We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01721226
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Human Immunodeficiency Virus
Interventions: Device: Intervention Arm (computer-based CARE+ Corrections tool)
Other: Educational video on opiate overdose prevention

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Control Arm   CARE Tool and Cell Phone/Text Messaging
STARTED   55   57 
Baseline   53   57 
Week 12   48   53 
Week 24   50   50 
COMPLETED   50   50 
NOT COMPLETED   5   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Control Arm   CARE Tool and Cell Phone/Text Messaging   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   57   112 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 39 
 (30 to 57) 
 42 
 (30 to 50) 
 41.5 
 (30 to 49) 
Gender, Customized 
[Units: Participants]
     
Male   32   33   65 
Female   13   14   27 
Transgender   10   10   20 
Baseline Viral Suppression 
[Units: Participants]
     
Virally suppressed (PVL<100)   37   32   69 
Not virally suppressed (PVL >=100)   17   22   39 


  Outcome Measures

1.  Primary:   Plasma Viral Load Suppression   [ Time Frame: 24 weeks ]

2.  Secondary:   Linkage to Community Care   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Irene Kuo
Organization: George Washington University
phone: 202-994-0367
e-mail: ikuo@gwu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01721226     History of Changes
Other Study ID Numbers: R01DA030747-01 ( U.S. NIH Grant/Contract )
First Submitted: October 16, 2012
First Posted: November 5, 2012
Results First Submitted: September 14, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017