Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.

INTRODUCTION: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. METHODS: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. RESULTS: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. CONCLUSIONS: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

Come from away: Best practices in mini-sabbaticals for the development of young investigators: a White Paper by the SEQUIN (mini-Sabbatical Evaluation and QUality ImprovemeNt) Group.

Mini-sabbaticals are formal short-term training and educational experiences away from an investigator's home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs. In this paper, we review the history of sabbaticals and mini-sabbaticals, report the results of surveys we performed to ascertain the use of mini-sabbaticals at Clinical and Translational Science Award hubs, and consider best practice recommendations for institutions seeking to establish formal mini-sabbatical programs.

Mass media as a population-level intervention tool for Chlamydia trachomatis screening: report of a pilot study.

PURPOSE: To determine the feasibility and affect of mass media use in a population-level intervention for chlamydia screening promotion. METHODS: A population-level chlamydia intervention protocol was field tested. The intervention, targeting 15-25-year-old individuals, was designed to: (a) increase awareness of personal risk for chlamydial infection; (b) facilitate dissemination of chlamydia knowledge by use of a telephone hot line; and (c) promote care-seeking behavior (report for a chlamydia screening program). The intervention activities included: (a) mail outreach, (b) a television and radio campaign, (c) a prerecorded Check-It-Out chlamydia hot line, (d) a staffed chlamydia Options information line, and (e) a free confidential urine ligase chain reaction (LCR) test for chlamydia. Mass mailings were scheduled at intervals, starting two-weeks before the beginning of the television advertisement. The 30-second television advertisement was aired on local television stations 130 times in a 6-week period. The outcome measures were quantity and characteristics of incoming calls to the automated hot line and staffed chlamydia information phone line in response to the chlamydia campaign, and response to the urine screening program. Descriptive and bivariate analyses were used to evaluate the outcomes. RESULTS: The hot line was called 642 times during the monitoring period (November 1, 1999 to March 8, 2000), the majority (92%) during the 6 weeks of television advertisement, with an average of 99 calls per week, compared with an average of 9 calls per week after the commercial ended. Each bulk mailing was accompanied by a boost in the incoming hot line calls. The research staff triaged 133 calls to the "Options" phone line, 81% in the 6 weeks of the TV ad. The mean age of the 133 callers was 23.9 +/- 7.7 years (range 14-49 years). A majority called for screening information; 67% of callers were females and 84% of female callers were under age 26 years. Five percent of callers identified themselves as a parent of a teenager. The majority credited the TV ad as their source of the hot line number. Thirty-one individuals reported for a confidential chlamydia screening, 27 of 31 (87%) during the 6 weeks of TV advertising. No negative responses regarding the chlamydia campaign were encountered. CONCLUSION: This report describes strategies used to implement and measure the effectiveness of a mass media campaign and demonstrates evidence that mass media is effective in delivering STD intervention messages to young people.

Douching behavior in high-risk adolescents. What do they use, when and why do they douche?

OBJECTIVES: To describe feminine hygiene practices and douching behavior in adolescent women. DESIGN: A cross-sectional anonymous survey. SUBJECTS: Adolescents (majority rural) admitted to a correctional institution for girls. MAIN OUTCOME MEASURES: Description of feminine hygiene practices, prevalence of vaginal douching, types of substances used, reported reasons for, and timing of douching. RESULTS: In a period of 16 weeks, 104 girls were surveyed within a week of admission. The mean age was 15.4 (SD 1.5; range 12-18) yr, and age at sexual debut 13.1 (SD 1.4) yr. Use of feminine hygiene products was reported by: 9% for feminine suppository, 33% towelettes, 40% spray, 67% feminine wash; only 18% reported no use of those feminine hygiene products listed. A history of ever having douched was reported by 79%; the mean first douching age was 14.0 (SD 1.3; range 11-16). Douching product users were significantly more likely to know someone who douches regularly (P <.0001) and have watched douche commercials (P =.0001) than those who did not douche. A majority used store-bought products, vinegar in water and scented solution being the most popular; baking soda, Betadine, Pine-sol, and Lysol were other products used. Commonly cited reasons for douching included to feel good and fresh (60%), and to rid of odor and of blood (47% each). Other reasons cited were to please partner (12%) and to avoid going to a doctor (6%). Timing of douching included: after period (69%), after sex (52%), before sex (16%), before going to a doctor (17%). Among those who douched, 51% douched once a month, and an additional 32% more often than that. CONCLUSION: This study provides troublesome findings regarding the feminine hygiene practices of mostly rural southern teenagers who have been incarcerated.

Vaginal douching among adolescent and young women: more challenges than progress.

The practice of vaginal douching dates back centuries. Numerous studies have shown that douching is quite prevalent and often begins during adolescence. Motivation for the initiation and maintenance of this practice appears complex, and presents challenges to the intervention efforts. The practice of douching remains controversial. Douching has been implicated in numerous adverse reproductive health outcomes such as increased risk for pelvic inflammatory disease, ectopic pregnancy, reduced fertility, and bacterial vaginosis. However, recent studies in developing countries have suggested that in certain circumstances, douching may actually be beneficial. We summarize key findings from the review of published literature and ongoing research, as well as highlight research challenges to our understanding of the role of vaginal douching in reproductive health.

Early onset of vaginal douching is associated with false beliefs and high-risk behavior.

BACKGROUND: Vaginal douching in young women has been linked to a variety of adverse reproductive health consequences. OBJECTIVES: To explore associations with early onset (< or =15 years old) of douching. STUDY DESIGN: A confidential survey was self-administered to convenience samples of women attending seven primary care clinics. RESULTS: The mean age of the 726 evaluable participants was 27.9 years (ranges, 14-63 years). Twenty-two percent of participants believed douching "kills germs that cause infections," and 27% agreed that "women believe douching prevents pregnancy." A history of having ever used douching products was reported by 73%. Of those who had douched, 24% began the practice at age < or =15 years. Compared with those who began at a later age, those who began at age < or =15 years were also more likely to have begun sexual intercourse under 16 years of age (AOR 2.63; P<0.001), to believe that douching kills germs that cause STDs (AOR=2.15 P=0.004), and to currently douche more than once per month (AOR=2.08; P=0.009). CONCLUSION: This study indicates that early onset of vaginal douching is associated with false beliefs and sexual debut at younger age.