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: Introduction: There is growing interest in health, developmental and survival outcomes of children who are born HIV‐free to women living with HIV (children born HIV‐free). To date, the research agenda has been largely determined by researchers, funders and policy makers, with limited involvement of parents, who are key stakeholders. Researchers at UCL Great Ormond Street Institute of Child Health in partnership with community‐based organisation 4M Network of Mentor Mothers conducted two workshops with parents in March 2022 to establish research priorities for children born HIV‐free, and key considerations for methodological approaches both to research and engagement with the affected communities. Discussion: When exploring research on children born HIV‐free, we consider the following: what aspects of current research are aligned with women and parents’ priorities, what is missing and what approaches would be preferred. A holistic approach to research on children born HIV‐free should be prioritised, focussing on a breadth of outcomes and how they intersect. Secondary use of existing data sources should be maximised to facilitate this, with a view of monitoring the long‐term effects of fetal antiretroviral drug exposure alongside other key health and developmental outcomes. Involving and engaging with parents, and children where possible, must be at the heart of research design to maximise relevance and impact of findings for the affected communities. Potential barriers to engaging with individuals who were children born HIV‐free include parental disclosure and individuals not identifying as a child born HIV‐free to a mother living with HIV. Stigma‐free language must be incorporated into the vocabulary of researchers and other stakeholders, avoiding reference to exposure; we propose the term “children born HIV‐free.” Conclusions: Mothers and parents living with HIV should be involved in research about their children born HIV‐free and are key in identifying research priorities so that findings may translate into an impact on their children's health and wellbeing. Meaningful involvement of women living with HIV through trusted community partners is an effective mechanism by which to elicit views on research about their children., INTRODUCTION Successes in preventing vertical transmission (VT) have led to substantially fewer children being born with HIV [1]. In parallel, the number of children who are born HIV‐free to women [...]

Introduction: Respondent-driven sampling (RDS) has been an effective sampling strategy for HIV research in many settings, but has had limited success among some youth in the United States. We evaluated a modified RDS approach for sampling Black and Latinx sexual and gender minority youth (BLSGMY) and explored how lived experiences and social contexts of BLSGMY youth may impact traditional RDS assumptions. Methods: RDS was implemented in three US cities, Baltimore, Philadelphia and Washington DC, to engage BLSGMY aged 15 to 24 years in HIV prevention or care intervention trials. RDS was modified to include targeted seed recruitment from venues, Internet and health clinics, and provided options for electronic or paper coupons. Qualitative interviews were conducted among a sub-sample of RDS participants to explore their experiences with RDS. Interviews were coded using RDS assumptions as an analytic framework. Results: Between August 2017 and October 2019, 405 participants were enrolled, 1670 coupons were distributed, with 133 returned, yielding a 0.079 return rate. The maximum recruitment depth was four waves among seeds that propagated. Self-reported median network size was 5 (IQR 2 to 10) and reduced to 3 (IQR 1 to 5) when asked how many peers were seen in the past 30 days. Qualitative interviews (n = 27) revealed that small social networks, peer trust and targeted referral of peers with certain characteristics challenged network, random recruitment, and reciprocity assumptions of RDS. HIV stigma and research hesitancy were barriers to participation and peer referral. Other situational factors, such as phone ownership and access to reliable transportation, reportedly created challenges for referred peers to participate in research. Conclusions: Small social networks and varying relationships with peers among BLSGMY challenge assumptions that underlie traditional RDS. Modified RDS approaches, including those that incorporate social media, may support recruitment for community-based research but may challenge assumptions of reciprocal relationships. Research hesitancy and situational barriers are relevant and must be addressed across any sampling method and study design that includes BLSGMY in the United States. Keywords: HIV; respondent-driven sampling; African-American; Latinx; Gay; Bisexual; Transgender; Youth, 1 | INTRODUCTION Respondent-driven sampling (RDS) has gained popularity in HIV research over the last two decades as a means to sample populations for whom a sampling frame is unavailable [...]

