Trial Outcomes & Findings for A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections (NCT NCT01366495)
NCT ID: NCT01366495
Last Updated: 2019-08-21
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
797 participants
Primary outcome timeframe
Baseline
Results posted on
2019-08-21
Participant Flow
Participant milestones
| Measure |
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.
|
Treatment As Usual
Passive referral to HIV community treatment provider.
|
On-site Testing
HIV testing on-site at probation/parole office
|
Off-Site Testing
Off-site HIV testing at a community health center or HIV clinic.
|
|---|---|---|---|---|
|
Testing Study
STARTED
|
0
|
0
|
349
|
348
|
|
Testing Study
COMPLETED
|
0
|
0
|
349
|
348
|
|
Testing Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
HIV Study
STARTED
|
50
|
50
|
0
|
0
|
|
HIV Study
COMPLETED
|
49
|
50
|
0
|
0
|
|
HIV Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allows for reporting of two RCT baseline measures.
Baseline characteristics by cohort
| Measure |
Project Bridge
n=50 Participants
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.
|
Treatment as Usual
n=50 Participants
Passive referral to HIV community treatment provider
|
On-site Testing
n=349 Participants
Rapid oral swab HIV testing on-site at a community supervision office.
|
Off-Site Testing
n=348 Participants
HIV testing at a community treatment clinic.
|
Total
n=797 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
HIV Intervention
|
46.8 years
STANDARD_DEVIATION 6.5 • n=50 Participants • Allows for reporting of two RCT baseline measures.
|
45.1 years
STANDARD_DEVIATION 8.6 • n=50 Participants • Allows for reporting of two RCT baseline measures.
|
—
|
—
|
45.9 years
STANDARD_DEVIATION 7.6 • n=100 Participants • Allows for reporting of two RCT baseline measures.
|
|
Age, Continuous
HIV Testing
|
—
|
—
|
39 years
STANDARD_DEVIATION 11.6 • n=349 Participants • Allows for reporting of two RCT baseline measures.
|
38.3 years
STANDARD_DEVIATION 11.1 • n=348 Participants • Allows for reporting of two RCT baseline measures.
|
38.7 years
STANDARD_DEVIATION 11.4 • n=697 Participants • Allows for reporting of two RCT baseline measures.
|
|
Sex: Female, Male
HIV Intervention · Female
|
11 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
11 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
22 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Sex: Female, Male
HIV Intervention · Male
|
39 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
39 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
78 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Sex: Female, Male
HIV Testing · Female
|
—
|
—
|
65 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
65 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
130 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Sex: Female, Male
HIV Testing · Male
|
—
|
—
|
284 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
283 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
567 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Intervention · Hispanic or Latino
|
1 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
2 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
3 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Intervention · Not Hispanic or Latino
|
49 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
48 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
97 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Intervention · Unknown or Not Reported
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Testing · Hispanic or Latino
|
—
|
—
|
44 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
51 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
95 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Testing · Not Hispanic or Latino
|
—
|
—
|
305 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
297 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
602 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Ethnicity (NIH/OMB)
HIV Testing · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · American Indian or Alaska Native
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · Asian
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · Black or African American
|
47 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
46 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
93 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · White
|
3 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
4 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
7 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · More than one race
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Intervention · Unknown or Not Reported
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=50 Participants • Allows for reporting of two RCT baseline measures
|
—
|
—
|
0 Participants
n=100 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · Asian
|
—
|
—
|
0 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · Black or African American
|
—
|
—
|
184 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
193 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
377 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · White
|
—
|
—
|
86 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
89 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
175 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · More than one race
|
—
|
—
|
0 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
0 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
|
Race (NIH/OMB)
HIV Testing · Unknown or Not Reported
|
—
|
—
|
79 Participants
n=349 Participants • Allows for reporting of two RCT baseline measures
|
66 Participants
n=348 Participants • Allows for reporting of two RCT baseline measures
|
145 Participants
n=697 Participants • Allows for reporting of two RCT baseline measures
|
PRIMARY outcome
Timeframe: BaselineAim 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).
Outcome measures
| Measure |
On-site Rapid HIV Testing
n=349 Participants
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
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.
|
Off-site Referral for HIV Testing
n=348 Participants
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
|
|---|---|---|
|
Number of Participants Willing to Undergo Rapid HIV Testing
|
318 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: 3-monthsNumber of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
Outcome measures
| Measure |
On-site Rapid HIV Testing
n=49 Participants
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
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.
|
Off-site Referral for HIV Testing
n=50 Participants
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
|
|---|---|---|
|
Number of Participants That Entered Community HIV Treatment
|
33 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 18 monthsNumber of Days with Retention in Community HIV Treatment
Outcome measures
| Measure |
On-site Rapid HIV Testing
n=49 Participants
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
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.
|
Off-site Referral for HIV Testing
n=50 Participants
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
|
|---|---|---|
|
Retention in Community HIV Treatment
|
377.04 days
Standard Deviation 187.44
|
318.82 days
Standard Deviation 208.78
|
SECONDARY outcome
Timeframe: 6,12,18-monthsPopulation: We were unable to obtain official medical records from treatment clinics.
To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
Outcome measures
Outcome data not reported
Adverse Events
Project Bridge
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Treatment As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
On-site Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Off-site Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Project Bridge
n=50 participants at risk
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.
|
Treatment As Usual
n=50 participants at risk
Passive referral to HIV community treatment provider.
|
On-site Testing
n=349 participants at risk
HIV testing on-site at probation/parole office.
|
Off-site Testing
n=348 participants at risk
HIV testing at a community health center or HIV clinic.
|
|---|---|---|---|---|
|
Social circumstances
Death
|
2.0%
1/50 • Number of events 1 • 18-months
|
0.00%
0/50 • 18-months
|
0.00%
0/349 • 18-months
|
0.00%
0/348 • 18-months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael S. Gordon, Senior Research Scientist
Friends Research Institute
Phone: 410-837-3977
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place