Assessing the acceptability and feasibility of reactive drug administration for malaria elimination in a Plasmodium vivax predominant setting: a qualitative study in two provinces in Thailand.

BACKGROUND: Reactive case detection (RACD) or testing and treatment of close contacts of recent malaria cases, is commonly practiced in settings approaching malaria elimination, but standard diagnostics have limited sensitivity to detect low level infections. Reactive drug administration (RDA), or presumptive treatment without testing, is an alternative approach, but better understanding regarding community acceptability and operational feasibility are needed. METHODS: A qualitative study was conducted as part of a two-arm cluster randomized-controlled trial evaluating the effectiveness of RDA targeting high-risk villages and forest workers for reducing Plasmodium vivax and P. falciparum malaria in Thailand. Key informant interviews (KIIs) and focus group discussions (FGDs) were conducted virtually among key public health staff, village health volunteers (VHVs), and household members that implemented or received RDA activities. Transcriptions were reviewed, coded, and managed manually using Dedoose qualitative data analysis software, then underwent qualitative content analysis to identify key themes. RESULTS: RDA was well accepted by household members and public health staff that implemented it. RDA participation was driven by fear of contracting malaria, eagerness to receive protection provided by malaria medicines, and the increased access to health care. Concerns were raised about the safety of taking malaria medicines without having an illness, particularly if underlying health conditions existed. Health promotion hospital (HPH) staff implementing RDA noted its operational feasibility, but highlighted difficulty in traveling to remote areas, and requested additional travel resources and hiring more VHVs. Other challenges were highlighted including the need for additional training for VHVs on malaria activities and the inability of HPH staff to conduct RDA due to other health priorities (e.g., Covid-19). More training and practice for VHVs were noted as ways to improve implementation of RDA. CONCLUSIONS: To maximize uptake of RDA, regular education and sensitization campaigns in collaboration with village leaders on the purpose and rationale of RDA will be critical. To alleviate safety concerns and increase participant safety, a rigorous pharmacovigilance program will be important. To accelerate uptake of RDA, trust between HPH staff and VHVs and the communities they serve must continue to be strengthened to ensure acceptance of the intervention. TRIAL REGISTRATION: This study was approved by the Committee on Human Research at the University of California San Francisco (19-28,060) and the local Ethics Committee for Research in Human Subjects at Tak Provincial Health office (009/63) and Kanchanaburi Provincial health office (Kor Chor 0032.002/2185). Local authorities and health officers in the provinces, districts, and villages agreed upon and coordinated the implementation of the study. All methods in this study were carried out in accordance with relevant guidelines and regulations.

Community acceptance of reactive focal mass drug administration and reactive focal vector control using indoor residual spraying, a mixed-methods study in Zambezi region, Namibia.

BACKGROUND: In Namibia, as in many malaria elimination settings, reactive case detection (RACD), or malaria testing and treatment around index cases, is a standard intervention. Reactive focal mass drug administration (rfMDA), or treatment without testing, and reactive focal vector control (RAVC) in the form of indoor residual spraying, are alternative or adjunctive interventions, but there are limited data regarding their community acceptability. METHODS: A parent trial aimed to compare the effectiveness of rfMDA versus RACD, RAVC versus no RAVC, and rfMDA + RAVC versus RACD only. To assess acceptability of these interventions, a mixed-methods study was conducted using key informant interviews (KIIs) and focus group discussions (FGDs) in three rounds (pre-trial and in years 1 and 2 of the trial), and an endline survey. RESULTS: In total, 17 KIIs, 49 FGDs were conducted with 449 people over three annual rounds of qualitative data collection. Pre-trial, community members more accurately predicted the level of community acceptability than key stakeholders. Throughout the trial, key participant motivators included: malaria risk perception, access to free community-based healthcare and IRS, and community education by respectful study teams. RACD or rfMDA were offered to 1372 and 8948 individuals in years 1 and 2, respectively, and refusal rates were low (< 2%). RAVC was offered to few households (n = 72) in year 1. In year 2, RAVC was offered to more households (n = 944) and refusals were < 1%. In the endline survey, 94.3% of 2147 respondents said they would participate in the same intervention again. CONCLUSIONS: Communities found both reactive focal interventions and their combination highly acceptable. Engaging communities and centering and incorporating their perspectives and experiences during design, implementation, and evaluation of this community-based intervention was critical for optimizing study engagement.

What about the men? Perinatal experiences of men of color whose partners were at risk for preterm birth, a qualitative study.

