Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans
NCT02760537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232
Last updated 2025-05-01
Summary
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
- Liver Neoplasms
- Hepatitis B
Interventions
- BEHAVIORAL
-
Lay Health Worker Intervention
Lay Health Worker Phone Intervention The second phase addressed phone intervention training, where LHWs who had completed the first phase and were willing to participate in the second phase learned the process for calling participants to remind them to complete a series of HBV vaccinations. The LHWs assigned to the intervention group conducted phone interventions by reminding participants about completing a series of vaccinations at Months 1, 2, and 6, and also provided accompanying resources and support.
- BEHAVIORAL
-
Placebo (a list of resources)
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Hee-Soon Juon, PhD · Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
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