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Trial Outcomes & Findings for Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2) (NCT NCT03369249)

NCT ID: NCT03369249

Last Updated: 2023-01-18

Results Overview

measured by participant report in the "Sexual Risk" section of the questionnaires

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

307 participants

Primary outcome timeframe

at 12-month follow-up

Results posted on

2023-01-18

Participant Flow

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

Participant milestones

Participant milestones
Measure
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.
Standard of Care
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention and instead receive services as usual.
Overall Study
STARTED
152
155
Overall Study
COMPLETED
135
139
Overall Study
NOT COMPLETED
17
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Link2CARE
n=152 Participants
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.
Standard of Care
n=155 Participants
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.
Total
n=307 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
152 Participants
n=5 Participants
155 Participants
n=7 Participants
307 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
21.23 years
STANDARD_DEVIATION 2.04 • n=5 Participants
21.02 years
STANDARD_DEVIATION 2.08 • n=7 Participants
21.13 years
STANDARD_DEVIATION 2.06 • n=5 Participants
Sex: Female, Male
Female
41 Participants
n=5 Participants
37 Participants
n=7 Participants
78 Participants
n=5 Participants
Sex: Female, Male
Male
111 Participants
n=5 Participants
118 Participants
n=7 Participants
229 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=5 Participants
11 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
100 Participants
n=5 Participants
103 Participants
n=7 Participants
203 Participants
n=5 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
11 Participants
n=7 Participants
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
35 Participants
n=5 Participants
27 Participants
n=7 Participants
62 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
152 participants
n=5 Participants
155 participants
n=7 Participants
307 participants
n=5 Participants

PRIMARY outcome

Timeframe: at 12-month follow-up

measured by participant report in the "Sexual Risk" section of the questionnaires

Outcome measures

Outcome measures
Measure
Link2CARE
n=152 Participants
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.
Standard of Care
n=155 Participants
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
baseline
32.76 unprotected sex occasions
Standard Deviation 60.44
44.00 unprotected sex occasions
Standard Deviation 76.65
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
12months
27.70 unprotected sex occasions
Standard Deviation 57.43
32.76 unprotected sex occasions
Standard Deviation 73.37

SECONDARY outcome

Timeframe: at 3-, 6-, and 12-month follow-ups

measured by participant report in the "Substance Use" section of the questionnaires

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at day 1 of enrollment

measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: between 6- and 12-month follow-ups

measured by participant report in the "STI Testing" section of the questionnaires

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at day 1 of enrollment

measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: between 6-month and 12-month follow-ups

measured by participant report in the "HIV Testing" section of the questionnaires

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Link2CARE

Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 25 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Link2CARE
n=152 participants at risk
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.
Standard of Care
n=155 participants at risk
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.
Social circumstances
Suicidal Ideation
15.8%
24/152 • 12 months
16.1%
25/155 • 12 months

Additional Information

Katherine Elkington

New York State Psychiatric Institute

Phone: 16467746965

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place