BACKGROUND: Preterm birth in the United States is associated with maternal clinical factors such as diabetes, hypertension and social factors including race, ethnicity, and socioeconomic status. In California, 8.7% of all live births are preterm, with African American and Black families experiencing the greatest burden. The impact of paternal factors on birth outcomes has been studied, but little is known about the experience of men of color (MOC). The purpose of this study was to explore the experiences of MOC who are partners to women at medical and social risk for preterm birth. METHODS: This study used a qualitative research design and focus group methods. The research was embedded within an existing study exploring experiences of women of color at risk for preterm birth conducted by the California Preterm Birth Initiative. RESULTS: Twelve MOC participated in the study and among them had 9 preterm children. Four themes emerged from thematic analysis of men's experiences: (1) "Being the Rock": Providing comfort and security; (2) "It's a blessing all the way around": Keeping faith during uncertainty; (3) "Tell me EVERYTHING": Unmet needs during pregnancy and delivery; (4) "Like a guinea pig": Frustration with the healthcare system. Participants identified many barriers to having a healthy pregnancy and birth including inadequate support for decision making, differential treatment, and discrimination. CONCLUSIONS: This study shows novel and shared narratives regarding MOC experiences during pregnancy, birth, and postpartum periods. Healthcare providers have an essential role to acknowledge MOC, their experience of discrimination and mistrust, and to assess needs for support that can improve birth outcomes. As MOC and their families are at especially high social and medical risk for preterm birth, their voice and experience should be central in all future research on this topic.

What is community engagement and how can it drive malaria elimination? Case studies and stakeholder interviews.

BACKGROUND: In light of increasing complexity of identifying and treating malaria cases in low transmission settings, operational solutions are needed to increase effective delivery of interventions. Community engagement (CE) is at the forefront of this conversation given the shift toward creating local and site-specific solutions. Malaria programmes often confuse CE with providing information to the community or implementing community-based interventions. This study seeks to expand on CE approaches for malaria by looking to a variety of health and development programmes for lessons that can be applied to malaria elimination. METHODS: Qualitative data was collected from key informant interviews and community-based focus group discussions. Manual analysis was conducted with a focus on key principles, programme successes and challenges, the operational framework, and any applicable results. RESULTS: Ten programmes were included in the analysis: Ebola, HIV/Hepatitis C, Guinea worm, malaria, nutrition, and water, sanitation and hygiene. Seven focus group discussions (FGDs) with 69 participants, 49 key informant (KI) interviews with programme staff, and 7 KI interviews with thought leaders were conducted between October-April 2018. Participants discussed the critical role that village leaders and community health workers play in CE. Many programmes stated understanding community priorities is key for CE and that CE should be proactive and iterative. A major theme was prioritizing bi-directional interpersonal communication led by local community health workers. Programmes reported that measuring CE is difficult, particularly since CE is ongoing and fluid. CONCLUSIONS: Results overwhelmingly suggest that CE must be an iterative process that relies on early involvement, frequent feedback and active community participation to be successful. Empowering districts and communities in planning and executing community-based interventions is necessary. Communities affected by the disease will ultimately achieve malaria elimination. For this to happen, the community itself must define, believe in, and commit to strategies to interrupt transmission.

"We were afraid of the lion that has roared next to us"; community response to reactive focal mass drug administration for malaria in Eswatini (formerly Swaziland).

BACKGROUND: Reactive focal mass drug administration (rfMDA), or presumptive treatment without malaria testing of household members and neighbours of a passively identified malaria case, is currently being explored as a possible malaria elimination strategy in low transmission settings. One of the primary factors determining the effectiveness of rfMDA on reducing or interrupting transmission is achieving high coverage of the target population with drug administration. This study aims to explore the acceptability of rfMDA and identify facilitators and barriers to its potential implementation, as well as the community's general knowledge, attitudes and beliefs with regard to malaria elimination. METHODS: A qualitative study was performed using focus group discussions (FGDs) among villagers that received rfMDA through the National Malaria Control Programme in the low transmission setting of Eswatini as part of a 2-year clinical trial. FGDs were audio-recorded, transcribed and translated into English. All transcripts were managed in Dedoose and underwent qualitative content analysis. RESULTS: The majority of participants perceived their community to be at high risk of malaria. Witnessing others in their community suffer from malaria, proximity to Mozambique, various ecological factors, and the presence of mosquitoes contributed to this perception. The greatest motivator of participation in rfMDA was witnessing someone else suffer from malaria, since most participants had not personally experienced malaria themselves. Participants valued the education on rfMDA and on malaria in general, particularly when communicated by nurses and other health workers from the Ministry of Health. Participants were overwhelmingly motivated to participate in rfMDA in order to obtain protection from malaria. Most participants did not understand the concept of sub-clinical infection and, therefore, did not perceive the anti-malarial medication given in rfMDA to be a treatment medication. CONCLUSIONS: Perceived risk for malaria was a major driver of acceptability; therefore, future intervention campaigns could aim to better quantify risk to inform interventions and encourage uptake. There were misunderstandings about the asymptomatic reservoir of parasites in humans. Given that this phenomenon is the rationale for rfMDA, this misunderstanding could threaten the uptake of the intervention if it persists in the community. Using local authorities to deliver messaging, additional education on this concept with re-inforcement that risk of malaria is ongoing, even in the absence of frequent cases, may help to maximize and maintain acceptability.

