Background Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities, and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics, and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement (CQI) intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. Methods We hypothesized that specialist physician investigators and coordinators trained in the trust-based CQI intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using CQI, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. Results RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three NIH Institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p-values >0.17). Conclusions RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based CQI intervention to increase minority recruitment into clinical trials. RECRUIT’s innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of CQI to tailor the intervention to each specialty clinic’s specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Introduction: The burden of cancers that can be prevented through early detection, specifically breast, cervical, and colorectal cancer, remains higher among medically underserved minority populations. Disparities in knowledge and awareness of screening contribute to the increased burden. We developed an innovative community theater program to educate and promote breast, cervical, and colorectal cancer screening among medically underserved Hispanic, African American, and Vietnamese communities of Harris County, TX. Methods: The program consists of two original plays and nine monologues that promote breast, cervical, or colorectal cancer screening and are culturally tailored to each racial/ethnic and linguistic group. They are all based on a health communications framework, specifically the Extended Parallel Process Model, built on the constructs of perceived susceptibility, perceived severity, self-efficacy, and response efficacy. Each play and monologue was written by an independent professional playwright with input on health messaging from health care professionals. The scripts were then worked through an iterative process between them and clinical and community advisory boards. Live performances by professional actors were held in community venues located in medically underserved zip codes. The monologues were developed in three different languages, English, Spanish, and Vietnamese. Anonymous surveys were self-conducted after each performance. Events included a performance of the monologue or play, a question-and-answer session with a health care professional, and distribution of educational materials. Typically, a representative from a partner institution was also available to connect audience members to health care services. Anonymous self-administered surveys are conducted after each performance. Results: Between January 2014 and present, 128 monologues were performed, including 32 for cervical cancer, 28 for colorectal cancer, and 68 for breast cancer. A total of 3,332 individuals attended the performances (average audience size = 26). Among the 2,745 participants who completed post-performance surveys (response rate = 82.4%), 82.1% indicated that they were very likely to obtain a screening test after watching the performance, compared to 68.5% prior to the performance (p < 0.05). Increase in the proportion of individuals with high intentions to screen was highest for cervical cancer (28.4% increase), followed by colorectal cancer (23.9%) and breast cancer (15.5%), and these differences were statistically significant (p < 0.05). The increase in the proportion of individuals with high intentions to screen was highest specifically for Hispanic audiences of the cervical cancer monologue. Discussion: Community theater performances are an effective method of improving knowledge and awareness of screening and cancer prevention among medically underserved minority populations in Harris County, TX. Performances were especially effective in Hispanic communities. This may be due to their success in breaking barriers associated with culturally taboo topics associated with these cancers. Citation Format: Veronica Landa, Jane Montealegre, Roshanda Chenier, Glori Chauca, Ivan Valverde, Maria Jibaja-Weiss. Using community theater to improve knowledge and awareness of cancer preventive health behaviors in Harris County, TX [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr C16.

Introduction: Although Latinos have higher HPV vaccination rates than non-Hispanic whites, coverage is far below the 80% Healthy People 2020 goal. Significant gaps in knowledge and awareness about HPV and the HPV vaccine persist. Community theater performances are an effective tool to communicate health messages to medically underserved minority populations. Here we describe the pilot test of a community theater-based intervention to increase HPV vaccination intention among Spanish-speaking parents of underserved Latino adolescents. Methods: The monologue script was written by a professional playwright and then modified in an iterative process based on recommendations from clinical and community advisory boards. The monologue performance was pilot tested in two groups, one at a charter school and another at a church in Harris County, TX. Audiences viewed a performance of the monologue and then participated in a question-and-answer session. After the intervention, they were asked questions about the performance and their comprehension of health messages. Additionally, participants answered a self-administered questionnaire. Feedback from the pilot audiences was compiled and incorporated into a revised monologue script. Results: The monologue pilot performances were attended by 36 people. They were mostly female around the average age of 41. 36% were very likely to get their children vaccinated for HPV before viewing the monologue, and 97% were very likely to get their children vaccinated for HPV after the viewing the monologue. This difference was statistically significant (p<0.001). Knowledge question responses revealed key messages that needed further emphasis. Specifically, messages about the vaccine's safety and efficacy and the connection between HPV and cancer were reinforced. Audiences also provided qualitative feedback about ideas they thought needed to be emphasized or clarified. Discussion: Responses to the pre- and post-performance intention-to-vaccinate item suggest that the monologue may increase Latino parents' intentions to vaccinate their adolescent children against the HPV vaccine. This suggests that community theater performances targeted to Latino parents may be an effective approach to communicate health messages and improve parents' knowledge and intentions to vaccinate their adolescent children for HPV. For the most part, audiences understood the main health messages of the monologue and were entertained by and identified with the character and scenarios depicted in the script. However, there were several key messages that audience members felt were not strongly conveyed in the original script: specifically, that the vaccine is about cancer prevention not sexual activity, why the recommended age for vaccination is 11 and 12 years, and the importance of vaccinating against HPV and other adolescent vaccines (Tdap and meningococcal). Changes made to the monologue script will be made based on the feedback from the pilot audiences. Community theater performances targeted to Latino parents may be an effective approach to communicate health messages and improve parents' knowledge and intentions to vaccinate their adolescent children for HPV. Citation Format: Veronica Landa, Jane Montealegre, Maria Jibaja-Weiss. Community theater outreach to increase HPV vaccine intention among parents of Latino adolescents: A pilot test [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr C17.