Faculty Bibliography

Reciprocal innovation, a model of sustained, multidirectional exchange in which health strategies are adapted, revisited, and refined across contexts, offers a compelling framework to rethink how implementation science can support global health equity by enabling dynamic, multidirectional learning across different contexts. Drawing on the EXTRA-CVD trial, a nurse-led cardiovascular disease prevention intervention designed to extend the HIV treatment cascade in United States (U.S.) HIV clinics, which adapted strategies informed by implementation research in Kenya and the U.S. Veterans Affairs health system, this perspective examines how reciprocal innovation can begin to emerge within existing research structures, as well as where opportunities for deeper exchange remain limited. We identify four operational domains of reciprocal innovation: care delivery strategies, end-user engagement, research methodologies, and research leadership and partnership. Across these domains, we describe how cross-context learning shaped intervention adaptation and site-level implementation in EXTRA-CVD, as well as missed opportunities where more intentional feedback, shared leadership, and methodological exchange could have strengthened multidirectional learning. Taken together, this work highlights both the potential and the practical challenges of reciprocal innovation in implementation research, emphasizing its role in moving beyond unidirectional knowledge transfer toward iterative, context-responsive learning. By embedding structures for iterative feedback, equity-centered governance, and multidirectional learning systems within research and implementation systems, future global partnerships can foster more inclusive, responsive, and sustainable health interventions.

BACKGROUND:Implementation strategies are dynamic and multi-faceted, and may require adaptations to fit implementation contexts, especially in lower-and-middle income countries. We report the adaptations for an ongoing late-stage implementation science trial (R01HL147811) that integrates hypertension management into HIV care in Lagos, Nigeria - a country with a high dual-disease burden - through the Task Strengthening Strategy for Hypertension (TASSH) intervention and Practice Facilitation implementation strategy. METHODS:FRAME (Framework for Reporting Adaptations and Modifications-Enhanced) modules were used to record adaptations to the intervention (i.e., TASSH) respectively, enhance participant recruitment and retention rates, and increase frequency of trainings. Data collection sources included (not limited to) patient records, nurses' logs, and minutes of implementation review meetings. Data across these sources was coded retrospectively by trained research staff and triangulated during virtual meeting discussions. Once consensus was reached, data was mapped onto the relevant framework modules using Microsoft Excel. RESULTS:We modified FRAME to include an additional component on 'what was originally planned' for the context of the adaptations. There were twelve adaptations identified during the implementation of the study. The adaptations characterized by using the frameworks included reordering recruitment start dates of study cohorts, providing patients incentives to attend follow-up visits, adding feeder sites to the study sites, and increasing the frequency of training to account for the high nurse turnover in the primary healthcare centers. Overall, 25% of the adaptations involved expanding the structure of the intervention and implementation strategies, and 33% involved adding new elements to the strategies. All adaptations occurred in the implementation phase of the trial. CONCLUSION/CONCLUSIONS:Based on our experiences, the characterization of the adaptations using FRAME demonstrates their combined applicability to an ongoing trial that can be tailored to fit the local context. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov ( NCT04704336). Registered on 11 January 2021.

Background: Pregnancy is a crucial period to improve cardiovascular health (CVH) for mothers and their families. The current study emphasizes framework-guided factors that influence the adaptation of an evidence-based intervention (Parents as Teachers and Healthy Eating Active Living Taught at Home [PAT + HEALTH]) to support healthy gestational weight gain and postpartum weight management among pregnant women with obesity and their infants in Nigeria. Methods: From May to June 2023, 43 in-depth interviews were conducted with 11 parents, 15 community health extension workers (CHEWs)/health educators, and 17 policymakers/ healthcare supervisors in the Federal Capital Territory, Nigeria. Additionally, nine focus groups were conducted with 75 participants. Interviews were recorded, de-identified, and transcribed. The updated Consolidated Framework for Implementation Research (CFIR 2.0) informed the development of the interview guides and the thematic analysis. Transcripts were double-coded using Dedoose. Results: We identified assessing context, tailoring strategies, local attitudes, and sustainability as constructs to consider when adapting and implementing the PAT + HEALTH intervention successfully within the Nigerian primary care context. For example, policymakers and healthcare supervisors emphasized the feasibility of the intervention, including raising community awareness, planning for hard-to-reach areas, and ensuring supportive supervision of CHEWs delivering the intervention. Additional factors included customizing educational content and delivery methods to fit the cultural, socioeconomic, and environmental contexts of Nigerian families. CHEWs highlighted the importance of public education on locally available foods for better nutrition. Potential barriers to the PAT + HEALTH intervention included local attitudes influenced by sociocultural factors, such as food taboos, and structural factors, including limited financial support for the long-term sustainability of some components of the home visiting program. Conclusions: Building on these formative activities, the ENHANCE CVH trial will advance dissemination and implementation science by adapting, testing, and evaluating the effectiveness and implementation of the PAT + HEALTH intervention among pregnant women with obesity and their infants in Nigeria in a cluster randomized trial. Trial registration: ClinicalTrials.gov/NCT06773299, Registration Date: January 14, 2025.

