CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC) (CARE+)
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|ClinicalTrials.gov Identifier: NCT01721226|
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Device: Intervention Arm (computer-based CARE+ Corrections tool) Other: Educational video on opiate overdose prevention||Not Applicable|
The intervention is modeled after CARE, a technology based HIV-counseling tool used in other settings. The investigators have adapted CARE to create CARE+ Corrections, a tool designed specifically for incarcerated and recently-released populations. New and innovative information communication tools (ICT), including a cell phone/text messaging component delivered in the community after release from jail, will be included in the intervention.
The study is a randomized controlled trial. One half of the participants will receive the intervention either inside the jail, in addition to standard discharge planning services, or in the community right after release. The other half of the participants will view an educational video related to the prevention of drug overdose following release, in addition to standard discharge planning services, or in the community right after release. The investigators will follow all participants for 6 months post release/study enrollment and determine if the linkage to community care and adherence to HIV medications was higher in the intervention arm.
The study also has an evaluation component to it. The evaluation component consists in a series of qualitative interviews with the goal of gaining a better understanding of the barriers and facilitators involved in implementing the CARE+ Corrections intervention and to better assess the usability and participants' experiences with the CARE+ Corrections intervention. The semi-structured interviews are being conducted among the following groups: 1) managers and staff at local correctional facilities and agencies which have interaction with HIV+ individuals transitioning to the community; 2) leadership and selected staff at relevant and targeted community-based organizations; and 3) selected study participants from the intervention group of the RCT. the interviews elicit perspectives on the foreseen facilitators and challenges in implementing the CARE+ Corrections tool at their respective organizations as well as their perception on the acceptability of the tool. We also ask their views about the intervention and the post-release experiences of HIV-positive individuals who complete the CARE+ Corrections Tool and receive the text message plan.
No prisoners will be involved in this subsection of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
Sham Comparator: 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.
Other: Educational video on opiate overdose prevention
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.
Experimental: 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.
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.)
- Plasma Viral Load Suppression [ Time Frame: 24 weeks ]Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
- Linkage to Community Care [ Time Frame: 24 weeks ]At least 1 visit to health care provider in past 24 weeks/6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721226
|United States, District of Columbia|
|Family and Medical Counseling Services|
|Washington DC, District of Columbia, United States, 20020|
|Principal Investigator:||Irene Kuo, PhD, MPH||George Washington University School of Public Health and Health Services|