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1558. Associations between gender identity and solicited adverse events after passive infusion of VRC01 or placebo in HVTN 704/HPTN 085

Abstract Background Gender minority individuals are understudied in clinical trials. Realizing the potential of HIV prevention options requires understanding product tolerability across diverse groups vulnerable to HIV acquisition. Within HVTN 704/HPTN 085, a phase 2b trial of the broadly neutralizing antibody (bnAb) VRC01 for HIV prevention, analyses of associations between gender identity and solicited adverse events (solAE) after infusions of VRC01 or saline placebo have not been reported. Methods HVTN 704/HPTN 085 enrolled men who have sex with men and transgender (TG) participants from Brazil, Peru, Switzerland and the US and randomized them 1:1:1 to receive an infusion every 8 weeks (10 total) of VRC01 30 mg/kg, VRC01 10 mg/kg or placebo. solAE were recorded for 3 days after each infusion. Gender was defined by self-report and sex assigned at birth. Odds ratios of the association of gender (cisgender men [CM] vs. gender minority participants [including TG women, TG men or other identity]) and frequency and severity of solAE were adjusted for age, race and ethnicity. Results Of 2,552 participants, 162 identified as TG women (6.3%), 75 as other identity (2.9%) and 15 as TG men (0.6%). Gender minority participants identified as Black/African American (8.7%), other (59.9%) and White (21.8%); 68.3% identified as Hispanic/Latino (Tab. 1). Overall, 867 (37.7%) CM and 107 (42.5%) gender minority participants reported a solAE (Tab. 2). Gender minority participants were more likely to report solAE than CM overall (OR 1.59, 95% CI 1.21-2.10, p=0.001) and among placebo recipients (1.72, 1.05-2.81, 0.032) (Tab. 3). SolAE severity (≥Grade 2) did not significantly differ overall (1.83, 0.79-4.20, 0.174). Grade 2 solAE were reported after 1% and 2% of infusions among CM and gender minority participants, respectively. Grade 3 and 4 events were rare in both groups (< 0.1%). Infusion completion did not differ.Table 1.Demographic and behavioral characteristics by gender identity of participants in HVTN 704/HPTN 085 who did not acquire HIV during the trial.Table 2.Frequency and severity of solicited adverse events by gender identity among VRC01 and placebo recipients.Table 3.Adjusted effect of gender identity on solicited adverse event frequency and severity. Conclusion HVTN 704/HPTN 085 is the first large-scale HIV bnAb preventive trial allowing assessment of associations between gender identity and solAE. Gender minority participants had more frequent solAE, but importantly, infusion completion did not differ and severe solAEs were rare. HIV prevention and bnAb trials must engage and include gender minority individuals to evaluate the tolerability of novel agents. Disclosures Srilatha Edupuganti, MD MPH FIDSA, Sanofi: Grant/Research Support

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Mapping density, diversity and species-richness of the Amazon tree flora

Using 2.046 botanically-inventoried tree plots across the largest tropical forest on Earth, we mapped tree species-diversity and tree species-richness at 0.1-degree resolution, and investigated drivers for diversity and richness. Using only location, stratified by forest type, as predictor, our spatial model, to the best of our knowledge, provides the most accurate map of tree diversity in Amazonia to date, explaining approximately 70% of the tree diversity and species-richness. Large soil-forest combinations determine a significant percentage of the variation in tree species-richness and tree alpha-diversity in Amazonian forest-plots. We suggest that the size and fragmentation of these systems drive their large-scale diversity patterns and hence local diversity. A model not using location but cumulative water deficit, tree density, and temperature seasonality explains 47% of the tree species-richness in the terra-firme forest in Amazonia. Over large areas across Amazonia, residuals of this relationship are small and poorly spatially structured, suggesting that much of the residual variation may be local. The Guyana Shield area has consistently negative residuals, showing that this area has lower tree species-richness than expected by our models. We provide extensive plot meta-data, including tree density, tree alpha-diversity and tree species-richness results and gridded maps at 0.1-degree resolution.

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Tailoring evidence into action: Using a co‐design approach for biodiversity information in the Tropical Andes

AbstractBiodiversity conservation is a complex and transdisciplinary problem that requires engagement and cooperation among scientific, societal, economic, and political institutions. However, historical approaches have often failed to bring together and address the needs of all relevant stakeholders in decision‐making processes. The Tropical Andes, a biodiversity hotspot where conservation efforts often conflict with socioeconomic issues and policies that prioritize economic development, provides an ideal model to develop and implement more effective approaches. In this study, we present a co‐design approach that mainstreams and improves the flow of biodiversity information in the Tropical Andes, while creating tailored outputs that meet the needs of economic and societal stakeholders. We employed a consultative process that brought together biodiversity information users and producers at the local, national, and regional levels through a combination of surveys and workshops. This approach identified priority needs and limitations of the flow of biodiversity information in the region, which led to the co‐design of user‐relevant biodiversity indicators. By leveraging the existing capacities of biodiversity information users and producers, we were able to co‐design multiple biodiversity indicators and prioritize two for full implementation ensuring that the data was findable, accessible, interoperable, and reusable based on the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This approach helped address limitations that were identified in the stakeholder engagement process, including gaps in data availability and the need for more accessible biodiversity information. Additionally, capacity‐building workshops were incorporated for all producers of biodiversity information involved, which aimed to not only improve the current flow of biodiversity information in the region but also facilitate its future sustainability. Our approach can serve as a valuable blueprint for mainstreaming biodiversity information and making it more inclusive in the future, especially considering the diverse worldviews, values, and knowledge systems between science, policy, and practice.

