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

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Arm (computer-based CARE+ Corrections tool)
Educational video on opiate overdose prevention
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Family and Medical Counseling Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control Arm

CARE tool and cell phone/text messaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Plasma Viral Load Suppression
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction

Secondary Outcome Measures

Linkage to Community Care
At least 1 visit to health care provider in past 24 weeks/6 months

Full Information

First Posted
October 16, 2012
Last Updated
December 20, 2016
Sponsor
George Washington University
Collaborators
The Miriam Hospital, New York University
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1. Study Identification

Unique Protocol Identification Number
NCT01721226
Brief Title
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
Acronym
CARE+
Official Title
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University
Collaborators
The Miriam Hospital, New York University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. The study also has an evaluation component to it. The evaluation component consists in a series of qualitative interviews with the goal of gaining a better understanding of the barriers and facilitators involved in implementing the CARE+ Corrections intervention and to better assess the usability and participants' experiences with the CARE+ Corrections intervention. The semi-structured interviews are being conducted among the following groups: 1) managers and staff at local correctional facilities and agencies which have interaction with HIV+ individuals transitioning to the community; 2) leadership and selected staff at relevant and targeted community-based organizations; and 3) selected study participants from the intervention group of the RCT. the interviews elicit perspectives on the foreseen facilitators and challenges in implementing the CARE+ Corrections tool at their respective organizations as well as their perception on the acceptability of the tool. We also ask their views about the intervention and the post-release experiences of HIV-positive individuals who complete the CARE+ Corrections Tool and receive the text message plan. No prisoners will be involved in this subsection of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
CARE tool and cell phone/text messaging
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Intervention Arm (computer-based CARE+ Corrections tool)
Intervention Description
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.)
Intervention Type
Other
Intervention Name(s)
Educational video on opiate overdose prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma Viral Load Suppression
Description
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Linkage to Community Care
Description
At least 1 visit to health care provider in past 24 weeks/6 months
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Kuo, PhD, MPH
Organizational Affiliation
George Washington University School of Public Health and Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family and Medical Counseling Services
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32053119
Citation
Uhrig Castonguay BJ, Cressman AE, Kuo I, Patrick R, Trezza C, Cates A, Olsen H, Peterson J, Kurth A, Bazerman LB, Beckwith CG. The Implementation of a Text Messaging Intervention to Improve HIV Continuum of Care Outcomes Among Persons Recently Released From Correctional Facilities: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Feb 13;8(2):e16220. doi: 10.2196/16220.
Results Reference
derived
PubMed Identifier
28081178
Citation
Beckwith C, Castonguay BU, Trezza C, Bazerman L, Patrick R, Cates A, Olsen H, Kurth A, Liu T, Peterson J, Kuo I. Gender Differences in HIV Care among Criminal Justice-Involved Persons: Baseline Data from the CARE+ Corrections Study. PLoS One. 2017 Jan 12;12(1):e0169078. doi: 10.1371/journal.pone.0169078. eCollection 2017.
Results Reference
derived

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

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