Communicating medical device recalls: A rapid review of the literature.

OBJECTIVES: The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented. METHODS: To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products. RESULTS: We identified 23 articles to include in our review. CONCLUSION: Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers. PRACTICE IMPLICATIONS: Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.

"Take care of their hierarchy of needs first": strategies used by data-to-care staff to address barriers to HIV care engagement.

Data-to-Care (D2C) is a public health strategy designed to engage out-of-care (OOC) persons with HIV (PWH) in HIV care. OOC PWH are identified through review of state and local HIV data and engaged in care through individualized efforts that address barriers to HIV care. Perspectives of D2C program staff can contribute to D2C program development and sustainability. We conducted semi-structured interviews in 2017 with 20 D2C program staff from Louisiana (n = 10) and Virginia (n = 10), states with distinct D2C programs. We used content and thematic analysis to analyze interview transcripts. In both states, common barriers to care for OOC PWH include limited transportation, stigma, substance use, poverty, homelessness, and mental illness. To address these barriers and engage OOC clients in HIV care, staff and programs provided transportation vouchers and housing assistance, integrated substance use and mental health services into care engagement processes, provided empathy and compassion, and assessed and addressed basic unmet needs. Identifying and addressing social and structural barriers to HIV care is a critical and often a necessary first step in engaging OOC clients in HIV care. These findings can be used for D2C program design and implementation, facilitating engagement in HIV care for OOC PWH.

Overcoming Challenges to HIV Medical Care-seeking and Treatment Among Data-to-Care Program Clients in Baton Rouge and New Orleans, Louisiana.

ABSTRACT: Data to Care (D2C) uses US public health surveillance data to identify persons with diagnosed HIV who are not receiving adequate medical care. These persons are linked to care and ancillary social services through personalized outreach. We conducted semistructured interviews with 36 adults with HIV in Louisiana who were engaged for the first time or reengaged back into HIV care through D2C efforts. Before D2C program staff contact, nearly 40% were not contemplating HIV care. Program clients cited barriers to HIV care, including difficulties with appointment scheduling and transportation, health care service and drug costs, low motivation, and competing non-HIV health needs. Thirty-four of the 36 clients said that D2C staff helped them overcome these barriers. Clients also described psychosocial support from D2C staff. After receiving D2C program assistance, more than 90% of clients reported consistently receiving HIV medical care and taking medications. Our findings suggest that D2C staff successfully identified client needs and provided tailored assistance.

Utilization of HIV Prevention, Care, and Treatment Services Among Young Men Who Have Sex With Men and Transgender Persons of Color in the U.S. South: A Qualitative Analysis.

To better understand utilization of HIV prevention, care, and treatment services by young men who have sex with men (YMSM) and young transgender persons (YTG), of Black race or Hispanic/Latino/Latina ethnicity in the U.S. South, we conducted semi-structured interviews with 127 clients at one of four community based organizations (CBOs) in Miami, Atlanta, New Orleans/Baton Rouge, or Columbia, South Carolina. Across sites, the service that most commonly drew respondents into the CBO was HIV and STD testing. Other services commonly used included HIV/STI treatment, counseling services/support groups, and PrEP services. Social/organizational/structural facilitators of service utilization include the welcoming climate/culture of the CBOs, ease of access to the services, and transportation services to reach the CBOs. Suggested service enhancements include broader range of comprehensive, navigational-type services beyond HIV testing and service co-location. Research on how to reduce stigma in the surrounding communities may help reduce health disparities experienced by these populations.

HIV Testing Program Activities and Challenges in Four U.S. Urban Areas.

The national "Ending the HIV Epidemic: A Plan for America" supports expanded testing in jurisdictions and groups with disproportionate HIV burden. Public health planners benefit from learning HIV testing service (HTS) strengths, challenges, and innovations. We conducted semistructured interviews with 120 HTS staff from local health departments, community-based organizations, and community members in Houston, Texas; Miami, Florida; New Orleans, Louisiana; and Washington, DC. We coded interview transcripts using qualitative methods to identify themes. Program strengths include HIV testing integration with other client services; prioritized testing and tailored incentives; multiple advertising methods; and partnerships among HTS providers. Challenges include stigma, fear, and disparities; funding requirements that create competition between providers; and service accessibility, unnecessary repeat testing, and insufficient innovation. The four jurisdictions addressed some, but not all, of these challenges. Cross-jurisdictional collaboration, together with state and federal partners plus program data may help identify additional strategies for strengthening HTS.