HIV/AIDSLINK2NCT03584932
Youth Services Navigation Intervention for HIV+ Youth Being Released From or At-risk for Incarceration
A study testing LINK2 Youth Services Navigation Intervention in people with HIV/AIDS, run by University of California, Los Angeles at 1 site in United States.
Trial summary
HIV prevalence among incarcerated youth living with HIV (YWH) is three times that of the general population and one in seven of all persons with HIV experience incarceration each year. Read more about this study
- Who is it for?
- Ages 16 to 25 years, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- LINK2 Youth Services Navigation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 25 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 1. Inability to give informed consent; 2. Parole hold or transfer to prison
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From or at Risk for Incarceration: A Randomized Control Trial
HIV prevalence among incarcerated youth living with HIV (YWH) is three times that of the general population and one in seven of all persons with HIV experience incarceration each year. Furthermore, less than half of all youth in the United States with HIV achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to meet the acute needs of youth with HIV who are at risk for incarceration, recently experienced incarceration or arrest, or those nearing reentry from a correctional facility. This holds particularly true in the high-need period following release from incarceration. The LINK2 study will develop and implement a youth service navigation (YSN) intervention to improve linkage and retention among YWH at risk for incarceration and with current incarceration and arrest histories and analyze results to address existing gaps in the literature.
The investigators will enroll 142 YWH, aged 16-25 (+364 days), incarcerated in Los Angeles and Chicago jails and through community providers serving those at risk for incarceration and YWH with recent incarceration and arrest histories. The investigators will randomize participants to the YSN intervention (n=71) vs. a usual-care control group (n=71). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support.
Read more
The proposed study has two Primary Specific Aims:
- Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to sexual and gender minority (SGM) culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for YWH, aged 16-25 (+364 days) upon release from large county jails and juvenile detention systems or with arrests in the prior 12 months and those at risk for incarceration based on various social determinants.
- Using a two-group RCT design, the investigators will test the effectiveness of the new YSN, youth SGM-sensitive intervention among YLWH aged 16-25 (+364 days), compared to controls offered standard of care. The investigators will evaluate the YSN Intervention's effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on substance use disorders, mental health, services utilization, and met needs. Secondary Aims: The investigators will assess YSN's effects on recidivism, costs and potential cost-offset/effectiveness.
- Conditions
- HIV/AIDS
- Being tested
- LINK2 Youth Services Navigation Intervention
- Keywords
- Youth,, Criminal justice, Sexual/gender minorities, Navigation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINK2 Youth Services Navigation InterventionBehavioural
There will be 6 in-person sessions delivered by a youth services navigator, plus weekly check-in calls after session 2 for a total of six months. As part of the learning sessions, the participant will learn important information about HIV and how to get the most out of his/her HIV care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Subjects participate in a youth service navigation intervention and are eligible to receive contingency management incentives. Receives: Behavioral: LINK2 Youth Services Navigation Intervention |
| Control arm | No intervention | Standard of care as set forth by the national HIV care guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression
Linkage to care HIV care is measured as HIV primary care provider visits; time to 1st post-release HIV care visit. Measures will involve survey and electronic record sources; self-reported measures derived from Outreach Initiative and HCSUS instrument. Retention in HIV care is measured as number of visits and missed visits to HIV primary care providers. Measurement tools include surveys and electronic record sources; self-reported measures derived from the Outreach Initiative and the HCSUS instrument. ART adherence is measured using a visual analogue scale of % (0-100) in surveys. Additional tools include electronic record sources; self-reported measures derived from Outreach Initiative; HCSUS instrument. Viral suppression is deemed undetectable at < 50 copies/ml as defined by the Los Angeles County Department of Public Health. Tools will include survey and electronic record sources and items from the HCSUS instrument and Outreach Initiative.
