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

Human Immunodeficiency Virus Clinical Trial

— CARE+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721226
• Other study ID #: R01DA030747-01
• Status: Completed
• Phase: N/A
• First received: October 16, 2012
• Last updated: April 19, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Family and Medical Counseling Services	Washington DC	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
George Washington University	New York University, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Viral Load Suppression	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.	24 weeks	No
Secondary	Linkage to community care	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.	24 weeks	No