BACKGROUND:Improved access to antiretroviral therapy (ART) has increased survival among people living with HIV (PLWH) but also the burden of cardiovascular risk factors like hypertension. While the task-strengthening strategy for hypertension control (TASSH) is a viable integrated care model, evidence of its clinical impact in Africa is limited. This report presents baseline findings from a trial evaluating two implementation strategies for integrating TASSH into HIV care across primary health centers (PHCs) in Lagos, Nigeria. METHODS:A total of 3504 PLWH on ART in 30 PHCs were screened, and 830 were enrolled. Baseline data on patient sociodemographic, clinical, laboratory results, and lifestyle characteristics were gathered. RESULTS:Among the 3504 screened, 1046 (29.9%) had hypertension. Of the 830 enrolled, mean [SD] age was 49.4 [9.5] years, 63.5% were women, 69.5% had at least secondary school education, 92.3% were employed, and 84.6% earned less than 100,000 Naira (64.74 USD) monthly. The median BP was 150.0/95.3 mmHg, and 63.9% were overweight or obese. 25.8% continued previously prescribed antihypertensive medications, while 66.3% received new prescriptions. Additionally, 25.1% and 1.8% were alcohol users and current smokers, while 30.9% were physically inactive. CONCLUSIONS:The prevalence of hypertension among PLWH was higher than previously reported. Although most participants adopted healthy lifestyle behaviors, the majority were overweight or obese, and many were not on antihypertensive medications. These findings highlight the importance of integrating hypertension control into HIV care across PHCs in Nigeria.

OBJECTIVES/OBJECTIVE:To identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria. DESIGN/METHODS:Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis. SETTING/METHODS:Peri-urban communities across the five administrative divisions of Lagos State, Nigeria. PARTICIPANTS/METHODS:128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female. INTERVENTIONS/METHODS:This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel. PRIMARY AND SECONDARY OUTCOME MEASURES/METHODS:Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors. RESULTS:Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access. CONCLUSIONS:Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT05048147.

BACKGROUND:Pregnancy is a crucial period to improve cardiovascular health (CVH) for mothers and their families. The current study emphasizes framework-guided factors that influence the adaptation of an evidence-based intervention (Parents as Teachers and Healthy Eating Active Living Taught at Home [PAT + HEALTH]) to support healthy gestational weight gain and postpartum weight management among pregnant women with obesity and their infants in Nigeria. METHODS:From May to June 2023, 43 in-depth interviews were conducted with 11 parents, 15 community health extension workers (CHEWs)/health educators, and 17 policymakers/ healthcare supervisors in the Federal Capital Territory, Nigeria. Additionally, nine focus groups were conducted with 75 participants. Interviews were recorded, de-identified, and transcribed. The updated Consolidated Framework for Implementation Research (CFIR 2.0) informed the development of the interview guides and the thematic analysis. Transcripts were double-coded using Dedoose. RESULTS:We identified assessing context, tailoring strategies, local attitudes, and sustainability as constructs to consider when adapting and implementing the PAT + HEALTH intervention successfully within the Nigerian primary care context. For example, policymakers and healthcare supervisors emphasized the feasibility of the intervention, including raising community awareness, planning for hard-to-reach areas, and ensuring supportive supervision of CHEWs delivering the intervention. Additional factors included customizing educational content and delivery methods to fit the cultural, socioeconomic, and environmental contexts of Nigerian families. CHEWs highlighted the importance of public education on locally available foods for better nutrition. Potential barriers to the PAT + HEALTH intervention included local attitudes influenced by sociocultural factors, such as food taboos, and structural factors, including limited financial support for the long-term sustainability of some components of the home visiting program. CONCLUSIONS:Building on these formative activities, the ENHANCE CVH trial will advance dissemination and implementation science by adapting, testing, and evaluating the effectiveness and implementation of the PAT + HEALTH intervention among pregnant women with obesity and their infants in Nigeria in a cluster randomized trial. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov/NCT06773299, Registration Date: January 14, 2025.

