Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

Sexually Transmitted Diseases

Urogenital Diseases

Genital Diseases

Disease Attributes

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker. Those not invited will constitute the usual care control group.

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker in the intervention group.

The intervention group will be made up of two sub groups. The group of individuals who accept the invitation to participate (IG1) in the intervention and receive it, and those randomized to the intervention group but who reject the opportunity to participate (IG2).

Community health workers (CHWs) in Hispanic communities, often referred to as "promotoras," are members of the community who use "resource sharing, partnership development, education, outreach, health promotion, and disease prevention strategies to improve the health" of their communities.

IG1: The intervention itself consists of a 45-minute one-on-one presentation and tailored planning session delivered by a CHW in a community setting of the new member's choosing. Presentations (in English or Spanish) will be delivered using a tablet computer or a hand held flipchart. Two booster telephone interactions will be performed at 2 and 4 months. At month 6, the participant will receive a call from the telephone interviewer to administer the informed patient choice survey.

Community health worker

Franciso AR Garcia, MD, MPH

The investigators propose to test a community-developed and targeted intervention that employs community health workers (CHWs) as aides to newly Medicaid-insured women. These women face the challenges of engaging with their healthcare and health and of making highly personal and socioculturally embedded decisions about reproductive health-related preventive services (e.g., contraception, STI and cancer screening).

All newly enrolled women in one of Arizona's state-wide Medicaid health plans (University Family Care) who are ambulatory and community-dwelling, and between the ages of 18-39, will be identified by the health plan on a monthly basis as eligible for this study. For at least the first month, these new health plan members will be randomized 2 to 1 (intervention to usual care control). Each month the health plan will provide the study team with the number of new members. A study team member will then provide the health plan with a list of numbers (1's and 0's) generated using the biased coin design to apply to those new members. To avoid bias, health plan staff will not be aware of members study arm.

All new health plan enrollees (as per current standard health plan practice) receive a series of welcome communications (by mail and electronically) from the health plan shortly after enrollment. These are designed to apprise new members of health plan policies and procedures related to covered benefits, facilitate the selection of a primary care provider, and provide general preventive health resources and information. This is followed by a second mailing at 3-months post enrollment, as well as a nurse follow-up call. The latter is designed to answer questions about covered services, finding a primary care provider, and/or otherwise provide support. Both intervention and control group member will receive identical communications from the health plan up to this point. Potential participants will be contacted by the health plan's call center. A brief verbal overview of the intervention including time requirement and content to be covered will be provided. The potential participants who have been randomly assigned to the intervention group will then be offered the opportunity to set up an individual confidential appointment with a community health worker (CHW) at her earliest convenience.

The call center will provide the research office a list of interested participants and their contact information. Once that list is received by the research office, a CHW will be assigned to each potential participant. The assigned CHW will call to introduce herself, to answer lingering questions about the intervention and proposed encounter and to confirm the participant's acceptance into the intervention. At that time, the CHW will confirm language and location preference, date/ time of proposed meeting, and the contact information for the research office for any questions. The CHW will meet with the subject and complete the informed consent process. Also, the baseline informed patient choice survey will be performed using a touch tablet device (to ascertain baseline knowledge, patient preferences, informed decision making, and health literacy). The CHW will tailor the individual education session to meet the unique needs of the participant (e.g., an individual who discloses a history of surgical sterilization will not receive information about contraception). The 45-minute intervention will be delivered as described above. The patient will be asked to personally assess her needs with regard to reproductive health-related issues. The CHW will work with the participant to develop a personalized plan to access the relevant targeted preventive services. This may involve assistance with contacting the Health Plan and assistance with identifying or making an appointment with a primary care provider. At the conclusion of the intervention, the patient will be encouraged to reach out to the CHW by telephone or electronically if she has any subsequent questions or concerns, and appointments for the two booster telephone calls will be scheduled. Finally, in consideration for her time and participation, the participant will be provided with a $40 gift card.

Booster telephone support calls will occur at 2 and 4 months post intervention. A telephone call guide will be used to reinforce and clarify key concepts from the initial intervention encounter as well as to help clients formulate relevant questions related to specific women's preventive services and other health concerns in anticipation of their next primary care provider (PCP) visit. Participants will also be queried specifically about any issues related to interactions with the health plan and/or contacting her primary care provider. The patient will be assisted with connecting to the health plan or her PCP's office for those issues that cannot be easily addressed by the CHW. Whenever possible, every effort will be made by the CHW to connect the patient to the appropriate outreach staff at that PCP's office (if such staff is available). Again the availability of the CHW by telephone or electronically for interval questions will be emphasized. At month 6, the participant will receive a call from the telephone interviewer to administer the 6-month informed patient choice survey identical to the survey that was completed at baseline. A $40 gift card incentive will be offered to complete this survey.