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Genome-Wide Association Study of Fiber Diameter in Alpacas.

The aim of this study was the identification of candidate genomic regions associated with fiber diameter in alpacas. DNA samples were collected from 1011 female Huacaya alpacas from two geographical Andean regions in Peru (Pasco and Puno), and three alpaca farms within each region. The samples were genotyped using an Affymetrix Custom Alpaca genotyping array containing 76,508 SNPs. After the quality controls, 960 samples and 51,742 SNPs were retained. Three association study methodologies were performed. The GWAS based on a linear model allowed us to identify 11 and 35 SNPs (-log10(p-values) > 4) using information on all alpacas and alpacas with extreme values of fiber diameter, respectively. The haplotype and marker analysis method allowed us to identify nine haplotypes with standardized haplotype heritability higher than six standard deviations. The selection signatures based on cross-population extended haplotype homozygosity (XP-EHH) allowed us to identify 180 SNPs with XP-EHH values greater than |3|. Four candidate regions with adjacent SNPs identified via two association methods of analysis are located on VPA6, VPA9, VPA29 and one chromosomally unassigned scaffold. This study represents the first analysis of alpaca whole genome association with fiber diameter, using a recently assembled alpaca SNP microarray.

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Temporal variation of Triatoma dimidiata abundance and infection with Trypanosoma cruzi in domestic and sylvatic habitats of rural Yucatan, Mexico

In the Yucatan Peninsula, Mexico, Triatoma dimidiata is the main vector of Chagas disease. This is a native species in the region that principally inhabits sylvatic habitats. Nevertheless, it shows a tolerant behavior to anthropogenic disturbance, with adult bugs frequently infesting human dwellings, principally during the warm and dry season. Yet, whether the temporal variation of abundance is independent of the habitat and how this is related to the infection rate with Trypanosoma cruzi in Yucatan is still poorly understood. The objective of this study was to simultaneously analyze the temporal variations of T. dimidiata abundance and infection with T. cruzi in domestic and sylvatic habitats from two localities of rural Yucatan (Sudzal, 20°52ʹ19″N, 88°59ʹ20″W and Teya, 21°02ʹ55″N, 89°04ʹ25″W) to help for the further improvement of locally adapted strategies aimed at controlling T. cruzi vector transmission. Using community participation and a combination of different trapping techniques, we collected T. dimidiata bugs during 29 consecutive months within domestic and sylvatic habitats. We then assessed by PCR the infection of the bugs with T. cruzi. Generalized linear models were used to evaluate the effect of climatic variables on the abundance of T. dimidiata and the effect of bug sex, season and habitat on the prevalence of infection with T. cruzi. Overall, 3640 specimens of T. dimidiata were collected. We clearly observed peaks of maximum abundance in both habitats during the warm and dry season and found a negative association of bug abundance with relative humidity. The overall prevalence of infection of the bugs with T. cruzi was 15.2 %. Additionally, bugs collected in domestic habitats displayed a significantly higher prevalence of infection than sylvatic bugs (19.6% vs. 6.1 %, respectively), suggesting an increased risk of T. cruzi transmission related with anthropogenic disturbance. Our study is the first to describe the annual pattern of abundance of T. dimidiata in sylvatic habitats of rural Yucatan and constitutes a contribution to the knowledge of T. dimidiata ecology and of T. cruzi transmission cycle dynamics in the region. In Yucatan, where the use of mosquito nets has shown to be effective to limit human dwelling infestation by T. dimidiata, reinforcing the awareness of local residents about the increased risk of T. cruzi transmission during the warm and dry season when realizing activities in the sylvatic ambient should be, among others, also considered to improve control strategies and limit the risk of vector transmission.

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Development and Implementation of Educational Material by Nurses for Parents/Caregivers of Children With Cancer: A Peruvian National Study.

Background: Education for parents and caregivers of children with cancer is one of the fundamental roles of nurses to avoid complications, provide quality care, promote adherence to treatment and maintain basic standards of care. This study aimed to design educational material for parents and caregivers of children with cancer in Peru on general information about childhood cancer and its care. Method: Within the framework of the WHO Global Initiative for Childhood Cancer in Peru, a multicenter working group was convened by the Peruvian Ministry of Health. A comprehensive needs assessment of parents and caregivers of children with cancer was performed through a survey in June and July 2020. The survey was conducted online (via Google Forms) and in person at nine hospitals to examine the preferred method of delivery and content of information. Results: Based on the findings from the parent needs assessment, a national nursing working group developed Spanish-language audiovisual materials (i.e., diagnosis and treatment videos for nurses to educate parents and caregivers). A total of 365 parents and caregivers were included. Most respondents (56.9%) were parents of children receiving treatment. Main topics were childhood cancer overview and side effects (85%), food and nutrition (75%), and palliative care (67%); most (70.9%) preferred information through talks and videos (64.7%). Twenty-three videos were developed with support by the Pan American Health Organization and the Ministry of Health. Discussion: Assessing the educational needs of parents and caregivers of children with cancer provides a starting point in the design of targeted strategies.

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