A Participatory Approach to Identifying Gaps in and Recommendations for Sexually Transmitted Infection and Preexposure Prophylaxis Clinical Services in Pierce County, Washington.

BACKGROUND: Pierce County, Washington, has a high burden of sexually transmitted infections (STIs) relative to Washington State and the United States. We used a participatory approach to identify gaps in STI and preexposure prophylaxis (PrEP) service provision in Pierce County and generate recommendations to address these gaps. METHODS: In collaboration with the Tacoma-Pierce County Health Department (TPCHD), we conducted 14 key informant interviews with local STI/PrEP providers from varied clinical settings. Using rapid qualitative analysis, we identified key gaps and strengths in service provision. Local, state, and national HIV/STI subject matter experts (SMEs) prioritized the gaps and recommendations to address them via an online survey. RESULTS: The primary 6 gaps ranked by SMEs (N = 32) in order of importance included the following: (1) inadequate availability of STI and PrEP services, (2) lack of awareness of STI and PrEP services, (3) need for free/low cost STI and PrEP care, (4) need for stronger relationships among providers and TPCHD, (5) reduced accessibility related to geographically distributed population and centralized services, and (6) frequent referrals pose a service barrier. Subject matter experts prioritized recommendations for each gap as follows: (1) create an STI specialty clinic, (2) implement an STI/PrEP service availability outreach campaign, (3) strengthen referral relationships between TPCHD and free/low-cost providers, (4) develop a provider support network, (5) create a mobile STI clinic, and (6) develop an STI specialty clinic. CONCLUSIONS: Sexually transmitted infection specialty clinics were prioritized by SMEs to improve access to STI and PrEP care in Pierce County, and to serve as a resource for local providers.

Defining optimal implementation packages for delivering community-wide mass drug administration for soil-transmitted helminths with high coverage.

BACKGROUND: Recent evidence suggests that community-wide mass drug administration (MDA) may interrupt the transmission of soil-transmitted helminths (STH), a group of intestinal worms that infect 1.5 billion individuals globally. Although current operational guidelines provide best practices for effective MDA delivery, they do not describe which activities are most essential for achieving high coverage or how they work together to produce effective intervention delivery. We aimed to identify the various packages of influential intervention delivery activities that result in high coverage of community-wide MDA for STH in Benin, India, and Malawi. METHODS: We applied coincidence analysis (CNA), a novel cross-case analytical method, to process mapping data as part of the implementation science research of the DeWorm3 Project, a Hybrid Type 1 cluster randomized controlled trial assessing the feasibility of interrupting the transmission of STH using bi-annual community-wide MDA in Benin, India, and Malawi. Our analysis aimed to identify any necessary and/or sufficient combinations of intervention delivery activities (i.e., implementation pathways) that resulted in high MDA coverage. Activities were related to drug supply chain, implementer training, community sensitization strategy, intervention duration, and implementation context. We used pooled implementation data from three sites and six intervention rounds, with study clusters serving as analytical cases (N = 360). Secondary analyses assessed differences in pathways across sites and over intervention rounds. RESULTS: Across all three sites and six intervention rounds, efficient duration of MDA delivery (within ten days) singularly emerged as a common and fundamental component for achieving high MDA coverage when combined with other particular activities, including a conducive implementation context, early arrival of albendazole before the planned start of MDA, or a flexible community sensitization strategy. No individual activity proved sufficient by itself for producing high MDA coverage. We observed four possible overall models that could explain effective MDA delivery strategies, all which included efficient duration of MDA delivery as an integral component. CONCLUSION: Efficient duration of MDA delivery uniquely stood out as a highly influential implementation activity for producing high coverage of community-wide MDA for STH. Effective MDA delivery can be achieved with flexible implementation strategies that include various combinations of influential intervention components.

Implementing Implementation Research: Teaching Implementation Research to HIV Researchers.