'Not all fevers are malaria': a mixed methods study of non-malarial fever management in rural southern Malawi.

INTRODUCTION: With the ability to diagnose malaria with rapid diagnostic tests (mRDT), interest in improving diagnostics for non-malarial fevers has increased. Understanding how health providers diagnose and treat fevers is important for identifying additional tools to improve outcomes and reduce unnecessary antibiotic prescribing, particularly in areas where access to laboratory diagnostics is limited. This study aimed to understand rural health providers' practice patterns, both quantitatively and qualitatively, and influences on diagnostic and treatment decision-making. METHODS: A mixed-methods study was conducted in Mulanje and Phalombe districts in southern Malawi. Retrospective data on diagnoses and treatments of febrile illness from seven mobile clinic logbooks were collected for a 2-month period in both the dry and wet seasons. Mobile health clinics visited remote villages in southern Malawi once every 7 days. Records from all patients with a recorded axillary temperature of 37.5ºC or higher or reported history of fever within 48 hours, and a negative mRDT, were included in the analysis. Key informant interviews were conducted with 31 mobile clinic health workers who triage, diagnose, and treat patients as well as dispense medication. RESULTS: In total, 30 672 febrile patients were seen during the study period. Of those, 9924 (32%) tested negative for malaria by mRDT. Acute respiratory infection was the most common diagnosis for mRDT-negative patients (44.6%), and this number increased in the rainy season as compared to the dry season (odds ratio=2.18, 95% confidence interval=2.01-2.36). Over half (60%) of mRDT-negative patients received antibiotics as a treatment. Almost all the health providers in this study reported limited training in non-malarial fever management, despite the fact that roughly 30% of all patients with fever seen at the mobile clinics tested negative by mRDT. Without diagnostic tools beyond mRDTs, providers relied heavily on patient history to guide treatment decisions. CONCLUSION: Additional simple-to-use diagnostic tests as well as additional training in patient examination and clinical assessment are needed in rural settings where health providers risk over-prescribing antibiotics or missing a potentially dangerous infection in febrile patients who test negative for malaria.

Bovine leukemia virus linked to breast cancer but not coinfection with human papillomavirus: Case-control study of women in Texas.

BACKGROUND: Bovine leukemia virus (BLV) and human papillomavirus (HPV) were previously identified in human breast tissue and have been associated with breast cancer in independent studies. The objective of the current study was to test for the presence of BLV and HPV in the same breast tissue specimens to determine whether the viruses were associated with breast cancer either singly or together. METHODS: Archival formalin-fixed paraffin-embedded breast tissue sections from 216 women were received from The University of Texas MD Anderson Cancer Center along with patient diagnosis. In situ polymerase chain reaction and/or DNA hybridization methods were used to detect targeted DNA segments of BLV and HPV. Standard statistical methods were used to calculate age-adjusted odds ratios, attributable risk, and P values for the trend related to the association between presence of a virus and a diagnosis of breast disease. RESULTS: Women diagnosed with breast cancer were significantly more likely to have BLV DNA in their breast tissue compared with women with benign diagnoses and no history of breast cancer. Women with breast pathology classified as premalignant and no history of breast cancer also were found to have an elevated risk of harboring BLV DNA in their breast tissue. HPV status was not associated with malignancy, premalignant breast disease, or the presence of BLV in the breast tissues. CONCLUSIONS: The data from the current study supported previous findings of a significant association between BLV DNA in breast tissue and a diagnosis of breast cancer, but did not demonstrate oncogenic strains of HPV associated with breast cancer or the presence of BLV DNA in breast tissue. The authors believe the findings of the current study contribute to overall knowledge regarding a possible causal role for viruses in human breast cancer. Cancer 2018;124:1342-9. © 2017 American Cancer Society.