INTRODUCTION/BACKGROUND:In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited. METHODS AND ANALYSIS/METHODS:Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026. ETHICS AND DISSEMINATION/BACKGROUND:The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT05048147.

BACKGROUND:Hypertension (HTN) is the leading cause of cardiovascular morbidity and mortality among people living with HIV (PLWH) in Africa, yet integration of hypertension treatment in HIV clinics is sub-optimal. Cost-effective strategies to implement evidence-based hypertension care for this population are urgently needed to preserve the life-expectancy gains of antiretroviral therapy. METHODS:Building on insights gained from a comprehensive mixed-methods formative assessment, we used a human-centered design approach to develop a multi-component HIV-HTN integration (HTN-PLUS) strategy. In a stepped-wedge cluster randomized trial, we are assessing the effectiveness, costs, and implementation of HTN-PLUS as well as a less resource intensive strategy of providing HTN medication and blood pressure cuffs (HTN-BASIC) free of charge to clinics. The trial is being conducted in 16 public and private not-for-profit HIV clinics in Kampala and Wakiso districts in Uganda. The co-primary effectiveness outcomes are population BP control (screened and documented BP < 140/90 mmHg) and HTN patient BP control [BP < 140/90 mmHg among PLWH with HTN]. The trial is designed to have > 80% power to detect a 12%-point increase in both outcomes compared to the pre-implementation control period across a range of scenarios of baseline hypertension prevalence and temporal improvements in the control period. At two pre-specified time points, we are conducting a Learn-As-You-Go optimization analysis and will adapt the HTN-PLUS strategy accordingly. To assess implementation outcomes, we have enrolled a prospective longitudinal mixed-methods cohort study of clinic health workers and PLWH with HTN. An extensive economic evaluation will include time and motion studies, facility-based costing, and out-of-pocket cost surveys to determine costs and cost-effectiveness from a societal perspective. DISCUSSION/CONCLUSIONS:Innovative implementation strategies to integrate evidence-based hypertension care for PLWH in Africa must be informed by the health workers and PLWH who are cared for across diverse HIV clinics. These clinics currently provide high quality HIV care as evidenced by high rates of HIV viral suppression but often lack the knowledge, skills and resources to provide HTN care. Funders and policymakers critically need to know both the effectiveness and costs to scale these strategies and potentially expand them to include other non-AIDS comorbidities. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05609513. Registered on November 11, 2022.

People with HIV are at increased risk of cardiovascular events; thus, care delivery strategies that increase access to comprehensive cardiovascular disease (CVD) risk management are a priority. We report the results of a multi-component telemedicine-based strategy to improve blood pressure control among people with HIV-Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living with HIV (AAIM-High). The AAIM High strategy is a virtual adaptation of our previously published EXTRA-CVD strategy and consisted of hypertension education and six components: nurse-led care coordination (delivered by teleconference or telephone), home systolic blood pressure (SBP) monitoring, evidence-based treatment algorithms, electronic health records tools, technology coach, and communication preferences assessment. People with HIV (n = 74) with comorbid hypertension at three academic medical centers were enrolled in a single arm implementation study from January 2021 to December 2022. Over 12 months, the average patient-performed home SBP decreased by 7.7 mmHg (95% CI -11.5, -3.9). The percentage of patients at treatment goal, defined as average SBP <130 mmHg, increased from 46.0% to 72.5% at 12 months. By adapting to the growing use of telemedicine in healthcare delivery, our study effectively improved hypertension control in people with HIV through a virtual, nurse-led intervention.