PURPOSE OF REVIEW: Given the growth in HIV-related implementation research, there is a need to expand the workforce and rigor through implementation science (IS) training and mentorship. Our objective is to review IS training opportunities for HIV-focused researchers and describe the approach and lessons learned from a recent HIV-related implementation research training initiative. RECENT FINDINGS: IS training opportunities range from degree programs to short- and longer-term professional development institutes and community-focused institutional trainings. Until recently, there have not been extensive dedicated opportunities for implementation research training for HIV-focused investigators. To meet this gap, an inter-Center for AIDS Research IS Fellowship for early-stage investigators was launched in 2019, building on lessons learned from dissemination and implementation training programs. Key components of the HIV-focused IS fellowship include didactic training, mentorship, grant-writing, and development of HIV-IS collaborative networks. Fellows to-date were two-thirds junior faculty and one-third post-doctoral fellows, the majority (69%) with prior public health training. Perceived value of the program was high, with a median rating of 9 [IQR 8-9] on a 10-point scale. Overall, 22/27 (81%) Fellows from the first cohort submitted IS-related grants within 12 months of Fellowship completion, and by 1 year 13 grants had been funded among 10 investigators, 37% overall among Fellows. Mentors identified framing of IS questions as the top-ranked training priority for HIV-investigators. Increasing knowledge of the utility of IS may support more grants focused on optimal implementation of HIV treatment and prevention strategies. Experiences from mentors and trainees engaged in an IS-focused fellowship for HIV investigators demonstrate the demand and value of a dedicated training program and reinforce the importance of mentorship.

Comparing COVID-19 physical distancing policies: results from a physical distancing intensity coding framework for Botswana, India, Jamaica, Mozambique, Namibia, Ukraine, and the United States.

BACKGROUND: Understanding the differences in timing and composition of physical distancing policies is important to evaluate the early global response to COVID-19. A physical distancing intensity monitoring framework comprising 16 domains was recently published to compare physical distancing approaches across 12 U.S. States. We applied this framework to a diverse set of low and middle-income countries (LMICs) (Botswana, India, Jamaica, Mozambique, Namibia, and Ukraine) to test the appropriateness of this framework in the global context and to compare the policy responses in these LMICs with a sample of U.S. States during the first 100-days of the pandemic. RESULTS: The LMICs in our sample adopted wide ranging physical distancing policies. The highest peak daily physical distancing intensity during this period was: Botswana (4.60); India (4.40); Ukraine (4.40); Namibia (4.20); Mozambique (3.87), and Jamaica (3.80). The number of days each country stayed at peak policy intensity ranged from 12-days (Jamaica) to more than 67-days (Mozambique). We found some key similarities and differences, including substantial differences in whether and how countries expressly required certain groups to stay at home. Despite the much higher number of cases in the US, the physical distancing responses in our LMIC sample were generally more intense than in the U.S. States, but results vary depending on the U.S. State. The peak policy intensity for the U.S. 12-state average was 3.84, which would place it lower than every LMIC in this sample except Jamaica. The LMIC sample countries also reached peak physical distancing intensity earlier in outbreak progression compared to the U.S. states sample. The easing of physical distancing policies in the LMIC sample did not discernably correlate with change in COVID-19 incidence. CONCLUSIONS: This physical distancing intensity framework was appropriate for the LMIC context with only minor adaptations. This framework may be useful for ongoing monitoring of physical distancing policy approaches and for use in effectiveness analyses. This analysis helps to highlight the differing paths taken by the countries in this sample and may provide lessons to other countries regarding options for structuring physical distancing policies in response to COVID-19 and future outbreaks.

Antihelminthics in helminth-endemic areas: effects on HIV disease progression.