Principles, practices and knowledge of clinicians when assessing febrile children: a qualitative study in Kenya.

BACKGROUND: Clinicians in low resource settings in malaria endemic regions face many challenges in diagnosing and treating febrile illnesses in children. Given the change in WHO guidelines in 2010 that recommend malaria testing prior to treatment, clinicians are now required to expand the differential when malaria testing is negative. Prior studies have indicated that resource availability, need for additional training in differentiating non-malarial illnesses, and lack of understanding within the community of when to seek care play a role in effective diagnosis and treatment. The objective of this study was to examine the various factors that influence clinician behavior in diagnosing and managing children presenting with fever to health centres in Kenya. METHODS: A total of 20 clinicians (2 paediatricians, 1 medical officer, 2 nurses, and 15 clinical officers) were interviewed, working at 5 different government-sponsored public clinic sites in two areas of Kenya where malaria is prevalent. Clinicians were interviewed one-on-one using a structured interview technique. Interviews were then analysed qualitatively for themes. RESULTS: The following five themes were identified: (1) Strong familiarity with diagnosis of malaria and testing for malaria; (2) Clinician concerns about community understanding of febrile illness, use of traditional medicine, delay in seeking care, and compliance; (3) Reliance on clinical guidelines, history, and physical examination to diagnose febrile illness and recognize danger signs; (4) Clinician discomfort with diagnosis of primary viral illness leading to increased use of empiric antibiotics; and (5) Lack of resources including diagnostic testing, necessary medications, and training modalities contributes to the difficulty clinicians face in assessing and treating febrile illness in children. These themes persisted across all sites, despite variation in levels of medical care. Within these themes, clinicians consistently expressed a need for reliable basic testing, especially haemograms and bacterial cultures. Clinicians discussed the use of counseling and education to improve community understanding of febrile illness in order to decrease preventable deaths in children. CONCLUSION: Results of this study suggest that since malarial testing has become more widespread, clinicians working in resource-poor environments still face difficulty when evaluating a child with fever, especially when malaria testing is negative. Improving access to additional diagnostics, continuing medical education, and ongoing evaluation and revision of clinical guidelines may lead to more consistent management of febrile illness by providers, and may potentially decrease prescription of unnecessary antibiotics. Additional interventions at the community level may also have an important role in managing febrile illness, however, more studies are needed to identify targets for intervention at both the clinic and community levels.

A qualitative study to assess community barriers to malaria mass drug administration trials in The Gambia.

BACKGROUND: Mass drug administration (MDA) is a strategy widely used in the control of human parasitic diseases but has been rarely attempted with malaria, the most common and dangerous parasitic disease in humans. MDA is an intervention strategy that involves simultaneously dispensing treatment to an entire population in a given geographic area. With some areas in sub-Saharan Africa documenting a decline in malaria transmission, the feasibility of MDA to further reduce malaria transmission is being considered. Understanding community perceptions of such an activity is vitally important for the design of the study and gaining the support of participants in order to maximize compliance and adherence. METHODS: A qualitative study to assess factors likely to influence community acceptance of MDA in the seasonal and low malaria transmission setting of The Gambia was conducted. Using in-depth interviews, the perceptions, knowledge and attitudes of medical personnel and community members who have undergone MDA trials in The Gambia were investigated. RESULTS: Several major themes emerged, namely: 1) the importance of timing of rounds of MDA doses for maximum participation; 2) the need to educate the target population with accurate information on the procedures, drug regimen, and possible side effects to enhance adherence; 3) the need for continuous sensitization meetings to maintain and increase uptake of MDA; and, 4) the importance for defining roles in the delivery and assessment of MDA, including existing healthcare structures. DISCUSSION: To increase the likelihood of participation in MDA trials in this setting, activities should be undertaken just before and during the rainy season when community members are less mobile. Importantly, fears regarding blood sampling and side effects of the drug regimen need to be addressed prior to the start of the trial and repeated throughout the study period. Accurate and frequent communication is essential, and village leaders should consistently be included in sensitization meetings to enhance community participation. Additionally, village healthcare workers should be included in training and implementation, with supervision by a fieldworker permanently posted in every few villages during the trial. Future collaboration with Senegal may prove important for enhanced elimination efforts in The Gambia.

