An interventional study of Link2CARE in HIV/AIDS, HIV Infections and Substance Use, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Prevention
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Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 222nd largest by enrollment of the 1,290 interventional ones that give a count, is one of 56 that started in 2017, is one of 642 with no phase, and was the 1,225th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:
Nicky Mehtani, MD, MPH · Sites in United States
Ages 25–64
Columbia University · Sites in United States
Ages 18+ · Healthy volunteers
BioNTech SE · Sites in United States, South Africa
Ages 18–50 · Healthy volunteers
CAN Community Health · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,670 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 384 · Phase 2 258 · Phase 3 156 · Phase 4 81
First in 1981; this study’s year is marked. 56 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 307 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
510 of 1,670 have an industry lead sponsor. The 10 most frequent:
New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
New York State Psychiatric Institute has 5 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
56 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Add all 56 to your calendar (.ics) → With an account.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Young Adults
Inclusion Criteria:
Exclusion Criteria:
Alternative to Sentencing Staff
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm is comprised of participants randomized to the 4-session Link2CARE intervention.
Behavioral: Link2CARE
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.
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.
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
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
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
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
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
Any STI Testing
measured by participant report in the "STI Testing" section of the questionnaires
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at day 1 of enrollment
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
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
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
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
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
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
| Milestone | Link2CARE | Standard of Care |
|---|---|---|
| Started | 152 | 155 |
| Completed | 135 | 139 |
| Not completed | 17 | 16 |
measured by participant report in the "Sexual Risk" section of the questionnaires
| unprotected sex occasions | Link2CARE | Standard of Care |
|---|---|---|
| baseline | 32.76 ± 60.44 | 44.00 ± 76.65 |
| 12months | 27.70 ± 57.43 | 32.76 ± 73.37 |
measured by participant report in the "Substance Use" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Referral" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Treatment" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Results for this outcome have not been posted.
measured by participant report in the "STI Testing" section of the questionnaires
Results for this outcome have not been posted.
measured by the Health Coach report in the Health Coach Logs and participant report in the "STI Referral" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "STI Treatment" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Results for this outcome have not been posted.
measured by participant report in the "HIV Testing" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "HIV Referral" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "HIV Treatment" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Referral" section of the questionnaires
Results for this outcome have not been posted.
measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Uptake" section of the questionnaires
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Link2CARE | 0/152 (0%) | 0/152 (0%) | 24/152 (15.8%) |
| Standard of Care | 1/155 (0.6%) | 0/155 (0%) | 25/155 (16.1%) |
| Event | Link2CARE | Standard of Care |
|---|---|---|
| Suicidal IdeationSocial circumstances | 24/152 | 25/155 |
| Age, Categorical(Participants) | Link2CARE | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 152 | 155 | 307 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Link2CARE | Standard of Care | Total |
|---|---|---|---|
| Mean | 21.23 ± 2.04 | 21.02 ± 2.08 | 21.13 ± 2.06 |
| Sex: Female, Male(Participants) | Link2CARE | Standard of Care | Total |
|---|---|---|---|
| Female | 41 | 37 | 78 |
| Male | 111 | 118 | 229 |
| Race (NIH/OMB)(Participants) | Link2CARE | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 11 | 13 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 100 | 103 | 203 |
| White | 8 | 11 | 19 |
| More than one race | 35 | 27 | 62 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Link2CARE | Standard of Care | Total |
|---|---|---|---|
| United States | 152 | 155 | 307 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Sep 2021, 45 months.
Results were first posted in Nov 2022, 1 year 1 month after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 45 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
New York State Psychiatric Institute →