Live in metropolitan Washington, DC area
  • Able to read at 8th grade level as assessed by brief literacy screen

Exclusion Criteria:

  • Expected release to restricted setting (or currently living in a restricted setting if recruited in the community), including residential drug treatment, sober house, half-way house, or similar
  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: NCT01721226

Contacts
Contact: Claudia Trezza, MPH 202-994-4676 ctrezza@gwu.edu

Locations
United States, District of Columbia
Vioices for a Second Chance Recruiting
Washington, District of Columbia, United States, 20003
Sponsors and Collaborators
George Washington University
The Miriam Hospital
New York University
Investigators
Principal Investigator: Irene Kuo, PhD, MPH George Washington University School of Public Health and Health Services
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01721226     History of Changes
Other Study ID Numbers: R01DA030747-01
Study First Received: October 16, 2012
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Linkage to HIV care following release from prison
Anti-retroviral therapy adherence after release from prison
HIV loads after release from prison
information technology and ART adherence
information technology and linkage to HIV care

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014