Internal and external validity of cluster randomised trials: systematic review of recent trials

Objectives To assess aspects of the internal validity of recently published cluster randomised trials and explore the reporting of information useful in assessing the external validity of these trials.Design Review of 34 cluster randomised trials in primary care published in 2004 and 2005 in seven journals (British Medical Journal, British Journal of General Practice, Family Practice, Preventive Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Pediatrics).Data sources National Library of Medicine (Medline) via PubMed.Data extraction To assess aspects of internal validity we extracted data on appropriateness of sample size calculations and analyses, methods of identifying and recruiting individual participants, and blinding. To explore reporting of information useful in assessing external validity we extracted data on cluster eligibility, cluster inclusion and retention, cluster generalisability, and the feasibility and acceptability of the intervention to health providers in clusters.Results 21 (62%) trials accounted for clustering in sample size calculations and 30 (88%) in the analysis; about a quarter were potentially biased because of procedures surrounding recruitment and identification of patients; individual participants were blind to allocation status in 19 (56%) and outcome assessors were blind in 15 (44%). In almost half the reports, information relating to generalisability of clusters was poorly reported, and in two fifths there was no information about the feasibility and acceptability of the intervention.Conclusions Cluster randomised trials are essential for evaluating certain types of interventions. Issues affecting their internal validity, such as appropriate sample size calculations and analysis, have been widely disseminated and are now better addressed by researchers. Blinding of those identifying and recruiting patients to allocation status is recommended but is not always carried out. There may be fewer barriers to internal validity in trials in which individual participants are not recruited. External validity seems poorly addressed in many trials, yet is arguably as important as internal validity in judging quality as a basis for healthcare intervention.     

Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials

Background

Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment.

Methods

Interviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters.

Results

Recruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients’ treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff.

Conclusions

The synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters’ roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.     

Multidimensional biases,gaps and uncertainties in global plant occurrence information

Plants are a hyperdiverse clade that plays a key role in maintaining ecological and evolutionary processes as well as human livelihoods. Biases, gaps and uncertainties in plant occurrence information remain a central problem in ecology and conservation, but these limitations remain largely unassessed globally. In this synthesis, we propose a conceptual framework for analysing gaps in information coverage, information uncertainties and biases in these metrics along taxonomic, geographical and temporal dimensions, and apply it to all c. 370 000 species of land plants. To this end, we integrated 120 million point‐occurrence records with independent databases on plant taxonomy, distributions and conservation status. We find that different data limitations are prevalent in each dimension. Different metrics of information coverage and uncertainty are largely uncorrelated, and reducing taxonomic, spatial or temporal uncertainty by filtering out records would usually come at great costs to coverage. In light of these multidimensional data limitations, we discuss prospects for global plant ecological and biogeographical research, monitoring and conservation and outline critical next steps towards more effective information usage and mobilisation. Our study provides an empirical baseline for evaluating and improving global floristic knowledge, along with a conceptual framework that can be applied to study other hyperdiverse clades.     

What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

Background aimsRecent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies.MethodsWe conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€).ResultsThe framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to help design manufacturing best practices.ConclusionsThis framework and methodology provide step-by-step guidance to estimate manufacturing costs specifically for cell-based therapies manufactured in academic and other small-scale enterprises. The framework and methodology can be used to inform and plan cost-conscious strategies for CBTs.     

Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556]

Background

There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments.

Methods

A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted.

Results

Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work.

Conclusion

There is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.     

