Considering Sex as a Variable at a Research University: Knowledge, Attitudes, and Practices.

Biomedical research has a history of excluding females as research subjects, which threatens rigor, reproducibility, and inclusivity. In 2016, to redress this bias, the U.S. National Institutes of Health (NIH) implemented a policy requiring the consideration of sex as a biological variable (SABV) in all studies involving vertebrate animals, including humans. Unless strongly justified, females and males must be included in all studies and results reported disaggregated by sex. Recent evidence indicates, however, that misunderstandings of the policy and other significant barriers impede its implementation. To shed light on those barriers at our home institution, we conducted a study funded by the Emory University Specialized Center of Research Excellence on Sex Differences (SCORE). In semistructured interviews of Emory principal investigators in the biological sciences, we noted their knowledge of what the policy entails and why it was implemented, their attitudes toward it, and the extent to which it has or has not changed their research practices. Although attitudes toward SABV were generally positive, most researchers face challenges with respect to its implementation. We suggest interventions that can be mounted at the level of home institutions, such as raising awareness of locally available core facilities, to help address these challenges. More training is needed on what the policy asks of researchers, how sex is defined, the nonhormonal ways that sex differences can manifest, and best practices for statistical analysis of sex-based data. Home institutions may also want to explore ways to lessen the stress associated with rollout of SABV policy.

Development of a Mobile App to Increase the Uptake of HIV Pre-exposure Prophylaxis Among Latino Sexual Minority Men: Qualitative Needs Assessment.

BACKGROUND: HIV disproportionally impacts Latino sexual minority men (SMM). Uptake of pre-exposure prophylaxis (PrEP), an effective biomedical intervention to prevent HIV, is low in this group compared with White SMM. Mobile health technology represents an innovative strategy to increase PrEP uptake among Latino SMM. OBJECTIVE: We aimed to describe the qualitative process leading to the development of SaludFindr, a comprehensive HIV prevention mobile app aiming to increase PrEP uptake, HIV testing, and condom use by Latino SMM. METHODS: We conducted 13 in-depth interviews with Latino SMM living in the Atlanta area to explore their main barriers and facilitators to PrEP uptake and to analyze their opinions of potential SaludFindr app functionalities. To explore potential app functions, we used HealthMindr, an existing HIV prevention app, as a template and added new proposed features intended to address the specific community needs. RESULTS: We identified general PrEP uptake barriers that, although common among non-Latino groups, had added complexities such as the influence of religion and family on stigma. Low perceived PrEP eligibility, intersectional stigma, lack of insurance, cost concerns, and misconceptions about PrEP side effects were described as general barriers. We also identified Latino-specific barriers that predominantly hinder access to existing services, including a scarcity of PrEP clinics that are prepared to provide culturally concordant services, limited availability of Spanish language information related to PrEP access, distrust of peers as credible sources of information, perceived ineligibility for low-cost services owing to undocumented status, fear of immigration authorities, and competing work obligations that prevent PrEP clinic attendance. Health care providers represented a trusted source of information, and 3 provider characteristics were identified as PrEP facilitators: familiarity with prescribing PrEP; being Latino; and being part of lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA+) group or ally. The proposed app was very well accepted, with a particularly high interest in features that facilitate PrEP access, including a tailored list of clinics that meet the community needs and a private platform to seek PrEP information. Spanish language availability and free or low-cost PrEP care represented the 2 main clinic criteria that would facilitate PrEP uptake. Latino representation in clinic staff and providers; clinic perception as a safe space for undocumented patients; and LGBTQIA+ representation was listed as additional criteria. Only 8 of 47 clinics listed on the Centers for Diseases Control and Prevention PrEP locator website for the Atlanta area fulfilled at least 2 main criteria. CONCLUSIONS: This study provides further evidence of the substantial PrEP uptake barriers that Latino SMM face; exposes the urgent need to increase the number of accessible PrEP-providing clinics for Latino SMM; and proposes an innovative, community-driven, and mobile technology-based tool as a future intervention to overcome some of these barriers.

Bone, Brain, Heart study protocol: A resilient nested, tripartite prospective cohort study of the role of estrogen depletion on HIV pathology.

PURPOSE: We describe the rationale for and design of an innovative, nested, tripartite prospective observational cohort study examining whether relative estrogen insufficiency-induced inflammation amplifies HIV-induced inflammation to cause end organ damage and worsen age-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (Brain), skeletal (Bone), and cardiovascular (Heart/vessels) organ systems (BBH Study). METHODS: The BBH parent study is the Multicenter AIDS Cohort/Women's Interagency HIV Study Combined Cohort Study (MWCCS) with participants drawn from the Atlanta MWCCS site. BBH will enroll a single cohort of n = 120 women living with HIV and n = 60 HIV-negative women, equally distributed by menopausal status. The innovative multipart nested study design of BBH, which draws on data collected by the parent study, efficiently leverages resources for maximum research impact and requires extensive oversight and management in addition to careful implementation. The presence of strong infrastructure minimized BBH study disruptions due to changes in the parent study and the COVID-19 pandemic. CONCLUSION: BBH is poised to provide insight into sex and HIV associations with the neuro-hypothalamic-pituitary-adrenal axis, skeletal, and cardiovascular systems despite several major, unexpected challenges.

Nested and multipart prospective observational studies, flaming fiasco or efficiently economical?: The Brain, Bone, Heart case study.

BACKGROUND: Collecting new data from cross-sectional/survey and cohort observational study designs can be expensive and time-consuming. Nested (hierarchically cocooned within an existing parent study) and/or Multipart (≥ 2 integrally interlinked projects) study designs can expand the scope of a prospective observational research program beyond what might otherwise be possible with available funding and personnel. The Brain, Bone, Heart (BBH) study provides an exemplary case to describe the real-world advantages, challenges, considerations, and insights from these complex designs. MAIN: BBH is a Nested, Multipart study conducted by the Specialized Center for Research Excellence (SCORE) on Sex Differences at Emory University. BBH is designed to examine whether estrogen insufficiency-induced inflammation compounds HIV-induced inflammation, leading to end-organ damage and aging-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (brain), musculoskeletal (bone), and cardiovascular (heart) organ systems. Using BBH as a real-world case study, we describe the advantages and challenges of Nested and Multipart prospective cohort study design in practice. While excessive dependence on its parent study can pose challenges in a Nested study, there are significant advantages to the study design as well. These include the ability to leverage a parent study's resources and personnel; more comprehensive data collection and data sharing options; a broadened community of researchers for collaboration; dedicated longitudinal research participants; and, access to historical data. Multipart, interlinked studies that share a common cohort of participants and pool of resources have the advantage of dedicated key personnel and the challenge of increased organizational complexity. Important considerations for each study design include the stability and administration of the parent study (Nested) and the cohesiveness of linkage elements and staff organizational capacity (Multipart). CONCLUSION: Using the experience of BBH as an example, Nested and/or Multipart study designs have both distinct advantages and potential vulnerabilities that warrant consideration and require strong biostatistics and data management leadership to optimize programmatic success and impact.