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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043122 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Center for Court Innovation | OTHER |
| The National Center on Addiction and Substance Abuse at Columbia University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Link2CARE | Experimental | This arm is comprised of participants randomized to the 4-session Link2CARE intervention. |
|
| Standard of Care | No Intervention | This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Link2CARE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Young Adults Substance Use in Past 30 Days | measured by participant report in the "Substance Use" section of the questionnaires | at 3-, 6-, and 12-month follow-ups |
| Number of Young Adults Referred to Substance Use Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 3-, 6-, and 12-month follow-ups |
| Number of HIV+ Young Adults Attending at Least One Treatment Appointment |
Young Adults
Inclusion Criteria:
Exclusion Criteria:
Alternative to Sentencing Staff
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Elkington, PhD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings County Criminal Court | Brooklyn | New York | 11201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38069927 | Derived | Ertl MM, Jones A, Hickson R, Achebe I, Gyamfi Ertl SL, Sichel CE, Campos S, O'Grady MA, Tross S, Wilson P, Cohall RM, Cohall AT, Elkington KS. Technology Access and Perceptions of Telehealth Services Among Young Adults Involved in the Court System. J Adolesc Health. 2024 Mar;74(3):582-590. doi: 10.1016/j.jadohealth.2023.09.019. Epub 2023 Dec 8. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2017 |
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| Columbia University |
| OTHER |
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|
measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Referral" section of the questionnaires
| at 3-, 6-, and 12-month follow-ups |
| 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 | at 3-, 6-, and 12-month follow-ups |
| Acceptance of STI Testing (Yes/no) | measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire | at day 1 of enrollment |
| Any STI Testing | measured by participant report in the "STI Testing" section of the questionnaires | between 6- and 12-month follow-ups |
| 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 | at 3-, 6-, and 12-month follow-ups |
| 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 | at 3-, 6-, and 12-month follow-ups |
| Acceptance of HIV Testing (Yes/no) | measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire | at day 1 of enrollment |
| Any HIV Testing | measured by participant report in the "HIV Testing" section of the questionnaires | between 6-month 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 |
| at 3-, 6-, and 12-month follow-ups |
| 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 | at 3-, 6-, and 12-month follow-ups |
| 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 | at 3-, 6-, and 12-month follow-ups |
| FG001 | Standard of Care | This arm is comprised of participants who will not receive the 4-session Link2CARE intervention and instead receive services as usual. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care | This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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 | Posted | Mean | Standard Deviation | unprotected sex occasions | at 12-month follow-up |
|
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| Secondary | Frequency of Young Adults Substance Use in Past 30 Days | measured by participant report in the "Substance Use" section of the questionnaires | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acceptance of STI Testing (Yes/no) | measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire | Not Posted | at day 1 of enrollment | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Any STI Testing | measured by participant report in the "STI Testing" section of the questionnaires | Not Posted | between 6- and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acceptance of HIV Testing (Yes/no) | measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire | Not Posted | at day 1 of enrollment | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Any HIV Testing | measured by participant report in the "HIV Testing" section of the questionnaires | Not Posted | between 6-month and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | at 3-, 6-, and 12-month follow-ups | Participants |
12 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 | 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. | 0 | 152 | 0 | 152 | 24 | 152 |
| EG001 | Standard of Care | This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. | 1 | 155 | 0 | 155 | 25 | 155 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Social circumstances | Systematic Assessment | Assessed via beck depression inventory at each study interview (baseline, 3m, 6m and 12m) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Elkington | New York State Psychiatric Institute | 16467746965 | ke2143@cumc.columbia.edu |
| Sep 27, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Cover Sheet | Dec 14, 2020 | Sep 23, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Authorization for the Release of Information | Dec 14, 2020 | Sep 23, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: YA IC for Participation in a Study BJI | Dec 14, 2020 | Sep 23, 2022 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: YA IC for Participation in a Study CASES | Dec 14, 2020 | Sep 23, 2022 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: HIPAA | Dec 14, 2020 | Sep 23, 2022 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: YA IC for HIV and/or STI Testing | Dec 14, 2020 | Sep 23, 2022 | ICF_006.pdf |
| ICF | No | No | Yes | Informed Consent Form: YA IC for HIV and/or STI Testing at 6 and12 Mo | Dec 14, 2020 | Sep 23, 2022 | ICF_007.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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