The first BILGENSA Research Network workshop in Zambia: identifying research priorities, challenges and needs in genital bilharzia in Southern Africa.

Female genital schistosomiasis (FGS) and male genital schistosomiasis (MGS) are gender-specific manifestations of urogenital schistosomiasis. Morbidity is a consequence of prolonged inflammation in the human genital tract caused by the entrapped eggs of the waterborne parasite, Schistosoma (S.) haematobium. Both diseases affect the sexual and reproductive health (SRH) of millions of people globally, especially in sub-Sahara Africa (SSA). Awareness and knowledge of these diseases is largely absent among affected communities and healthcare workers in endemic countries. Accurate burden of FGS and MGS disease estimates, single and combined, are absent, mostly due to the absence of standardized methods for individual or population-based screening and diagnosis. In addition, there are disparities in country-specific FGS and MGS knowledge, research and implementation approaches, and diagnosis and treatment. There are currently no WHO guidelines to inform practice. The BILGENSA (Genital Bilharzia in Southern Africa) Research Network aimed to create a collaborative multidisciplinary network to advance clinical research of FGS and MGS across Southern African endemic countries. The workshop was held in Lusaka, Zambia over two days in November 2022. Over 150 researchers and stakeholders from different schistosomiasis endemic settings attended. Attendees identified challenges and research priorities around FGS and MGS from their respective countries. Key research themes identified across settings included: 1) To increase the knowledge about the local burden of FGS and MGS; 2) To raise awareness among local communities and healthcare workers; 3) To develop effective and scalable guidelines for disease diagnosis and management; 4) To understand the effect of treatment interventions on disease progression, and 5) To integrate FGS and MGS within other existing sexual and reproductive health (SRH) services. In its first meeting, the BILGENSA Network set forth a common research agenda across S. haematobium endemic countries for the control of FGS and MGS.

Diagnostic Accuracy of an Integrated AI Tool to Estimate Gestational Age From Blind Ultrasound Sweeps.

Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device. Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography. Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard). Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days. Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, -0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index. Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people. Trial Registration: ClinicalTrials.gov Identifier: NCT05433519.

Post-abortion care services in Zambian health facilities: a qualitative study of users' experiences and perceptions.

BACKGROUND: Despite attempts to increase Universal Health Coverage, availability, accessibility, acceptability, and quality-related challenges remain barriers to receiving essential services by women who need them. We aimed to explore the experiences and perceptions of women receiving post-abortal care services in Zambia, within a human-rights framework. METHODS: A qualitative case study was conducted between August and September 2021 in Lusaka and Copperbelt provinces of Zambia. Fifteen (15) women seeking post-abortion care services were` interviewed using audio recorders; transcribed data was analyzed using thematic analysis. We report women's experiences and perceptions of the healthcare system, their experiences of abortion, and healthcare-seeking behaviour. We used the availability, accessibility, acceptability, and quality (AAAQ) framework to understand how women claimed their right to healthcare as they sought and utilized post-abortion care services. RESULTS: Women who experienced spontaneous abortions delayed seeking health care by viewing symptoms as 'normal pregnancy symptoms' and not dangerous. Women also delayed seeking care because they feared the negative attitudes from their communities and the health care providers towards abortion in general, despite it being legal in Zambia. Some services were considered costly, impeding their right to access quality care. CONCLUSIONS: Women delayed seeking care compounded by fear of negative attitudes from the community and healthcare providers. To ensure the provision and utilization of quality all abortion-related healthcare services, there is a need to increase awareness of the availability and legality of safe abortion services, the importance of seeking healthcare early for any abortion-related discomfort, and the provision and availability of free services at all levels of care should be emphasized.

Unsafe abortions continue to be an avoidable public health concern both globally and locally. In Zambia, a fifth of maternal deaths are related to unsafe abortions. Unsafe abortions have been defined as any induced termination of pregnancy outside the health facility, performed by untrained health personnel. Several strides have been made including the provision of comprehensive abortion care in all facilities, and the training of health personnel to provide these services at different levels of healthcare. Despite the increased availability of comprehensive abortion care through liberalized abortion laws and regulations and the training of health personnel to provide these services at different levels of healthcare, the need for quality post-abortion care specifically persists. As such, we carried out in-depth interviews to explore the experiences of women who present at healthcare facilities in Lusaka and the Copperbelt provinces in Zambia seeking post-abortion services. It was found that delay in seeking care at a health facility was due to fear that the service is illegal; alongside judgment from health care providers and society for seeking such a service that is generally perceived as evil. The assumption that the cost of receiving such services is high and a general lack of awareness about the service being provided free was also expressed. The study highlighted the need for community awareness of the legal framework on abortions to ensure women access services at any time necessary without fear of being judged, which will consequently reduce the number of abortion-related disabilities and deaths.

