UCLA-Amity Parolee Health Promotion Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Adeline Nyamathi, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01844414
First received: March 21, 2013
Last updated: May 8, 2014
Last verified: May 2014

March 21, 2013
May 8, 2014
February 2010
January 2014   (final data collection date for primary outcome measure)
  • Primary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    ● Number of re-incarcerations
  • Primary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    ● Completion of the Hepatitis A/B vaccine (for HBV negative participants);
  • Primary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    ● Completion of six months of a community-based residential drug treatment program;
Same as current
Complete list of historical versions of study NCT01844414 on ClinicalTrials.gov Archive Site
  • Secondary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Reduction in drug and alcohol use and sexual risk behaviors;
  • Secondary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Number of visits to health care or social service providers;
  • Secondary Outcome Measure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cost Effectiveness of each of the three programs
Same as current
Not Provided
Not Provided
 
UCLA-Amity Parolee Health Promotion Study
Health Promotion Coaching/Vaccine for Homeless Parolees

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hepatitis B
  • Hepatitis C
  • HIV
  • Drug Addiction
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
March 2015
January 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01844414
10000358
Yes
Adeline Nyamathi, MD, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Adeline Nyamathi, PhD University of California, Los Angeles
University of California, Los Angeles
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP