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UCLA-Amity Parolee Health Promotion Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01844414
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.

Condition or disease Intervention/treatment
Hepatitis B Hepatitis C HIV Drug Addiction Behavioral: Parolee Comprehensive Care + Phone Coach Behavioral: Parolee Brief HBV Program + Phone Coach Behavioral: Usual Care Group

Detailed Description:

Homeless parolees pose a particular challenge for successful reentry into the community as they have underlying mental health issues combined with substance use and abuse and must contend with unstable housing situations, disorganized lives, unemployment, and limited access to health care and social services. Generally about 50% of all parolees scheduled to enroll in community-based drug treatment fail to enroll and less than 10% of enrollees actually complete treatment. Not surprisingly, about two-thirds of all individuals on parole are rearrested and return to custody within three years of release from prison. Recent data also revealed homeless persons who were least likely to complete a Hepatitis A/B (HAV/HBV) vaccine series were young (< 40) men who had been discharged from prison. Therefore, it is critical to engage paroled adults in comprehensive intervention programs that not only protect them from hepatitis B, but also reduce risky behavior, promote access to health care, social and employment services, and enable positive coping and communication skills.

Building upon advice from community partners who have successfully treated parolees and the research team's experience with hepatitis vaccination work, this study is designed to conduct a prospective, three-group study that randomly assigns 700 ready-for-discharge parolees, scheduled to enter a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and referrals, the HAV/HBV vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, the HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, and the HAV/HBV vaccine. This study will advance the research team's knowledge about drug treatment and HBV vaccine completion and recidivism among homeless parolees. Findings from this study can inform targeted interventions and lay the groundwork for health policy decisions that may impact hepatitis and HIV risk reduction and recidivism in this group who are a reservoir for these viruses in the general population, and are returning to prison at unprecedented numbers.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health Promotion Coaching/Vaccine for Homeless Parolees
Study Start Date : February 2010
Primary Completion Date : January 2014
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Parolee Comprehensive Care + Phone Coach
PCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Behavioral: Parolee Comprehensive Care + Phone Coach
A nurse case managed and specialized hepatitis education program with the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone).
Other Name: PCPC
Experimental: Parolee Brief HBV program + Phone Coach
PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series.
Behavioral: Parolee Brief HBV Program + Phone Coach
A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Other Name: PBPC
Active Comparator: Usual Care Group
UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.
Behavioral: Usual Care Group
Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
Other Name: UC


Outcome Measures

Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 5 years ]
    ● Number of re-incarcerations

  2. Primary Outcome Measure [ Time Frame: 5 years ]
    ● Completion of the Hepatitis A/B vaccine (for HBV negative participants);

  3. Primary Outcome Measure [ Time Frame: 5 years ]
    ● Completion of six months of a community-based residential drug treatment program;


Secondary Outcome Measures :
  1. Secondary Outcome Measure [ Time Frame: 5 years ]
    Reduction in drug and alcohol use and sexual risk behaviors;

  2. Secondary Outcome Measure [ Time Frame: 5 years ]
    Number of visits to health care or social service providers;

  3. Secondary Outcome Measure [ Time Frame: 5 years ]
    Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;

  4. Secondary Outcome Measure [ Time Frame: 5 years ]
    Cost Effectiveness of each of the three programs


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parolees enrolled in Amity's Amistad's program;
  2. Age 18-60;
  3. Discharged from prison or jail within the last six months;
  4. History of drug use 12 months prior to most recent incarceration;
  5. Previously homeless prior to most recent incarceration; and
  6. Willing to provide informed consent

Exclusion Criteria:

  1. Monolingual speakers of languages other than English; and
  2. Persons judged to be cognitively impaired by the research staff.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844414


Locations
United States, California
Amistad de Los Angeles
Los Angeles, California, United States, 90007
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Adeline Nyamathi, PhD University of California, Los Angeles
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adeline Nyamathi, PhD, Distinguished Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01844414     History of Changes
Other Study ID Numbers: 10000358
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Adeline Nyamathi, PhD, University of California, Los Angeles:
Homeless Men
Parolees
Hepatitis B
Hepatitis C
HIV
Community Drug Treatment
Recidivism

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Chemically-Induced Disorders
Mental Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs