Human Immunodeficiency Virus
Conditions
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
Brief 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 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.
Interventions
DEVICEIntervention 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.)
OTHEREducational 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.
Sponsors
The Miriam Hospital
New York University
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Viral Load Suppression | 24 weeks | Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Community Care | 24 weeks | At least 1 visit to health care provider in past 24 weeks/6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 57 |
| Total | 112 |
Baseline characteristics
| Characteristic | Control Arm | CARE Tool and Cell Phone/Text Messaging | Total |
|---|---|---|---|
| Age, Continuous | 39 years | 42 years | 41.5 years |
| Baseline Viral Suppression Not virally suppressed (PVL >=100) | 17 participants | 22 participants | 39 participants |
| Baseline Viral Suppression Virally suppressed (PVL<100) | 37 participants | 32 participants | 69 participants |
| Sex/Gender, Customized Female | 13 participants | 14 participants | 27 participants |
| Sex/Gender, Customized Male | 32 participants | 33 participants | 65 participants |
| Sex/Gender, Customized Transgender | 10 participants | 10 participants | 20 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 57 |
| serious Total, serious adverse events | 0 / 55 | 0 / 57 |
Outcome results
Primary
Plasma Viral Load Suppression
Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction
Time frame: 24 weeks
Population: All study participants with available PVL data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm | Plasma Viral Load Suppression | Virally suppressed (PVL<100) | 26 participants |
| Control Arm | Plasma Viral Load Suppression | Not virally suppressed (PVL >=100) | 23 participants |
| CARE Tool and Cell Phone/Text Messaging | Plasma Viral Load Suppression | Virally suppressed (PVL<100) | 23 participants |
| CARE Tool and Cell Phone/Text Messaging | Plasma Viral Load Suppression | Not virally suppressed (PVL >=100) | 24 participants |
Secondary
Linkage to Community Care
At least 1 visit to health care provider in past 24 weeks/6 months
Time frame: 24 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Linkage to Community Care | Yes-achieved outcome | 45 Participants |
| Control Arm | Linkage to Community Care | No-did not achieve outcome | 6 Participants |
| CARE Tool and Cell Phone/Text Messaging | Linkage to Community Care | Yes-achieved outcome | 47 Participants |
| CARE Tool and Cell Phone/Text Messaging | Linkage to Community Care | No-did not achieve outcome | 5 Participants |