NCT01721226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

October 16, 2012

Results QC Date

September 14, 2016

Last Update Submit

December 20, 2016

Conditions

Human Immunodeficiency Virus

Keywords

Linkage to HIV care following release from prisonAnti-retroviral therapy adherence after release from prisonHIV loads after release from prisoninformation technology and ART adherenceinformation technology and linkage to HIV care

Outcome Measures

Primary Outcomes (1)

  • Plasma Viral Load Suppression

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

    24 weeks

Secondary Outcomes (1)

  • Linkage to Community Care

    24 weeks

Study Arms (2)

Control Arm

SHAM COMPARATOR

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.

Other: Educational video on opiate overdose prevention

CARE tool and cell phone/text messaging

EXPERIMENTAL

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.

Device: Intervention Arm (computer-based CARE+ Corrections tool)

Interventions

Intervention Arm (computer-based CARE+ Corrections tool)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.)

CARE tool and cell phone/text messaging
Educational video on opiate overdose preventionOTHER

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.

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently detained in jail or released from the jail/prison 6 months ago or less
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family and Medical Counseling Services

Washington D.C., District of Columbia, 20020, United States

Location

Related Publications (2)

  • 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.

    PMID: 32053119DERIVED

  • 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.

    PMID: 28081178DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Irene Kuo
Organization
George Washington University
ikuo@gwu.edu
202-994-0367

Study Officials

  • Irene Kuo, PhD, MPH

    George Washington University School of Public Health and Health Services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

November 5, 2012

Study Start

August 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-12

Locations

US(1)