BACKGROUND: Helminth infections, such as soil-transmitted helminths, schistosomiasis, onchocerciasis, and lymphatic filariasis, are prevalent in many countries where human immunodeficiency virus (HIV) infection is also common. There is some evidence from observational studies that HIV and helminth co-infection may be associated with higher viral load and lower CD4+ cell counts. Treatment of helminth infections with antihelminthics (deworming drugs) may have benefits for people living with HIV beyond simply clearance of worm infections.This is an update of a Cochrane Review published in 2009 and we have expanded it to include outcomes of anaemia and adverse events. OBJECTIVES: To evaluate the effects of deworming drugs (antihelminthic therapy) on markers of HIV disease progression, anaemia, and adverse events in children and adults. SEARCH METHODS: In this review update, we searched online for published and unpublished studies in the Cochrane Library, MEDLINE, EMBASE, CENTRAL, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICRTP), ClinicalTrials.gov, and the WHO Global Health Library up to 29 September 2015. We also searched databases listing conference abstracts, scanned reference lists of articles, and contacted the authors of included studies. SELECTION CRITERIA: We searched for randomized controlled trials (RCTs) that compared antihelminthic drugs with placebo or no intervention in HIV-positive people. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trials for eligibility and risk of bias. The primary outcomes were changes in HIV viral load and CD4+ cell count, and secondary outcomes were anaemia, iron deficiency, adverse events, and mortality events. We compared the effects of deworming using mean differences, risk ratios (RR), and 95% confidence intervals (CIs). We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: Eight trials met the inclusion criteria of this review, enrolling a total of 1612 participants. Three trials evaluated the effect of providing antihelminthics to all adults with HIV without knowledge of their helminth infection status, and five trials evaluated the effects of providing deworming drugs to HIV-positive individuals with confirmed helminth infections. Seven trials were conducted in sub-Saharan Africa and one in Thailand. Antihelminthics for people with unknown helminth infection statusProviding antihelminthics (albendazole and praziquantel together or separately) to HIV-positive adults with unknown helminth infection status may have a small suppressive effect on mean viral load at six weeks but the 95% CI includes the possibility of no effect (difference in mean change -0.14 log10 viral RNA/mL, 95% CI -0.35 to 0.07, P = 0.19; one trial, 166 participants, low quality evidence).Repeated dosing with deworming drugs over two years (albendazole every three months plus annual praziquantel), probably has little or no effect on mean viral load (difference in mean change 0.01 log10 viral RNA, 95% CI: -0.03 to -0.05; one trial, 917 participants, moderate quality evidence), and little or no effect on mean CD4+ count (difference in mean change 2.60 CD4+ cells/µL, 95% CI -10.15 to 15.35; P = 0.7; one trial, 917 participants, low quality evidence). Antihelminthics for people with confirmed helminth infectionsTreating confirmed helminth infections in HIV-positive adults may have a small suppressive effect on mean viral load at six to 12 weeks following deworming (difference in mean change -0.13 log10 viral RNA, 95% CI -0.26 to -0.00; P = 0.04; four trials, 445 participants, low quality evidence). However, this finding is strongly influenced by a single study of praziquantel treatment for schistosomiasis. There may also be a small favourable effect on mean CD4+ cell count at 12 weeks after deworming in HIV-positive populations with confirmed helminth infections (difference in mean change 37.86 CD4+ cells/µL, 95% CI 7.36 to 68.35; P = 0.01; three trials, 358 participants, low quality evidence). Adverse events and mortality There is no indication that antihelminthic drugs impart additional risks in HIV-positive populations. However, adverse events were not well reported (very low quality evidence) and trials were underpowered to evaluate effects on mortality (low quality evidence). AUTHORS' CONCLUSIONS: There is low quality evidence that treating confirmed helminth infections in HIV-positive adults may have small, short-term favourable effects on markers of HIV disease progression. Further studies are required to confirm this finding. Current evidence suggests that deworming with antihelminthics is not harmful, and this is reassuring for the routine treatment of confirmed or suspected helminth infections in people living with HIV in co-endemic areas.Further long-term studies are required to make confident conclusions regarding the impact of presumptively deworming all HIV-positive individuals irrespective of helminth infection status, as the only long-term trial to date did not demonstrate an effect.

Adolescents' Perspective Regarding a Community-Wide Mass Drug Administration Program for Soil-Transmitted Helminths in India.

This study was undertaken to understand the perspective of adolescents in endemic communities of India regarding soil-transmitted helminth (STH) infections and community-wide mass drug administration (cMDA). A multicountry community-based cluster-randomized trial, the Deworm3 trial, tested the feasibility of interrupting STH transmission with cMDA, where all individuals aged 1-99 are treated empirically with albendazole. Using a guideline based on the Consolidated Framework for Implementation Research, eight focus group discussions were conducted among 57 adolescents from the trial site in India and analyzed on ATLAS.ti 8.0 software using an a priori thematic codebook. Adolescents believed that adults could be a source of STH infection because they were not routinely dewormed like the children through the national deworming program. Perceived benefits of cMDA for all were better health and increased work efficiency. Perceived barriers to adults' participation in cMDA was their mistrust about the program, fear of side effects, perceived low risk of infection, and absence during drug distribution. To encourage adult participation in cMDAs, adolescents suggested community outreach activities, engaging village influencers and health workers, and tailoring drug distribution to when adults would be available. Adolescents were confident in their ability to be change agents within their households for treatment compliance. Adolescents provided insights into potential barriers and solutions to improve adult participation in cMDA, identified best practices of cMDA delivery, and suggested that they have unique roles as change agents to increase their household participation in cMDA.

