Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans

NCT02760537 | Completed

• 3 other identifiers: HopkinsIRB-000045375R01CA163805-02JT 7061
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Liver Neoplasms; Hepatitis B; Hepatitis B vaccination; Asian Americans; Lay health workers; Community health workers

Outcome Measures

Primary Outcomes (1)

• self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records

  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. Their self-reported vaccinations were verified with the medical records. Participants were asked to provide information about the date of vaccinations as well as the location of the clinic or doctor's office where participants received vaccinations. Participants were also asked to sign a medical release form giving project staff permission to request medical records regarding their vaccinations. Each participant was given a stamped vaccination card to fill out the date and provide the signature of their physician following each completed hepatitis B vaccination. Participants were asked to mail the card back to the research team once the card was completed.

  Seven months after mailing the results

Study Arms (2)

Lay Health Worker Intervention

EXPERIMENTAL

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.

Behavioral: Lay Health Worker Intervention

Placebo (a list of resources)

PLACEBO COMPARATOR

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.

Behavioral: Placebo (a list of resources)

Interventions

Lay Health Worker Intervention BEHAVIORAL

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.

Lay Health Worker Intervention

Placebo (a list of resources) BEHAVIORAL

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.

Placebo (a list of resources)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• foreign-born Asian American adults
• years of age and older
• unprotected (HbsAg-/HbsAb-)

You may not qualify if:

• None

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Related Publications (10)

• Anderson GF, Hussey PS. Population aging: a comparison among industrialized countries. Health Aff (Millwood). 2000 May-Jun;19(3):191-203. doi: 10.1377/hlthaff.19.3.191.

  PMID: 10812799 BACKGROUND

• Caulfield 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 BACKGROUND

• Earp 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 BACKGROUND

• Glasgow 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 BACKGROUND

• Han 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 BACKGROUND

• Hsu 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 BACKGROUND

• Juon 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.

  PMID: 18363085 BACKGROUND

• Lefebvre RC, Flora JA. Social marketing and public health intervention. Health Educ Q. 1988 Fall;15(3):299-315. doi: 10.1177/109019818801500305.

  PMID: 3056876 BACKGROUND

• Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005 Apr;6(2):134-47. doi: 10.1177/1524839904273387.

  PMID: 15855283 BACKGROUND

• Juon HS, Strong C, Kim F, Park E, Lee S. Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial. PLoS One. 2016 Sep 12;11(9):e0162683. doi: 10.1371/journal.pone.0162683. eCollection 2016.

  PMID: 27617742 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Hepatitis B

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Hee-Soon Juon, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 3, 2016
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share