Intervenciones basadas en el ejercicio y el entorno para la prevención de caídas en personas con deterioro cognitivo que viven en centros de cuidado: revisión sistemática y metaanálisis

This systematic review aims to report the effectiveness of interventions based on exercise and/or physical environment for reducing falls in cognitively impaired older adults living in long-term care facilities.In July 2014, a literature search was conducted using main databases and specialised sources. Randomised controlled trials assessing the effectiveness of fall prevention interventions, which used exercise or physical environment among elderly people with cognitive impairment living in long-term care facilities, were selected. Two independent reviewers checked the eligibility of the studies, and evaluated their methodological quality. If it was adequate, data were gathered.Fourteen studies with 3,539 participants using exercise and/or physical environment by a single or combined approach were included. The data gathered from studies that used both interventions showed a significant reduction in fall rate.Further research is needed to demonstrate the effectiveness of those interventions for preventing falls in the elderly with cognitive impairment living in long-term care establishments.     

Investigating the effect of increasing robot group sizes on the human psychophysiological state in the context of human–swarm interaction

We study the psychophysiological state of humans when exposed to robot groups of varying sizes. In our experiments, 24 participants are exposed sequentially to groups of robots made up of 1, 3 and 24 robots. We measure both objective physiological metrics (skin conductance level and heart rate), and subjective self-reported metrics (from a psychological questionnaire). These measures allow us to analyse the psychophysiological state (stress, anxiety, happiness) of our participants. Our results show that the number of robots to which a human is exposed has a significant impact on the psychophysiological state of the human and that higher numbers of robots provoke a stronger response.     

Assessing Impacts of Wind-Energy Development on Nocturnally Active Birds and Bats: A Guidance Document

ABSTRACT Our purpose is to provide researchers, consultants, decision-makers, and other stakeholders with guidance to methods and metrics for investigating nocturnally active birds and bats in relation to utility-scale wind-energy development. The primary objectives of such studies are to 1) assess potential impacts on resident and migratory species, 2) quantify fatality rates on resident and migratory populations, 3) determine the causes of bird and bat fatalities, and 4) develop, assess, and implement methods for reducing risks to bird and bat populations and their habitats. We describe methods and tools and their uses, discuss limitations, assumptions, and data interpretation, present case studies and examples, and offer suggestions for improving studies on nocturnally active birds and bats in relation to wind-energy development. We suggest best practices for research and monitoring studies using selected methods and metrics, but this is not intended as cookbook. We caution that each proposed and executed study will be different, and that decisions about which methods and metrics to use will depend upon several considerations, including study objectives, expected and realized risks to bird and bat populations, as well as budgetary and logistical considerations. Developed to complement and extend the existing National Wind Coordinating Committee document “Methods and Metrics for Assessing Impacts of Wind Energy Facilities on Wildlife” (Anderson et al. 1999), we provide information that stakeholders can use to aid in evaluating potential and actual impacts of wind power development on nocturnally active birds and bats. We hope that decision-makers will find these guidelines helpful as they assemble information needed to support the permitting process, and that the public will use this guidance document as they participate in the permitting processes. We further hope that the wind industry will find valuable guidance from this document when 1) complying with data requirements as a part of the permitting process, 2) evaluating sites for potential development, 3) assessing impacts of operational wind-energy facilities, and 4) mitigating local and cumulative impacts on nocturnally active birds and bats.     

Old and new challenges in using species diversity for assessing biodiversity

Although the maintenance of diversity of living systems is critical for ecosystem functioning, the accelerating pace of global change is threatening its preservation. Standardized methods for biodiversity assessment and monitoring are needed. Species diversity is one of the most widely adopted metrics for assessing patterns and processes of biodiversity, at both ecological and biogeographic scales. However, those perspectives differ because of the types of data that can be feasibly collected, resulting in differences in the questions that can be addressed. Despite a theoretical consensus on diversity metrics, standardized methods for its measurement are lacking, especially at the scales needed to monitor biodiversity for conservation and management purposes. We review the conceptual framework for species diversity, examine common metrics, and explore their use for biodiversity conservation and management. Key differences in diversity measures at ecological and biogeographic scales are the completeness of species lists and the ability to include information on species abundances. We analyse the major pitfalls and problems with quantitative measurement of species diversity, look at the use of weighting measures by phylogenetic distance, discuss potential solutions and propose a research agenda to solve the major existing problems.     