Prevalence and correlates of paediatric guideline non-adherence for initial empirical care in six low and middle-income settings: a hospital-based cross-sectional study.

OBJECTIVES: This study evaluated the prevalence and correlates of guideline non-adherence for common childhood illnesses in low-resource settings. DESIGN AND SETTING: We used secondary cross-sectional data from eight healthcare facilities in six Asian and African countries. PARTICIPANTS: A total of 2796 children aged 2-23 months hospitalised between November 2016 and January 2019 with pneumonia, diarrhoea or severe malnutrition (SM) and without HIV infection were included in this study. PRIMARY OUTCOME MEASURES: We identified children treated with full, partial or non-adherent initial inpatient care according to site-specific standard-of-care guidelines for pneumonia, diarrhoea and SM within the first 24 hours of admission. Correlates of guideline non-adherence were identified using generalised estimating equations. RESULTS: Fully adherent care was delivered to 32% of children admitted with diarrhoea, 34% of children with pneumonia and 28% of children with SM when a strict definition of adherence was applied. Non-adherence to recommendations was most common for oxygen and antibiotics for pneumonia; fluid, zinc and antibiotics for diarrhoea; and vitamin A and zinc for SM. Non-adherence varied by site. Pneumonia guideline non-adherence was more likely among patients with severe disease (OR 1.82; 95% CI 1.38, 2.34) compared with non-severe disease. Diarrhoea guideline non-adherence was more likely among lower asset quintile groups (OR 1.16; 95% CI 1.01, 1.35), older children (OR 1.10; 95% CI 1.06, 1.13) and children presenting with wasting (OR 6.44; 95% CI 4.33, 9.57) compared with those with higher assets, younger age and not wasted. CONCLUSIONS: Non-adherence to paediatric guidelines was common and associated with older age, disease severity, and comorbidities, and lower household economic status. These findings highlight opportunities to improve guidelines by adding clarity to specific recommendations.

Identifying opportunities to optimize mass drug administration for soil-transmitted helminths: A visualization and descriptive analysis using process mapping.

BACKGROUND: The control of soil-transmitted helminths (STH) is achieved through mass drug administration (MDA) with deworming medications targeting children and other high-risk groups. Recent evidence suggests that it may be possible to interrupt STH transmission by deworming individuals of all ages via community-wide MDA (cMDA). However, a change in delivery platforms will require altering implementation processes. METHODS: We used process mapping, an operational research methodology, to describe the activities required for effective implementation of school-based and cMDA in 18 heterogenous areas and over three years in Benin, India, and Malawi. Planned activities were identified during workshops prior to initiation of a large cMDA trial (the DeWorm3 trial). The process maps were updated annually post-implementation, including adding or removing activities (e.g., adaptations) and determining whether activities occurred according to plan. Descriptive analyses were performed to quantify differences and similarities at baseline and over three implementation years. Comparative analyses were also conducted between study sites and areas implementing school-based vs. cMDA. Digitized process maps were developed to provide a visualization of MDA processes and inspected to identify implementation bottlenecks and inefficient activity flows. RESULTS: Across three years and all clusters, implementation of cMDA required an average of 13 additional distinct activities and was adapted more often (5.2 adaptations per year) than school-based MDA. An average of 41% of activities across both MDA platforms did not occur according to planned timelines; however, deviations were often purposeful to improve implementation efficiency or effectiveness. Visualized process maps demonstrated that receipt of drugs at the local level may be an implementation bottleneck. Many activities rely on the effective setting of MDA dates and estimating quantity of drugs, suggesting that the timing of these activities is important to meet planned programmatic outcomes. CONCLUSION: Implementation processes were heterogenous across settings, suggesting that MDA is highly context and resource dependent and that there are many viable ways to implement MDA. Process mapping could be deployed to support a transition from a school-based control program to community-wide STH transmission interruption program and potentially to enable integration with other community-based campaigns. TRIAL REGISTRATION: NCT03014167.

"Our desire is to make this village intestinal worm free": Identifying determinants of high coverage of community-wide mass drug administration for soil transmitted helminths in Benin, India, and Malawi.

