Gates Open Research

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EISSN : 25724754
Current Publisher: F1000 Research Ltd (10.12688)
Total articles ≅ 322
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Published: 3 April 2020
Gates Open Research; doi:10.12688/gatesopenres

Amy Tsui, Philip Anglewicz, Titilope Akinlose, Varsha Srivatsan, Pierre Akilimali, Souleymane Alzouma, Fiacre Bazie, Peter Gichangi, Georges Guiella, Patrick Kayembe, et al.
Published: 25 March 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13119.1

Abstract:
The Performance Monitoring and Accountability 2020 (PMA2020) project implemented a multi-country sub-project called PMA Agile, a system of continuous data collection for a probability sample of urban public and private health facilities and their clients that began November 2017 and concluded December 2019. The objective was to monitor the supply, quality and consumption of family planning services. In total, across 14 urban settings, nearly 2300 health facilities were surveyed three to six times in two years and a total sample of 48,610 female and male clients of childbearing age were interviewed in Burkina Faso, Democratic Republic of Congo, India, Kenya, Niger and Nigeria. Consenting female clients with access to a cellphone were re-interviewed by telephone after four months; two rounds of the client exit, and follow-up interviews were conducted in nearly all settings. This paper reports on the PMA Agile data system protocols, coverage and early experiences. An online dashboard is publicly accessible, analyses of measured trends are underway, and the data are publicly available.
Johnny Vlaminck, Piet Cools, Marco Albonico, Shaali Ame, Thipphavanh Chanthapaseuth, Vanisaveth Viengxay, Dung Do Trung, Mike Y. Osei-Atweneboana, Elias Asuming-Brempong, Mohammad Jahirul Karim, et al.
Published: 10 March 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13115.1

Abstract:
To eliminate soil-transmitted helminth (STH) infections as a public health problem, the administration of benzimidazole (BZ) drugs to children has recently intensified. But, as drug pressure increases, the development of anthelmintic drug resistance (AR) becomes a major concern. Currently, there is no global surveillance system to monitor drug efficacy and the emergence of AR. Consequently, it is unclear what the current efficacy of the used drugs is and whether AR is already present. The aim of this study is to pilot a global surveillance system to assess anthelmintic drug efficacy and the emergence of AR in STH control programs. For this, we will incorporate drug efficacy trials into national STH control programs of eight countries (Bangladesh, Cambodia, Lao PDR, Vietnam, Ghana, Rwanda, Senegal and a yet to be defined country in the Americas). In each country, one trial will be performed in one program implementation unit to assess the efficacy of BZ drugs against STHs in school-aged children by faecal egg count reduction test. Stool samples will be collected before and after treatment with BZs for Kato-Katz analysis and preserved to purify parasite DNA. The presence and frequency of known single nucleotide polymorphisms (SNPs) in the β-tubulin genes of the different STHs will subsequently be assessed. This study will provide a global pattern of drug efficacy and emergence of AR in STH control programs. The results will provide complementary insights on the validity of known SNPs in the ß-tubulin gene as a marker for AR in human STHs as well as information on the technical and financial resources required to set up a surveillance system. Finally, the collected stool samples will be an important resource to validate different molecular technologies for the detection of AR markers or to identify novel potential molecular markers associated with AR in STH.
Jennifer F. Morton, Laura Myers, Katherine Gill, Linda-Gail Bekker, Gabrielle Stein, Katherine K. Thomas, Menna Duyver, Ariane Van Der Straten, Margaret McConnell, Robert Aunger, et al.
Published: 10 March 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13103.1

Abstract:
Background: There is an urgent need to find effective interventions that reduce young South African women’s vulnerability to HIV, and pre-exposure prophylaxis (PrEP) is highly effective when taken consistently. As national programs in Africa launch PrEP programs for young women, it is critical to understand how to effectively create awareness, stimulate interest, and increase uptake of PrEP. Methods: Behavior-centered design (BCD) guided the development of a PrEP social marketing campaign for young women. Ethnographic observations, in-depth interviews, and focus-group discussions with young South African women informed the content and design of a 90-second PrEP demand creation video and two informational brochures. A short survey was administered to young women at their homes after watching a video to evaluate PrEP interest. Of 800 households with a 16-25-year-old female identified from a Cape Town township census, 320 women in these households viewed the video and completed a survey about the video and their interest in PrEP. Results: In focus groups, young women from the township preferred local characters and messaging that was empowering, simple, and motivational. From the household survey of young women who viewed the video, most reported interest in learning more about PrEP (67.7% ‘definitely interested’ and 9.4% ‘somewhat interested’) and taking PrEP (56.4% ‘definitely interested’ and 12.5% ‘somewhat interested’). Factors significantly associated with interest in taking PrEP were having a primary partner with whom they regularly have sex (80.0% vs. 65.2% without a primary partner; adjusted odds ratio (AOR)=3.1, 95% CI: 1.3, 7.0) and being in a sexual partnership for 12 months; AOR=3.0, 95% CI: 1.2, 7.3). Conclusions: A positively framed PrEP demand creation video generated high interest in PrEP among young South African women, particularly among women with a primary partner and a shorter-term relationship. Registration: NCT03142256; registered on 5 May 2017.
Daniel M. Weinberger, Joshua L. Warren
Published: 9 March 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13116.1