Measured: 12 months
Secondary outcomes (1)
Effects on recidivism, costs and potential cost-offset/effectiveness
Cost offsets/effectiveness will be measured as number of outpatient HIV/general primary and specialty care; number of mental health and substance abuse treatment visits and stays. Measures will involve electronic data sets for outpatient HIV primary and specialty care; and data sets for mental health and substance abuse treatment visits/stays.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Aug 2019
- Primary completion23 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, University of Chicago, Cook County Health & Hospitals System
- Responsible party
- Principal investigator, Nina T. Harawa, MPH, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584932
- Sponsor's protocol ID
- R01MD011773-02
- Acronym
- LINK2
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2018
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From or at Risk for Incarceration: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03584932
- Acronym / sponsor ID
- LINK2 / R01MD011773-02
- Conditions
- HIV/AIDS
- Keywords
- Youth,, Criminal justice, Sexual/gender minorities, Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, University of Chicago, Cook County Health & Hospitals System
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV prevalence among incarcerated youth living with HIV (YWH) is three times that of the general population and one in seven of all persons with HIV experience incarceration each year. Furthermore, less than half of all youth in the United States with HIV achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to meet the acute needs of youth with HIV who are at risk for incarceration, recently experienced incarceration or arrest, or those nearing reentry from a correctional facility. This holds particularly true in the high-need period following release from incarceration. The LINK2 study will develop and implement a youth service navigation (YSN) intervention to improve linkage and retention among YWH at risk for incarceration and with current incarceration and arrest histories and analyze results to address existing gaps in the literature.
The investigators will enroll 142 YWH, aged 16-25 (+364 days), incarcerated in Los Angeles and Chicago jails and through community providers serving those at risk for incarceration and YWH with recent incarceration and arrest histories. The investigators will randomize participants to the YSN intervention (n=71) vs. a usual-care control group (n=71). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support.
The proposed study has two Primary Specific Aims:
- Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to sexual and gender minority (SGM) culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for YWH, aged 16-25 (+364 days) upon release from large county jails and juvenile detention systems or with arrests in the prior 12 months and those at risk for incarceration based on various social determinants.
- Using a two-group RCT design, the investigators will test the effectiveness of the new YSN, youth SGM-sensitive intervention among YLWH aged 16-25 (+364 days), compared to controls offered standard of care. The investigators will evaluate the YSN Intervention's effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on substance use disorders, mental health, services utilization, and met needs. Secondary Aims: The investigators will assess YSN's effects on recidivism, costs and potential cost-offset/effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: LINK2 Youth Services Navigation InterventionSubjects participate in a youth service navigation intervention and are eligible to receive contingency management incentives. |
| Control arm | No intervention | –Standard of care as set forth by the national HIV care guidelines. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. Inability to give informed consent; 2. Parole hold or transfer to prison
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 |
|---|---|---|
| LINK2 Youth Services Navigation InterventionThere will be 6 in-person sessions delivered by a youth services navigator, plus weekly check-in calls after session 2 for a total of six months. As part of the learning sessions, the participant will learn important information about HIV and how to get the most out of his/her HIV care. | Behavioural | Intervention arm |
Primary outcome
Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression
Time frame: 12 months
Linkage to care HIV care is measured as HIV primary care provider visits; time to 1st post-release HIV care visit. Measures will involve survey and electronic record sources; self-reported measures derived from Outreach Initiative and HCSUS instrument. Retention in HIV care is measured as number of visits and missed visits to HIV primary care providers. Measurement tools include surveys and electronic record sources; self-reported measures derived from the Outreach Initiative and the HCSUS instrument. ART adherence is measured using a visual analogue scale of % (0-100) in surveys. Additional tools include electronic record sources; self-reported measures derived from Outreach Initiative; HCSUS instrument. Viral suppression is deemed undetectable at < 50 copies/ml as defined by the Los Angeles County Department of Public Health. Tools will include survey and electronic record sources and items from the HCSUS instrument and Outreach Initiative.
1 secondary outcome
Effects on recidivism, costs and potential cost-offset/effectiveness
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINK2 Youth Services Navigation Intervention in people with HIV/AIDS, run by University of California, Los Angeles 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 0 inclusion and 1 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 5 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.