HIV/AIDSNCT03369249
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
A study testing Link2CARE in people with HIV/AIDS and HIV Infections, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Infections, Substance Use
- What is being tested?
- Link2CARE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Currently employed at the alternative to sentencing program
- Between ages of 18-80
Who cannot join
- Cognitively unable to complete the interview
- HIV positive
- Alternative to Sentencing Staff
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Kings County Criminal Court
Brooklyn, New York, 11201
About this study
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.
- Conditions
- HIV/AIDS, HIV Infections, Substance Use, Substance Abuse, Substance Use Disorders, Sexually Transmitted Diseases
- Being tested
- Link2CARE
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Link2CAREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Link2CARE | Experimental | This arm is comprised of participants randomized to the 4-session Link2CARE intervention. Receives: Behavioral: Link2CARE |
| Standard of Care | No intervention | This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12-month follow-up
Secondary outcomes (9)
Frequency of Young Adults Substance Use in Past 30 Days
measured by participant report in the "Substance Use" section of the questionnaires
Measured: 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
Measured: 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
Measured: 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
Measured: at day 1 of enrollment
Any STI Testing
measured by participant report in the "STI Testing" section of the questionnaires
Measured: 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
Measured: 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
Measured: 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
Measured: at day 1 of enrollment
Any HIV Testing
measured by participant report in the "HIV Testing" section of the questionnaires
Measured: between 6-month and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start9 Dec 2017
- Primary completion30 Sep 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Court Innovation, The National Center on Addiction and Substance Abuse at Columbia University, National Institute on Drug Abuse (NIDA), Columbia University
- Responsible party
- Principal investigator, Katherine Elkington, New York State Psychiatric Institute
- Investigators
- Katherine Elkington, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369249
- Sponsor's protocol ID
- 7574
- Other IDs
- R01DA043122
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2017
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38069927
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
- ClinicalTrials.gov ID
- NCT03369249
- Acronym / sponsor ID
- 7574
- Conditions
- HIV/AIDS, HIV Infections, Substance Use, Substance Abuse, Substance Use Disorders, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Center for Court Innovation, The National Center on Addiction and Substance Abuse at Columbia University, National Institute on Drug Abuse (NIDA), Columbia University
- Study start
- 9 Dec 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 22 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Link2CARE | Experimental | Behavioral: Link2CAREThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Currently employed at the alternative to sentencing program
Key exclusion criteria (4 listed)
- Cognitively unable to complete the interview
- HIV positive
- Alternative to Sentencing Staff
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Link2CAREThe 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. | Behavioural | Link2CARE |
Primary outcome
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
Time frame: at 12-month follow-up
measured by participant report in the "Sexual Risk" section of the questionnaires
9 secondary outcomes
Frequency of Young Adults Substance Use in Past 30 Days
Time frame: at 3-, 6-, and 12-month follow-ups
Number of Young Adults Referred to Substance Use Treatment
Time frame: at 3-, 6-, and 12-month follow-ups
Number of Young Adults Attending Intake Plus One Treatment Session
Time frame: at 3-, 6-, and 12-month follow-ups
Acceptance of STI Testing (Yes/no)
Time frame: at day 1 of enrollment
Any STI Testing
Time frame: between 6- and 12-month follow-ups
Number of STI+ Young Adults Referred to STI Treatment
Time frame: at 3-, 6-, and 12-month follow-ups
Number of STI+ Young Adults Attending 1 or More Treatment Appointments
Time frame: at 3-, 6-, and 12-month follow-ups
Acceptance of HIV Testing (Yes/no)
Time frame: at day 1 of enrollment
Any HIV Testing
Time frame: between 6-month and 12-month follow-ups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38069927Ertl 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Elkington, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Link2CARE in people with HIV/AIDS and HIV Infections, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months (time frame: at 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.