Abstract:
When evaluating the effects of vaccination programs, it is common to estimate changes in rates of disease before and after vaccine introduction. There are a number of related approaches that attempt to adjust for trends unrelated to the vaccine and to detect changes that coincide with introduction. However, characteristics of the data can influence the ability to estimate such a change. These include, but are not limited to, the number of years of available data prior to vaccine introduction, the expected strength of the effect of the intervention, the strength of underlying secular trends, and the amount of unexplained variability in the data. Sources of unexplained variability include model misspecification, epidemics due to unidentified pathogens, and changes in ascertainment or coding practice among others. In this study, we present a simple simulation framework for estimating the power to detect a decline and the precision of these estimates. We use real-world data from a pre-vaccine period to generate simulated time series where the vaccine effect is specified a priori. We present an interactive web-based tool to implement this approach. We also demonstrate the use of this approach using observed data on pneumonia hospitalization from the states in Brazil from a period prior to introduction of pneumococcal vaccines to generate the simulated time series. We relate the power of the hypothesis tests to the number of cases per year and the amount of unexplained variability in the data and demonstrate how fewer years of data influence the results.
Petrus S Steyn, Victoria Boydell, Joanna Paula Cordero, Heather McMullen, Ndema Habib, Thi My Huong Nguyen, Dela Nai, Donat Shamba, James Kiarie, CaPSAI Project
Published: 5 March 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13075.1

Abstract:
Background: There are numerous barriers leading to a high unmet need for family planning and contraceptives (FP/C). These include limited knowledge and information, poor access to quality services, structural inefficiencies in service provision and inadequately trained and supervised health professionals. Recently, social accountability programs have shown promising results in addressing barriers to accessing sexual and reproductive health services. As a highly complex participatory process with multiple and interrelated components, steps and actors, studying social accountability poses methodological challenges. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project study protocol was developed to measure the impact of a social accountability process on contraceptive uptake and use and to understand the mechanisms and contextual factors that influence and generate these effects (with emphasis on health services actors and community members). Methods: CaPSAI Project is implementing a social accountability intervention where service users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services. In the project, a quasi-experimental study utilizing an interrupted time series design with a control group is conducted in eight intervention and eight control facilities in each study country, which are Ghana and Tanzania. A cross-sectional survey of service users and health care providers is used to measure social accountability outcomes, and a cohort of women who are new users of FP/C is followed up after the completion of the intervention to measure contraceptive use and continuation. The process evaluation utilizes a range of methods and data sources to enable a fuller description of how the findings were produced. Conclusion: This complex study design could provide researchers and implementers with the means to better measure and understand the mechanisms and contextual factors that influence social accountability processes in reproductive health, adding important findings to the evidence base.
Manish Gehani, Manoj Pal, Anupama Arya, Shobhana Singh, Kaushik S., Kathryn A. O’Connell, Levent Cagatay, Sumon Sengupta, Sunita Singal
Published: 4 March 2020
Gates Open Research, Volume 3; doi:10.12688/gatesopenres.12997.3

Abstract:
Background: To accelerate progress toward Family Planning 2020 (FP2020) goals, the government of India focused on improving the quality of intrauterine device (IUD) services. EngenderHealth, an international sexual and reproductive health and rights organization, has been supporting the governments of Gujarat and Rajasthan since 2014 through the Expanding Access to IUD Services in India (EAISI) project by building the capacity of service providers, monitoring compliance with standard practices, and strengthening health systems. This study sought to assess whether EAISI-trained providers offer higher quality IUD services than non-EAISI-trained providers, as indicated by a reduction in confirmed IUD complications. Methods: The study team conducted an analytical cross-sectional study of secondary data collected from follow-up registers at 176 intervention facilities (38 in Gujarat and 138 in Rajasthan) during Phase I of the EAISI project. The analysis included follow-up clients who returned to the same facility between April 2018 and March 2019. We performed a multivariate logistic regression to determine factors associated with IUD complications. Results: During the period of assessment, 56,733 clients received IUD insertions, and 10,747 (18.9%) clients returned for follow-up services. Of the returning clients, 49.4% (N=5,305) had received IUDs from EAISI-trained providers, while 50.6% (N=5,442) had received IUDs from non-EAISI-trained providers. A total of 4.0% (N=432) of all returning clients experienced complications (expulsion: 1.3%, missing strings: 1.7%, infection: 1.1%). Clients who received IUDs from non-EAISI-trained providers were 55.5% more likely (95% CI [26.2%, 91.5%], p Conclusion: Our findings indicate that intensive, practical clinical skills training for IUD insertion can reduce the prevalence of complications.
WHO Rabies Modelling Consortium
Published: 4 March 2020
Gates Open Research, Volume 3; doi:10.12688/gatesopenres.13074.2

