Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth interviews with 140 pregnant women living with or at risk of HIV-70 in Malawi, 70 in the United States-exploring their views on requiring paternal consent for pregnant women's participation in trials offering the prospect of direct benefit solely to the fetus. The majority of women supported such a requirement; others raised concerns. A trio of themes-the father's or pregnant woman's rights, fetal protection, and gender/relationship dynamics-characterized views both supporting and against a paternal consent requirement, expanding the range of considerations that should inform approaches to paternal involvement in research with pregnant women.
Introduction Despite historical exclusion, there has been recent recognition of the need to address the health of pregnant women in research on vaccines against emerging pathogens. However, pregnant women’s views and decision-making processes about vaccine research participation during infectious disease outbreaks remain underexplored. This study aims to examine women’s decision-making processes around vaccine research participation during infectious disease outbreaks. Methods We conducted qualitative semi-structured in-depth interviews with pregnant and recently pregnant women (n = 13), eliciting their views on four hypothetical Zika Virus vaccine research scenarios and probing their decision-making processes around participation. After recorded interviews were transcribed, thematic analysis was conducted based on a priori and emergent themes. Results Most women interviewed were accepting of vaccine research scenarios. Three broad themes—evidence, risk, and trust—characterized women’s decision-making processes. Women varied in how different types and levels of evidence impacted their considerations, which risks were most salient to their decision-making processes, and from whom they trusted recommendations about vaccine research participation. Exemplary quotes from each theme are presented, and lessons for vaccine development during the current COVID-19 pandemic and future outbreaks are discussed. Conclusion Some pregnant women are accepting of participation in vaccine research during infectious disease outbreaks. Incorporating their priorities into trial design may facilitate their participation and generation of evidence for this important population.
IntroductionGaps in information about the safety and efficacy of COVID-19 vaccines in pregnancy have led to substantial global variation in public health guidance regarding the use of COVID-19 vaccines in pregnancy over the course of the pandemic.MethodsWe conducted systematic screenings of public health authorities’ websites across 224 countries and territories every 3 weeks to track the development of policies on COVID-19 vaccine use in pregnancy. Policies were categorised using a 1–5 permissiveness scale, with 1 indicating policies that recommended use, and 5 indicating policies that recommended against use.ResultsAs of 30 September 2021, 176 countries/territories had issued explicit guidance on COVID-19 vaccine use in pregnancy, with 38% recommending use, 28% permitting use, 15% permitting use with qualifications, 2% not recommending but with exceptions, and 17% not recommending use whatsoever. This represented a significant shift from May 2021, when only 6% of countries/territories with such policies recommended the use of COVID-19 vaccines in pregnancy (p<0.001). However, no policy positions could be found for 21% of all countries and territories, the vast majority being low and middle income. Policy positions also varied widely by vaccine product, with Pfizer/BioNTech and Moderna vaccines being most commonly recommended or permitted.ConclusionOur study highlights the evolution of policies regarding COVID-19 vaccine use in pregnancy over a 5-month period in 2021, the role of pregnancy-specific data in shaping these policies and how inequities in access for pregnant people persist, both within countries and globally.
Objective: Despite increasing representation of older women in US jail and prison facilities, their menopause experiences and access to related care remain uncharacterized. Our objective is to explore the menopause experiences of women incarcerated in jail and prison facilities. Methods: We conducted a pilot study of four semi-structured in-depth interviews with women in the community who experienced menopause symptoms while incarcerated in either a prison or jail facility. Results: Preliminary findings suggest critical gaps in access to menopause-related resources and medical care. Participants described that lifestyle and medical interventions for menopause in prison were inaccessible, and that untreated symptoms contributed to significant distress. Participants reported feeling as though medical staff did not believe their concerns and were dismissive of their complaints. In some cases, menopause symptoms and symptom management exacerbated the ways in which institutional barriers reproduce criminalization within the carceral system. Conclusions: Individuals going through the menopause transition while experiencing incarceration have significant unmet needs and poor access to relieving lifestyle changes or medical interventions. Policy and practice changes should address menopause-related needs of individuals experiencing incarceration. Video Summary: http://links.lww.com/MENO/A730.
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