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Trial record 10 of 31 for:    " September 26, 2012":" October 26, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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:
The Miriam Hospital
New York University
Information provided by (Responsible Party):
George Washington University

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
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Arm CARE Tool and Cell Phone/Text Messaging
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 55 57
Baseline 53 57
Week 12 48 53
Week 24 50 50
Completed 50 50
Not Completed 5 7
Arm/Group Title Control Arm CARE Tool and Cell Phone/Text Messaging Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 55 57 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 55 participants 57 participants 112 participants
39
(30 to 57)
42
(30 to 50)
41.5
(30 to 49)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Male 32 33 65
Female 13 14 27
Transgender 10 10 20
Baseline Viral Suppression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Virally suppressed (PVL<100) 37 32 69
Not virally suppressed (PVL >=100) 17 22 39
1.Primary Outcome
Title Plasma Viral Load Suppression
Hide Description Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All study participants with available PVL data
Arm/Group Title Control Arm CARE Tool and Cell Phone/Text Messaging
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 49 47
Measure Type: Number
Unit of Measure: participants
Virally suppressed (PVL<100) 26 23
Not virally suppressed (PVL >=100) 23 24
2.Secondary Outcome
Title Linkage to Community Care
Hide Description At least 1 visit to health care provider in past 24 weeks/6 months
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm CARE Tool and Cell Phone/Text Messaging
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 51 52
Measure Type: Count of Participants
Unit of Measure: Participants
Yes-achieved outcome
45
  88.2%
47
  90.4%
No-did not achieve outcome
6
  11.8%
5
   9.6%
Time Frame Enrollment and follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Arm CARE Tool and Cell Phone/Text Messaging
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Control Arm CARE Tool and Cell Phone/Text Messaging
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Arm CARE Tool and Cell Phone/Text Messaging
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Arm CARE Tool and Cell Phone/Text Messaging
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/57 (0.00%) 
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
EMail: ikuo@gwu.edu
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