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

Human Immunodeficiency Virus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Human Immunodeficiency Virus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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 preventionParticipants 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Control ArmParticipants 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.

CARE tool and cell phone/text messagingThe 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.

Study Status

Completed

Start Date: August 2013

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Plasma Viral Load Suppression

Secondary Outcome: Linkage to Community Care

Study sponsors, principal investigator, and references

Principal Investigator: Irene Kuo, PhD, MPH

Lead Sponsor: George Washington University

Collaborator: The Miriam Hospital

More information:https://clinicaltrials.gov/show/NCT01721226

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