UCLA-Amity Parolee Health Promotion Study

NCT ID: NCT01844414

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B Hepatitis C HIV Drug Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Parolee Comprehensive Care + Phone Coach

Intervention Type BEHAVIORAL

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).

Parolee Brief HBV program + Phone Coach

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

Group Type EXPERIMENTAL

Parolee Brief HBV Program + Phone Coach

Intervention Type BEHAVIORAL

A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.

Usual Care Group

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

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type BEHAVIORAL

Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine

Interventions

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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).

Intervention Type BEHAVIORAL

Parolee Brief HBV Program + Phone Coach

A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.

Intervention Type BEHAVIORAL

Usual Care Group

Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine

Intervention Type BEHAVIORAL

Other Intervention Names

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PCPC PBPC UC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Adeline Nyamathi, PhD

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adeline Nyamathi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Amistad de Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23155727 (View on PubMed)

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.

Reference Type RESULT
PMID: 21767252 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27124254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25932697 (View on PubMed)

Other Identifiers

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10000358

Identifier Type: -

Identifier Source: org_study_id

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