Comparison of Contact Patterns Relevant for Transmission of Respiratory Pathogens in Thailand and the Netherlands Using Respondent-Driven Sampling

Understanding infection dynamics of respiratory diseases requires the identification and quantification of behavioural, social and environmental factors that permit the transmission of these infections between humans. Little empirical information is available about contact patterns within real-world social networks, let alone on differences in these contact networks between populations that differ considerably on a socio-cultural level. Here we compared contact network data that were collected in the Netherlands and Thailand using a similar online respondent-driven method. By asking participants to recruit contact persons we studied network links relevant for the transmission of respiratory infections. We studied correlations between recruiter and recruited contacts to investigate mixing patterns in the observed social network components. In both countries, mixing patterns were assortative by demographic variables and random by total numbers of contacts. However, in Thailand participants reported overall more contacts which resulted in higher effective contact rates. Our findings provide new insights on numbers of contacts and mixing patterns in two different populations. These data could be used to improve parameterisation of mathematical models used to design control strategies. Although the spread of infections through populations depends on more factors, found similarities suggest that spread may be similar in the Netherlands and Thailand.     

Ethics in Indigenous Research – Connecting with Community

The challenge for those responsible for funding, brokering and assessing the merit of proposed Indigenous research is to identify and then work co-operatively with appropriate representatives of Indigenous interests in order to increase the flow of benefits from research to Indigenous peoples. Experience in Australia has shown that this is not a straightforward process. In this paper we indicate some reasons why it is important for the research community to broker research with representative Indigenous organisations and to involve Indigenous peoples in the ethical assessment and conduct of research. We then identify some barriers to the achievement of these objectives and outline recently developed interventions from the field of health research that aim to promote a more effective working relationship between Indigenous peoples and members of the research community.

Emergence pattern and hatching cues of Daphnia pulicaria (Crustacea, Cladocera) in an alpine lake

We developed a methodology to predict brook trout (Salvelinus fontinalis) distribution using summer temperature metrics as predictor variables. Our analysis used long-term fish and hourly water temperature data from the Dog River, Vermont (USA). Commonly used metrics (e.g., mean, maximum, maximum 7-day maximum) tend to smooth the data so information on temperature variation is lost. Therefore, we developed a new set of metrics (called event metrics) to capture temperature variation by describing the frequency, area, duration, and magnitude of events that exceeded a user-defined temperature threshold. We used 16, 18, 20, and 22°C. We built linear discriminant models and tested and compared the event metrics against the commonly used metrics. Correct classification of the observations was 66% with event metrics and 87% with commonly used metrics. However, combined event and commonly used metrics correctly classified 92%. Of the four individual temperature thresholds, it was difficult to assess which threshold had the “best” accuracy. The 16°C threshold had slightly fewer misclassifications; however, the 20°C threshold had the fewest extreme misclassifications. Our method leveraged the volumes of existing long-term data and provided a simple, systematic, and adaptable framework for monitoring changes in fish distribution, specifically in the case of irregular, extreme temperature events.     

The components of biodiversity,with a particular focus on phylogenetic information

