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HIVNCT00841711

Transitions: Linkages From Jail To Community

A study testing Intensive Case Management in people with HIV and Substance Abuse, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use evidence-based interventions and adapt them to create a comprehensive transitional program in Waterbury and New Haven County, Connecticut. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Substance Abuse, HIV Infections
What is being tested?
Intensive Case Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Aug 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV Seropositive
  • 18 years of age or older
  • male and female
  • incarcerated but not sentenced inmates
  • releasing to New Haven area
  • releasing to Waterbury area
  • within 30 days post release from jail

Who cannot join

  • Not meeting inclusion criteria

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Yale Clinical Research

    New Haven, Connecticut, 06510

  • Waterbury Hosp ID Clinic

    Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: Transitions: Linkages From Jail to Community

TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use evidence-based interventions and adapt them to create a comprehensive transitional program in Waterbury and New Haven County, Connecticut. Evidence-based interventions will include, but not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment from the jail to the community setting and a novel Money Management (MM) program.

The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University AIDS Program, in collaboration with the Connecticut Department of Correction and the Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate substitution treatment and to enhance clinical and social services for PLWHA, who are transitioning from the jail to the community setting.

As part of Transitions, we will develop a model Money Management program that we have used in community settings to improve health outcomes for socially and medically marginalized populations and adapt it for a jail-release program. The Transitions program will incorporate these elements into a combined intervention and will result in a clinical trial to compare the additional contribution of a money management program.

Read the detailed description

TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use evidence-based interventions and adapt them to create a comprehensive transitional program in New Haven County, Connecticut. Evidence-based interventions will include, but not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment from the jail to the community setting and a novel Money Management (MM) program that is predicated on contingency management and has been used to reduce recidivism to jail, homelessness, mental and social instability and improve social functioning. Individuals to be targeted for rapid HIV testing will be those who enter the facility with substance use disorder and mental illness. All individuals who are either diagnosed with the enhanced HIV testing or who self-identify as being HIV+ will be evaluated by the Infectious Diseases Contact Nurse (IDCN) who will work in collaboration with the Referrals Coordinator (RC). The IDCN will coordinate the medical care of the detainee within the correctional setting while the Referrals Coordinator will begin the process of coordinating the care upon release and work with the Intensive Case Managers in New Haven and Waterbury upon release.

The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University AIDS Program, in collaboration with the Connecticut Department of Correction and the Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate substitution treatment and to enhance clinical and social services for PLWHA, who are transitioning from the jail to the community setting in New Haven county. This work builds on our previous work to enhance HIV testing in prisons and jails, , , to provide comprehensive HIV services within prisons and jails, , to implement the country's first buprenorphine treatment program in jails, to establish effective prison-released programs for sentenced prisoners, to establish buprenorphine treatment programs in mobile outreach and in HIV clinical care settings in the community, , and to establish adherence programs for PLWHA in community settings. Each of these programs and milestones have been evidence-based, rigorously studied and have resulted in replication in many parts of the country. As part of Transitions, we will develop a model Money Management program that we have used in community settings to improve health outcomes for socially and medically marginalized populations and adapt it for a jail-release program. The Transitions program will incorporate these elements into a combined intervention and will result in a clinical trial to compare the additional contribution of a money management program. The target population will include drug users who are either being released from or who have recently been released from prison or jail. Individuals will be fully assessed by a jail-based Referrals Coordinator and an intensive case manager (ICM) and a treatment plan organized. Screening and referral will take place either prior to release from the correctional setting or after release to the New Haven or Waterbury communities. HIV+ jail inmates who are returning to New Haven and Waterbury will be eligible for this study. As part of a randomized controlled trial, a subset of these will be randomized 2:1 to a Money Management program that will be adapted for our population. Direct services provided by Transitions will include enhanced rapid HIV testing within the jail setting, continuity of buprenorphine treatment from the correctional system to the community setting, intensive case management provided as modified Assertive Community Treatment and provision of a Money Management service. The strengths of this proposal are the:

  • Addressing unmet medical, drug treatment, case management needs in New Haven county - these are statewide priority areas for PLWHA according to our state needs assessment;
  • Collective experience and expertise in the collaboration between the Yale University HIV in Prisons Program, the CHCV, the Connecticut Department of Correction, the Waterbury Hospital ID Clinic, and a number of collaborating institutions within New Haven County;
  • Novelty of introducing an approved treatment modality for opiate dependence (buprenorphine), that to date, has not been fully expanded to meet the needs of PLWHA;
  • Novelty of prescribing opiate substitution therapy for released prisoners with DSM-IV criteria for opioid dependence BEFORE relapse to drug use;
  • Novelty that the Connecticut Department of Correction is the first and most comprehensive system to provide buprenorphine for supervised opiate withdrawal (detox) for opioid dependent patients, thus allowing for its prescription as part of a relapse prevention program from prison and/or jail;
  • Benefit of having an integrated correctional system that means that the jails and prisons are one system in Connecticut and thus able to track inmates throughout both the jail and prison system;
  • Novelty of applying an evidence-based Money Manager program to released prisoners, most of whom have significant problems with substance abuse, mental illness and homelessness;
  • Use of evidence-based interventions, including elements of buprenorphine maintenance treatment, intensive case management teams and money management strategies to retain released jail detainees with multiple medical and social co-morbidities.

