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Completed

NCT Number: NCT01844414

UCLA-Amity Parolee Health Promotion Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parolee Comprehensive Care + Phone Coach

Behavioral

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 names: PCPC

Parolee Brief HBV Program + Phone Coach

Behavioral

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

Other names: PBPC

Usual Care Group

Behavioral

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

Other names: UC

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 5 years

    ● Number of re-incarcerations

  2. Primary Outcome Measure

    Time frame: 5 years

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

  3. Primary Outcome Measure

    Time frame: 5 years

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

Secondary outcomes

  1. Secondary Outcome Measure

    Time frame: 5 years

    Reduction in drug and alcohol use and sexual risk behaviors;

  2. Secondary Outcome Measure

    Time frame: 5 years

    Number of visits to health care or social service providers;

  3. 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;

  4. Secondary Outcome Measure

    Time frame: 5 years

    Cost Effectiveness of each of the three programs

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Health Promotion Coaching/Vaccine for Homeless Parolees

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
May 1, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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