Human Immunodeficiency VirusCARE+NCT01721226
CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
A study testing Intervention Arm (computer-based CARE+ Corrections tool) and Educational video on opiate overdose prevention in people with Human Immunodeficiency Virus, run by George Washington University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Intervention Arm (computer-based CARE+ Corrections tool) and Educational video on opiate overdose prevention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently detained in jail or released from the jail/prison 6 months ago or less
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Family and Medical Counseling Services
Washington D.C., District of Columbia, 20020
About this study
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.
Read the detailed description
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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Intervention Arm (computer-based CARE+ Corrections tool), Educational video on opiate overdose prevention
- Keywords
- Linkage to HIV care following release from prison, Anti-retroviral therapy adherence after release from prison, HIV loads after release from prison, information technology and ART adherence, information technology and linkage to HIV care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Intervention Arm (computer-based CARE+ Corrections tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Viral Load Suppression
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Measured: 24 weeks
Secondary outcomes (1)
Linkage to Community Care
At least 1 visit to health care provider in past 24 weeks/6 months
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, New York University
- Responsible party
- Sponsor
- Investigators
- Irene Kuo, PhD, MPH, Principal investigator, George Washington University School of Public Health and Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721226
- Sponsor's protocol ID
- R01DA030747-01
- Acronym
- CARE+
- Status last verified
- Dec 2016
- First submitted
- 16 Oct 2012
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32053119Beckwith 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.
PubMed 28081178
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)
- ClinicalTrials.gov ID
- NCT01721226
- Acronym / sponsor ID
- CARE+ / R01DA030747-01
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Linkage to HIV care following release from prison, Anti-retroviral therapy adherence after release from prison, HIV loads after release from prison, information technology and ART adherence, information technology and linkage to HIV care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital, New York University
- Study start
- Aug 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Sham comparator | Other: Educational video on opiate overdose preventionParticipants 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 | Experimental | Device: Intervention Arm (computer-based CARE+ Corrections tool)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently detained in jail or released from the jail/prison 6 months ago or less
- 18 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.) | Device | CARE tool and cell phone/text messaging |
| Educational video on opiate overdose preventionParticipants 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. | Other | Control Arm |
Primary outcome
Plasma Viral Load Suppression
Time frame: 24 weeks
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
1 secondary outcome
Linkage to Community Care
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32053119Uhrig 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.
- Derived from this study: PubMed 28081178Beckwith 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.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Kuo, PhD, MPH principal investigator
George Washington University School of Public Health and Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm (computer-based CARE+ Corrections tool) and Educational video on opiate overdose prevention in people with Human Immunodeficiency Virus, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Viral Load Suppression (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.