Evaluation of a Ureteral Stent Removal Protocol in Adult Kidney Transplant Recipients.

Existing literature on best practices to reduce the risk of infectious complications associated with ureteral stent removal in kidney transplant recipients is limited. Prior to 2021, a formal process surrounding stent removal was not in place at our institution. In June 2021, a stent removal protocol was established.

Implementing a Process to Systematically Identify and Address Poor Medication Adherence in Pediatric Liver Transplant Recipients.

Objectives: Poor adherence to medication following pediatric liver transplantation remains a major challenge, with some estimates suggesting that 50% of adolescent liver transplant recipients exhibit reduced medication adherence. To date, no gold standard has emerged to address this challenge; however, system interventions are most likely to be successful. We sought to implement a system to identify and address adherence barriers in a liver transplant clinic.

Attitudes and perceptions towards novel objective measures of ARV-based vaginal ring use: Results from a global stakeholder survey.

Results of recent microbicide and pre-exposure prophylaxis clinical trials have shown adherence to be a significant challenge with new HIV prevention technologies. As the vaginal ring containing dapivirine moves into two open label follow-on studies (HOPE/MTN-025 and DREAM) and other antiretroviral-based and multi-purpose prevention technology ring products advance through the development pipeline, there is a need for more accurate and reliable measures of adherence to microbicide ring products. We previously conducted a comprehensive landscape analysis to identify new technologies that could be applied to adherence measurement of vaginal rings containing antiretrovirals.

Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.

Introduction: Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage.

In vivo release of levonorgestrel from Sino-implant (II) — an innovative comparison of explant data.

Objectives: Measuring the amount of progestin remaining in contraceptive implants used for different lengths of time provides useful information on in vivo release kinetics including change over time. We compared estimated in vivo levonorgestrel (LNG) release rates derived from Sino-implant (II) explants with similar data from removed Jadelle.

Study Design: We measured LNG remaining in 44 sets of Sino-implant (II) used for up to 7 years and removed in four Chinese clinics.

Towards the development of a longer-acting injectable contraceptive: past research and current trends.

Objectives: A longer-acting injectable contraceptive that lasts for 6 months would be a valuable addition to the contraceptive method mix and ideal for women who are interested in spacing births and/or uncertain about their future reproductive plans. Here we review past applications of drug delivery technologies to injectable contraceptives as well as recent advancements in sustained drug delivery technologies that hold promise for the development of a new longer-acting injectable contraceptive product.

Study Design: A global landscape analysis was conducted, promising sustained drug delivery technologies, and research opportunities and partnerships were established with experts in the fields of contraception and drug delivery to identify new approaches in developing a longer-acting injectable contraceptive product.

An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings.

Introduction: Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline.

Designing a multipurpose technology for acceptability and adherence.

Multipurpose Prevention Technologies (MPTs) are new tools aimed at reducing or preventing multiple and overlapping sexual and reproductive health risks faced by women and couples around the globe. While MPTs could prove more acceptable and easier to adhere to than single-purpose prevention products, continuing high rates of HIV and unintended pregnancy remind us that these new products will need to be efficacious, acceptable and effectively used to achieve a public health impact. In this paper, we describe how a range of research methods can be applied during the pre-clinical phase of product development to inform decisions related to formulation and vehicle or product delivery mechanisms, and consider how choices in product-related characteristics may influence future demand for, delivery and use of future products.

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

Background: The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance.

Dilution of microbicide gels with vaginal fluid and semen simulants: effect on rheological properties and coating flow.

Microbicides are agents applied topically to the vagina to prevent HIV transmission. Microbicide products formulated as semi-solid dosage forms or "gels" coat vulnerable tissue to deliver active ingredients. Effective microbicide delivery vehicles must have appropriate rheological properties to ensure appropriate deployment in vivo.

Optical imaging and analysis of human vaginal coating by drug delivery gels.

Objective: We used a new optical imaging technique to compare human intravaginal coating distributions of Conceptrol (Advanced Care Products, Brunswick, NJ) and Advantage (Columbia Laboratories, Aventuna, FL). These gels are surrogates for future microbicidal gels, differing in molecular structures and biophysical properties.

Methods: For each protocol, a 3-mL gel bolus was inserted to the posterior fornix while the woman was in the supine position.

Temperature and pH sensitive hydrogels: an approach towards smart semen-triggered vaginal microbicidal vehicles.

Microbicides are drug delivery systems (DDSs) for the prevention of sexual transmission of HIV and other STDs. A topically applied vaginal microbicidal gel should provide uniform coating of vaginal tissue, retention of this gel layer prior to intercourse, and controlled release kinetics of antivirals to inactivate the viral load potentially introduced during sexual activity. Here, we describe the microbicide-oriented characterization of a DDS made with a dual pH sensitive and thermosensitive smart polymer gel composed of a random terpolymer of N-isopropyl acrylamide, butyl methacrylate, and acrylic acid.

Biophysical analysis of prototype microbicidal gels.

The objective of this study was to evaluate the distribution and retention (deployment) of four prototype vehicles for delivery of prophylactic microbicides against vaginal HIV transmission. Study gels were created with different molecular compositions, producing different biophysical properties governing vaginal deployment. The study employed three techniques: direct rheological measurement of gel properties, direct observation of gel surface coating erosion, and dissolution by a vaginal fluid simulant, and mathematical modeling of gel squeezing flow processes.

A review of the physical and chemical properties of human semen and the formulation of a semen simulant.

A fluid medium was developed to simulate the salient physical and chemical properties of human semen. The composition of the medium was based upon an extensive review of the literature on constituents of human semen. In choosing the ingredients for this medium, the goal was to emphasize properties that influence interactions of human semen with topical contraceptive, prophylactic, or therapeutic products.

Effect of temperature and pH on contraceptive gel viscosity.

The rheological properties of four commercially available spermicidal gels (two polyacrylic acid derivatives and two carboxymethylcellulose based) and their dilutions with a vaginal fluid simulant (pH 4.2) and a semen simulant (pH 7.7) were measured at 25 degrees C and 37 degrees C over a biologically relevant range of shear rates.