UCLA-Amity Parolee Health Promotion Study

May 26, 2015 updated by: Adeline Nyamathi, PhD, University of California, Los Angeles

Health Promotion Coaching/Vaccine for Homeless Parolees

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Amistad de Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • UC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: 5 years
● Number of re-incarcerations
5 years
Primary Outcome Measure
Time Frame: 5 years
● Completion of the Hepatitis A/B vaccine (for HBV negative participants);
5 years
Primary Outcome Measure
Time Frame: 5 years
● Completion of six months of a community-based residential drug treatment program;
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measure
Time Frame: 5 years
Reduction in drug and alcohol use and sexual risk behaviors;
5 years
Secondary Outcome Measure
Time Frame: 5 years
Number of visits to health care or social service providers;
5 years
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;
5 years
Secondary Outcome Measure
Time Frame: 5 years
Cost Effectiveness of each of the three programs
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Adeline Nyamathi, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Parolee Comprehensive Care + Phone Coach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe