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

October 16, 2012
May 23, 2014
August 2013
March 2015   (final data collection date for primary outcome measure)
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.
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 if chart review is not available. In addition, Plasma Viral Load will be obtained by GWU study staff at 12 and 24 weeks.
Complete list of historical versions of study NCT01721226 on ClinicalTrials.gov Archive Site
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.
Linkage to community care [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
During the two follow-up visits after discharge from jail (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.
Not Provided
Not Provided
 
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Human Immunodeficiency Virus
  • 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.)
  • 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.
  • 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.
    Intervention: Other: Educational video on opiate overdose prevention
  • 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.
    Intervention: Device: Intervention Arm (computer-based CARE+ Corrections tool)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
November 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Claudia Trezza, MPH 202-994-4676 ctrezza@gwu.edu
United States
 
NCT01721226
R01DA030747-01
Yes
George Washington University
George Washington University
  • The Miriam Hospital
  • New York University
Principal Investigator: Irene Kuo, PhD, MPH George Washington University School of Public Health and Health Services
George Washington University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP