Hepatitis BHBVNCT00926146
Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV
A study testing NCMIT and SCMIT in people with Hepatitis B and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis C, HIV
- What is being tested?
- NCMIT and SCMIT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- homeless males self-reporting gay or bisexual behaviors in the last 12 months
- age 18-39
- methamphetamine and/or cocaine/crack use currently or in the last three months
- no self-reported participation in drug treatment in the last 30 days
- willing to provide informed consent
- willing to undergo hepatitis B and C and HIV antibody testing at baseline
- found to be HBV antibody negative
Who cannot join
- persons with Guillian Barre, or allergy to yeast or neomycin
- monolingual speakers of languages other than English or Spanish
- persons judged to be cognitively impaired by the nurse
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Community Center
Los Angeles, California, 90028
About this study
Official title: HBV Prevention for Homeless at Risk for HBV/HCV/HIV
In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case management strategies, found successful with homeless adults as well as contingency management strategies, found successful with gay and bisexual homeless adults by the community partners, the investigators will evaluate the effectiveness of a program that combines both strategies. As stimulant use threatens to increase homeless persons' risk of exposure to hepatitis A and B viruses, particularly among young users who may not yet be HBV-infected, this research is targeted to engage this group in treatment, until they are suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.
Read the detailed description
Homeless adults are at high risk for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV infection due to high rates of injection drug use and unprotected sexual activity. Our NIDA-funded RO1 award has enabled us to implement a successful intervention designed to evaluate the effectiveness of a HBV vaccination intervention with homeless adults. Our findings revealed that a greater percent of homeless adults randomized to the Nurse Case Managed Plus Incentive and Tracking group completed the HAV/HBV vaccine series compared to a Standard program without tracking. Homeless persons least likely to complete the vaccine series were young (< 40), and were men having sex with men (MSM); a significant number of these young adults also reported methamphetamine (MA) and cocaine/crack use. Stimulants (SAs), including MA and cocaine/crack are commonly used by homeless MSM, who contend with disorganized lives, unemployment, and little access to health and social services; thus, HBV vaccination is particularly challenging in this population. HAV/HBV vaccination and effective behavioral treatment are two of the most important strategies for reducing HBV infection among this at-risk group of SA users.
Based upon advice from our community partners who have successfully treated SA-using gay and bisexual men (GBM), we will incorporate contingency management into our vaccination completion program, which had lower completion rates among young adults and MSMs. Thus, in this competitive renewal, we propose a randomized, experimental, two-group design to evaluate the effectiveness of a Nurse Case Managed Program, which includes specialized education and Contingency Management and Tracking (NCCMT), with a Standard Program, including brief education, Contingency Management and Tracking (SCMT) with 500 homeless, young (18-39), SA-using GBM, on completion of the Twinrix HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. This study is innovative in that it will allow us to look at the effect of an enhanced case management and contingency management program versus a standard contingency management program. The proposed study combines optimal strategies to approach, engage and intervene with a hidden and high-risk population to assess the feasibility and efficacy of interventions that may prove beneficial in preventing HBV and HAV infections. We will also assess the relative cost of these programs in terms of completion of the HAV/HBV vaccination series. As use of SAs threatens to intensify homeless persons' risk of exposure to HAV and HBV, particularly among young users who may not yet be HBV-infected, research targeted to engage this group in treatment, until they are suitably protected from HBV, is critical.
- Conditions
- Hepatitis B, Hepatitis C, HIV, HIV Infections
- Being tested
- NCMIT, SCMIT
- Keywords
- Hepatitis B and C, HIV, nurse case management, HIV seronegativity
- Medical subject headings
- Hepatitis B, Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCMITBehavioural
Nurse Case Management Plus Contingency Management and Tracking (NCCMT) Program includes 20 minute case management, delivered by the NCCMT nurse and a separate 45 minute culturally competent specialized education, delivered by the two assigned nurses and research assistants weekly over 8 weeks. Participants of this group will also receive the HBV vaccine subsequently at one month and four months after baseline and incentives for three-weekly urine samples.