Midwives' experience of telehealth and remote care: a systematic mixed methods review.

INTRODUCTION: Increasing the midwifery workforce has been identified as an evidence-based approach to decrease maternal mortality and reproductive health disparities worldwide. Concurrently, the profession of midwifery, as with all healthcare professions, has undergone a significant shift in practice with acceleration of telehealth use to expand access. We conducted a systematic literature review to identify and synthesize the existing evidence regarding how midwives experience, perceive and accept providing sexual and reproductive healthcare services at a distance with telehealth. METHODS: Five databases were searched, PubMed, CINHAL, PsychInfo, Embase and the Web of Science, using search terms related to 'midwives', 'telehealth' and 'experience'. Peer-reviewed studies with quantitative, qualitative or mixed methods designs published in English were retrieved and screened. Studies meeting the inclusion criteria were subjected to full-text data extraction and appraisal of quality. Using a convergent approach, the findings were synthesized into major themes and subthemes. RESULTS: After applying the inclusion/exclusion criteria, 10 articles on midwives' experience of telehealth were reviewed. The major themes that emerged were summarized as integrating telehealth into clinical practice; balancing increased connectivity; challenges with building relationships via telehealth; centring some patients while distancing others; and experiences of telehealth by age and professional experience. CONCLUSIONS: Most current studies suggest that midwives' experience of telehealth is deeply intertwined with midwives' experience of the response to COVID-19 pandemic in general. More research is needed to understand how sustained use of telehealth or newer hybrid models of telehealth and in-person care are perceived by midwives.

Evaluating a clinical mentorship intervention on maternal and neonatal complications in primary health facilities in Blantyre district, Malawi: A longitudinal analysis of the Global Action in Nursing program.

BACKGROUND: While Malawi has made great strides increasing the number of facility-based births, maternal and neonatal mortality remains high. An intervention started in 2019 provided short-course training followed by year-long longitudinal bedside mentorship for nurse midwives at seven health facilities in Blantyre district. The intervention was initiated following invitation from the district to improve outcomes for patients during childbirth. This study examined the impact of the intervention on the reporting of obstetric and neonatal complications and related care. METHODS: Patient level data were collected from the District Health Information System 2 database from intervention and non-intervention facilities. Bivariate analysis explored the impact of longitudinal bedside mentorship on select District Health Information System 2 variables at six-month intervals. Outcomes were then analyzed using nonlinear quantile mixed models to better account for the impact of time and clustering at the facility level. RESULTS: Significant changes were found in the reporting of obstetric and neonatal complications over time at intervention facilities compared to non-intervention facilities. Intervention facilities showed statistically significant increases in the reporting of prolonged labor, pre/eclampsia, fetal distress, retained placenta, and premature labor. There was also a statistically significant decrease in the reporting of no complications in the multivariate model (95%CI: -0.8 to -0.2). In both the bivariate and multivariate models, the reporting of 'None' significantly decreased (0.8 % median), while the reporting of prematurity (0.2 % median) and asphyxia (0.3 % median) both significantly increased. The missingness of data at intervention facilities decreased to almost zero compared to non-intervention facilities. DISCUSSION: The increase in reported maternal and neonatal complications suggests improved early identification of complications at the facility level. The improved accuracy of patient data from intervention facilities shows the impact mentorship has on data quality which is crucial for the allocation of resources. By highlighting the apparent dose-response relationship of longitudinal bedside mentorship, this study will inform the broader use of mentorship in training programs. Future research is needed to explore the impact of longitudinal mentorship on quality of care.

Febrile illness management in children under five years of age: a qualitative pilot study on primary health care workers' practices in Zanzibar.

