HIV
Conditions
Keywords
Seek, Test, Treat
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALProject 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Probation or Parole; 2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Willing to Undergo Rapid HIV Testing | Baseline | 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). |
| Number of Participants That Entered Community HIV Treatment | 3-months | Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Community HIV Treatment | 18 months | Number of Days with Retention in Community HIV Treatment |
| Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable | 6,12,18-months | To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Treatment as Usual Passive referral to HIV community treatment provider | 50 |
| On-site Testing Rapid oral swab HIV testing on-site at a community supervision office. | 349 |
| Off-Site Testing HIV testing at a community treatment clinic. | 348 |
| Total | 797 |
Baseline characteristics
| Characteristic | Project Bridge | Treatment as Usual | Total | On-site Testing | Off-Site Testing |
|---|---|---|---|---|---|
| Age, Continuous HIV Intervention | 46.8 years STANDARD_DEVIATION 6.5 | 45.1 years STANDARD_DEVIATION 8.6 | 45.9 years STANDARD_DEVIATION 7.6 | — | — |
| Age, Continuous HIV Testing | — | — | 38.7 years STANDARD_DEVIATION 11.4 | 39 years STANDARD_DEVIATION 11.6 | 38.3 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) HIV Intervention Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants | — | — |
| Ethnicity (NIH/OMB) HIV Intervention Not Hispanic or Latino | 49 Participants | 48 Participants | 97 Participants | — | — |
| Ethnicity (NIH/OMB) HIV Intervention Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — |
| Ethnicity (NIH/OMB) HIV Testing Hispanic or Latino | — | — | 95 Participants | 44 Participants | 51 Participants |
| Ethnicity (NIH/OMB) HIV Testing Not Hispanic or Latino | — | — | 602 Participants | 305 Participants | 297 Participants |
| Ethnicity (NIH/OMB) HIV Testing Unknown or Not Reported | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) HIV Intervention American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) HIV Intervention Asian | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) HIV Intervention Black or African American | 47 Participants | 46 Participants | 93 Participants | — | — |
| Race (NIH/OMB) HIV Intervention More than one race | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) HIV Intervention Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) HIV Intervention Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) HIV Intervention White | 3 Participants | 4 Participants | 7 Participants | — | — |
| Race (NIH/OMB) HIV Testing American Indian or Alaska Native | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) HIV Testing Asian | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) HIV Testing Black or African American | — | — | 377 Participants | 184 Participants | 193 Participants |
| Race (NIH/OMB) HIV Testing More than one race | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) HIV Testing Native Hawaiian or Other Pacific Islander | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) HIV Testing Unknown or Not Reported | — | — | 145 Participants | 79 Participants | 66 Participants |
| Race (NIH/OMB) HIV Testing White | — | — | 175 Participants | 86 Participants | 89 Participants |
| Sex: Female, Male HIV Intervention Female | 11 Participants | 11 Participants | 22 Participants | — | — |
| Sex: Female, Male HIV Intervention Male | 39 Participants | 39 Participants | 78 Participants | — | — |
| Sex: Female, Male HIV Testing Female | — | — | 130 Participants | 65 Participants | 65 Participants |
| Sex: Female, Male HIV Testing Male | — | — | 567 Participants | 284 Participants | 283 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 0 / 50 | 0 / 349 | 0 / 348 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 349 | 0 / 348 |
| serious Total, serious adverse events | 1 / 50 | 0 / 50 | 0 / 349 | 0 / 348 |
Outcome results
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.
Time frame: 3-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-site Rapid HIV Testing | Number of Participants That Entered Community HIV Treatment | 33 Participants |
| Off-site Referral for HIV Testing | Number of Participants That Entered Community HIV Treatment | 35 Participants |
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).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-site Rapid HIV Testing | Number of Participants Willing to Undergo Rapid HIV Testing | 318 Participants |
| Off-site Referral for HIV Testing | Number of Participants Willing to Undergo Rapid HIV Testing | 60 Participants |
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.
Time frame: 6,12,18-months
Population: We were unable to obtain official medical records from treatment clinics.
Secondary
Retention in Community HIV Treatment
Number of Days with Retention in Community HIV Treatment
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| On-site Rapid HIV Testing | Retention in Community HIV Treatment | 377.04 days | Standard Deviation 187.44 |
| Off-site Referral for HIV Testing | Retention in Community HIV Treatment | 318.82 days | Standard Deviation 208.78 |