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

NCT ID: NCT01721226

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Educational video on opiate overdose prevention

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Intervention Arm (computer-based CARE+ Corrections tool)

Intervention Type: DEVICE

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.)

Interventions

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.)

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Kuo, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

George Washington University School of Public Health and Health Services

Locations

Family and Medical Counseling Services

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32053119 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28081178 (View on PubMed)

Other Identifiers

R01DA030747-01

Identifier Type: NIH

Identifier Source: org_study_id

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