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia.

INTRODUCTION: Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia. METHODS AND ANALYSIS: This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15-50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. ETHICS AND DISSEMINATION: The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

The WHO atlas for female-genital schistosomiasis: Co-design of a practicable diagnostic guide, digital support and training.

Up to 56 million young and adult women of African origin suffer from Female Genital Schistosomiasis (FGS). The transmission of schistosomiasis happens through contact with schistosomiasis infested fresh water in rivers and lakes. The transmission vector is the snail that releases immature worms capable of penetrating the human skin. The worm then matures and mates in the blood vessels and deposits its eggs in tissues, causing urogenital disease. There is currently no gold standard for FGS diagnosis. Reliable diagnostics are challenging due to the lack of appropriate instruments and clinical skills. The World Health Organisation (WHO) recommends "screen-and-treat" cervical cancer management, by means of visual inspection of characteristic lesions on the cervix and point-of-care treatment as per the findings. FGS may be mistaken for cervical cancer or sexually transmitted diseases. Misdiagnosis may lead to the wrong treatment, increased risk of exposure to other infectious diseases (human immunodeficiency virus and human papilloma virus), infertility and stigmatisation. The necessary clinical knowledge is only available to a few experts in the world. For an appropriate diagnosis, this knowledge needs to be transferred to health professionals who have minimal or non-existing laboratory support. Co-design workshops were held with stakeholders (WHO representative, national health authority, FGS experts and researchers, gynaecologists, nurses, medical doctors, public health experts, technical experts, and members of the public) to make prototypes for the WHO Pocket Atlas for FGS, a mobile diagnostic support tool and an e-learning tool for health professionals. The dissemination targeted health facilities, including remote areas across the 51 anglophone, francophone and lusophone African countries. Outcomes were endorsed by the WHO and comprise a practical diagnostic guide for FGS in low-resource environments.

Female Genital Schistosomiasis Lesion Resolution Post-Treatment with Praziquantel in Zambian Adults.

We evaluated changes in female genital schistosomiasis (FGS) 6 to 12 months after praziquantel treatment among 43 adult Zambian women. Most women (60%) experienced decreased FGS severity and 23% experienced complete lesion resolution. This is the first study to demonstrate a meaningful effect of praziquantel treatment of FGS in adult women.

Determinants of the Implementation of Human Papillomavirus Vaccination in Zambia: Application of the Consolidated Framework for Implementation Research.

Cervical cancer can be prevented, primarily by the administration of the human papillomavirus (HPV) vaccine. Healthcare workers (HCWs) and teachers play important roles when schools are used for vaccine delivery; however, challenges exist. This study aimed to understand the barriers and facilitators to HPV vaccination that are perceived by HCWs and teachers. Guided by the consolidated framework for implementation research (CFIR), key informant interviews were conducted in Lusaka district between June 2021 and November 2021 using a semi-structured questionnaire. Recorded interviews were transcribed verbatim and imported into NVIVO 12 for data management and analysis. We coded transcripts inductively and deductively based on the adapted CFIR codebook. We reached saturation with 23 participants. We identified barriers and facilitators across the five CFIR domains. Facilitators included offering the HPV vaccine free of charge, HPV vaccine effectiveness, stakeholder engagement, and timely planning of the HPV vaccination. Barriers included vaccine mistrust due to its perceived novelty, low levels of parental knowledge, myths and misinformation about the vaccine, lack of parental consent to vaccinate daughters, lack of transport for vaccination outreach, lack of staff incentives, and inadequate sensitisation. Using the CFIR as a guiding framework, we have identified implementation barriers and facilitators to HPV vaccination among HCWs and teachers. Most of the identified barriers are modifiable, hence it is prudent that these are addressed for a high HPV vaccine uptake.