The call center will administer a similar 6-month survey by phone to a sample of the group randomized to invitation, but who did not accept the invitation (IG2) and the group not invited (CG). A $30 gift card incentive will be offered to complete this survey.

Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable

The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.

The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.

The number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.

The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.

The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.

Patient-Centered Outcomes Research Institute

RAND

University of Arizona

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited will constitute the usual care control group.

Control Group (CG)

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group will be made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Intervention Group (IG1)

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group will be made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

Intervention Group (IG2)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The health plan was unable to contact the majority of the population to make the offer of CHW services, and the young, generally healthy population made impacts on avoidable ED visits and hospitalizations difficult to detect within a 6 month period.

Dr. Ada Wilkinson-Lee, Co-Investigator

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.

Identify and Utilization of Primary Care Provider (PCP)

The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services

Members who had an ED visit during the first 6 months of their enrollment.

The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits

Members who had a hospital visit during the first 6 months of enrollment.

The Impact of the Intervention on Preventable Hospital Stays

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

IG1 at Baseline: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Baseline: Intervention Group (IG1)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

IG1 at 6-Month Follow-up: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

6-Month Follow-up: Intervention Group (IG1)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker.

CG and IG2 at 6-Month Follow-up: Those not invited constituted the usual care control group (CG). The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

6-Month Follow-up: Control Group (CG)&Intervention Group (IG2)

IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.

Informed Decision Making Regarding the Healthcare System and Their Health

Overall Study

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.

Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.

clinician-collection methods using speculum and cervical swabs

Workshop plus Clinician-Collected Cervical Swab

Evalyn® Brush (Rovers® Medical Devices, Netherlands)

Workshop plus Participant-Collected Cervical Swab

Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)

HPV testing on Participant-Collected Cervical Swab Samples

Jessica Dalby, MD

The primary purpose of this study is to determine whether educational workshops paired with self-collected high-risk human papillomaviruses (hrHPV) screening will increase participation in cervical cancer screening among Southeast Asian Immigrant and Refugee populations in Wisconsin compared with offering clinician collected screening (total sample size: 250 participants). The investigators hypothesize that participation in cervical cancer screening will be higher among women in the intervention group as compared to the control group.

The effectiveness of offering self-collection sampling options to Southeast Asian refugee and immigrant populations to improve cervical cancer screening participation has not been investigated. The Milwaukee Consortium for Hmong Health (MCHH), supported by the Well Woman Program, has had success increasing participation in breast cancer screening through outreach and education activities. However, it continues to have limited success engaging women in cervical cancer screening. The investigators have established a partnership with MCHH to develop innovative cervical cancer workshops that combine community health worker (CHW)-led engagement with self-collected hrHPV screening, with the primary objective of increasing participation, awareness, and engagement in cervical cancer screening and treatment activities among this population.

Research Intervention: Control workshops are workshops where participants are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs. Intervention workshops are workshops where participants are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method. After each workshop, each group will be offered to participate in their assigned group's screening method (clinician-collected or self-collected).

* Primary Objective: To evaluate whether educational workshops paired with self-collected hrHPV screening will increase participation in cervical cancer screening among Southeast Asian refugee and immigrant populations in Wisconsin compared with offering clinician-collected screening.
* Secondary Objectives: To evaluate participant satisfaction with the educational workshops using satisfaction surveys.

Workshops are randomized to either a control or intervention group

Participants will be informed of random assignment into two groups. Participants will not be aware of which group they belong to. Participants in the control group are initially only provided educational materials about the standard of care for cervical cancer screening and offered clinician-collection for screening as the recommended method. Whereas the intervention group is provided additional materials about self-collection in the core educational material and is offered the Evalyn Device for self-collection as a screening option immediately at the end of the workshop. All participants will be made aware during a debrief session at the end of the study about what information could not be given at the time of consenting, and why they could not be told at that time.

Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women

Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin

The results will be reported through summary statistics of the number of participants in each group subsequently engaging or seeking out cervical cancer screening either through services offered after workshop education or self-reported desire to follow up through their community health care provider.

Participant satisfaction with the educational workshops will be assessed using mixed methods satisfaction surveys. 4-items on the pre- and post-workshop surveys scored on a 5 point likert scale from 1 (not likely) to 5 (very likely) for a total possible range of scores from 5 to 20 where higher scores are a proxy for positive workshop impact on participant. Additional items will include open ended questions on satisfaction.

