Clinical trial · Interventional
Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study was conducted between April 2013 and October 2014. In the parent study, 600 foreign-born Asian American adults 18 years of age and older were drawn from the community in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method, foreign-born Asian American adults, 18 years of age and older, were recruited from the community. After providing informed consent, all the participants were asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the assistance of a bilingual interviewer when necessary. Then, all of the participants were instructed and given 5 to 10 to minutes to read culturally integrated and linguistically appropriate educational material (e.g., Photo novel) developed and validated for efficacy from a prior study. All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600 completed the survey and screening. A week later, they received the results of the screening test. Based on the screening results, all participants were categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We sent the results by mail to participants who were unprotected and protected. Among those 600 screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible to HBV infection (unprotected). LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were randomly assigned to either the intervention (n=124) or the control (n=108) groups by computer-automated random assignment. Randomization was used to assure equivalence between groups on key factors that may potentially influence the outcome of HBV vaccinations: gender, age, education, length of stay in the U.S. LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments. Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lay Health Worker Intervention | Behavioral | — | UNRESOLVED |
| Placebo (a list of resources) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lay Health Worker Intervention
- description
- LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those who had health insurance were encouraged to complete vaccinations through their providers. If participants did not have health insurance, LHWs provided resources to help those in the intervention access vaccinations by referring them to free vaccine events in the community.
- interventionNames
- Behavioral: Lay Health Worker Intervention
- type
- PLACEBO_COMPARATOR
- label
- Placebo (a list of resources)
- description
- Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments.
- interventionNames
- Behavioral: Placebo (a list of resources)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * foreign-born Asian American adults * 18 years of age and older * unprotected (HbsAg-/HbsAb-) Exclusion Criteria: None
References
Publications (10)
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- BACKGROUNDCaulfield LE, Gross SM, Bentley ME, Bronner Y, Kessler L, Jensen J, Weathers B, Paige DM. WIC-based interventions to promote breastfeeding among African-American Women in Baltimore: effects on breastfeeding initiation and continuation. J Hum Lact. 1998 Mar;14(1):15-22. doi: 10.1177/089033449801400110. PMID 9543954
- BACKGROUNDEarp JA, Viadro CI, Vincus AA, Altpeter M, Flax V, Mayne L, Eng E. Lay health advisors: a strategy for getting the word out about breast cancer. Health Educ Behav. 1997 Aug;24(4):432-51. doi: 10.1177/109019819702400404. PMID 9247823
- BACKGROUNDGlasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001 Aug;44(2):119-27. doi: 10.1016/s0738-3991(00)00186-5. PMID 11479052
- BACKGROUNDHan HR, Lee H, Kim MT, Kim KB. Tailored lay health worker intervention improves breast cancer screening outcomes in non-adherent Korean-American women. Health Educ Res. 2009 Apr;24(2):318-29. doi: 10.1093/her/cyn021. Epub 2008 May 7. PMID 18463411
- BACKGROUNDHsu CE, Liu LC, Juon HS, Chiu YW, Bawa J, Tillman U, Li M, Miller J, Wang M. Reducing liver cancer disparities: a community-based hepatitis-B prevention program for Asian-American communities. J Natl Med Assoc. 2007 Aug;99(8):900-7. PMID 17722668
- BACKGROUNDJuon HS, Strong C, Oh TH, Castillo T, Tsai G, Oh LD. Public health model for prevention of liver cancer among Asian Americans. J Community Health. 2008 Aug;33(4):199-205. doi: 10.1007/s10900-008-9091-y.