We present a framework for biodiversity metrics that organizes the growing panoply of metrics. Our framework distinguishes metrics based on the type of information–abundance, phylogeny, function–and two common properties–magnitude and variability. Our new metrics of phylogenetic diversity are based on a partition of the total branch lengths of a cladogram into the proportional share of each species, including: a measure of divergence which standardizes the amount of evolutionary divergence by species richness and time depth of the cladogram; a measure of regularity which is maximal when the tree is perfectly symmetrical so that all species have the same proportional branch lengths; a measure that combines information on the magnitude and variability of abundance with phylogenetic variability, and a measure of phylogenetically weighted effective mean abundance; and indicate how those metrics can be decomposed into α and β components. We illustrate the utility of these new metrics using empirical data on the bat fauna of Manu, Peru. Divergence was greatest in lowland rainforest and at the transition between cloud and elfin forests, and least in upper elfin forests and in cloud forests. In contrast, regularity was greatest in lowland rainforest, dipping to its smallest values in mid‐elevation cloud forests, and then increasing in high elevation elfin forests. These patterns indicate that the first species to drop out with increasing elevation are ones that are closely related to other species in the metacommunity. Measures of the effective number of phylogenetically independent or distinct species decreased very rapidly with elevation, and β‐diversity was larger. In contrast, a comparison of feeding guilds shows a different effect of phylogenetic patterning. Along the elevational gradient, each guild generally loses some species from each clade–rather than entire clades–explaining the maintenance of functional diversity as phylogenetic diversity decreases.     

Obese women's barriers to mammography and pap smear: the possible role of personality

Obese women are at increased risk of developing and dying from cancer, but are less likely than nonobese women to receive cancer screening examinations. Our qualitative study explores obese women's barriers to Pap smears and mammograms in greater depth than previous research. We also seek to understand why some obese women undergo screening whereas others do not. A purposive sample of moderately to severely obese women over age 40 was recruited from community-based organizations, health clinics, and retail establishments. Semi-structured in-depth interviews (N = 33) informed by the Theory of Care-Seeking Behavior and three prior focus groups of obese women (N = 18) were recorded and transcribed. Qualitative analysis was iterative, using a grounded theory approach involving a series of immersion/crystallization cycles. Participants verified many barriers to cervical and breast cancer screening previously identified in the general population, including fear, modesty, competing demands, and low perceived risk. Participants also highlighted several weight-related barriers, including insensitive comments about weight and equipment and gowns that could not accommodate them. Comparison of participants who were up-to-date with both Pap smears and mammograms with those not up-to-date with either screening showed no discernable differences in these barriers, however. Instead, we found that the participants who followed through on their cancer screenings may share certain personality traits, such as conscientiousness or self-regulatory ability, that allow them to complete difficult or feared tasks. Our research therefore suggests that personality may act as an important mediator in health behavior, and should be taken into account in future theoretical models and health behavior interventions, particularly for obese women.     

A guide to phylogenetic metrics for conservation,community ecology and macroecology

The use of phylogenies in ecology is increasingly common and has broadened our understanding of biological diversity. Ecological sub‐disciplines, particularly conservation, community ecology and macroecology, all recognize the value of evolutionary relationships but the resulting development of phylogenetic approaches has led to a proliferation of phylogenetic diversity metrics. The use of many metrics across the sub‐disciplines hampers potential meta‐analyses, syntheses, and generalizations of existing results. Further, there is no guide for selecting the appropriate metric for a given question, and different metrics are frequently used to address similar questions. To improve the choice, application, and interpretation of phylo‐diversity metrics, we organize existing metrics by expanding on a unifying framework for phylogenetic information. Generally, questions about phylogenetic relationships within or between assemblages tend to ask three types of question: how much; how different; or how regular? We show that these questions reflect three dimensions of a phylogenetic tree: richness, divergence, and regularity. We classify 70 existing phylo‐diversity metrics based on their mathematical form within these three dimensions and identify ‘anchor’ representatives: for α‐diversity metrics these are PD (Faith's phylogenetic diversity), MPD (mean pairwise distance), and VPD (variation of pairwise distances). By analysing mathematical formulae and using simulations, we use this framework to identify metrics that mix dimensions, and we provide a guide to choosing and using the most appropriate metrics. We show that metric choice requires connecting the research question with the correct dimension of the framework and that there are logical approaches to selecting and interpreting metrics. The guide outlined herein will help researchers navigate the current jungle of indices.     