BACKGROUND: In Zanzibar, malaria prevalence dropped substantially in the last decade and presently most febrile patients seen in primary health care facilities (PHCF) test negative for malaria. The availability of rapid diagnostic tests (RDTs) allows rural health workers to reliably rule out malaria in fever patients. However, additional diagnostic tools to identify alternative fever causes are scarce, often leaving RDT-negative patients without a clear diagnosis and management plan. This pilot study aimed to explore health workers' practices with febrile children and identify factors influencing their diagnostic and management decisions in non-malarial fever patients. METHODS: Semi-structured key informant interviews were conducted with 12 health workers in six PHCFs in North A district, Zanzibar, April to June 2011. Interviews were coded using Atlas.ti to identify emerging themes that play a role in the diagnosis and management of febrile children. RESULTS: The following themes were identified: 1) health workers use caregivers' history of illness and RDT results for initial diagnostic and management decisions, but suggest caregivers need more education to prevent late presentation and poor health outcomes; 2) there is uncertainty regarding viral versus bacterial illness and health workers feel additional point-of-care diagnostic tests would help with differential diagnoses; 3) stock-outs of medications and limited caregivers' resources are barriers to delivering good care; 4) training, short courses and participation in research as well as; 5) weather also influences diagnostic decision-making. CONCLUSIONS: This pilot study found that health workers in Zanzibar use caregiver history of fever and results of malaria RDTs to guide management of febrile children. However, since most febrile children test negative for malaria, health workers believe additional training and point-of-care tests would improve their ability to diagnose and manage non-malarial fevers. Educating caregivers on signs and symptoms of febrile illness, as well as the introduction of additional tests to differentiate between viral and bacterial illness, would be important steps to get children to PHCFs earlier and decrease unnecessary antibiotic prescribing without compromising patient safety. More research is needed to expand an understanding of what would improve fever management in other resource-limited settings with decreasing malaria.

Perception of malaria risk in a setting of reduced malaria transmission: a qualitative study in Zanzibar.

BACKGROUND: Malaria transmission has declined dramatically in Zanzibar in recent years. Continuing use of preventive measures such as long-lasting insecticidal-treated nets (LLINs), and use of malaria rapid diagnostic tests (RDTs) are essential to prevent malaria resurgence. This study employed qualitative methods to explore community perceptions of malaria risk and adherence to prevention measures in two districts in Zanzibar. METHODS: Key informant interviews with 24 primary health care providers and 24 focus group discussions with local residents in Zanzibar districts Wete and Central were conducted during April and May 2012 focusing on perception of malaria risk, current preventive practices used, reasons for using preventive practices and effective strategies for malaria control. RESULTS: Health care providers and residents appear to be aware of the decreasing incidence of malaria. Both groups continue the use of malaria preventive practices in this low and seasonal transmission setting. The most important preventive measures identified were LLINs, indoor residual spraying (IRS), and education. Barriers to malaria prevention include: lack of staff at clinics, insufficient number of LLINs distributed, and inadequate malaria education. Reasons for continued use of preventive practices include: fear of malaria returning to high levels, presence of mosquitoes during rainy seasons, and concern about local cases from other villages or imported cases from mainland Tanzania. Mosques, clinics, schools and community meetings were listed as most important sources of education. However, residents express the desire for more education. CONCLUSION: Health care providers and residents generally reported consistent use of malaria preventive measures. However, maintaining and continuing to reduce malaria transmission will require ongoing education for both health care providers and residents to reinforce the importance of using preventive measures. Successful efforts to reduce malaria in Zanzibar will be jeopardized if residents believe that they are no longer at risk for malaria. In future studies, a year-round evaluation of the perception of malaria risk and use of preventive measures will inform the timing of education and prevention strategies for sustained malaria control.

Exploring the impact of COVID-19 on reported maternal and neonatal complications and access to maternal health care in five government health facilities in Blantyre, Malawi.

BACKGROUND: There is a dearth of studies assessing the effects of SARS-CoV-2 on the healthcare system and access to care, especially in lower- and middle-income countries such as Malawi. We aimed to assess the impacts of COVID-19 on reported maternal and neonatal complications as well as potential changes in maternal care access to care among five primary care health facilities in Blantyre, Malawi. METHODS: This retrospective cohort study assessed maternal and neonatal register data from five participating health centers in Blantyre, Malawi using the Malawi District Health Information Software 2 (DHIS2) to compare outcomes from 15 months before COVID-19 emerged, defined as the pre-Covid period (January 2019 -March 2020) with nine months after COVID-19 (April 2020 -December 2020). RESULTS: There was a significant decrease in reported use of vacuum extraction, which went from <0.01%in the pre-COVID period to 0% in the COVID period (p = 0.01). The proportion of births reporting fetal distress almost tripled from 0.46% to 1.36% (p = 0.001) during the COVID-19 period. Additionally, reported anticonvulsant use significantly increased from 0.01% to 1.2% (p<0.01), and antibiotic use significantly increased from 0.45% to 1.6% (p = 0.01). Asphyxia was the only significant neonatal complication variable reported, increasing from 2.80% to 3.45% (p = 0.01). CONCLUSION: Our findings suggest that significant outcomes were mainly due to the indirect effects of COVID-19 rather than the virus itself. Based on our findings and the contextual qualitative interviews with two Malawian expert midwives, we concluded that mothers may have been affected more due to understaffing and shortage of skilled personnel in the study health facilities. Therefore, the development of highly skilled health workers may contribute to better outcomes, along with adequate staffing and a streamlined referral process.

