Characteristics of patients displaying ABMR on indication biopsy.

<p>Characteristics of patients displaying ABMR on indication biopsy.</p

Relationship between proteinuria (early morning “spot” albumin:creatinine ration; UACR) and percentage glomerulosclerosis in patients with IFTA on indication biopsy proximate to graft failure (n = 25).

<p>Relationship between proteinuria (early morning “spot” albumin:creatinine ration; UACR) and percentage glomerulosclerosis in patients with IFTA on indication biopsy proximate to graft failure (n = 25).</p

Characteristics of patients displaying IFTA on indication biopsy.

<p>Characteristics of patients displaying IFTA on indication biopsy.</p

Demographics of 171 studies patients experiencing graft failure.

<p>Demographics of 171 studies patients experiencing graft failure.</p

Characteristics of patients not undergoing transplant biopsy proximate to graft failure.

<p>Characteristics of patients not undergoing transplant biopsy proximate to graft failure.</p

Causes of graft failure by period following transplantation.

<p>Causes of graft failure by period following transplantation.</p

Characteristics of patients displaying TCMR on indication biopsy.

<p>Microcirculation injury evident in 4 patients. None displayed circulating donor-specific HLA antibodies or C4d staining and therefore did not fulfil current criteria for ABMR. In addition to interstitial infiltrates these patients displayed the following: glomerulitis n = 1; chronic transplant glomerulopathy n = 1; chronic transplant glomerulopathy with nonadherence n = 1; glomerulitis and chronic transplant glomerulopathy with nonadherence n = 1.</p

A weight management programme for fathers of children aged 4–11 years: cultural adaptation and the Healthy Dads, Healthy Kids UK feasibility RCT

Background: More men than women in the UK are living with overweight or obesity, but men are less likely to engage with weight loss programmes. Healthy Dads, Healthy Kids is an effective Australian weight management programme that targets fathers, who participate with their primary school-aged children. Behavioural interventions do not always transfer between contexts, so an adaptation of the Healthy Dads, Healthy Kids programme to an ethnically diverse UK setting was trialled. Objectives: To adapt and test the Australian Healthy Dads, Healthy Kids programme for delivery to men in an ethnically diverse, socioeconomically disadvantaged UK setting. Design: Phase 1a studied the cultural adaptation of the Healthy Dads, Healthy Kids programme and was informed by qualitative data from fathers and other family members, and a theoretical framework. Phase 1b was an uncontrolled feasibility trial. Phase 2 was a randomised controlled feasibility trial. Setting: Two ethnically diverse, socioeconomically disadvantaged UK cities. Participants: In phase 1a, participants were parents and family members from black and minority ethnic groups and/or socioeconomically deprived localities. In phases 1b and 2, participants were fathers with overweight or obesity and their children aged 4–11 years. Interventions: The adapted Healthy Dads, Healthy Kids intervention comprised nine sessions that targeted diet and physical activity and incorporated joint father–child physical activity. Healthy Dads, Healthy Kids was delivered in two programmes in phase 1b and four programmes in phase 2. Those in the comparator arm in phase 2 received a family voucher to attend a local sports centre. Main outcome measures: The following outcomes were measured: recruitment to the trial, retention, intervention fidelity, attendance, feasibility of trial processes and collection of outcome data. Results: Forty-three fathers participated (intervention group, n = 29) in phase 2 (48% of recruitment target), despite multiple recruitment locations. Fathers’ mean body mass index was 30.2 kg/m2 (standard deviation 5.1 kg/m2); 60.2% were from a minority ethnic group, with a high proportion from disadvantaged localities. Twenty-seven (63%) fathers completed follow-up at 3 months. Identifying sites for delivery at a time that was convenient for the families, with appropriately skilled programme facilitators, proved challenging. Four programmes were delivered in leisure centres and community venues. Of the participants who attended the intervention at least once (n = 20), 75% completed the programme (attended five or more sessions). Feedback from participants rated the sessions as ‘good’ or ‘very good’ and participants reported behavioural change. Researcher observations of intervention delivery showed that the sessions were delivered with high fidelity. Conclusions: The intervention was well delivered and received, but there were significant challenges in recruiting overweight men, and follow-up rates at 3 and 6 months were low. We do not recommend progression to a definitive trial as it was not feasible to deliver the Healthy Dads, Healthy Kids programme to fathers living with overweight and obesity in ethnically diverse, socioeconomically deprived communities in the UK. More work is needed to explore the optimal ways to engage fathers from ethnically diverse socioeconomically deprived populations in research

Results from a linear mixed models with logistic link function estimating the odds ratio of reporting High (A) Acceptability to Study Product and (B) Adherence to Study product, for the Rectal Insert and Rectal Suppository, relative to the Rectal Enema, after accounting for site and sequence order.

Results from a linear mixed models with logistic link function estimating the odds ratio of reporting High (A) Acceptability to Study Product and (B) Adherence to Study product, for the Rectal Insert and Rectal Suppository, relative to the Rectal Enema, after accounting for site and sequence order.</p

Number of adverse events (AEs) reported.

Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18–35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting “high acceptability” was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide.</div