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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- HIV, Substance Abuse, HIV Infections
- 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 group | Role | What they receive |
|---|---|---|
| Behavioral counseling | Other | Not described Receives: Behavioral: Intensive Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use outcomes measured by self-report
Measured: weekly reporting
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.
- First posted11 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick L Altice, MD, Principal investigator, Yale University
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 22065234Althoff 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 23161210Chitsaz 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 23673792Williams 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 23314801Fu 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 24037440Zelenev 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 23657757Krishnan 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitions: Linkages From Jail to Community
- ClinicalTrials.gov ID
- NCT00841711
- Acronym / sponsor ID
- 0711003262
- Conditions
- HIV, Substance Abuse, HIV Infections
- Keywords
- HIV, AIDS, Buprenorphine, Intensive Case Management, Money Management, Rapid Testing, Substance Abuse, Opioid Dependance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Feb 2009 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral counseling | Other | Behavioral: Intensive Case Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV Seropositive
- 18 years of age or older
- male and female
- incarcerated but not sentenced inmates
- releasing to New Haven area
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Intensive Case ManagementTransitions 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. | Behavioural | Behavioral counseling |
Primary outcome
Substance use outcomes measured by self-report
Time frame: weekly reporting
Urine toxicology results
Time frame: weekly report
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 12 Aug 2016.
- Background: PubMed 22065234Chen 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.
- Background: PubMed 23161210Althoff 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.
- Background: PubMed 23673792Chitsaz 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.
- Background: PubMed 23314801Williams 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.
- Background: PubMed 24037440Fu 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.
- Background: PubMed 23657757Zelenev 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.
- Background: PubMed 23142854Krishnan 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.
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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.
Frederick L Altice, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
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.