Clinical trial NCT01721226: CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
Official title: CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: New York University
First posted: 2012-11-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Plasma Viral Load Suppression
timeFrame: 24 weeks
Secondary outcomes:
measure: Linkage to Community Care
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Family and Medical Counseling Services
state: District of Columbia
Study officials:
affiliation: George Washington University School of Public Health and Health Services
name: Irene Kuo, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.