UCLA-Amity Parolee Health Promotion Study

Tracking Information
First Submitted Date ICMJE	March 21, 2013
First Posted Date ICMJE	May 1, 2013
Last Update Posted Date	May 28, 2015
Study Start Date ICMJE	February 2010
Actual Primary Completion Date	January 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 26, 2013)	Primary Outcome Measure [ Time Frame: 5 years ]● Number of re-incarcerations; Primary Outcome Measure [ Time Frame: 5 years ]● Completion of the Hepatitis A/B vaccine (for HBV negative participants);; Primary Outcome Measure [ Time Frame: 5 years ]● Completion of six months of a community-based residential drug treatment program;
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01844414 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 26, 2013)	Secondary Outcome Measure [ Time Frame: 5 years ]Reduction in drug and alcohol use and sexual risk behaviors;; Secondary Outcome Measure [ Time Frame: 5 years ]Number of visits to health care or social service providers;; 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;; Secondary Outcome Measure [ Time Frame: 5 years ]Cost Effectiveness of each of the three programs
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	UCLA-Amity Parolee Health Promotion Study
Official Title ICMJE	Health Promotion Coaching/Vaccine for Homeless Parolees
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Hepatitis B; Hepatitis C; HIV; Drug Addiction
Intervention ICMJE	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 Name: PCPC; 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 Name: PBPC; Behavioral: Usual Care Group Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine Other Name: UC
Study Arms	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. Intervention: Behavioral: Parolee Comprehensive Care + Phone Coach; 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. Intervention: Behavioral: Parolee Brief HBV Program + Phone Coach; Active Comparator: Usual Care Group UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine. Intervention: Behavioral: Usual Care Group
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 26, 2015)	600
Original Estimated Enrollment ICMJE; (submitted: April 26, 2013)	700
Actual Study Completion Date	May 2015
Actual Primary Completion Date	January 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01844414
Other Study ID Numbers ICMJE	10000358
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Adeline Nyamathi, PhD, University of California, Los Angeles
Study Sponsor ICMJE	University of California, Los Angeles
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Adeline Nyamathi, PhD University of California, Los Angeles
PRS Account	University of California, Los Angeles
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP