An interventional study of Intervention Arm (computer-based CARE+ Corrections tool) and Educational video on opiate overdose prevention in Human Immunodeficiency Virus, sponsored by George Washington University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by George Washington University · Not applicable, Interventional, and Supportive care
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 112 is close to the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.)
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.
Plasma Viral Load Suppression
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Time frame: 24 weeks
Linkage to Community Care
At least 1 visit to health care provider in past 24 weeks/6 months
Time frame: 24 weeks
| Milestone | 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 |
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
| participants | Control Arm | CARE Tool and Cell Phone/Text Messaging |
|---|---|---|
| Virally suppressed (PVL<100) | 26 | 23 |
| Not virally suppressed (PVL >=100) | 23 | 24 |
At least 1 visit to health care provider in past 24 weeks/6 months
| Participants | Control Arm | CARE Tool and Cell Phone/Text Messaging |
|---|---|---|
| Yes-achieved outcome | 45 | 47 |
| No-did not achieve outcome | 6 | 5 |
Collected over Enrollment and follow-up period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Arm | — | 0/55 (0%) | 0/55 (0%) |
| CARE Tool and Cell Phone/Text Messaging | — | 0/57 (0%) | 0/57 (0%) |
| Age, Continuous(years) | Control Arm | CARE Tool and Cell Phone/Text Messaging | Total |
|---|---|---|---|
| Median | 39 (30 to 57) | 42 (30 to 50) | 41.5 (30 to 49) |
| Sex/Gender, Customized(participants) | Control Arm | CARE Tool and Cell Phone/Text Messaging | Total |
|---|---|---|---|
| Male | 32 | 33 | 65 |
| Female | 13 | 14 | 27 |
| Transgender | 10 | 10 | 20 |
| Baseline Viral Suppression(participants) | Control Arm | CARE Tool and Cell Phone/Text Messaging | Total |
|---|---|---|---|
| Virally suppressed (PVL<100) | 37 | 32 | 69 |
| Not virally suppressed (PVL >=100) | 17 | 22 | 39 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
George Washington University