UCLA-Amity Parolee Health Promotion Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01844414|
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B Hepatitis C HIV Drug Addiction||Behavioral: Parolee Comprehensive Care + Phone Coach Behavioral: Parolee Brief HBV Program + Phone Coach Behavioral: Usual Care Group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Health Promotion Coaching/Vaccine for Homeless Parolees|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||May 2015|
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.
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
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.
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
Active Comparator: Usual Care Group
UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine.
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
- 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;
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844414
|United States, California|
|Amistad de Los Angeles|
|Los Angeles, California, United States, 90007|
|Principal Investigator:||Adeline Nyamathi, PhD||University of California, Los Angeles|