search
Back to results

UCLA-Amity Parolee Health Promotion Study

Primary Purpose

Hepatitis B, Hepatitis C, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parolee Comprehensive Care + Phone Coach
Parolee Brief HBV Program + Phone Coach
Usual Care Group
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis B focused on measuring Homeless Men, Parolees, Hepatitis B, Hepatitis C, HIV, Community Drug Treatment, Recidivism

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Amistad de Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Parolee Comprehensive Care + Phone Coach

Parolee Brief HBV program + Phone Coach

Usual Care Group

Arm Description

PCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring.

PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series.

UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Outcome Measure
Reduction in drug and alcohol use and sexual risk behaviors;
Secondary Outcome Measure
Number of visits to health care or social service providers;
Secondary Outcome Measure
Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;
Secondary Outcome Measure
Cost Effectiveness of each of the three programs

Full Information

First Posted
March 21, 2013
Last Updated
May 26, 2015
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT01844414
Brief Title
UCLA-Amity Parolee Health Promotion Study
Official Title
Health Promotion Coaching/Vaccine for Homeless Parolees
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis C, HIV, Drug Addiction
Keywords
Homeless Men, Parolees, Hepatitis B, Hepatitis C, HIV, Community Drug Treatment, Recidivism

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parolee Comprehensive Care + Phone Coach
Arm Type
Experimental
Arm Description
PCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Arm Title
Parolee Brief HBV program + Phone Coach
Arm Type
Experimental
Arm Description
PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series.
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Parolee Comprehensive Care + Phone Coach
Other Intervention Name(s)
PCPC
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Parolee Brief HBV Program + Phone Coach
Other Intervention Name(s)
PBPC
Intervention Description
A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Other Intervention Name(s)
UC
Intervention Description
Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
● Number of re-incarcerations
Time Frame
5 years
Title
Primary Outcome Measure
Description
● Completion of the Hepatitis A/B vaccine (for HBV negative participants);
Time Frame
5 years
Title
Primary Outcome Measure
Description
● Completion of six months of a community-based residential drug treatment program;
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Secondary Outcome Measure
Description
Reduction in drug and alcohol use and sexual risk behaviors;
Time Frame
5 years
Title
Secondary Outcome Measure
Description
Number of visits to health care or social service providers;
Time Frame
5 years
Title
Secondary Outcome Measure
Description
Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;
Time Frame
5 years
Title
Secondary Outcome Measure
Description
Cost Effectiveness of each of the three programs
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parolees enrolled in Amity's Amistad's program; Age 18-60; Discharged from prison or jail within the last six months; History of drug use 12 months prior to most recent incarceration; Previously homeless prior to most recent incarceration; and Willing to provide informed consent Exclusion Criteria: Monolingual speakers of languages other than English; and Persons judged to be cognitively impaired by the research staff.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Nyamathi, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amistad de Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23155727
Citation
Nyamathi A, Marlow E, Zhang S, Hall E, Farabee D, Marfisee M, Khalilifard F, Faucette M, Leake B. Correlates of serious violent crime for recently released parolees with a history of homelessness. Violence Vict. 2012;27(5):793-810. doi: 10.1891/0886-6708.27.5.793.
Results Reference
result
PubMed Identifier
21767252
Citation
Nyamathi A, Leake B, Albarran C, Zhang S, Hall E, Farabee D, Marlow E, Marfisee M, Khalilifard F, Faucette M. Correlates of depressive symptoms among homeless men on parole. Issues Ment Health Nurs. 2011;32(8):501-11. doi: 10.3109/01612840.2011.569111.
Results Reference
result
PubMed Identifier
27124254
Citation
Nyamathi AM, Zhang SX, Wall S, Hall EA, Salem BE, Farabee D, Faucette M, Yadav K. Drug Use and Multiple Sex Partners Among Homeless Ex-Offenders: Secondary Findings From an Experimental Study. Nurs Res. 2016 May-Jun;65(3):179-90. doi: 10.1097/NNR.0000000000000150.
Results Reference
derived
PubMed Identifier
25932697
Citation
Nyamathi A, Salem BE, Zhang S, Farabee D, Hall B, Khalilifard F, Leake B. Nursing case management, peer coaching, and hepatitis a and B vaccine completion among homeless men recently released on parole: randomized clinical trial. Nurs Res. 2015 May-Jun;64(3):177-89. doi: 10.1097/NNR.0000000000000083.
Results Reference
derived

Learn more about this trial

UCLA-Amity Parolee Health Promotion Study

We'll reach out to this number within 24 hrs