SCMITBehavioural
Standard with Contingency Management and Tracking (SCMT) Program. Participants in the SCMT group will interact three times a week over the four-month intervention period with the research nurse and research assistant and will be offered: 1) a brief HBV/HCV education program; 2) receipt of the vaccine subsequently at one month and four months after baseline; and 3) voucher incentives for three-weekly urine samples. The SCMT participants will not receive the specialized education sessions nor the case management delivered weekly over the first 8 weeks sessions.
| Study group | Role | What they receive |
|---|---|---|
| NCMIT | Experimental | Nurse Case Management Plus Contingency Management and Tracking and the HBV vaccine Receives: Behavioral: NCMIT |
| SCMIT | Active comparator | Standard with Contingency Management and Tracking (SCMT) and HBV vaccine Receives: Behavioral: SCMIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period.
Measured: 5 years
Secondary outcomes (1)
Document the occurrences of HCV and HIV infections as baseline among these homeless HBV antibody negative stimulant users, and the factors associated with these infections at baseline.
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 posted23 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 451 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
- NCT00926146
- Sponsor's protocol ID
- 090602901
- Other IDs
- DA016147
- Acronym
- HBV
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2009
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nyamathi A, Shoptaw S, Cohen A, Greengold B, Nyamathi K, Marfisee M, de Castro V, Khalilifard F, George D, Leake B. Effect of motivational interviewing on reduction of alcohol use. Drug Alcohol Depend. 2010 Feb 1;107(1):23-30. doi: 10.1016/j.drugalcdep.2009.08.021.
PubMed 19836904Nyamathi A, Reback CJ, Shoptaw S, Salem BE, Zhang S, Yadav K. Impact of Tailored Interventions to Reduce Drug Use and Sexual Risk Behaviors Among Homeless Gay and Bisexual Men. Am J Mens Health. 2017 Mar;11(2):208-220. doi: 10.1177/1557988315590837. Epub 2016 Jul 8.
PubMed 26130725Nyamathi AM, Nandy K, Greengold B, Marfisee M, Khalilifard F, Cohen A, Leake B. Effectiveness of intervention on improvement of drug use among methadone maintained adults. J Addict Dis. 2011 Jan;30(1):6-16. doi: 10.1080/10550887.2010.531669.
PubMed 21218306
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBV Prevention for Homeless at Risk for HBV/HCV/HIV
- ClinicalTrials.gov ID
- NCT00926146
- Acronym / sponsor ID
- HBV / 090602901
- Conditions
- Hepatitis B, Hepatitis C, HIV, HIV Infections
- Keywords
- Hepatitis B and C, HIV, nurse case management, HIV seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Jun 2009 (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.
In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case management strategies, found successful with homeless adults as well as contingency management strategies, found successful with gay and bisexual homeless adults by the community partners, the investigators will evaluate the effectiveness of a program that combines both strategies. As stimulant use threatens to increase homeless persons' risk of exposure to hepatitis A and B viruses, particularly among young users who may not yet be HBV-infected, this research is targeted to engage this group in treatment, until they are suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.
Detailed description
Homeless adults are at high risk for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV infection due to high rates of injection drug use and unprotected sexual activity. Our NIDA-funded RO1 award has enabled us to implement a successful intervention designed to evaluate the effectiveness of a HBV vaccination intervention with homeless adults. Our findings revealed that a greater percent of homeless adults randomized to the Nurse Case Managed Plus Incentive and Tracking group completed the HAV/HBV vaccine series compared to a Standard program without tracking. Homeless persons least likely to complete the vaccine series were young (< 40), and were men having sex with men (MSM); a significant number of these young adults also reported methamphetamine (MA) and cocaine/crack use. Stimulants (SAs), including MA and cocaine/crack are commonly used by homeless MSM, who contend with disorganized lives, unemployment, and little access to health and social services; thus, HBV vaccination is particularly challenging in this population. HAV/HBV vaccination and effective behavioral treatment are two of the most important strategies for reducing HBV infection among this at-risk group of SA users.
