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.

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.

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.

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.

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.

Policy stakeholder perspectives on barriers and facilitators to launching a community-wide mass drug administration program for soil-transmitted helminths.

BACKGROUND: Recent evidence suggests that soil-transmitted helminth (STH) transmission interruption may be feasible through community-wide mass drug administration (cMDA) that deworms community members of all ages. A change from school-based deworming to cMDA will require reconfiguring of STH programs in endemic countries. We conducted formative qualitative research in Benin, India, and Malawi to identify barriers and facilitators to successfully launching a cMDA program from the policy-stakeholder perspective. METHODS: We conducted 40 key informant interviews with policy stakeholders identified as critical change agents at national, state/district, and sub-district levels. Participants included World Health Organization country office staff, implementing partners, and national and sub-national government officials. We used the Consolidated Framework for Implementation Research to guide data collection, coding, and analysis. Heat maps were used to organize coded data and differentiate perceived facilitators and barriers to launching cMDA by stakeholder. RESULTS: Key facilitators to launching a cMDA program included availability of high-quality, tailored sensitization materials, and human and material resources that could be leveraged from previous MDA campaigns. Key barriers included the potential to overburden existing health workers, uncertainty of external funding to sustain a cMDA program, and concerns about weak intragovernmental coordination to implement cMDA. Cross-cutting themes included the need for rigorous trial evidence on STH transmission interruption to gain confidence in cMDA, and implementation evidence to effectively operationalize cMDA. Importantly, if policy stakeholders anticipate a cMDA program cannot be sustained due to cost and human resource barriers in the long term they may be less likely to support the launch of a program in the short term. CONCLUSIONS: Overall, policy stakeholders were optimistic about implementing cMDA primarily because they believe that the tools necessary to successfully implement cMDA are already available. Policy stakeholders in this study were cautiously optimistic about launching cMDA to achieve STH transmission interruption and believe that it is feasible to implement. However, launching cMDA as an alternative policy to school-based deworming will require addressing key resource and evidence barriers. Trial registration This study was registered in the U.S. National Library of Medicine Clinical Trials registry (NCT03014167).

Community Drug Distributor Knowledge, Attitudes, and Motivation Surrounding Mass Drug Administration for Soil-Transmitted Helminths in India.

Background: DeWorm3 is an ongoing multi-country community-based cluster-randomized trial assessing the feasibility of interrupting transmission of soil-transmitted helminths (STH) with community-wide mass drug administration (cMDA). In Tamil Nadu, India, community drug distributors (CDDs) worked with DeWorm3 field staff to counsel community members and deliver door-to-door deworming treatment. As CDDs were likely to influence successful delivery of cMDA, we describe drivers of CDDs' knowledge, attitudes, and motivation toward delivery of cMDA. Methods: In this convergent mixed-methods study, a questionnaire on STH and cMDA was administered to 104 CDDs and 17 focus group discussions (FGDs) were conducted. Key outcomes in the quantitative and qualitative analyses included CDDs' knowledge about STH and cMDA and attitudes toward cMDA for STH. Univariate and multivariable logistic regression analyses were performed to determine the strength of associations between independent and outcome variables. The FGDs were analyzed using a priori thematic coding. Results: CDDs who completed at least secondary school education [adjusted odds ratio (aOR): 2.71, 95% CI: 1.16-6.33] and had prior experience in health programs (aOR: 2.72, 95% CI: 1.15-6.44) were more knowledgeable about STH and cMDA. CDDs belonging to the scheduled castes and scheduled tribes (aOR: 2.37, 95% CI: 1.04-5.39), and to households engaged in a skilled occupation (aOR: 2.77, 95% CI: 1.21-6.34) had a more positive attitude toward cMDA for STH. The FGDs showed that while there were myths and misconceptions about STH, many CDDs believed that the adult population in their communities were infected with STH, and that a door-to-door drug delivery strategy would be optimal to reach adults. Conclusions: Educational and socioeconomic backgrounds and experience in health programs should be considered while designing CDD trainings. Along with cMDA delivery for STH, as CDD do share community myths and misconceptions around STH, they should be proactively addressed during the CDD training to strengthen competency in counseling.

Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study.

BACKGROUND: Current soil-transmitted helminth (STH) control programs target pre-school and school-age children with mass drug administration (MDA) of deworming medications, reducing morbidity without interrupting ongoing transmission. However, evidence suggests that STH elimination may be possible if MDA is delivered to all community members. Such a change to the STH standard-of-care would require substantial systems redesign. We measured baseline structural readiness to launch community-wide MDA for STH in Benin, India, and Malawi. METHODS: After field piloting and adaptation, the structural readiness survey included two constructs: Organizational Readiness for Implementing Change and Organizational Capacity for Change. Sub-constructs of organizational readiness include change commitment and change efficacy. Sub-constructs of organizational capacity include flexibility, organizational structure, and demonstrated capacity. Survey items were also separately organized into seven implementation domains. Surveys were administered to policymakers, mid-level managers, and implementers in each country using a five-point Likert scale. Item, sub-construct, construct, and domain-level medians and interquartile ranges were calculated for each stakeholder level within each country. RESULTS: Median organizational readiness for change scores were highest in Malawi (5.0 for all stakeholder groups). In India, scores were 5.0, 4.0, and 5.0 while in Benin, scores were 4.0, 3.0, and 4.0 for policymakers, mid-level managers, and implementers, respectively. Median change commitment was equal to or higher than median change efficacy across all countries and stakeholder groups. Median organizational capacity for change was highest in India, with a median of 4.5 for policymakers and mid-level managers and 5.0 for implementers. In Malawi, the median capacity was 4.0 for policymakers and implementers, and 3.5 for mid-level managers. In Benin, the median capacity was 4.0 for policymakers and 3.0 for mid-level managers and implementers. Median sub-construct scores varied by stakeholder and country. Across countries, items reflective of the implementation domain 'policy environment' were highest while items reflective of the 'human resource' domain were consistently lower. CONCLUSION: Across all countries, stakeholders valued community-wide MDA for STH but had less confidence in their collective ability to effectively implement it. Perceived capacity varied by stakeholder group, highlighting the importance of accounting for multi-level stakeholder perspectives when determining organizational preparedness to launch new public health initiatives. TRIAL REGISTRATION: NCT03014167.

Implementation Science to Respond to the COVID-19 Pandemic.

The COVID-19 pandemic continues to expand globally, requiring massive public health responses from national and local governments. These bodies have taken heterogeneous approaches to their responses, including when and how to introduce and enforce evidence-based interventions-such as social distancing, hand-washing, personal protective equipment (PPE), and testing. In this commentary, we reflect on opportunities for implementation science to contribute meaningfully to the COVID-19 pandemic response. We reflect backwards on missed opportunities in emergency preparedness planning, using the example of PPE stockpiling and supply management; this planning could have been strengthened through process mapping with consensus-building, microplanning with simulation, and stakeholder engagement. We propose current opportunities for action, focusing on enhancing the adoption, fidelity, and sustainment of hand washing and social distancing; we can combine qualitative data, policy analysis, and dissemination science to inform agile and rapid adjustment to social marketing strategies to enhance their penetration. We look to future opportunities to enhance the integration of new evidence in decision-making, focusing on serologic and virologic testing systems; we can leverage simulation and other systems engineering modeling to identify ideal system structures. Finally, we discuss the ways in which the COVID-19 pandemic challenges implementation science to become more rapid, rigorous, and nimble in its approach, and integrate with public health practice. In summary, we articulate the ways in which implementation science can inform, and be informed by, the COVID-19 pandemic, looking backwards, proposing actions for the moment, and approaches for the future.