TRANSITIONS is a novel demonstration program for managing HIV+ clients as they transition from the jail to the community setting in New Haven County, Connecticut. TRANSITIONS builds on our previous experience with developing and evaluating novel projects: 1) Project TLC (Kaiser Family Foundation, Altice, PI), the country's first transitional case management program for sentenced prisoners; 2) Project BEST (SAMHSA, Altice, PI), the country's first buprenorphine induction and stabilization program administered through a mobile health care program; and 3) and Project BELIEVE (HRSA, Altice, PI), one of ten SPNS projects integrating buprenorphine into HIV clinical care settings. Dr. Altice is also the PI for Project PLUS, two federally funded studies to develop and test pre-release (CDC, Altice, PI) and post-release (NIDA, Altice, PI) risk reduction interventions for HIV+ prisoners. The target population includes HIV+ jail detainees from New Haven County who are either being released from or who have recently been released from jail. Prison-release programs where sufficient time to plan for discharge have demonstrated significant success, however guidance for jail-release programs is urgently needed. This jail population desperately needs integrated services because of the high prevalence of HIV/AIDS, mental illness and recurrent homelessness that this incredibly vulnerable population faces as it attempts to reintegrate into the community.

Central to TRANSITIONS, we propose to develop and integrate effective, evidence-based interventions that include the following elements: 1) intensive case management (ICM) which is community-based outreach that employs feature of assertive community treatment; 2) opiate substitution therapy, primarily in the form of buprenorphine maintenance therapy; 3) enhanced communication linkages between the jail and the community. Eligible clients will include those who are HIV+ and who are either pre-release or who were released within the past 30 days. All eligible patients will receive these core elements. All Transitions clients will then be randomized 2:1 to receive additional Money Management (MM) services or no additional services. Money Management services, whose principles are predicated on contingency management, have been demonstrated to stabilize patients through improved social functioning, adherence to care, and decreased homelessness and substance misuse among patients with substance use disorder and severe mental illness.

Being tested
Intensive Case Management
Keywords
HIV, AIDS, Buprenorphine, Intensive Case Management, Money Management, Rapid Testing, Substance Abuse, Opioid Dependance, Inmate Population
Medical subject headings
Substance-Related Disorders, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Case ManagementBehavioural

    Transitions involves the integration of evidence-based interventions, intensive case management that incorporates outreach elements similar to assertive community treatment (ACT). Intensive case management goes beyond the tenets of case management and incorporates community outreach. This model of case management has its roots in assertive community treatment (ACT) and has demonstrated a 37% greater reduction in homelessness and a 26% greater improvement in psychiatric symptom severity compared with standard case management treatments. As such, intensive case management is likely to result in important outcomes for the target population, is evidence-based and has been validated in prison-release programs.

Study groups in NCT00841711
Study groupRoleWhat they receive
Behavioral counselingOtherNot described
Receives: Behavioral: Intensive Case Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substance use outcomes measured by self-report

    Measured: weekly reporting

  2. Urine toxicology results

    Measured: weekly report

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionAug 2012
  4. Study completionAug 2013

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00841711
Sponsor's protocol ID
0711003262
Other IDs
H97HA08541
Status last verified
Aug 2016
First submitted
10 Feb 2009
Last updated
12 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Chen NE, Meyer JP, Avery AK, Draine J, Flanigan TP, Lincoln T, Spaulding AC, Springer SA, Altice FL. Adherence to HIV treatment and care among previously homeless jail detainees. AIDS Behav. 2013 Oct;17(8):2654-66. doi: 10.1007/s10461-011-0080-2.

    PubMed 22065234
  • Althoff AL, Zelenev A, Meyer JP, Fu J, Brown SE, Vagenas P, Avery AK, Cruzado-Quinones J, Spaulding AC, Altice FL. Correlates of retention in HIV care after release from jail: results from a multi-site study. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S156-70. doi: 10.1007/s10461-012-0372-1.

    PubMed 23161210
  • Chitsaz E, Meyer JP, Krishnan A, Springer SA, Marcus R, Zaller N, Jordan AO, Lincoln T, Flanigan TP, Porterfield J, Altice FL. Contribution of substance use disorders on HIV treatment outcomes and antiretroviral medication adherence among HIV-infected persons entering jail. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S118-27. doi: 10.1007/s10461-013-0506-0.

    PubMed 23673792
  • Williams CT, Kim S, Meyer J, Spaulding A, Teixeira P, Avery A, Moore K, Altice F, Murphy-Swallow D, Simon D, Wickersham J, Ouellet LJ. Gender differences in baseline health, needs at release, and predictors of care engagement among HIV-positive clients leaving jail. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S195-202. doi: 10.1007/s10461-012-0391-y.

    PubMed 23314801
  • Fu JJ, Herme M, Wickersham JA, Zelenev A, Althoff A, Zaller ND, Bazazi AR, Avery AK, Porterfield J, Jordan AO, Simon-Levine D, Lyman M, Altice FL. Understanding the revolving door: individual and structural-level predictors of recidivism among individuals with HIV leaving jail. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S145-55. doi: 10.1007/s10461-013-0590-1.

    PubMed 24037440
  • Zelenev A, Marcus R, Kopelev A, Cruzado-Quinones J, Spaulding A, Desabrais M, Lincoln T, Altice FL. Patterns of homelessness and implications for HIV health after release from jail. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S181-94. doi: 10.1007/s10461-013-0472-6.

    PubMed 23657757
  • Krishnan A, Wickersham JA, Chitsaz E, Springer SA, Jordan AO, Zaller N, Altice FL. Post-release substance abuse outcomes among HIV-infected jail detainees: results from a multisite study. AIDS Behav. 2013 Oct;17 Suppl 2(0 2):S171-80. doi: 10.1007/s10461-012-0362-3.

    PubMed 23142854

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Case Management in people with HIV and Substance Abuse, run by Yale University at 2 sites 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 7 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Substance use outcomes measured by self-report (time frame: weekly reporting). The study lists 2 primary outcomes in all. 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 NCT00841711, which also lists 7 linked publications.

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 12 Aug 2016.

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