BACKGROUND: Soil-transmitted helminth infections (STH) are associated with substantial morbidity in low-and-middle-income countries, accounting for 2.7 million disability-adjusted life years annually. Current World Health Organization guidelines recommend controlling STH-associated morbidity through periodic deworming of at-risk populations, including children and women of reproductive age (15-49 years). However, there is increasing interest in community-wide mass drug administration (cMDA) which includes deworming adults who serve as infection reservoirs as a method to improve coverage and possibly to interrupt STH transmission. We investigated determinants of cMDA coverage by comparing high-coverage clusters (HCCs) and low-coverage clusters (LCCs) receiving STH cMDA in three countries. METHODS: A convergent mixed-methods design was used to analyze data from HCCs and LCCs in DeWorm3 trial sites in Benin, India, and Malawi following three rounds of cMDA. Qualitative data were collected via 48 community-level focus group discussions. Quantitative data were collected via routine activities nested within the DeWorm3 trial, including annual censuses and coverage surveys. The Consolidated Framework for Implementation Research (CFIR) guided coding, theme development and a rating process to determine the influence of each CFIR construct on cMDA coverage. RESULTS: Of 23 CFIR constructs evaluated, we identified 11 constructs that differentiated between HCCs and LCCs, indicating they are potential drivers of coverage. Determinants differentiating HCC and LCC include participant experiences with previous community-wide programs, communities' perceptions of directly observed therapy (DOT), perceptions about the treatment uptake behaviors of neighbors, and women's agency to make household-level treatment decisions. CONCLUSION: The convergent mixed-methods study identified barriers and facilitators that may be useful to NTD programs to improve cMDA implementation for STH, increase treatment coverage, and contribute to the successful control or elimination of STH. TRIAL REGISTRATION: The parent trial was registered at clinicaltrials.gov (NCT03014167).

Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study.

Background: Comparative costs of public health interventions provide valuable data for decision making. However, the availability of comprehensive and context-specific costs is often limited. The Enterics for Global Health (EFGH) Shigella surveillance study-a facility-based diarrhea surveillance study across 7 countries-aims to generate evidence on health system and household costs associated with medically attended Shigella diarrhea in children. Methods: EFGH working groups comprising representatives from each country (Bangladesh, Kenya, Malawi, Mali, Pakistan, Peru, and The Gambia) developed the study methods. Over a 24-month surveillance period, facility-based surveys will collect data on resource use for the medical treatment of an estimated 9800 children aged 6-35 months with diarrhea. Through these surveys, we will describe and quantify medical resources used in the treatment of diarrhea (eg, medication, supplies, and provider salaries), nonmedical resources (eg, travel costs to the facility), and the amount of caregiver time lost from work to care for their sick child. To assign costs to each identified resource, we will use a combination of caregiver interviews, national medical price lists, and databases from the World Health Organization and the International Labor Organization. Our primary outcome will be the estimated cost per inpatient and outpatient episode of medically attended Shigella diarrhea treatment across countries, levels of care, and illness severity. We will conduct sensitivity and scenario analysis to determine how unit costs vary across scenarios. Conclusions: Results from this study will contribute to the existing body of literature on diarrhea costing and inform future policy decisions related to investments in preventive strategies for Shigella.

Soil-transmitted helminth surveillance in Benin: A mixed-methods analysis of factors influencing non-participation in longitudinal surveillance activities.

