Hepatitis BNCT01844414
UCLA-Amity Parolee Health Promotion Study
A study testing Parolee Comprehensive Care + Phone Coach and Parolee Brief HBV Program + Phone Coach in people with Hepatitis B and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis C, HIV
- What is being tested?
- Parolee Comprehensive Care + Phone Coach and Parolee Brief HBV Program + Phone Coach
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Monolingual speakers of languages other than English; and
- Persons judged to be cognitively impaired by the research staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Amistad de Los Angeles
Los Angeles, California, 90007
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis B, Hepatitis C, HIV, Drug Addiction
- Being tested
- Parolee Comprehensive Care + Phone Coach, Parolee Brief HBV Program + Phone Coach, Usual Care Group
- Keywords
- Homeless Men, Parolees, Hepatitis B, Hepatitis C, HIV, Community Drug Treatment, Recidivism
- Medical subject headings
- Hepatitis B, Hepatitis C, Substance-Related Disorders, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parolee Comprehensive Care + Phone CoachBehavioural
Also called PCPC
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 CoachBehavioural
Also called PBPC
A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
Usual Care GroupBehavioural
Also called UC
Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
| Study group | Role | What they receive |
|---|---|---|
| Parolee Comprehensive Care + Phone Coach | Experimental | PCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring. Receives: Behavioral: Parolee Comprehensive Care + Phone Coach |
| Parolee Brief HBV program + Phone Coach | Experimental | PBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series. Receives: Behavioral: Parolee Brief HBV Program + Phone Coach |
| Usual Care Group | Active comparator | UC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
● Number of re-incarcerations
Measured: 5 years
Primary Outcome Measure
● Completion of the Hepatitis A/B vaccine (for HBV negative participants);
Measured: 5 years
Primary Outcome Measure
● Completion of six months of a community-based residential drug treatment program;
Measured: 5 years
Secondary outcomes (4)
Secondary Outcome Measure
Reduction in drug and alcohol use and sexual risk behaviors;
Measured: 5 years
Secondary Outcome Measure
Number of visits to health care or social service providers;
Measured: 5 years
Secondary Outcome Measure
Improved knowledge of Hepatitis/HIV and communication skills between 6 and 12 months or over the one-year study period;
Measured: 5 years
Secondary Outcome Measure
Cost Effectiveness of each of the three programs
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startFeb 2010
- Primary completionJan 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeline Nyamathi, PhD, University of California, Los Angeles
- Investigators
- Adeline Nyamathi, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844414
- Sponsor's protocol ID
- 10000358
- Status last verified
- May 2015
- First submitted
- 21 Mar 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1891/0886-6708.27.5.793.
PubMed 23155727Nyamathi 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.
PubMed 21767252Nyamathi 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.
PubMed 27124254Nyamathi 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.
PubMed 25932697
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion Coaching/Vaccine for Homeless Parolees
- ClinicalTrials.gov ID
- NCT01844414
- Acronym / sponsor ID
- 10000358
- Conditions
- Hepatitis B, Hepatitis C, HIV, Drug Addiction
- Keywords
- Homeless Men, Parolees, Hepatitis B, Hepatitis C, HIV, Community Drug Treatment, Recidivism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parolee Comprehensive Care + Phone Coach | Experimental | Behavioral: Parolee Comprehensive Care + Phone CoachPCPC Intervention: Eight specialized nurse case managed hepatitis education sessions, the Hepatitis A/B vaccine series and coach-facilitated mentoring. |
| Parolee Brief HBV program + Phone Coach | Experimental | Behavioral: Parolee Brief HBV Program + Phone CoachPBPC Intervention: Eight twenty minute hepatitis education sessions, coach facilitated mentoring and the Hepatitis A/B vaccine series. |
| Usual Care Group | Active comparator | Behavioral: Usual Care GroupUC Control Group: One brief general health information program, one-on-one coaching and the Hepatitis A/B vaccine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Monolingual speakers of languages other than English; and
- Persons judged to be cognitively impaired by the research staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parolee Comprehensive Care + Phone CoachAlso: PCPCA 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). | Behavioural | Parolee Comprehensive Care + Phone Coach |
| Parolee Brief HBV Program + Phone CoachAlso: PBPCA brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring. | Behavioural | Parolee Brief HBV program + Phone Coach |
| Usual Care GroupAlso: UCControl Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine | Behavioural | Usual Care Group |
Primary outcome
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;
4 secondary outcomes
Secondary Outcome Measure
Time frame: 5 years
Secondary Outcome Measure
Time frame: 5 years
Secondary Outcome Measure
Time frame: 5 years
Secondary Outcome Measure
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Results publication: PubMed 23155727Nyamathi 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. doi: 10.1891/0886-6708.27.5.793.
- Results publication: PubMed 21767252Nyamathi 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.
- Derived from this study: PubMed 27124254Nyamathi 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.
- Derived from this study: PubMed 25932697Nyamathi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Nyamathi, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parolee Comprehensive Care + Phone Coach and Parolee Brief HBV Program + Phone Coach in people with Hepatitis B and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01844414, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.