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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).
The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period. Exclusion criteria will be: 1) unable to give informed consent. The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care. Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care. Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole. Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-site Rapid HIV Testing | Experimental | On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office. |
|
| Off-site Referral for HIV Testing | No Intervention | Off-site referral for rapid HIV testing at a community health center or HIV testing clinic | |
| Project Bridge | Experimental | Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. |
|
| Treatment as Usual | No Intervention | Passive referral to HIV community treatment provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Bridge | Behavioral | Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Willing to Undergo Rapid HIV Testing | Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek). Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test). | Baseline |
| Number of Participants That Entered Community HIV Treatment | Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period. | 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Community HIV Treatment | Number of Days with Retention in Community HIV Treatment | 18 months |
| Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Gordon, D.P.A. | Friends Research Institute, Inc. | Principal Investigator |
| Josiah D Rich, M.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation | Baltimore | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33492021 | Derived | Crable EL, Blue TR, McKenzie M, Rich JD, Gordon MS. Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2021 May 1;87(1):755-762. doi: 10.1097/QAI.0000000000002624. | |
| 23536140 | Derived | Gordon MS, Kinlock TW, McKenzie M, Wilson ME, Rich JD. Rapid HIV testing for individuals on probation/parole: outcomes of an intervention trial. AIDS Behav. 2013 Jul;17(6):2022-30. doi: 10.1007/s10461-013-0456-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Project Bridge | Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. |
| FG001 | Treatment As Usual | Passive referral to HIV community treatment provider. |
| FG002 | On-site Testing | HIV testing on-site at probation/parole office |
| FG003 | Off-Site Testing | Off-site HIV testing at a community health center or HIV clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Testing Study |
| |||||||||||||
| HIV Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Project Bridge | Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Allows for reporting of two RCT baseline measures. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Willing to Undergo Rapid HIV Testing | Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek). Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test). | Posted | Count of Participants | Participants | Baseline |
|
18-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Project Bridge | Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. Project Bridge: Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Social circumstances | Non-systematic Assessment | overdose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael S. Gordon, Senior Research Scientist | Friends Research Institute | 410-837-3977 | 251 | mgordon@friendsresearch.org |
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To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
| 6,12,18-months |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment as Usual | Passive referral to HIV community treatment provider |
| BG002 | On-site Testing | Rapid oral swab HIV testing on-site at a community supervision office. |
| BG003 | Off-Site Testing | HIV testing at a community treatment clinic. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Allows for reporting of two RCT baseline measures | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Allows for reporting of two RCT baseline measures | Count of Participants | Participants |
|
| Race (NIH/OMB) | Allows for reporting of two RCT baseline measures | Count of Participants | Participants |
|
| OG001 |
| Off-site Referral for HIV Testing |
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic |
|
|
| Primary | Number of Participants That Entered Community HIV Treatment | Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period. | Posted | Count of Participants | Participants | 3-months |
|
|
|
| Secondary | Retention in Community HIV Treatment | Number of Days with Retention in Community HIV Treatment | Posted | Mean | Standard Deviation | days | 18 months |
|
|
|
| Secondary | Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable | To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections. | We were unable to obtain official medical records from treatment clinics. | Posted | 6,12,18-months |
|
|
| 1 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | Treatment As Usual | Passive referral to HIV community treatment provider. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | On-site Testing | HIV testing on-site at probation/parole office. | 0 | 349 | 0 | 349 | 0 | 349 |
| EG003 | Off-site Testing | HIV testing at a community health center or HIV clinic. | 0 | 348 | 0 | 348 | 0 | 348 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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