Trial Outcomes & Findings for CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC) (NCT NCT01721226)
NCT ID: NCT01721226
Last Updated: 2017-02-10
Results Overview
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
57
|
|
Overall Study
Baseline
|
53
|
57
|
|
Overall Study
Week 12
|
48
|
53
|
|
Overall Study
Week 24
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
Baseline characteristics by cohort
| Measure |
Control Arm
n=55 Participants
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
n=57 Participants
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
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
42 years
n=7 Participants
|
41.5 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Baseline Viral Suppression
Virally suppressed (PVL<100)
|
37 participants
n=5 Participants
|
32 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Baseline Viral Suppression
Not virally suppressed (PVL >=100)
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All study participants with available PVL data
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Outcome measures
| Measure |
Control Arm
n=49 Participants
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
n=47 Participants
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.
|
|---|---|---|
|
Plasma Viral Load Suppression
Virally suppressed (PVL<100)
|
26 participants
|
23 participants
|
|
Plasma Viral Load Suppression
Not virally suppressed (PVL >=100)
|
23 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 24 weeksAt least 1 visit to health care provider in past 24 weeks/6 months
Outcome measures
| Measure |
Control Arm
n=51 Participants
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
n=52 Participants
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.
|
|---|---|---|
|
Linkage to Community Care
Yes-achieved outcome
|
45 Participants
|
47 Participants
|
|
Linkage to Community Care
No-did not achieve outcome
|
6 Participants
|
5 Participants
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CARE Tool and Cell Phone/Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place