Estimating the complex patterns of survey availability for loggerhead turtles

Successful management strategies are important for conservation and allow accurate surveying and monitoring of populations for presence, abundance, and trend. This becomes challenging for cryptic, low-density species, and for animals that have complicated life histories where not every stage of the life cycle can be surveyed effectively. We used information from animal-borne data loggers to characterize the dive-surfacing behavior of cryptic loggerhead turtles (Caretta caretta) in the northwest Atlantic from 2009–2018. Our data covered a large geographic area off the east coast of North America, and allowed us to present estimates for and variation in 3 metrics that can be used to assess availability bias affecting visual surveys: average dive duration, average surface duration, and the proportion of time at the surface. We used a stochastic partial differential equation approach to construct spatiotemporal regression models for the availability bias metrics. Model predictions showed pronounced individual, spatial, and spatiotemporal (seasonal) variation among the 245 turtles. Overall, we estimated an average dive duration of 14.5 ± 1.36 minutes (SE), an average surface duration of 15.1 ± 2.77 minutes, and an average proportion of time at the surface of 0.50 (95% CI = 0.41–0.59). We made predictions of the 3 availability bias metrics on a 20-km × 20-km grid and further used predictions to explore seasonal variations. Our results contribute new insights into loggerhead turtle behavior and provide information that enables survey counts to be translated into more accurate abundance estimates.     

Using Fish Communities to Assess Streams in Romania: Initial Development of an Index of Biotic Integrity*

Multimetric biotic indices increasingly are used to complement physicochemical data in assessments of stream quality. We initiated development of multimetric indices, based on fish communities, to assess biotic integrity of streams in two physiographic regions of central Romania. Unlike previous efforts to develop such indices for European streams, our metrics and scoring criteria were selected largely on the basis of empirical relations in the regions of interest. We categorised 54 fish species with respect to ten natural-history attributes, then used this information to compute 32 candidate metrics of five types (taxonomic, tolerance, abundance, reproductive, and feeding) for each of 35 sites. We assessed the utility of candidate metrics for detecting anthropogenic impact based on three criteria: (a) range of values taken, (b) relation to a site-quality index (SQI), which incorporated information on hydrologic alteration, channel alteration, land-use intensity, and water chemistry, and (c) metric redundancy. We chose seven metrics from each region to include in preliminary multimetric indices (PMIs). Both PMIs included taxonomic, tolerance, and feeding metrics, but only two metrics were common to both PMIs. Although we could not validate our PMIs, their strong association with the SQI in each region suggests that such indices would be valuable tools for assessing stream quality and could provide more comprehensive assessments than the traditional approaches based solely on water chemistry.     

Effect of habitat quality and phenotypic variation on abundance- and trait-based early warning signals of population collapses

Loss of resilience in population numbers in response to environmental perturbations may be predicted with statistical metrics called early warning signals (EWS) that are derived from abundance time series. These signals, however, have been shown to have limited success, leading to the development of trait-based EWS that are based on information collected from phenotypic traits such as body size. Experimental work assessing the efficacy of EWS under varying ecological and environmental factors are rare. In addition, disentangling how such warning signals are affected under varying ecological and environmental factors is key to their application in biological conservation. Here, we experimentally test how different rates of environmental forcing (i.e. warming) and varying ecological factors (i.e. habitat quality and phenotypic diversity) affected population stability and predictive power of early warning signals of population collapse. We analyzed population density and body size time series data from three phenotypically different populations of a protozoan ciliate Askenasia volvox in two levels of habitat quality subjected to three different treatments of warming (i.e. no warming, fast warming and slow warming). We then evaluated how well abundance- and trait-based EWS predicted population collapses under different levels of phenotypic diversity, habitat quality and warming treatments. Our results suggest that habitat quality and warming treatments had more profound effects than phenotypic diversity had on both population stability and on the performance of abundance-based signals of population collapse. In addition, trait-based EWS generally performed well, were reliable and more robust in forecasting population collapse than abundance-based EWS, regardless of variation in environmental and ecological factors. Our study points towards the development of a predictive framework that includes information from phenotypic traits such as body size as an indicator of loss of resilience of ecological systems in response to environmental perturbations.     