Background University Medical Centers (UMCs) must do their part for clinical trial transparency by fostering practices such as prospective registration, timely results reporting, and open access. However, research institutions are often unaware of their performance on these practices. Baseline assessments of these practices would highlight where there is room for change and empower UMCs to support improvement. We performed a status quo analysis of established clinical trial registration and reporting practices at German UMCs and developed a dashboard to communicate these baseline assessments with UMC leadership and the wider research community. Methods and findings We developed and applied a semiautomated approach to assess adherence to established transparency practices in a cohort of interventional trials and associated results publications. Trials were registered in ClinicalTrials.gov or the German Clinical Trials Register (DRKS), led by a German UMC, and reported as complete between 2009 and 2017. To assess adherence to transparency practices, we identified results publications associated to trials and applied automated methods at the level of registry data (e.g., prospective registration) and publications (e.g., open access). We also obtained summary results reporting rates of due trials registered in the EU Clinical Trials Register (EUCTR) and conducted at German UMCs from the EU Trials Tracker. We developed an interactive dashboard to display these results across all UMCs and at the level of single UMCs. Our study included and assessed 2,895 interventional trials led by 35 German UMCs. Across all UMCs, prospective registration increased from 33% (n = 58/178) to 75% (n = 144/193) for trials registered in ClinicalTrials.gov and from 0% (n = 0/44) to 79% (n = 19/24) for trials registered in DRKS over the period considered. Of trials with a results publication, 38% (n = 714/1,895) reported the trial registration number in the publication abstract. In turn, 58% (n = 861/1,493) of trials registered in ClinicalTrials.gov and 23% (n = 111/474) of trials registered in DRKS linked the publication in the registration. In contrast to recent increases in summary results reporting of drug trials in the EUCTR, 8% (n = 191/2,253) and 3% (n = 20/642) of due trials registered in ClinicalTrials.gov and DRKS, respectively, had summary results in the registry. Across trial completion years, timely results reporting (within 2 years of trial completion) as a manuscript publication or as summary results was 41% (n = 1,198/2,892). The proportion of openly accessible trial publications steadily increased from 42% (n = 16/38) to 74% (n = 72/97) over the period considered. A limitation of this study is that some of the methods used to assess the transparency practices in this dashboard rely on registry data being accurate and up-to-date. Conclusions In this study, we observed that it is feasible to assess and inform individual UMCs on their performance on clinical trial transparency in a reproducible and publicly accessible way. Beyond helping institutions assess how they perform in relation to mandates or their institutional policy, the dashboard may inform interventions to increase the uptake of clinical transparency practices and serve to evaluate the impact of these interventions., Author(s): Delwen L. Franzen *, Benjamin Gregory Carlisle, Maia Salholz-Hillel, Nico Riedel, Daniel Strech Introduction Valid medical decision-making depends on an evidence base composed of clinical trials that were prospectively [...]

PU01.01 Sexuality and HIV education begins in the homes of adolescents G. Mdlalose and V. Dubula-Majola Stellenbosch University, Africa Centre for HIV/AIDS Management, Cape Town, South Africa Background: In the [...]

PE05.01 Recruiting adolescent girls and young women into the MTN-034 Study: lessons learnt from the Kampala and Johannesburg sites M.J. Nambusi (1) ; H. Rampyapedi (2) ; Y. Naidoo (2) [...]

The prevalence of ASD remains relatively stable across the lifespan, necessitating a quantitative understanding of how intervention clinical research is applied across age groups. Here we report a systematic review of treatment studies between 2013 and 2017, enrolling 11,213 subjects with ASD in 218 studies. Individuals under 18 years old constituted the majority of studies (84%) and subjects (92%). Subjects under 18 years old were more likely to be enrolled in behavioral studies (OR (CI) = 1.34 (1.17-1.54)), and less likely to be enrolled in pharmacological (OR = 0.60 (0.52-0.69)) studies than subjects [greater than or equal to] 18 years old. Identified disparities in both intervention modalities and outcome measures should serve to guide future research priorities., Author(s): Alan S. Lewis [sup.1] [sup.2] [sup.3] [sup.4] [sup.5] [sup.6] , Gerrit Ian van Schalkwyk [sup.7] Author Affiliations: (1) grid.412807.8, 0000 0004 1936 9916, Department of Psychiatry and Behavioral Sciences, [...]

Author(s): Mayookha Mitra-Majumdar, Aaron S. Kesselheim * Medical guidelines and decision-making are informed by an understanding of publicly reported clinical trial results, with the assumption that the evidence base is [...]