BACKGROUND: Despite the significant success of deworming programs in reducing morbidity due to soil-transmitted helminth (STH) infections globally, efforts to achieve elimination of STH as a public health problem or to potentially interrupt transmission will require improving and intensifying surveillance. However, non-participation in surveillance threatens the ability of programs to adequately monitor program status and limited research has been conducted to investigate drivers of non-participation in stool-based surveillance. METHODOLOGY/PRINCIPAL FINDINGS: This mixed-methods exploratory sequential study took place in Comé, Benin in association with the DeWorm3 Project. Six focus group discussions were conducted with individuals invited to participate in annual DeWorm3 stool surveillance. Thematic analysis was used to identify facilitators and barriers to participation and inform the quantitative analysis. A mixed-effects logistic regression model was built using baseline DeWorm3 survey data to identify factors associated with non-participation. Qualitative and quantitative findings were merged for interpretation. Among the 7,039 individuals invited to participate in baseline stool surveillance, the refusal rate was 8.1%. Qualitative themes included: community members weighing community-level benefits against individual-level risks, circulating rumors about misuse of stool samples, interpersonal communication with field agents, and cultural norms around handling adult feces. The quantitative analysis demonstrated that adults were significantly less likely to provide a stool sample than school-aged children (OR:0.69, 95%CI: 0.55-0.88), a finding that converged with the qualitative results. Individuals from areas in the highest quartile of population density were more likely to refuse to participate (OR:1.71, 95%CI:1.16-2.52). Several variables linked to community-affinity aligned with qualitative results; residing mainly in the community (OR:0.36, 95%CI:0.20-0.66) and having lived in the community for more than 10 years (OR:0.82, 95%CI:0.54-1.25) decreased likelihood of refusal. CONCLUSIONS/SIGNIFICANCE: Optimizing STH surveillance will require that programs reimagine STH surveillance activities to address community concerns and ensure that no subpopulations are inadvertently excluded from surveillance data.

Perceptions Associated with Noncompliance to Community-Wide Mass Drug Administration for Soil-Transmitted Helminths.

Mass drug administration (MDA) is a key strategy for the control of soil-transmitted helminths (STHs). Within MDA programs, poor and non-random compliance threaten successful control of STHs. A case-control study was conducted comparing perceptions among non-compliant participants with compliant participants during a community-wide MDA (cMDA) with albendazole in southern India. Common reasons cited for non-compliance were that the individual was not infected with STH (97.4%), the perception that he/she was healthy (91%), fear of side-effects (12.8%), and dislike of consuming tablets (10.3%). Noncompliance was associated with poor awareness of intestinal worms (odds ratio [OR]: 9.63, 95% CI: 2.11-43.84), the perception that cMDA was only required for those with worms (OR: 2.14, 95% CI: 1.06-4.36), and the perception that the drug is not safe during pregnancy (OR: 2.19, 95% CI: 1.18-4.07) or when on concomitant medications (OR: 3.14, 95% CI: 1.38-7.15). Understanding of perceptions driving noncompliance can provide valuable insights to optimize participation during MDA for STHs.

Monitoring and evaluating the implementation of essential packages of health services.

Essential packages of health services (EPHS) are a critical tool for achieving universal health coverage, especially in low-income and lower middle-income countries. However, there is a lack of guidance and standards for monitoring and evaluation (M&E) of EPHS implementation. This paper is the final in a series of papers reviewing experiences using evidence from the Disease Control Priorities, third edition publications in EPHS reforms in seven countries. We assess current approaches to EPHS M&E, including case studies of M&E approaches in Ethiopia and Pakistan. We propose a step-by-step process for developing a national EPHS M&E framework. Such a framework would start with a theory of change that links to the specific health system reforms the EPHS is trying to accomplish, including explicit statements about the 'what' and 'for whom' of M&E efforts. Monitoring frameworks need to consider the additional demands that could be placed on weak and already overstretched data systems, and they must ensure that processes are put in place to act quickly on emergent implementation challenges. Evaluation frameworks could learn from the field of implementation science; for example, by adapting the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to policy implementation. While each country will need to develop its own locally relevant M&E indicators, we encourage all countries to include a set of core indicators that are aligned with the Sustainable Development Goal 3 targets and indicators. Our paper concludes with a call to reprioritise M&E more generally and to use the EPHS process as an opportunity for strengthening national health information systems. We call for an international learning network on EPHS M&E to generate new evidence and exchange best practices.

Rapid ethnography and participatory techniques increase onchocerciasis mass drug administration treatment coverage in Benin: a difference-in-differences analysis.

