Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of nonbiological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavirritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated highdose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.
Background Accessibility of sexual and reproductive health (SRH) services in many lower-and-middle-income countries (LMICs) and humanitarian settings remains limited, particularly for young people. Young people facing humanitarian crises are also at higher risk for mental health problems, which can further exacerbate poor SRH outcomes. This review aimed to explore, describe and evaluate SRH interventions for young people in LMIC and humanitarian settings to better understand both SRH and psychosocial components of interventions that demonstrate effectiveness for improving SRH outcomes. Methods We conducted a systematic review of studies examining interventions to improve SRH in young people in LMIC and humanitarian settings following Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) standards for systematic reviews. Peer-reviewed journals and grey literature from January 1, 2000 to December 31, 2018 were included. Two authors performed title, abstract and full-text screening independently. Data was extracted and analyzed using a narrative synthesis approach and the practice-wise clinical coding system. Results The search yielded 813 results, of which 55 met inclusion criteria for full-text screening and thematic analysis. Primary SRH outcomes of effective interventions included: contraception and condom use skills, HIV/STI prevention/education, SRH knowledge/education, gender-based violence education and sexual self-efficacy. Common psychosocial intervention components included: assertiveness training, communication skills, and problem-solving. Conclusions Findings suggest that several evidence-based SRH interventions may be effective for young people in humanitarian and LMIC settings. Studies that use double blind designs, include fidelity monitoring, and focus on implementation and sustainability are needed to further contribute to this evidence-base.
Objective To conduct a comprehensive mapping of published indicators for monitoring and evaluation (M&E) of sexual and reproductive health (SRH) services and outcomes in humanitarian settings. Methods A systematic search of the peer-reviewed and grey literature published between January 2008 and May 2018 was conducted to identify all references describing indicator sets for M&E of SRH services and outcomes in humanitarian settings. The databases MEDLINE, Web of Science, and Global Health, as well as 85 websites of relevant organizations involved in humanitarian response were searched. Characteristics of identified indicator sets and data from individual indicators was extracted. Findings Of 3278 records identified, 20 met the review’s inclusion criteria and 9 existing indicator sets were identified. A total of 179 relevant indicators were included in the mapping, and removal of duplicates yielded 132 unique indicators. Twenty-seven percent fell within the maternal health domain, followed by the HIV/AIDS domain (26%) and the gender-based violence domain (23%). The distribution of indicators by type (process/output, outcome, impact) was balanced overall but varied substantially across domains. The most commonly used data collection platforms were facility-based systems or population-based surveys. Domains covered and indicator definitions were inconsistent across indicator sets. Conclusion Results demonstrate the need to standardize data collection efforts for M&E of SRH services and outcomes in humanitarian settings and to critically appraise the extent to which different domains should be covered. A core list of indicators is essential for assessing response status over time as well as across countries.
Background Rohingya diaspora or Forcibly Displaced Myanmar Nationals (FDMNs), took shelter in the refugee camps of Cox’s Bazar, Bangladesh due to armed conflict in the Rakhine state of Myanmar. In such humanitarian crises, delivering sexual and reproductive health (SRH) services is critical for better health outcomes of this most-at-risk population where more than half are adolescent girls and women. This is a reflective paper on challenges and related mitigation strategies to conduct SRH research among FDMNs. The research on which this paper is based employed a concurrent mixed-method design combining a cross-sectional survey and qualitative interviews and group discussions with FDMNs to understand their SRH needs and demand-side barriers. Assessment of health facilities and qualitative interviews with healthcare providers and key stakeholders were carried out to assess facility readiness and supply-side barriers. Challenges and strategies The researchers faced different challenges while conducting this study due to the unique characteristics of the FDMN population and the location of the refugee camps. The three key challenges researchers encountered include: sensitivity regarding SRH in the FDMNs, identifying appropriate sampling strategies, and community trust issues. The key approaches to overcome these challenges involved: actively engaging community members and gatekeepers in the data collection process to access respondents, identifying sensitive SRH issues through survey and exploring in-depth during qualitative interviews; and contextually modifying the sampling strategy. Conclusion Contextual adaptation of research methods and involving community and local key stakeholders in data collection are the key lessons learnt from this study. Another important lesson was researchers’ identity and positionality as a member of the host country may create distrust and suspicion among the refugees. The multi-level complexities of humanitarian settings may introduce unforeseen challenges and interrupt research plans at different stages of research which require timely and contextual adaptations.
Background The Syrian refugee crisis has led to massive displacement into neighboring countries including Jordan. This crisis has caused a significant strain on the sexual and reproductive health (SRH) services to the host communities and Syrian refugees. The Minimum Initial Service Package (MISP) is a standard package of services that should be implemented at the onset of an emergency. Due to their importance in protracted humanitarian crisis, this systematic review aimed to assess the utilization of SRH and MISP after 9 years of the crisis. Methods We searched PubMed, Medline/Ovid and Scopus for both quantitative and qualitative studies from 1 January 2011 to 30 November 2019. Our search included both free text key words and Medical Subject Headings (MeSH) for various forms and acronmym of the following terms: (Sexual and) Reproductive Health, Sexual/Gender-based/Family/Intimate partner violence, Minimum Initial Service Package, MISP, Women, Girls, Adolescents, Syrian, Refugee, Jordan, Humanitarian crisis, War, (armed) conflict, and Disaster. Boolean operators and star truncation (*) were used as needed. We further conducted an in-depth review of the available grey literature published during the same timeframe. Using a narrative synthesis approach, two authors independently extracted and analyzed data from published papers. After removal of duplicates, screening, and assessing for eligibility of 161 initially identified citations, 19 papers were selected for review. Results Findings from this review indicated a number of barriers to access, utilization, and implementation of SRH services, including lack of reliable information on sexual and gender-based violence (SGBV), aggravation of early marriages by crisis setting, gaps in the knowledge and use of family planning services, inadequate STIs and HIV coverage, and some issues around the provision of maternal health services. Conclusion The findings from this review are suggestive of a number of barriers pertaining to access, utilization, and implementation of SRH services. This is especially true for transitioning from MISP to comprehensive SRH services, and particularly for refugees outside camps. Following are needed to address identified barriers: improved inter-agency coordination, better inclusion/engagement of local initiatives and civil societies in SRH services delivery, improved quality of SRH services, adequate and regular training of healthcare providers, and increased awareness of Syrian women and adolescent girls. Also, more implementing research is required to identify ways to transition SRH provision from the MISP to comprehensive care for the Syrian refugee population in Jordan.
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