UCLA-Amity Parolee Health Promotion Study

Not Applicable

Completed

• Conditions: Hepatitis C; Drug Addiction; Hepatitis B; HIV
• Interventions: Behavioral: Parolee Comprehensive Care + Phone Coach; Behavioral: Usual Care Group; Behavioral: Parolee Brief HBV Program + Phone Coach

• Registration Number: NCT01844414
• Lead Sponsor: University of California, Los Angeles

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-05-01
• Primary Completion: 2014-01
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 600

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parolee Comprehensive Care + Phone Coach	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.
Usual Care Group	Usual Care Group	UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.
Parolee Brief HBV program + Phone Coach	Parolee Brief HBV Program + Phone Coach	PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	5 years	● Completion of six months of a community-based residential drug treatment program;

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure	5 years	Cost Effectiveness of each of the three programs

Trial Locations

Locations (1)

Amistad de Los Angeles; 🇺🇸 Los Angeles, California, United States