General willingness to use a HPV self-collect device at home and/or as the preferred collection method for cervical cancer screening, assessed via mixed methods survey.

Milwaukee Consortium for Hmong Health (MCHH)

University of Wisconsin, Madison

Digestive System Diseases

Hepatitis A

Hepatitis

Hepatitis B

Liver Neoplasms

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

All Drugs and Chemicals

Hematinics

Vaccines

Liver Extracts

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.

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.

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)

Hee-Soon Juon, PhD

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.

Specific Aim 1. Develop a training protocol and certification program for lay health workers (LHWs)

People of Asian backgrounds are likely to exhibit cultural relativism leaning toward collectivism compared to individualism. The personal interactions within their self-identified cultural communities may closely relate to development of their perceived beliefs and subjective norms, which influence to act upon identified health behaviors (Ajzen, Albarracin \& Hornik 2007). The investigators will develop a lay health worker (LHW) model that highlights the effects of culturally competent human and educational interactions on facilitating the Chinese-, Korean- and Vietnamese-American (CKV-A) community's active behaviors in hepatitis B screening, vaccination, and treatments. To develop an efficacious and effective LHW intervention that will contribute for creating a critical mass toward sustainable Chinese, Korean and Vietnamese (CKV) changes, our strategic approaches include as follows:

1. Review the liver cancer education program guidebook in English, (developed by previous project R25).
2. Refine/revise the approaches through work group reviews: Through a series of bi-monthly meetings with participants from community advisory board (CAB), CKV-A communities, health practitioners and outreach workers, and experts in hepatitis B virus (HBV) and liver cancer education (Juon and Lee), and education and evaluation (Park), the investigators will confirm/specify the approaches of the available materials and develop additional assessment approaches and forms in English.
3. Test the validities of subgroup language versions with pilot CKV groups: Through assessments with each group (n=10) of CKV-As, the investigators will produce the refined validated LHW protocol (after translation and back-translation). It will include common and unique approaches across/within subgroup(s) to be congruent with cultural values.
4. Test the pilot LHW implementation
5. Establish the LHW model to certify satisfactory practicum experience in Patient Navigation training module: Through ongoing assessments with the study participants and participating health care systems, the investigators will monitor the LHW experiential learning module to provide patient navigation function. The approach will identify barriers to hinder access to timely screening, follow-up, and treatment upon diagnosis.

Recruitment: Earp et al. (1997) suggest effective LHWs would have some or all of the following characteristics and skills: (1) the ability to comfortably and effectively access the health care system; (2) the ability to balance the demands of lay helping with other life responsibilities; (3) an interest in AA's health and social issues; (4) maintain close, supportive, and reciprocal connections with others; and (5) leadership skills. LHW models depend on genuine natural helpers to function. To increase recruitment potential for CKVs having desired characteristics: First, the investigators will reach a broad pool of adult volunteers, regardless of gender, income level, or health care experience, who have these characteristics and also have the ability to speak, read and write Chinese, Korean, or Vietnamese languages at or above 2nd grade level. Second, adopting a referral recruitment strategy in social market theory (Lefebvre et al. 1988) as it may be more effective for people who may be more responsive to their sense of collective cultural group's interactions, the investigators will recruit the first 10 LHW candidates per each ethnic group referred by word of mouth, faith-based organization leaders, community advisory groups, and health and social service agencies. Finally, the investigators will expand our recruitment continuously in the community. In Year 1, the investigators plan to train a total of 60 certified LHWs (20 from each ethnic group). The investigators estimate retention of 40 (67%) certified LHWs at the end of the Year 1, based upon literature reviews (Anderson 2000; Caulfield et al. 1998; Han et al. 2009). To replace drop-out LHWs in subsequent years, the investigators plan to recruit and train a total of 30 additional LHWs (10 for each ethnic group) from Years 2 to 3.

Process Evaluation: Using evaluation model of Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) (Glasgow et al. 2001), a framework that emphasized on Reach, Effectiveness, Adoption, Implementation and Maintenance, the investigators will examine the extent to which the LHW program is carried out through processes as intended. At individual level, the investigators will focus on Reach (R) of the LHW certification program and hepatitis B free events and on the Efficacy/Effectiveness (E) of the LHW certification program. For the group level of aggregated individuals, the investigators will assess on Adoption (A), Implementation (I), and Maintenance (M). The investigators will assess general administrative processes of LHW program during the study period in the selected perspectives of fidelity (e.g. logistic reviews, completion rates), dose (e.g. satisfaction survey), and method on translated forms and tools (Saunders, Evans, \& Joshi 2005).

