Hepatitis BNCT02421666
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
A study testing PNMI in people with Hepatitis B, run by Temple University.
Trial summary
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- PNMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identified Chinese, Korean and Vietnamese ethnicity
- age 18 and above
- accessible by telephone with text message feature
- presence in the same geographic study area for a period of one year
- not enrolled in any chronic HBV adherence management intervention
- medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and
- Never or non compliant with HBV monitoring guidelines.
Who cannot join
- Patients were excluded from the study for the following conditions:
- diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
- concurrent hepatitis C infection, and
- concurrent HIV infection
About this study
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial.
Read the detailed description
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. Inadequate chronic hepatitis B (CHB) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial. The primary outcome of the study is Asian CHB patient adherence (measured as "having seen a doctor for CHB monitoring") to hepatitis B (HBV) monitoring guidelines at 6-month and 12-month assessments post-intervention.
Patient partners and stakeholders were engaged in all study stages. The findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.
- Conditions
- Hepatitis B
- Being tested
- PNMI
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNMIBehavioural
Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| behavioral PNMI | Experimental | eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care. Receives: Behavioral: PNMI |
| control | No intervention | eligible chronic HBV patients received standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
The primary outcome is adherence to recommended clinical care for the monitoring of chronic HBV infection, specifically: 1) whether they visited doctors for their CHB, and 2) whether they received a blood test every 6 months such as alanine transaminase (ALT). All primary outcome measures were assessed at both the 6-month and 12-month follow-up surveys.
Measured: 6-month and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startSep 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Grace X Ma, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421666
- Sponsor's protocol ID
- PCORI-HBV
- Status last verified
- Oct 2020
- First submitted
- 10 Apr 2015
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ma GX, Zhu L, Tan Y, Zhai S, Ma X, Ogunwobi OO, Yang WJ, Ting T, Kim S, Wang MQ. A Comparative Trial of Improving Care for Underserved Asian Americans Infected with Hepatitis B Virus. Dig Dis Sci. 2023 Jun;68(6):2333-2343. doi: 10.1007/s10620-023-07840-5. Epub 2023 Feb 7.
PubMed 36749506
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
- ClinicalTrials.gov ID
- NCT02421666
- Acronym / sponsor ID
- PCORI-HBV
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2014
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial.
Detailed description
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. Inadequate chronic hepatitis B (CHB) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial. The primary outcome of the study is Asian CHB patient adherence (measured as "having seen a doctor for CHB monitoring") to hepatitis B (HBV) monitoring guidelines at 6-month and 12-month assessments post-intervention.
Patient partners and stakeholders were engaged in all study stages. The findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral PNMI | Experimental | Behavioral: PNMIeligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care. |
| control | No intervention | –eligible chronic HBV patients received standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identified Chinese, Korean and Vietnamese ethnicity
- age 18 and above
- accessible by telephone with text message feature
- presence in the same geographic study area for a period of one year
- not enrolled in any chronic HBV adherence management intervention
Key exclusion criteria (4 listed)
- diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
- concurrent hepatitis C infection, and
- concurrent HIV infection
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 |
|---|---|---|
| PNMIEligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks. | Behavioural | behavioral PNMI |
Primary outcome
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Time frame: 6-month and 12-month follow up
The primary outcome is adherence to recommended clinical care for the monitoring of chronic HBV infection, specifically: 1) whether they visited doctors for their CHB, and 2) whether they received a blood test every 6 months such as alanine transaminase (ALT). All primary outcome measures were assessed at both the 6-month and 12-month follow-up surveys.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36749506Ma GX, Zhu L, Tan Y, Zhai S, Ma X, Ogunwobi OO, Yang WJ, Ting T, Kim S, Wang MQ. A Comparative Trial of Improving Care for Underserved Asian Americans Infected with Hepatitis B Virus. Dig Dis Sci. 2023 Jun;68(6):2333-2343. doi: 10.1007/s10620-023-07840-5. Epub 2023 Feb 7.
- Individual participant dataSharing planned: Undecided
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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.
Grace X Ma, PhD principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
A study testing PNMI in people with Hepatitis B, run by Temple University.
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 4 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection (time frame: 6-month and 12-month follow up). 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 NCT02421666, which also lists 1 linked publication.
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 8 Oct 2020.