Abstract ED04-04: Methodological issues and tools for community-based trials to reduce cancer health disparities Free

This workshop will cover important methodological issues and tools for conducting community-based trials with examples from an on-going NCI-funded program project to increase Hepatitis B testing among three Asian American populations. Three main issues will be discussed which are closely related to each other: community-based participatory research (CBPR), assessment tools and intervention development.

Community-based participatory research. Community-based participatory research is defined as “a collaborative research approach that is designed to ensure and establish structures for participation by communities affected by the issue being studied, representatives of organizations, and researchers in all aspects of the research process to improve health and well-being through taking action, including social change (Viswanathan et al., 2004). Benefits of CBPR include co-learning and reciprocal transfer of expertise by all research partners on the issues that are studied, shared decision-making power and mutual ownership of the research products.

Participation in all aspects of the research process starts with conceptualizing the proposed study and writing the proposal. While the writing process is usually done by the academic partner and the health issue to be studied is sometimes determined by the funding opportunity, discussions with community partners will ensure that the study design is acceptable to community members, that the recruitment methods are feasible and that the interventions have the potential to be institutionalized if the research shows that they are successful. In one of our studies to increase Hepatitis B testing among Korean American, for example, we conduct small-group interactive educational sessions on Hepatitis B in Korean American churches. These sessions are well accepted by Korean Americans, because the churches routinely offer a variety of programs, including health related programs, in addition to religious service. With almost 80% of Korean Americans being regular church goers, churches are a good way to reach a large number of Korean Americans, even those who do not regularly obtain health care. In order to make our study attractive to church leaders, all participants receive an educational session on an important health issues, including subjects in the control arm of the study. When some church leaders did not want to participate in our study because eligibility is limited to subjects under 65 years of age, we were able to win their participation by modifying our protocol to offer educational sessions to over 65 year olds without entering them into the study. While discussing study details with community members takes time and resources, it usually improves the “buy-in” by respected community members, which in turn results in better recruitment and fewer refusals and therefore more representative and less biased samples.

In our program project to increase Hepatitis B testing, each of the studies has a community advisory board that will provide direction throughout the study and has assisted us in the development of assessment tools and the intervention. The San Francisco study is testing the efficacy of a mass media campaign promoting Hepatitis B testing in the Vietnamese community. This investigator group has a long history of working with the Vietnamese community and their advisory group has been involved in a number of prior studies. The Los Angeles study, which tests the efficacy of small group education in Korean American churches, had to establish an advisory group for this project and it will take some time to develop close working relationships. The project in Sacramento is partnering with the Hmong Women's Heritage Association in developing and implementing a lay-health worker intervention targeting individuals in the Hmong community. Their community advisory group consists of only male leaders in the Hmong community to balance the strong involvement of the Hmong Women's Heritage Association. The male only advisory group is sensitive to the cultural norms in this community.

Development of assessment instruments. The community partners also made very important contributions to the development of the assessment instruments. We developed a Hepatitis B core questionnaire that is being used by all three projects in the three Asian communities and will allow comparisons among the three ethnic groups. In addition to demographic characteristics including acculturation, the questionnaire includes questions from all domains of the health behavior framework (described previously) that were deemed important for Hepatitis B testing by the academic and community investigators and that had been associated with cancer screening in Asian American populations in prior studies. We conducted key informant interviews and focus groups in the Vietnamese, Korean, and Hmong community to gain a better understanding of the issues surrounding Hepatitis B testing, the knowledge and misperceptions regarding Hepatitis B transmission, and attitudes regarding Hepatitis B. This work informed the development of the assessment tools and the intervention. Some concepts were assessed with single items to keep questionnaires short. In wording the items, we were striving to keep them as simple as possible and to have few response categories (e.g., yes/no, agree/disagree or 3 point Likert Scale). The translation protocol included forward and back translations by independent bilingual individuals, feedback from bilingual members of the advisory committee or community members and pilot testing of items with 10–20 subjects in each project. Discrepancies between the Asian and English language versions of items have been discussed in conference calls. In few instances, the English language items were revised to better reflect the Asian language items. In the final assessment tools, the meaning of the items was identical in all 4 languages, despite small discrepancies in the wording.

Although the assessment instruments for the three component projects have a common Hepatitis B core questionnaire, there are also differences, some of which are due to the different study designs for the three component projects. The San Francisco study will conduct two cross-sectional surveys at the beginning and the end of the study period in the Vietnamese community. Therefore, both surveys will have to assess demographic characteristics, acculturation, and access to health care. In contrast, the Sacramento study will administer baseline and follow-up surveys to the same Hmong sample. Because demographic and acculturation variables usually don't change from baseline to follow-up, they will only be assessed at baseline. The Los Angeles study will interview a very large sample of Korean-Americans at baseline and follow-up. Taking advantage of the large sample size, this study will administer a short versus long baseline questionnaire to a random half of the sample to assess to what extent the long questionnaire influences subsequent Hepatitis B testing. This study also explores the effect of changing the sequence of questions. For example, at follow-up, a random half of the sample will be asked about intention of obtain Hepatitis B testing prior to the actual behavior, while the other half will be asked both questions in reverse order to explore the effect of sequence of the questions on self-reported Hepatitis B testing during the follow-up period.

Development of interventions. The intervention format and content for each project was developed based on input from community partners, pilot work in the respective Asian ethnic groups, and the theoretical foundation of the Health Behavior Framework. The interventions of all three component projects include appropriate information on knowledge, including knowledge about the nature of the hepatitis B virus, symptoms of hepatitis B, transmission routes, function of the liver, availability of a blood test to assess hepatitis B status; health beliefs, including perceived susceptibility and perceived severity; social norms; cultural factors; communication with providers; and barriers to hepatitis B testing. The content in all these domains is project-specific. For example, each component project addresses barriers that have emerged during pilot work with their specific population: The Vietnamese project addresses lack of health insurance and not knowing where to get tested. The Hmong project addresses not knowing how to request a test from the provider, language barriers and fear of finding hepatitis B infection. The Korean project addresses lack of health insurance, not knowing where to get tested, not knowing how to request a test from the provider and lack of time to get tested. In order to keep the Hmong intervention materials simple, we have agreed to omit the following information in the flip chart: information on possible results of the Hepatitis B blood test: never exposed, immune, chronic carrier; and information on vaccination. However, the lay health advisors in the Hmong project will assist subjects in interpreting test results and will also provide information on vaccination. The delivery formats (mass media versus individual interactions with lay health workers versus small group sessions in churches) have been used in interventions addressing health issues other than hepatitis B testing in Asian American and other populations, but they have not always resulted in improved health behaviors. Because studies are lacking, there are currently no evidence-based interventions to improve hepatitis B testing. Our studies will add to the evidence base for this health behavior.