UCLA-Amity Parolee Health Promotion Study

HIV Clinical Trial

Official title:

Health Promotion Coaching/Vaccine for Homeless Parolees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844414
• Other study ID #: 10000358
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: May 26, 2015
• Start date: February 2010
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Drug Addiction
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV

Intervention

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).
• Parolee Brief HBV Program + Phone Coach
A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
• Usual Care Group
Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine

Locations

Country	Name	City	State
United States	Amistad de Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	? Number of re-incarcerations	5 years	No
Primary	Primary Outcome Measure	? Completion of the Hepatitis A/B vaccine (for HBV negative participants);	5 years	No
Primary	Primary Outcome Measure	? Completion of six months of a community-based residential drug treatment program;	5 years	No
Secondary	Secondary Outcome Measure	Reduction in drug and alcohol use and sexual risk behaviors;	5 years	No
Secondary	Secondary Outcome Measure	Number of visits to health care or social service providers;	5 years	No
Secondary	Secondary Outcome Measure	Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;	5 years	No
Secondary	Secondary Outcome Measure	Cost Effectiveness of each of the three programs	5 years	No