Basic emergency care course and longitudinal mentorship completed in a rural Neno District, Malawi: A feasibility, acceptability, and impact study.

BACKGROUND: Frontline providers mostly outside specific emergency areas deliver emergency care around the world, yet often they do not receive dedicated training in managing emergency conditions. When designed for low-resource settings, emergency care training has been shown to improve provider skills, facilitate efficient use of available resources, and reduce death and disability by ensuring timely access to life-saving care. METHODS: The WHO/ICRC Basic Emergency Care (BEC) Course with follow up longitudinal mentorship for 6 months was implemented in rural Neno District Malawi from September 2019-April 2020. We completed a mixed-methods analysis of the course and mentorship included mentor and participant surveys and feedback, mentorship quantification, and participant examination results. Simple descriptive statistics and boxplot visuals were used to describe participant demographics and mentorship quantification with a Wilcoxon signed-rank test to evaluate pre- and post-test scores. Qualitative feedback from participants and mentors were inductively analyzed using Dedoose. RESULTS: The median difference of BEC course examination percentage score between participants before the BEC course and immediately following the course was 18.0 (95% CI 14.0-22.0; p<0.001). Examination scores from the one-year post-test was lower but sustained above the pre-course test score with a median difference of 11.9 (95% CI 4.0-16.0; p<0.009). There were 174 mentorship activities with results suggesting that a higher number of mentorship touches and hours of mentor-mentee interactions may assist in sustained knowledge test scores. Reported strengths included course delivery approach leading to improved knowledge with mentorship enhancing skills, learning and improved confidence. Suggestions for improvement included more contextualized training and increased mentorship. CONCLUSION: The BEC course and subsequent longitudinal mentorship were feasible and acceptable to participants and mentors in the Malawian low resource context. Follow-up longitudinal mentorship was feasible and acceptable and is likely important to cementing the course concepts for long-term retention of knowledge and skills.

Limited evidence of human papillomavirus in [corrected] breast tissue using molecular in situ methods.

BACKGROUND: Human papillomavirus (HPV) has been proposed as an etiologic agent of breast cancer based on numerous reports of high-risk (oncogenic) HPV types in malignant breast tissues. However, most of those studies used standard and nested solution polymerase chain reaction (PCR) techniques, both of which are disadvantaged by vulnerability to laboratory contamination from positive control DNA and the inability to localize the signal to a specific cell type. To overcome these drawbacks, the authors of this report explored the use of in situ molecular methods of viral detection to reassess the frequency of HPV in malignant breast tissue. METHODS: In situ hybridization (ISH) was used with probes that were specific for the capsid region of 12 oncogenic HPV types, and in situ PCR (IS-PCR) was used with primers that were specific for the capsid region of HPV-16, which is the most common oncogenic HPV type. These methods were resistant to molecular contamination and allowed identification of the positive cell type. The specimens examined were malignant tissues from patients with 70 breast cancer patients at The University of Texas M. D. Anderson Cancer Center in Houston, Texas. RESULTS: HPV was observed in 4 of 70 specimens (5.7%) using ISH and in 2 of 70 specimens (2.9%) of specimens using IS-PCR. Concordance between the 2 methods was high for negative specimens; both methods yielded negative results in 66 of 70 specimens (94.3%). However, there was no concordance for the few positive specimens, probably because of differences in sensitivity and the targeted HPV types. CONCLUSIONS: Oncogenic (high-risk) HPV types were present in malignant breast epithelium very infrequently and, thus, may be causative agents of only a relatively small proportion of all breast cancers.

Epstein-Barr virus is seldom found in mammary epithelium of breast cancer tissue using in situ molecular methods.

