Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network’s PROMISE trial for resource-limited regions

Background: We describe enrollment and accrual challenges in the “Promoting Maternal and Infant Survival Everywhere” (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study. Methods: PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment. The PROMISE breastfeeding protocol (1077BF) used a sequential randomization design with up to three randomizations (Antepartum, Postpartum, and Maternal Health). The PROMISE formula-feeding protocol (1077FF) had two randomizations (Antepartum and Maternal Health). Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization. Results: The study was conducted at 14 sites in seven countries and opened to enrollment in April 2011. A total of 3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed were randomized in the Antepartum component. A total of 204 Late Presenters were registered during labor or after delivery. Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected). The successful overall enrollment and final primary study analyses results were attributed to substantial preparation before the study opened, collaboration among all stakeholders, close study monitoring during implementation and the flexibility to change and streamline the protocol. Conclusions: Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials.

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The challenges and lessons learned in conducting clinical trials in pregnant women with antiphospholipid syndrome

Thrombosis Research ◽

10.1016/j.thromres.2020.05.035 ◽

2020 ◽

Vol 194 ◽

pp. 54-56

Author(s):

Leslie Skeith ◽

Shannon M. Bates ◽

Veronica Bates ◽

Marc A. Rodger

Keyword(s):

Clinical Trials ◽

Pregnant Women ◽

Antiphospholipid Syndrome ◽

Lessons Learned

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Personalizing HIV Therapeutics in Resource-Limited Rural Communities: Lessons Learned From the Use of New Tools in Africa

Current Pharmacogenomics and Personalized Medicine ◽

10.2174/1875692111666140315001955 ◽

2014 ◽

Vol 12 (1) ◽

pp. 1-14 ◽

Cited By ~ 1

Author(s):

Andrea Calcagno ◽

Mohammed Lamorde ◽

Antonio D'Avolio ◽

Stefano Bonora

Keyword(s):

Rural Communities ◽

Lessons Learned ◽

Resource Limited

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Long-Term IoT-Based Maternal Monitoring: System Design and Evaluation

Sensors ◽

10.3390/s21072281 ◽

2021 ◽

Vol 21 (7) ◽

pp. 2281

Author(s):

Fatemeh Sarhaddi ◽

Iman Azimi ◽

Sina Labbaf ◽

Hannakaisa Niela-Vilén ◽

Nikil Dutt ◽

...

Keyword(s):

Energy Efficiency ◽

Maternal Health ◽

Pregnant Women ◽

Health Monitoring ◽

Quality Care ◽

Well Being ◽

Pregnancy And Postpartum ◽

Comprehensive Framework ◽

Specific Health

Pregnancy is a unique time when many mothers gain awareness of their lifestyle and its impacts on the fetus. High-quality care during pregnancy is needed to identify possible complications early and ensure the mother’s and her unborn baby’s health and well-being. Different studies have thus far proposed maternal health monitoring systems. However, they are designed for a specific health problem or are limited to questionnaires and short-term data collection methods. Moreover, the requirements and challenges have not been evaluated in long-term studies. Maternal health necessitates a comprehensive framework enabling continuous monitoring of pregnant women. In this paper, we present an Internet-of-Things (IoT)-based system to provide ubiquitous maternal health monitoring during pregnancy and postpartum. The system consists of various data collectors to track the mother’s condition, including stress, sleep, and physical activity. We carried out the full system implementation and conducted a real human subject study on pregnant women in Southwestern Finland. We then evaluated the system’s feasibility, energy efficiency, and data reliability. Our results show that the implemented system is feasible in terms of system usage during nine months. We also indicate the smartwatch, used in our study, has acceptable energy efficiency in long-term monitoring and is able to collect reliable photoplethysmography data. Finally, we discuss the integration of the presented system with the current healthcare system.

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In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽

10.1186/s13063-020-05002-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aldo Badano

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Medical Devices ◽

In Silico ◽

Lessons Learned ◽

Patient Access ◽

High Quality ◽

Virtual Imaging ◽

Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

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Whither Magnetic Hyperthermia? A Tentative Roadmap

Materials ◽

10.3390/ma14040706 ◽

2021 ◽

Vol 14 (4) ◽

pp. 706

Author(s):

Irene Rubia-Rodríguez ◽

Antonio Santana-Otero ◽

Simo Spassov ◽

Etelka Tombácz ◽

Christer Johansson ◽

...

Keyword(s):

Clinical Trials ◽

Nanoparticle Synthesis ◽

Careful Analysis ◽

Magnetic Hyperthermia ◽

Lessons Learned ◽

In Vivo Testing ◽

Evolution Of Science ◽

Made In ◽

Critical Aspects

The scientific community has made great efforts in advancing magnetic hyperthermia for the last two decades after going through a sizeable research lapse from its establishment. All the progress made in various topics ranging from nanoparticle synthesis to biocompatibilization and in vivo testing have been seeking to push the forefront towards some new clinical trials. As many, they did not go at the expected pace. Today, fruitful international cooperation and the wisdom gain after a careful analysis of the lessons learned from seminal clinical trials allow us to have a future with better guarantees for a more definitive takeoff of this genuine nanotherapy against cancer. Deliberately giving prominence to a number of critical aspects, this opinion review offers a blend of state-of-the-art hints and glimpses into the future of the therapy, considering the expected evolution of science and technology behind magnetic hyperthermia.

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Exploring COVID-19 Related Factors Influencing Antenatal Care Services Uptake: A Qualitative Study among Women in a Rural Community in Southwest Ethiopia

Journal of Primary Care & Community Health ◽

10.1177/2150132721996892 ◽

2021 ◽

Vol 12 ◽

pp. 215013272199689

Author(s):

Shewangizaw Hailemariam ◽

Wubetu Agegnehu ◽

Misganaw Derese

Keyword(s):

Health Care ◽

Maternal Health ◽

Qualitative Study ◽

Antenatal Care ◽

Pregnant Women ◽

Health Facility ◽

Care Service ◽

Maternal Health Service ◽

Related Factors ◽

Factors Influencing

Introduction: Evidences suggest a significant decline in maternal health service uptake following the coronavirus disease 2019 (COVID-19) pandemic in Ethiopia. However, COVID-19 related factors impacting the service uptake are not sufficiently addressed. Hence, the current study was intended to explore COVID-19 related factors influencing antenatal care service uptake in rural Ethiopia. Methods: A community-based qualitative study was conducted from September 25/2020 to November 25/2020 among selected pregnant women residing in rural districts of Bench-Sheko Zone, and healthcare providers working in the local health care facilities. Six focus group discussions and 9 in-depth interviews were made between pregnant women, and health care providers, respectively. Data was collected by health education and behavioral science professionals who also have experience in qualitative data collection procedure. Data were transcribed, translated, and analyzed thematically using Open Code 4.0 software. Result: The study revealed several COVID-19 related factors influencing the uptake of antenatal care service during the pandemic. Health facility related barriers, perceived poor quality of care during the pandemic, government measures against COVID-19, anxiety related to the pandemic, and risk minimization were the identified factors possibly influencing the current antenatal care service uptake among women in rural Bench-Sheko Zone. Conclusion: COVID-19 preventive measures, and health facility related factors and individual factors were responsible for the current decline in antenatal care service uptake. Preserving essential health care service is critical to prevent avoidable losses of maternal and child lives during the pandemic period. Hence, programs and strategies designed to maintain maternal health services particularly, antenatal care service have better take the above determinants into consideration.

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