Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

Caregivers of Black and Latino/a/x Students and School Personnel Perspectives on School-Based SARS-CoV-2 Testing: Implications for Testing and Test-to-Stay Programs in K-12 Schools.

BACKGROUND: "Test-to-stay" (TTS) is an effective approach for keeping students in school post-exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To prepare for school-based SARS-CoV-2 testing, we implemented formative research to gather perspectives on school-based testing among school personnel, as well as caregivers of Black and Latino/a/x students given systemic racism, existing school inequalities, and the disproportionate effect of COVID-19 on Black and Latino/a/x populations. METHODS: We conducted in-depth interviews with caregivers of K-12 grade Black and Latino/a/x students and focus group discussions with K-12 school personnel. We described the forthcoming school-based SARS-CoV-2 testing program and explored potential benefits and concerns, including concerns about testing-related stigma and discrimination, particularly toward Black and Latino/a/x students, and implementation recommendations. RESULTS: Perceived testing benefits included school community reassurance and preventing school outbreaks. Concerns included potential student anxiety, classroom disruption, inaccurate results, and limited information for caregivers. Some participants mentioned that testing-related stigma and discrimination could happen based on the testing selection process or results but not due to race or ethnicity. Participants provided numerous testing recommendations, including suggestions to prevent negative outcomes. CONCLUSIONS: Participants believed that stigma and discrimination from SARS-CoV-2 testing is possible, although differential treatment based on race or ethnicity was not anticipated. Participants' narratives provide support for school-based testing and the testing component of TTS.

HIV Prevention During the COVID-19 Pandemic: Sexual Activity and PrEP Use Among Black Same-Gender-Loving Men and Black Cisgender Women.

Black populations in the U.S. South are disproportionally affected by HIV and COVID-19 due to longstanding inequalities. We conducted 20 in-depth interviews-12 with Black same-gender-loving men and 8 with Black cisgender women-to explore the impact of the initial phase of the COVID-19 pandemic on sexual activities and PrEP use. Almost all participants reduced the frequency of sex and number of partners. Women described little interest in sex, whereas men began to connect with some sexual partners after stay-at-home orders were lifted. Both populations were concerned about contracting COVID-19 through sexual partners, and men described selecting partners based on perceived COVID-19 risk. Participants valued PrEP and could access it, although several men who were not having sex stopped taking it. Risk of acquiring HIV during this time was likely limited. Future qualitative research is needed to understand how sexual behaviors and PrEP use changed as the pandemic continued.

Masking Adherence in K-12 Schools and SARS-CoV-2 Secondary Transmission.

OBJECTIVES: Masking is an essential coronavirus 2019 mitigation tool assisting in the safe return of kindergarten through 12th grade children and staff to in-person instruction; however, masking adherence, compliance evaluation methods, and potential consequences of surveillance are currently unknown. We describe 2 school districts' approaches to promote in-school masking and the consequent impact on severe acute respiratory syndrome coronavirus 2 secondary transmission. METHODS: Two North Carolina school districts developed surveillance programs with daily versus weekly interventions to monitor in-school masking adherence. Safety teams recorded the proportion of students and staff appropriately wearing masks and provided real-time education after observation of improper masking. Primary infections, within-school transmission, and county-level severe acute respiratory syndrome coronavirus 2 infection rates were assessed. RESULTS: Proper mask use was high in both intervention groups and districts. There were variations by grade level, with lower rates in elementary schools, and proper adherence being higher in the weekly surveillance group. Rates of secondary transmission were low in both districts with surveillance programs, regardless of intervention frequency. CONCLUSIONS: Masking surveillance interventions are effective at ensuring appropriate masking at all school levels. Creating a culture of safety within schools led by local leadership is important and a feasible opportunity for school districts with return to in-person school. In our study of schools with high masking adherence, secondary transmission was low.