Specific Aim 2. To assess the prevalence of HBV infection by providing screening test

A total of 600 Asian American adults (200 Chinese, Koreans, and Vietnamese each), 18 years of age and older will be drawn from the community.

Recruitment strategy. The investigators have two major channels to recruit participants with the help of certified LHWs including hepatitis B initiative of Washington DC (HBI-DC) screening events and Asian American Health Center (AAHC). First, in the past 10 years, the HBI-DC has screened over 3000 individuals in the Baltimore-Washington Metropolitan Area and approximately 8 to 11% are positive for the surface antigen of the hepatitis B virus (HBsAg). Thus, many individuals are availing themselves of the free testing services. LHWs will announce upcoming screening events in their community by advertising in Korean churches or Chinese language schools or by word-of-mouth. Our research team and LHWs will attend these events to recruit potential participants. Based on previous experiences, each screening event attracted about 100 to 150 Asian Americans. Second, the investigators will go to AAHC volunteer clinics to recruit participants every Saturday. About 10 to 12 Chinese or Korean patients visit the clinic. Patients usually come with family members. So, the investigators estimate to recruit about 15 to 20 participants at the clinics every Saturday. Finally, the investigators will identify potential participants by advertising in ethnic media and ethnic groceries.

Sample size estimate: Based on our previous studies (Juon et al. 2008; Hsu et al. 2007), the investigators estimate that about 10% of all the participants will test hepatitis B virus (HBV) positive, 40 to 50% will be HBV negative but protected, and about 50% will be unprotected. In the preliminary analysis of R25, there were significant mean differences of knowledge of HBV transmission (score ranged 0-10) in intervention (7.21±1.83SD) and control group (5.54±2.07SD) in post-test. The investigators estimated our sample size to be 50 in each intervention and control group among those unprotected. Assuming a conservative rate of attrition about 20%, the investigators calculated the study power based on sample size at follow-up. The sample size of 50 at pre-test is to detect mean difference in knowledge outcome at 96% power (1-β) and type I error of 0.05.Thus, our proposed sample size (n=50) for each group among those unprotected has sufficient power. Our total sample size is 600 (50/group x 2 groups x 2 (infected and protected-50% of study population) x 3 ethnic groups).

Specific Aim 3. To implement LHW intervention among those unprotected Procedures

1. Pre-test/Education program: After obtaining the informed consent for pre-test, screening test, and blood banking, all the participants will be asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese, with the assistance of a bilingual interviewer when necessary. Then, LHW will provide a liver cancer education session to all participants in a small group setting.
2. HBV screening test/initial biospecimen banking: All participants will receive hepatitis B testing. For blood sampling procedure, the investigators will have a part-time phlebotomist working in the field with a bilingual staff and LHW. The phlebotomist will draw two tubes of blood from study participants at the study site. He/she will then transport one tube of the blood in red-top tube to certified clinical labs (i.e., Johns Hopkins Medical Institute (JHMI), Quest, LabCorp) for hepatitis B tests (e.g., HBsAg, HBsAb (surface antibody of HBV), HBcAb (core antibody of HBV)). The other tube will be processed for research sample banking.
3. Informing the results of screening test: All the participants will receive the results one week after their screening. Based on the screening results, all participants will be categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), and (3) protected (HbsAg-/HbsAb+). The investigators will order all screening tests and review all test results from the certified clinical labs. The investigators will mail the results to participants who are unprotected and protected. The investigators will not follow up healthy participants who are protected. The investigators will be responsible for informing the results by calling those infected individuals. The participants will provide counseling on what the results mean and treatment options.
4. Follow up for those infected: Those infected can either be referred through their primary care physicians to a hepatologist or directly to a hepatologist. If participants do not have a hepatologist, participants will be referred to hepatologists in the study team. This will be based on their language preference and geographic location.
5. LHW Intervention/follow up for those unprotected: Those unprotected will be randomly assigned to either the intervention or the control groups by computer-automated random assignment. Randomization will be used to assure equivalence between groups on key factors that may potentially influence the primary outcome of HBV vaccinations (e.g., gender, age, education, length of stay in the U.S.).