Based upon advice from our community partners who have successfully treated SA-using gay and bisexual men (GBM), we will incorporate contingency management into our vaccination completion program, which had lower completion rates among young adults and MSMs. Thus, in this competitive renewal, we propose a randomized, experimental, two-group design to evaluate the effectiveness of a Nurse Case Managed Program, which includes specialized education and Contingency Management and Tracking (NCCMT), with a Standard Program, including brief education, Contingency Management and Tracking (SCMT) with 500 homeless, young (18-39), SA-using GBM, on completion of the Twinrix HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. This study is innovative in that it will allow us to look at the effect of an enhanced case management and contingency management program versus a standard contingency management program. The proposed study combines optimal strategies to approach, engage and intervene with a hidden and high-risk population to assess the feasibility and efficacy of interventions that may prove beneficial in preventing HBV and HAV infections. We will also assess the relative cost of these programs in terms of completion of the HAV/HBV vaccination series. As use of SAs threatens to intensify homeless persons' risk of exposure to HAV and HBV, particularly among young users who may not yet be HBV-infected, research targeted to engage this group in treatment, until they are suitably protected from HBV, is critical.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCMIT | Experimental | Behavioral: NCMITNurse Case Management Plus Contingency Management and Tracking and the HBV vaccine |
| SCMIT | Active comparator | Behavioral: SCMITStandard with Contingency Management and Tracking (SCMT) and HBV vaccine |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- homeless males self-reporting gay or bisexual behaviors in the last 12 months
- age 18-39
- methamphetamine and/or cocaine/crack use currently or in the last three months
- no self-reported participation in drug treatment in the last 30 days
- willing to provide informed consent
Key exclusion criteria (3 listed)
- persons with Guillian Barre, or allergy to yeast or neomycin
- monolingual speakers of languages other than English or Spanish
- persons judged to be cognitively impaired by the nurse
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 |
|---|---|---|
| NCMITNurse Case Management Plus Contingency Management and Tracking (NCCMT) Program includes 20 minute case management, delivered by the NCCMT nurse and a separate 45 minute culturally competent specialized education, delivered by the two assigned nurses and research assistants weekly over 8 weeks. Participants of this group will also receive the HBV vaccine subsequently at one month and four months after baseline and incentives for three-weekly urine samples. | Behavioural | NCMIT |
| SCMITStandard with Contingency Management and Tracking (SCMT) Program. Participants in the SCMT group will interact three times a week over the four-month intervention period with the research nurse and research assistant and will be offered: 1) a brief HBV/HCV education program; 2) receipt of the vaccine subsequently at one month and four months after baseline; and 3) voucher incentives for three-weekly urine samples. The SCMT participants will not receive the specialized education sessions nor the case management delivered weekly over the first 8 weeks sessions. | Behavioural | SCMIT |
Primary outcome
Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period.
Time frame: 5 years
1 secondary outcome
Document the occurrences of HCV and HIV infections as baseline among these homeless HBV antibody negative stimulant users, and the factors associated with these infections at baseline.
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 30 Jan 2017.
- Background: PubMed 19836904Nyamathi A, Shoptaw S, Cohen A, Greengold B, Nyamathi K, Marfisee M, de Castro V, Khalilifard F, George D, Leake B. Effect of motivational interviewing on reduction of alcohol use. Drug Alcohol Depend. 2010 Feb 1;107(1):23-30. doi: 10.1016/j.drugalcdep.2009.08.021.
- Derived from this study: PubMed 26130725Nyamathi A, Reback CJ, Shoptaw S, Salem BE, Zhang S, Yadav K. Impact of Tailored Interventions to Reduce Drug Use and Sexual Risk Behaviors Among Homeless Gay and Bisexual Men. Am J Mens Health. 2017 Mar;11(2):208-220. doi: 10.1177/1557988315590837. Epub 2016 Jul 8.
- Derived from this study: PubMed 21218306Nyamathi AM, Nandy K, Greengold B, Marfisee M, Khalilifard F, Cohen A, Leake B. Effectiveness of intervention on improvement of drug use among methadone maintained adults. J Addict Dis. 2011 Jan;30(1):6-16. doi: 10.1080/10550887.2010.531669.
- Individual participant dataSharing planned: No
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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 NCMIT and SCMIT 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 7 inclusion and 3 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 30 Jan 2017. 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?
Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period. (time frame: 5 years). 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 NCT00926146, which also lists 3 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 30 Jan 2017.