Epstein-Barr virus (EBV) has been proposed as a possible etiological agent of breast cancer based on 21 reports of EBV in malignant breast tissues. Most of these studies used standard and nested solution polymerase chain reaction (PCR) techniques, both disadvantaged by susceptibility to contamination from laboratory EBV, and the inability to localize the signal to a specific cell type. To avoid these issues, we used in situ molecular methods of viral detection to reassess the frequency of EBV in malignant breast tissue. We used a commercial in situ hybridization (ISH) system with an EBER genome target, and a non-commercial in situ PCR (IS-PCR) method using primers specific for the BamH1 region. The assays were performed on malignant breast tissue sections from 70 breast cancer patients at the M. D. Anderson Cancer Center, Houston, TX. EBV was found in mammary epithelial cells, the cell type from which most breast cancers arise, in 2/70 (2.9%) of specimens using IS-PCR and in none of the specimens using ISH. Based on these findings that EBV was present in human mammary epithelial cells so infrequently, it is unlikely to play a causative role in most types of breast cancer.

Assessing Combined Longitudinal Mentorship and Skills Training on Select Maternal and Neonatal Outcomes in Rural and Urban Health Facilities in Malawi.

INTRODUCTION: Despite successful efforts to improve clinical access and skilled birth attendance in Malawi, it still faces high rates of maternal and neonatal mortality. In 2017, the UCSF-GAIN partnership began a nurse-midwifery clinical education and longitudinal mentorship program. While it has received positive reviews, it is unclear whether routinely collected indicators can assess such a program's impact. METHOD: A longitudinal review of the Malawian DHIS2 database explored variables associated with maternal and newborn care and outcomes before and after the intervention. Data were analyzed using generalized estimating equations (GEE) to account for facility-level correlations over time. RESULTS: Quality issues with DHIS2 data were identified. Significant changes potentially associated with the GAIN intervention were noted. DISCUSSION: The GAIN approach appears to be associated with positive trends in maternal and neonatal care. National summary databases are problematic, however, for evaluating targeted interventions and the provision of care to specific outcomes.

Alignment between expectations and experiences of egg donors: what does it mean to be informed?

This study evaluated the retrospective perceptions of egg donors regarding information communicated about immediate and long-term risks during the process of becoming an egg donor, and the alignment of that perception with their experiences and expectations of egg donation. Data were collected using an anonymous online survey. Egg donors' demographics, perceptions of being informed about immediate complications and long-term risks, and alignment between their expectations and experiences were analysed. In total, 375 current and former egg donors participated in an online survey about their decisions and experiences. Participants ranged in age from 18 to 57 years, with a median age of 24 years at first donation for compensated donors. The majority of the participants (81%) provided eggs in the USA, and 86.1% reported being compensated beyond direct reimbursement. Overall, 66% of egg donors surveyed reported feeling that their experiences matched their expectations based upon what they had been told during the informed consent process. While most participants (64.8%) felt well informed about potential short-term risks, 55.2% did not feel well informed about potential long-term risks. The findings indicate that while the majority of egg donors felt informed about immediate complications, there are gaps in knowledge about potential long-term risks. Results from this research provide insight into how egg donors understand risks and benefits, and can be used to improve counselling and informed consent forms and processes. The findings also indicate that longitudinal research on the health and well-being of egg donors is needed in order to improve informed consent.

SARS-CoV-2 PCR and antibody testing for an entire rural community: methods and feasibility of high-throughput testing procedures.

BACKGROUND: Early in the pandemic, inadequate SARS-CoV-2 testing limited understanding of transmission. Chief among barriers to large-scale testing was unknown feasibility, particularly in non-urban areas. Our objective was to report methods of high-volume, comprehensive SARS-CoV-2 testing, offering one model to augment disease surveillance in a rural community. METHODS: A community-university partnership created an operational site used to test most residents of Bolinas, California regardless of symptoms in 4 days (April 20th - April 23rd, 2020). Prior to testing, key preparatory elements included community mobilization, pre-registration, volunteer recruitment, and data management. On day of testing, participants were directed to a testing lane after site entry. An administrator viewed the lane-specific queue and pre-prepared test kits, linked to participants' records. Medical personnel performed sample collection, which included finger prick with blood collection to run laboratory-based antibody testing and respiratory specimen collection for polymerase chain reaction (PCR). RESULTS: Using this 4-lane model, 1,840 participants were tested in 4 days. A median of 57 participants (IQR 47-67) were tested hourly. The fewest participants were tested on day 1 (n = 338 participants), an intentionally lower volume day, increasing to n = 571 participants on day 4. The number of testing teams was also increased to two per lane to allow simultaneous testing of multiple participants on days 2-4. Consistent staffing on all days helped optimize proficiency, and strong community partnership was essential from planning through execution. CONCLUSIONS: High-volume ascertainment of SARS-CoV-2 prevalence by PCR and antibody testing was feasible when conducted in a community-led, drive-through model in a non-urban area.