LHWs will conduct telephone interventions by reminding participants of a series of vaccinations at Months 1, 2, and 6 among those assigned to the intervention group. Those who have health insurance will be encouraged to complete vaccinations through their providers. If participants do not have health insurance, LHWs will provide resources to help those in the intervention access vaccinations by referring them to the AAHC, or County Health Departments who provide vaccinations to at risk populations. Those in the control group will receive a list of resources by mail that offers free vaccinations, such as local health departments along with their results. Upon completing follow-up, the investigators will provide the delayed LHW intervention for those who do not have vaccinations in the control group.

Seven months after mailing the results, those unprotected will be followed by phone to ask about their status of the series of vaccinations and promoters or barriers to vaccinations. Their self-reported vaccination will be verified with medical records. Participants will be 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 will also be asked to sign a medical release form giving project staff permission to request medical records for their vaccinations. The bilingual interviewers are blinded about participants being in the intervention or control group at post-test.

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

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.

National Cancer Institute (NCI)

Thomas Jefferson University

Skin and Connective Tissue Diseases

Breast Neoplasms

Prostatic Neoplasms

Frailty

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention.

In Visit 1 the community health worker/promotora will assess frailty, cognition, polypharmacy, depression, symptom burden, and social support. In Visits 2 and 3 the community health worker will deliver interpersonal communication techniques to deliver the problem solving coaching format, leverage cultural congruence with clients, and provide social support to assist in adopting healthy behaviors.

Geriatric Assessment and Promotora Coaching

Alex Fauer, PhD MS

Alex J Fauer, PhD MS

The goal of this clinical trial is to test a new way to help older adults who have had cancer.

The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.

The proposed study is a single arm feasibility study of a supportive care intervention. Phase is not applicable because this is not a drug trial. The study involves enrolling older adult non-metastatic cancer survivors between 1 month and 24 months after the completion of any definitive (e.g., curative intent) cancer treatment. The objective is to determine if a Community Health Worker (CHW)-led geriatric assessment and coaching intervention to assess geriatric syndromes is a feasible modality in community-dwelling older adult cancer survivors. The tailored assessment intervention (geriatric assessment and coaching) is hypothesized to potentially be a feasible process to monitor patients that would otherwise not access geriatric services after completing cancer treatment. Coping and social support are hypothesized mediators to the relationship between physical function and health outcomes (e.g., physical function, mental health), influenced by sociodemographic contextual factors. Implementation science concepts, such as acceptability and scalability will also be collected. The study CHW will perform the geriatric assessment and coaching components with each of the patients in the study. The assessment component of the bundle intervention involves screening for frailty and cognition, occurring prior to the coaching session. The CHW will conduct a more thorough geriatric assessment for polypharmacy, depression, symptom burden, and social support. In follow up visits after the geriatric assessment the CHW will deliver the coaching component (derived from the Problem Solving Coaching Model) to participants. Each of the intervention sessions will consist of 45-minute appointments with tailored feedback of the geriatric assessment domains, caregiver and family support, and navigation to additional palliative care resources at the study institution. The researchers developed the content in the tailored assessment intervention from preliminary work and thorough review of scientific literature.

Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

Tailored Geriatric Assessment and Promotores Pilot Feasibility Study

Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)

Patient-Reported Outcomes Measurement Information System \[PROMIS\] Physical Function

Patient-Reported Outcomes Measurement Information System \[PROMIS\] Depression, Anxiety, and Fatigue

Patient-Reported Outcomes Measurement Information System \[PROMIS\] Self-Efficacy

Patient-Reported Outcomes Measurement Information System \[PROMIS\] Emotional Support

European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire in the Elderly 14 item questionnaire \[QLQ-ELD14\]. Range 0 to 100, higher scores indicate better quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable	NCT02157168	Contraception Sexually Transm... Cervical Cancer	Community healt...	18 Years - 39 Years	University of Arizona
Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women	NCT05286749	Cervical Cancer...	Workshop plus C... Workshop plus P... HPV testing on ...	25 Years - 65 Years	University of Wisconsin, Madison
Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans	NCT02760537	Liver Neoplasms Hepatitis B	Lay Health Work... Placebo (a list...	18 Years -	Thomas Jefferson University
Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women	NCT05286749	Cervical Cancer...	Workshop plus C... Workshop plus P... HPV testing on ...	25 Years - 65 Years	University of Wisconsin, Madison
Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans	NCT02760537	Liver Neoplasms Hepatitis B	Lay Health Work... Placebo (a list...	18 Years -	Thomas Jefferson University
Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study	NCT06125145	Breast Cancer Colorectal Canc... Prostate Cancer	Geriatric Asses...	65 Years - 90 Years	University of California, Davis

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