BACKGROUND: Onchocerciasis, a neglected tropical disease (NTD) that causes blindness, is controlled via mass drug administration (MDA) where entire endemic communities are targeted with preventative chemotherapeutic treatment. However, in many settings, MDA coverage remains low. The purpose of this project was to determine if engaging communities in the development of implementation strategies improves MDA coverage. METHODS: This study took place in an intervention and a control commune in Benin, West Africa. We conducted rapid ethnography in each commune to learn about community member perceptions of onchocerciasis, MDA, and opportunities to increase MDA coverage. Findings were shared with key stakeholders and a structured nominal group technique was used to derive implementation strategies most likely to increase treatment coverage. The implementation strategies were delivered prior to and during onchocerciasis MDA. We conducted a coverage survey within 2 weeks of MDA to determine treatment coverage in each commune. A difference-in-differences design was used to determine if the implementation package effectively increased coverage. A dissemination meeting was held with the NTD program and partners to share findings and determine the perceived acceptability, appropriateness, and feasibility of implementing rapid ethnography as part of routine program improvement. RESULTS: During rapid ethnography, key barriers to MDA participation included trust in community drug distributors, poor penetration of MDA programs in rural or geographically isolated areas, and low demand for MDA among specific sub-populations driven by religious or socio-cultural beliefs. Stakeholders developed a five-component implementation strategy package, including making drug distributor trainings dynamic, redesigning distributor job aids, tailoring community sensitization messages, formalizing supervision, and preparing local champions. After implementing the strategy package, MDA coverage increased by 13% (95% CI: 11.0-15.9%) in the intervention commune relative to the control commune. Ministry of Health and implementing partners found the approach to be largely acceptable and appropriate; however, there was mixed feedback regarding the feasibility of future implementation of rapid ethnography. CONCLUSIONS: Implementation research conducted in Benin, and indeed throughout sub-Saharan Africa, is often implemented in a top-down manner, with both implementation determinants and strategies derived in the global North. This project demonstrates the importance of participatory action research involving community members and implementers to optimize program delivery.

Optimising scale-up for public health impact: a multimethod implementation science research protocol to improve infant health outcomes in Ethiopia.

INTRODUCTION: Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns' nutritional status, early illness identification and treatment, and vaccination completeness.Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale. METHODS AND ANALYSIS: We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider's perspective. ETHICS AND DISSEMINATION: The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.

Participatory development of a target policy profile to support soil-transmitted helminth elimination.

Introduction: Soil-transmitted helminths (STH) are parasitic worms that infect nearly a quarter of the world's population, particularly those living in communities without access to adequate water, sanitation, and housing. Emerging evidence suggests that it may be possible to interrupt transmission of STH by deworming individuals of all ages via community-wide MDA (cMDA), as opposed to only treating children and other focal populations. Transitioning from a policy of STH control to STH elimination in targeted areas would require a fundamental shift in STH policy and programming. This policy change would require updated guidance to support countries as they adapt their current approaches for STH surveillance, supply chain management, community mobilization, and core programmatic activities in pursuit of STH elimination. There is an opportunity to engage with key stakeholders, such as program implementers and implementation partners, to understand what evidence they need to confidently adopt a new policy guideline and to deliver guideline adherent management at scale. Methods: We aimed to engage with STH stakeholders to develop a Target Policy Profile (TPoP), a single document that describes optimal characteristics and evidence requirements that STH stakeholders prioritized in future potential STH transmission interruption efforts. Steps in TPoP development included a scoping review and key informant interviews (KIIs), which were used to design a two-stage Delphi technique to identify and verify TPoP components. Results: The scoping review resulted in 25 articles, and 8 experts participated in KII's. Twenty respondents completed the first Delphi survey and 10 respondents completed the second. This systematic effort resulted in a net of 3 key information domains (background/context, clinical considerations, and implementation considerations) encompassing 24 evidence categories (examples include evidence regarding safety and adverse events, implementation feasibility, or evidence dissemination). For each evidence category, STH stakeholders reviewed, endorsed, or revised a range of options for how the evidence could be presented. Discussion: This information can be used by guideline committees or global policy makers prior to convening guideline advisory groups. The TPoP tool may also speed the process of stakeholder consensus building around guidelines, accelerating progress towards implementing evidence-based policy at scale.

Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India.

