Objective: To investigate potential linkages between pressure injury (PrI) recurrence following spinal cord injury (SCI) and muscle-based and circulatory biomarkers, specifically fatty metabolites ...and inflammatory cytokines.
Design: Observational study.
Setting: Tertiary Care Center.
Participants: 30 individuals with complete or incomplete SCI. Study participants either had never developed a PrI (Group I) or had a history of recurrent PrI (Group II).
Interventions: Not applicable.
Outcome Measures: Gluteal muscle histology, immunohistochemistry, muscle-based and circulatory fatty metabolites and inflammatory cytokines.
Results: Gluteal intramuscular adipose tissue (IMAT) was greater than 15% in most Group II (83%) individuals. Muscle tissue histology confirmed intramuscular structural differences. Fatty acid binding protein 4 (FABP4) and fatty acid binding protein 3 (FABP3) were reliably detected in muscle and blood and significantly correlated with IMAT (P < 0.001). FABP4 was significantly higher in Group II muscle and blood (P < 0.05). FABP3 was significantly higher in Group I muscle (P < 0.05). Circulatory FABP3 levels were lower for Group I. Inflammatory biomarkers were more reliably detected in blood. Colony-Stimulating Factor-1 was slightly higher in Group II muscle. Circulatory interleukin-13 was significantly higher (P < 0.01) in Group I. Vascular endothelial growth factor (VEGF-A) was significantly increased (P < 0.05) in Group I muscle and blood.
Conclusion: Identifying individuals with SCI at highest risk for recurrent PrI may impact patient management. IMAT content evaluation illustrates that muscle quality is a key biomarker. Low circulatory inflammatory biomarker expression potentially limits clinical significance for between group differences. Circulatory levels of FABP4 hold great potential as a recurrent PrI risk biomarker.
We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability ...measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15–30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were ‘very likely’ to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not “very likely” to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure.
Trial Registration
ClinicalTrials.gov Identifier: NCT01617096.
Background: Enteral nutrition (EN) provisions are typically calculated based on a 24-hour infusion period. However, feedings are often interrupted for daily activities, procedures, or ...gastrointestinal intolerance. The study’s objective was to determine the delivered EN quantities provided to stable hospitalized patients, using cellular time and measured volumes to verify our EN calculation adjustment. Methods: A supply of consecutively numbered ready-to-hang (RTH) EN product was delivered to the bedside of 26 inpatients with established EN tolerance at goal rates on various types of nursing units. The dietitian weighed the volume remaining in the infusing product and recorded the measurement time. On the following days, the dietitian continued to weigh the infusing RTH product and the empty RTH bottles saved by nursing. The primary outcome was the difference between the prescribed and delivered EN provisions, which was calculated with a paired t test. Results: Patients received significantly more calories in the delivered enteral feeding (mean SD, 1678 385 kcal) than prescribed calories in the EN order (1489 246 kcal; t = 3.736, P = .001), adjusting for observed time. No significant differences were found between nursing units, product, and rate. Conclusion: EN delivered may actually exceed ordered amounts by 5%–21% (mean, 12%) with feeding pump inaccuracy as the primary contributing factor. This differs from what others have found. Our findings support using a volume-based ordering system vs a rate-based ordering system for more accurate EN delivery.
BACKGROUND:Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. ...However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence.
METHODS:During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels.
RESULTS:An upward trend in adherence was observed (P < 0.0001); the proportion of samples from subjects in the active arm with dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015.
CONCLUSIONS:Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.
Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring ...is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.
Gender roles and imbalances in sexual power contribute to the heightened HIV-1 risk faced by women in Sub-Saharan Africa. This has led prevention research to focus on the development of female ...controlled methods. Despite the design of products such as vaginal rings to be used autonomously by women, male partners and women’s perceptions of relationships influence HIV prevention choices. To understand the influences that male partners and dyadic dynamics had on the use of the Dapivirine Vaginal Ring in the ASPIRE trial, this analysis of qualitative data explored the types of intimate partner relationships that women engaged in. This paper describes how partners facilitated or challenged women’s ring use and how women dealt with these challenges within six different types of relationships characterized by power dynamics and commitment levels. We offer insights into how future use of female-initiated HIV prevention products can be promoted through recognition of different relationship types.
We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine ...relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women’s internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence.
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