Introduction Implementation fidelity is a challenge for the adoption of evidence-based programs within social service broadly and child welfare specifically. However, implementation fidelity is critical for maintaining the integrity of clinical trials and for ensuring successful delivery of services in public health settings. Methods Promoting First Relationships.sup.® (PFR), a 10-week home visiting parenting intervention, was evaluated in two randomized clinical trials with populations of families in child welfare. Seven providers from community agencies participated in the trials and administered PFR. Fidelity data collected included observational measures of provider behavior, provider records, and input from clients to assess training uptake, adherence to content, quality of delivery, program dosage, and participant satisfaction. Results In mock cases to assess training uptake, providers demonstrated an increase in PFR verbalization strategies and a decrease non-PFR verbalizations from pre to post PFR training, and overall this was maintained a year later (Mann-Whitney U's = 0, p's < .01). Adherence to content in actual cases was high, with M = 97% of the program elements completed. Quality of delivery varied across providers, indicated by PFR consultation strategies (Wilks' Lambda F = 18.24, df = 15, p < .001) and global ratings (F = 13.35, df = 5, p < .001). Program dosage was high in both trials (71 and 86% receiving 10 sessions), and participant satisfaction was high (M = 3.9, SD = 0.2; 4 = greater satisfaction). Discussion This system of training and monitoring provides an example of procedures that can be used effectively to achieve implementation fidelity with evidence-based programs in social service practice., Author(s): Monica L. Oxford [sup.1] , Susan J. Spieker [sup.1] , Mary Jane Lohr [sup.1] , Charles B. Fleming [sup.2] , Colleen Dillon [sup.1] , Jennifer Rees [sup.1] Author Affiliations: [...]

: Introduction: The HIV care cascade examines the attrition of people living with HIV from diagnosis to the use of antiretroviral therapy (ART) and suppression of viral replication. We reviewed the literature from sub‐Saharan Africa to assess the definitions used for the different steps in the HIV care cascade. Methods: We searched PubMed, Embase and CINAHL for articles published from January 2004 to December 2020. Longitudinal and cross‐sectional studies were included if they reported on at least one step of the UNAIDS 90‐90‐90 cascade or two steps of an extended 7‐step cascade. A step was clearly defined if authors reported definitions for numerator and denominator, including the description of the eligible population and methods of assessment or measurement. The review protocol has been published and registered in Prospero. Results and discussion: Overall, 3364 articles were screened, and 82 studies from 19 countries met the inclusion criteria. Most studies were from Southern (38 studies, 34 from South Africa) and East Africa (29 studies). Fifty‐eight studies (71.6%) were longitudinal, with a median follow‐up of three years. The medium number of steps covered out of 7 steps was 3 (interquartile range [IQR] 2 to 4); the median year of publication was 2015 (IQR 2013 to 2019). The number of different definitions for the numerators ranged from four definitions (for step “People living with HIV”) to 21 (step “Viral suppression”). For the denominators, it ranged from three definitions (“Diagnosed and aware of HIV status”) to 14 (“Viral suppression”). Only 12 studies assessed all three of the 90‐90‐90 steps. Most studies used longitudinal data, but denominator–denominator or denominator–numerator linkages over several steps were rare. Also, cascade data are lacking for many countries. Our review covers the academic literature but did not consider other data, such as government reports on the HIV care cascade. Also, it did not examine disengagement and reengagement in care. Conclusions: The proportions of patients retained at each step of the HIV care cascade cannot be compared between studies, countries and time periods, nor meta‐analysed, due to the many different definitions used for numerators and denominators. There is a need for standardization of methods and definitions., INTRODUCTION The Joint United Nations Programme on HIV/AIDS (UNAIDS) adopted the 90‐90‐90 targets in 2014 to track progress towards ending the HIV epidemic. Targets to be reached by 2020 include [...]

Pregnancy and COVID-19 According to the US Centers for Disease Control and Prevention (CDC), one-quarter of reproductive-aged women (i.e., 15-49 years of age) hospitalized with coronavirus disease 2019 (COVID-19) from [...]

SUMMARY A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we [...]

The impact of the severe acute respiratory syndrome coronavirus 2 pandemic is placing tremendous pressure on government and the biomedical research enterprise to quickly develop safe, effective therapies and move [...]

Dietary modification is central to obesity treatment. Weight loss diets are available that include various permutations of energy restriction, macronutrients, foods, and dietary intake patterns. Caloric restriction is the common pathway for weight reduction, but different diets may induce weight loss by varied additional mechanisms, including by facilitating dietary adherence. This narrative Review of meta-analyses and select clinical trials found that lower-calorie diets, compared with higher-calorie regimens, reliably induced larger short-term (12 months). Few significant long-term differences in weight loss were observed for diets of varying macronutrient composition, although some regimens were found to have short-term advantages (e.g., low carbohydrate versus low fat). Progress in improving dietary adherence, which is critical to both short- and long-term weight loss, could result from greater efforts to identify behavioral and metabolic phenotypes among dieters., Introduction Dietary modification is a cornerstone of weight control. At a fundamental level, weight loss requires achieving a state of negative energy balance. The best way to attain this balance [...]