Abstract:
Dog-mediated rabies continues to kill tens of thousands of people every year in low- and middle-income countries despite being an entirely vaccine-preventable disease. WHO and partners have launched a global campaign to reach zero human deaths from dog-mediated rabies by 2030. The primary tools for reaching this target are mass dog vaccination to interrupt transmission in domestic dog populations that maintain infection, appropriate post-exposure prophylaxis (PEP) for rabies-exposed persons to prevent the fatal onset of disease, together with education to support their effective uptake. Models have been developed to assess the feasibility, impact and cost-effectiveness of these measures. From these models, we argue that the 2030 target of zero human rabies deaths is achievable, but will require concerted effort, engagement and investment. A proposed Gavi investment in human rabies vaccines has potential to drive progress towards the 2030 target; however, concomitant investment is needed to scale up mass dog vaccination or this target will be missed. Predicted economic benefits of mass dog vaccination vary according to national PEP provisioning and healthcare access. Integrated Bite Case Management can enhance surveillance and rationalize PEP use, but needs adapting to and integrating within local health systems and international reporting systems to improve PEP accountability, monitor impacts and support verification of disease freedom. Modelling approaches need refining to project realistic and geographically specific timelines for achieving targets. Model iterations informed by data on the implementation of interventions can be used to evaluate progress and guide future strategies. Critically such models are needed to advocate for investment, since the greatest risk to the ‘Zero by 30’ strategy is the limited long-term cross-sectoral or targeted financing to support countries to deliver and sustain mass dog vaccination.
Kristin Wall, Rosine Ingabire, Susan Allen, Etienne Karita
Published: 28 February 2020
Gates Open Research, Volume 2; doi:10.12688/gatesopenres.12858.4

Abstract:
Introduction: In two high-volume government hospitals, their two affiliated health facilities, and two additional health facilities, we developed and implemented postpartum intrauterine device (PPIUD) and postpartum (PP) implant promotional counseling and service delivery procedures between May-July 2017 in Kigali, Rwanda. Between August 2017 and July 2018, 9,073 pregnant women received PPIUD/PP implant promotions who later delivered in one of our selected facilities. Of those, 2,633 had PPIUDs inserted, and 955 had PP implants inserted. The goal of the present analysis is to detail implementation expenditures and estimate incremental costs per insertion and couple years of protection (CYP) for PPIUD and PP implant users. Methods: We detail the incremental costs during the implementation from the health system perspective (including both the implementation costs and the cost of contraceptive methods) and use of standard methods to estimate the cost per insertion and CYP for PPIUD and PP implant users. In addition to the incremental costs of labor and supplies, the costs of promotional activities are included. Research costs for formative work were excluded. Results: A total of $74,147 USD was spent on the implementation between August 2017 and July 2018. The largest expense (34% of total expenses) went toward personnel, including doctoral-level, administrative, data management and nurse counseling staff. Training for PPIUD and implant providers and promoters comprised 8% of total expenses. Recruitment and reimbursements comprised 6% of expenses. Costs of implants to the government comprised 12% of the expenses, much higher than the cost of IUDs (1%). Costs per insertion were $25/PPIUDs and $77/PP implant. Costs per CYP were $6/PPIUDs and $21/PP implant. Conclusion: Understanding the cost per PPIUD/PP implant inserted and CYP can help to inform the cost of scaling up PPIUD/PP implant service implementation activities and resource allocation decision-making by the Rwandan Ministry of Health.
Sophie E. Moore, Andrew M. Doel, Ken K. Ong, Professor David Dunger, Nabeel A. Affara, Andrew M. Prentice, Robin M. Bernstein, HERO-G Working Group
Published: 24 February 2020
Gates Open Research, Volume 4; doi:10.12688/gatesopenres.13101.1

Abstract:
Growth retardation (stunting, wasting and poor organ development) among children in low-income countries has major short and long-term health consequences yet very little is known about the nutritional and environmental influences on the key hormonal axes regulating child growth in these settings, nor the tempo and timing of faltering episodes. Here we describe the study protocol and provide a cohort description of the Hormonal and Epigenetic Regulators of Growth (HERO-G) study. This prospective cohort study from rural Gambia, West Africa, followed mothers and children longitudinally from pre-conception, through pregnancy, delivery, and to two years of child age A total of 251 eligible mother-infant pairs were recruited into the HERO-G study, with 206 (82%) followed up until two years of age. Women were seen at scheduled antenatal appointments at 20, 28 and 36 weeks of gestation, and at delivery, where possible. Between one week and 12 months of age, infants were visited every second day for collection of detailed anthropometry and morbidity data. Infants identified as about to enter a growth faltering episode at these visits entered a more detailed 20-day protocol, with the collection of dried blood spots, anthropometry and body composition. All infants were seen for scheduled clinic visits at 3, 6, 9, 12, 18 and 24 months of age for clinical examination and venous blood draw. Data from the HERO-G study is being used to explore three major mechanistic pathways influencing growth: 1) genome-wide investigations for signatures of epigenetic effects on any loci that might affect growth; 2) frequent anthropometric measurement coupled with non-invasive monitoring for rapid identification and interrogation of real-time faltering patterns and aetiology; 3) focused measurement of hormones and cytokines that act together in an integrated manner, both in utero and after birth, to coordinate patterns of growth with immune activation, inflammation, and nutritional status.