HIV/AIDS, HIV Infections, Sexually Transmitted Diseases, Substance Abuse, Substance Use, Substance Use Disorders
Conditions
Brief summary
This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.
Interventions
BEHAVIORALLink2CARE
The Link2CARE intervention consists of 4 sessions. Session 1 consists of a one-on-one meeting with a Health Coach, during which participants will be offered an oral rapid HIV test and STI test. Sessions 2, 3, and 4 are group-based. During these sessions, participants will engage in discussions and activities regarding sexual and substance use risk behaviors.
Sponsors
Center for Court Innovation
The National Center on Addiction and Substance Abuse at Columbia University
National Institute on Drug Abuse (NIDA)
Columbia University
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Young Adults Inclusion Criteria: * Between 18-24 years of age * Currently enrolled at the alternative to sentencing program * Conversant in English * Engaged in any unprotected or vaginal sexual activity (in the past 12 months)
Exclusion criteria
* Cognitively unable to complete the interview * HIV positive Alternative to Sentencing Staff Inclusion Criteria: * Currently employed at the alternative to sentencing program * Between ages of 18-80
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | at 12-month follow-up | measured by participant report in the Sexual Risk section of the questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Young Adults Referred to Substance Use Treatment | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Referral section of the questionnaires |
| Number of STI+ Young Adults Referred to STI Treatment | at 3-, 6-, and 12-month follow-ups | measured by the Health Coach report in the Health Coach Logs and participant report in the STI Referral section of the questionnaires |
| Number of STI+ Young Adults Attending 1 or More Treatment Appointments | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the STI Treatment section of the questionnaires |
| Acceptance of HIV Testing (Yes/no) | at day 1 of enrollment | measured by Health Coach report in the Session 1 Sexual Risk questionnaire |
| Any HIV Testing | between 6-month and 12-month follow-ups | measured by participant report in the HIV Testing section of the questionnaires |
| Any STI Testing | between 6- and 12-month follow-ups | measured by participant report in the STI Testing section of the questionnaires |
| Number of Young Adults Attending Intake Plus One Treatment Session | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Treatment section of the questionnaires |
| Frequency of Young Adults Substance Use in Past 30 Days | at 3-, 6-, and 12-month follow-ups | measured by participant report in the Substance Use section of the questionnaires |
| Acceptance of STI Testing (Yes/no) | at day 1 of enrollment | measured by Health Coach report in the Session 1 Sexual Risk questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the PrEP Referral section of the questionnaires |
| Number of Young Adults Behaviorally PrEP Eligible Attending at Least One HIV Care Appointment | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the PrEP Uptake section of the questionnaires |
| Number of HIV+ Young Adults Attending at Least One Treatment Appointment | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the HIV Treatment section of the questionnaires |
| Number of HIV+ Young Adults Referred to HIV Treatment | at 3-, 6-, and 12-month follow-ups | measured by Health Coach report in the Health Coach logs and participant report in the HIV Referral section of the questionnaires |
Countries
United States
Participant flow
Recruitment details
participants were recruited at the County Court house; screening took place and if eligible the participant was scheduled an appointment for baseline survey and randomized to study group. The first session either happened the same day or a few days later if the participant was unable to stay following the survey
Participants by arm
| Arm | Count |
|---|---|
| Link2CARE This arm is comprised of participants randomized to the 4-session Link2CARE intervention.
Link2CARE: The Link2CARE intervention consists of 4 sessions. Session 1 consists of a one-on-one meeting with a Health Coach, during which participants will be offered an oral rapid HIV test and STI test. Sessions 2, 3, and 4 are group-based. During these sessions, participants will engage in discussions and activities regarding sexual and substance use risk behaviors. | 152 |
| Standard of Care This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. | 155 |
| Total | 307 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Link2CARE |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 155 Participants | 307 Participants | 152 Participants |
| Age, Continuous | 21.02 years STANDARD_DEVIATION 2.08 | 21.13 years STANDARD_DEVIATION 2.06 | 21.23 years STANDARD_DEVIATION 2.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 13 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 203 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 27 Participants | 62 Participants | 35 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 8 Participants |
| Region of Enrollment United States | 155 participants | 307 participants | 152 participants |
| Sex: Female, Male Female | 37 Participants | 78 Participants | 41 Participants |
| Sex: Female, Male Male | 118 Participants | 229 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 152 | 1 / 155 |
| other Total, other adverse events | 24 / 152 | 25 / 155 |
| serious Total, serious adverse events | 0 / 152 | 0 / 155 |
Outcome results
Primary
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
measured by participant report in the Sexual Risk section of the questionnaires
Time frame: at 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Link2CARE | Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | 12months | 27.70 unprotected sex occasions | Standard Deviation 57.43 |
| Link2CARE | Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | baseline | 32.76 unprotected sex occasions | Standard Deviation 60.44 |
| Standard of Care | Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | baseline | 44.00 unprotected sex occasions | Standard Deviation 76.65 |
| Standard of Care | Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | 12months | 32.76 unprotected sex occasions | Standard Deviation 73.37 |
p-value: 0.63595% CI: [-0.46, 0.75]generalized estimating equations
Secondary
Acceptance of HIV Testing (Yes/no)
measured by Health Coach report in the Session 1 Sexual Risk questionnaire
Time frame: at day 1 of enrollment
Secondary
Acceptance of STI Testing (Yes/no)
measured by Health Coach report in the Session 1 Sexual Risk questionnaire
Time frame: at day 1 of enrollment
Secondary
Any HIV Testing
measured by participant report in the HIV Testing section of the questionnaires
Time frame: between 6-month and 12-month follow-ups
Secondary
Any STI Testing
measured by participant report in the STI Testing section of the questionnaires
Time frame: between 6- and 12-month follow-ups
Secondary
Frequency of Young Adults Substance Use in Past 30 Days
measured by participant report in the Substance Use section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Secondary
Number of STI+ Young Adults Attending 1 or More Treatment Appointments
measured by Health Coach report in the Health Coach logs and participant report in the STI Treatment section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Secondary
Number of STI+ Young Adults Referred to STI Treatment
measured by the Health Coach report in the Health Coach Logs and participant report in the STI Referral section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Secondary
Number of Young Adults Attending Intake Plus One Treatment Session
measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Treatment section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Secondary
Number of Young Adults Referred to Substance Use Treatment
measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Referral section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Other Pre-specified
Number of HIV+ Young Adults Attending at Least One Treatment Appointment
measured by Health Coach report in the Health Coach logs and participant report in the HIV Treatment section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Other Pre-specified
Number of HIV+ Young Adults Referred to HIV Treatment
measured by Health Coach report in the Health Coach logs and participant report in the HIV Referral section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Other Pre-specified
Number of Young Adults Behaviorally PrEP Eligible Attending at Least One HIV Care Appointment
measured by Health Coach report in the Health Coach logs and participant report in the PrEP Uptake section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups
Other Pre-specified
Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care
measured by Health Coach report in the Health Coach logs and participant report in the PrEP Referral section of the questionnaires
Time frame: at 3-, 6-, and 12-month follow-ups