Altered Network Topologies and Hub Organization in Adults with Autism: A Resting-State fMRI Study

Recent functional magnetic resonance imaging (fMRI) studies on autism spectrum condition (ASC) have identified dysfunctions in specific brain networks involved in social and non-social cognition that persist into adulthood. Although increasing numbers of fMRI studies have revealed atypical functional connectivity in the adult ASC brain, such functional alterations at the network level have not yet been fully characterized within the recently developed graph-theoretical framework. Here, we applied a graph-theoretical analysis to resting-state fMRI data acquired from 46 adults with ASC and 46 age- and gender-matched controls, to investigate the topological properties and organization of autistic brain network. Analyses of global metrics revealed that, relative to the controls, participants with ASC exhibited significant decreases in clustering coefficient and characteristic path length, indicating a shift towards randomized organization. Furthermore, analyses of local metrics revealed a significantly altered organization of the hub nodes in ASC, as shown by analyses of hub disruption indices using multiple local metrics and by a loss of “hubness” in several nodes (e.g., the bilateral superior temporal sulcus, right dorsolateral prefrontal cortex, and precuneus) that are critical for social and non-social cognitive functions. In particular, local metrics of the anterior cingulate cortex consistently showed significant negative correlations with the Autism-Spectrum Quotient score. Our results demonstrate altered patterns of global and local topological properties that may underlie impaired social and non-social cognition in ASC.     

Integration of Social,Cultural, and Biomedical Strategies into an Existing Couple-Based Behavioral HIV/STI Prevention Intervention: Voices of Latino Male Couples

Introduction

Successful HIV prevention and treatment requires evidence-based approaches that combine biomedical strategies with behavioral interventions that are socially and culturally appropriate for the population or community being prioritized. Although there has been a push for a combination approach, how best to integrate different strategies into existing behavioral HIV prevention interventions remains unclear. The need to develop effective combination approaches is of particular importance for men who have sex with men (MSM), who face a disproportionately high risk of HIV acquisition.

Materials and Methods

We collaborated with Latino male couples and providers to adapt Connect ‘n Unite, an evidence-based intervention for Black male couples, for Latino male couples. We conducted a series of three focus groups, each with two cohorts of couples, and one focus group with providers. A purposive stratified sample of 20 couples (N = 40, divided into two cohorts) and 10 providers provided insights into how to adapt and integrate social, cultural, and biomedical approaches in a couples-based HIV/AIDS behavioral intervention.

Results

The majority (N = 37) of the couple participants had no prior knowledge of the following new biomedical strategies: non-occupational post-exposure prophylaxis (nPEP); pre-exposure prophylaxis (PrEP); and HIV self-testing kits. After they were introduced to these biomedical interventions, all participants expressed a need for information and empowerment through knowledge and awareness of these interventions. In particular, participants suggested that we provide PrEP and HIV self-testing kits by the middle or end of the intervention. Providers suggested a need to address behavioral, social and structural issues, such as language barriers; and the promotion of client-centered approaches to increase access to, adaptation of, and adherence to biomedical strategies. Corroborating what couple participants suggested, providers agreed that biomedical strategies should be offered after providing information about these tools. Regarding culturally sensitive and responsive approaches, participants identified stigma and discrimination associated with HIV and sexual identity as barriers to care, language barriers and documentation status as further barriers to care, the couple-based approach as ideal to health promotion, and the need to include family topics in the intervention.

Discussion

We successfully adapted an evidence-based behavioral HIV prevention intervention for Latino male couples. The adapted intervention, called Conectando Latinos en Pareja, integrates social, cultural, behavioral and biomedical strategies to address the HIV epidemic among Latino MSM. The study highlights the promise regarding the feasibility of implementing a combination approach to HIV prevention in this population.