: Introduction: Despite the advent of HIV cure‐related clinical trials (HCRCT) for people living with HIV (PLWH), the risks and uncertainty involved raise ethical issues. Although research has provided insights into the levers and barriers to PLWH and physicians' participation in these trials, no information exists about stakeholders' preferences for HCRCT attributes, about the different ways PLWH and physicians value future HCRCT, or about how personal characteristics affect these preferences. The results from the present study will inform researchers' decisions about the most suitable HCRCT strategies to implement, and help them ensure ethical recruitment and well‐designed informed consent. Methods: Between October 2016 and March 2017, a discrete choice experiment was conducted among 195 virally controlled PLWH and 160 physicians from 24 French HIV centres. Profiles within each group, based on individual characteristics, were obtained using hierarchical clustering. Trade‐offs between five HCRCT attributes (trial duration, consultation frequency, moderate (digestive disorders, flu‐type syndrome, fatigue) and severe (allergy, infections, risk of cancer) side effects (SE), outcomes) and utilities associated with four HCRCT candidates (latency reactivation, immunotherapy, gene therapy and a combination of latency reactivation and immunotherapy), were estimated using a mixed logit model. Results: Apart from severe SE – the most decisive attribute in both groups – PLWH and physicians made different trade‐offs between HCRCT attributes, the latter being more concerned about outcomes, the former about the burden of participation (consultation frequency and moderate SE). These different trades‐offs resulted in differences in preferences regarding the four candidate HCRCT. PLWH significantly preferred immunotherapy, whereas physicians preferred immunotherapy and combined therapy. Despite the heterogeneity of characteristics within the PLWH and physician profiles, results show some homogeneity in trade‐offs and utilities regarding HCRCT. Conclusions: Severe SE, not outcomes, was the most decisive attribute determining future HCRCT participation. Particular attention should be paid to providing clear information, in particular on severe SE, to potential participants. Immunotherapy would appear to be the best HCRCT candidate for both PLWH and physicians. However, if the risk of cancer could be avoided, gene therapy would become the preferred strategy for the latter and the second choice for the former., Introduction HIV cure research, a desired but risky and “uncomfortable” innovation, raises several ethical questions. More specifically, to test the effectiveness of new HIV cure‐related clinical trials (HCRCT), clinicians must [...]

Background: We conducted a systematic review and meta-analysis to determine the association between serum lipid levels and suicidality, as evidence from previous studies has been inconsistent. Methods: We identified relevant studies by searching Medline, Web of Science, EMBASE, and the Cochrane Database of Systematic Reviews (1980 to Dec. 5, 2014). Studies assessing the association between serum total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and/or triglycerides (TG) levels and suicidality were included. We used a random-effects model to take into account heterogeneity among studies. Results: We included 65 studies with a total of 510 392 participants in our analysis. Compared with the nonsuicidal patients, suicidal patients had significantly lower serum TC (weighted mean difference [WMD] -22.35, 95% confidence interval [CI] -27.95 to -16.75), LDL-C (WMD -19.56, 95% CI -26.13 to -12.99) and TG (WMD -23.40, 95% CI -32.38 to -14.42) levels, while compared with the healthy controls, suicidal patients had significantly lower TC (WMD -24.75, 95% CI -27.71 to -21.78), HDL-C (WMD -1.75, 95% CI -3.01 to - 0.48) and LDL-C (WMD -3.85, 95% CI -7.45 to -0.26) levels. Furthermore, compared with the highest serum TC level category, a lower serum TC level was associated with a 112% (95% CI 40%-220%) higher risk of suicidality, including a 123% (95% CI 24%-302%) higher risk of suicide attempt and an 85% (95 CI 7%-221%) higher risk of suicide completion. The cut-off values for low and high serum TC level were in compliance with the categories reported in the original studies. Limitations: A major limitation of our study is the potential heterogeneity in most of the analyses. In addition, the suicidal behaviour was examined using different scales or methods across studies, which may further explain heterogeneity among the studies. Conclusion: We identified an inverse association between serum lipid levels and suicidality. More mechanistic studies are needed to further explain this association., Introduction Suicide is an important public health problem and is one of the leading causes of death worldwide. (1,2) Suicide can generate a wave of psychiatric events in affected families, [...]

Byline: Sonu. Gupta, Ravinder. Bansal INTRODUCTION: Clinical trials are integral to innovation in the treatment modalities and are conducted to assess the safety and efficacy of novel drugs. Clinical trials [...]

ABSTRACT Background: In the past decade, garlic has become one of the most popular complementary therapies for blood pressure (BP) control used by hypertensive patients. Numerous clinical studies have focused [...]