BACKGROUND: The World Health Organization Neglected Tropical Disease (NTD) guidelines recommend control of soil transmitted helminth (STH)-associated morbidity with targeted deworming of preschool and school-aged children who are disproportionately affected by STH-associated morbidity. However, this strategy leaves many adults untreated and reinfection within communities perpetuates transmission even when mass drug administration (MDA) coverage of children is high. Evidence suggests that it may be possible to interrupt STH transmission by expanding MDA to a community-wide MDA (cMDA). METHODS: This multi-methods study of organizational readiness survey, key informant interviews, and program mapping, were conducted with government stakeholders in three Indian states, Goa, Sikkim, and Odisha, to assess readiness of the states for transitioning from school-based MDA to cMDA and identify opportunities to leverage existing infrastructure from other NTD programs like lymphatic filariasis (LF) for STH cMDA. PRINCIPAL FINDINGS: Overall, all three states indicated a highly favorable policy environment, effective leadership structure, adequate material resources, demonstrated technical capacity, and adequate community infrastructure needed to launch a STH cMDA program. The findings indicated a high-level of health system readiness to implement provided human resources and financial resources to deliver cMDA is strengthened. Areas with a significant overlap between LF and STH MDA platforms, particularly at the community-level, may be best primed for transitioning. Immunization, maternal child health, and non-communicable disease control programs were the other programs for possible integration of cMDA. States indicated having effective leadership structures in place at the state-level, however, engaging local leaders and community groups were considered crucial for successful implementation of cMDA. In-migration was a perceived challenge for estimating drug requirement and preventing possible stockouts. CONCLUSIONS: Findings from this study are intended to proactively support government decision making, prioritization, and program planning across heterogenous implementation contexts in India to speed the translation of research findings into practice. CLINICAL TRIAL REGISTRATION: NCT03014167; ClinicalTrials.gov.

Remote evaluation of STH program coverage: Experiences from the DeWorm3 study, India.

BACKGROUND: The DeWorm3 trial is a multi-country study testing the feasibility of interrupting transmission of soil-transmitted helminths by community-wide mass drug administration (cMDA). Treatment coverage during cMDA delivery was validated by in-person coverage evaluation surveys (CES) after each round of treatment. A mobile phone-based CES was carried out in India when access to households was restricted during the COVID-19 lockdown. METHODS: Two focus group discussions were conducted with the survey implementers to document their experiences of conducting phone-based CES via mobile-phone voice calls. PRINCIPAL FINDINGS: In the phone-based CES, only 56% of sampled households were reached compared to 89% during the in-person CES (89%). This was due to phone numbers being wrongly recorded, or calls being unanswered leading to a higher number of households that had to be sampled in order to achieve the sample size of 2,000 households in phone-based CES compared in-person CES (3,600 and 2,352 respectively). Although the phone-based CES took less time to complete than in person coverage evaluations, the surveyors highlighted the lack of gender representation among phone survey participants as it was mostly men who answered calls and were then interviewed. The surveyors also mentioned that eliciting responses to open-ended questions and confirming treatment compliance from every member of the household was challenging during phone based CES. These observations were confirmed by analysing the survey participation data which showed women's participation in CES was significantly lower in phone-based CES (66%) compared to in-person CES (94%) (Z = -22.38; p<0.01) and that a significantly higher proportion of households provided proxy responses in phone-based CES (51%) compared to in-person CES (21%) (Z = 20.23; p<0.01). CONCLUSIONS: The phone-based CES may be a viable option to evaluate treatment coverage but issues such as participation bias, gender inclusion, and quality of responses will need to be addressed to optimize this methodology.

Persons 'never treated' in mass drug administration for lymphatic filariasis: identifying programmatic and research needs from a series of research review meetings 2020-2021.

As neglected tropical disease programs rely on participation in rounds of mass drug administration (MDA), there is concern that individuals who have never been treated could contribute to ongoing transmission, posing a barrier to elimination. Previous research has suggested that the size and characteristics of the never-treated population may be important but have not been sufficiently explored. To address this critical knowledge gap, four meetings were held from December 2020 to May 2021 to compile expert knowledge on never treatment in lymphatic filariasis (LF) MDA programs. The meetings explored four questions: the number and proportion of people never treated, their sociodemographic characteristics, their infection status and the reasons why they were not treated. Meeting discussions noted key issues requiring further exploration, including how to standardize measurement of the never treated, adapt and use existing tools to capture never-treated data and ensure representation of never-treated people in data collection. Recognizing that patterns of never treatment are situation specific, participants noted measurement should be quick, inexpensive and focused on local solutions. Furthermore, programs should use existing data to generate mathematical models to understand what levels of never treatment may compromise LF elimination goals or trigger programmatic action.

Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach.

BACKGROUND: The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention - the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP. METHODS: We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes. RESULTS: We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%). CONCLUSION: Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility. TRIAL REGISTRATION: Trial registered on ClinicalTrial.gov as NCT03574129.