NCT01844414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

March 21, 2013

Last Update Submit

May 26, 2015

Conditions

Keywords

Homeless MenParoleesHepatitis BHepatitis CHIVCommunity Drug TreatmentRecidivism

Outcome Measures

Primary Outcomes (3)

  • Primary Outcome Measure

    ● Number of re-incarcerations

    5 years

  • Primary Outcome Measure

    ● Completion of the Hepatitis A/B vaccine (for HBV negative participants);

    5 years

  • Primary Outcome Measure

    ● Completion of six months of a community-based residential drug treatment program;

    5 years

Secondary Outcomes (4)

  • Secondary Outcome Measure

    5 years

  • Secondary Outcome Measure

    5 years

  • Secondary Outcome Measure

    5 years

  • Secondary Outcome Measure

    5 years

Study Arms (3)

Parolee Comprehensive Care + Phone Coach

EXPERIMENTAL

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

Parolee Brief HBV program + Phone Coach

EXPERIMENTAL

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

Usual Care Group

ACTIVE COMPARATOR

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

Behavioral: Usual Care Group

Interventions

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).

Also known as: PCPC
Parolee Comprehensive Care + Phone Coach

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

Also known as: PBPC
Parolee Brief HBV program + Phone Coach

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

Also known as: UC
Usual Care Group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amistad de Los Angeles

Los Angeles, California, 90007, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hepatitis BHepatitis CSubstance-Related DisordersRecidivism

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus InfectionsChemically-Induced DisordersMental DisordersCriminal BehaviorBehavior

Study Officials

  • Adeline Nyamathi, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

March 21, 2013

First Posted

May 1, 2013

Study Start

February 1, 2010

Primary Completion

January 1, 2014

Study Completion

May 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations