Browsing by Author "Edwards JK"
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Item Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial.(2024-Jun-06) Herce ME; Bosomprah S; Masiye F; Mweemba O; Edwards JK; Mandyata C; Siame M; Mwila C; Matenga T; Frimpong C; Mugala A; Mbewe P; Shankalala P; Sichone P; Kasenge B; Chunga L; Adams R; Banda B; Mwamba D; Nachalwe N; Agarwal M; Williams MJ; Tonwe V; Pry JM; Musheke M; Vinikoor M; Mutale W; Institute of Public Health, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.; Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Department of Health Promotion and Education, School of Public Health, University of Zambia, Ridgeway Campus, Lusaka, Zambia.; Department of Epidemiology, School of Medicine, University of California at Davis, Davis, CA, USA.; Department of Medicine, Division of Infectious Diseases, University Teaching Hospital, Lusaka, Zambia.; Division of Infectious Diseases, Department of Medicine, University of Alabama, Birmingham, AL, USA.; Department of Health Economics, School of Public Health, University of Zambia, Ridgeway Campus, Lusaka, Zambia.; Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, NC, USA. michael.herce@cidrz.org.; Department of Paediatrics and Child Health, School of Medicine, University of Zambia, Lusaka, Zambia.; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, U.S. National Institutes of Health, Bethesda, MD, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia. michael.herce@cidrz.org.; Department of Health Policy and Management, School of Public Health, University of Zambia, Lusaka, Zambia.BACKGROUND: Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as "TASKPEN," that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness. METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor's Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM. DISCUSSION: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).Item Gone But Not Lost: Implications for Estimating HIV Care Outcomes When Loss to Clinic Is Not Loss to Care.(2020-Jul) Edwards JK; Lesko CR; Herce ME; Murenzi G; Twizere C; Lelo P; Anastos K; Tymejczyk O; Yotebieng M; Nash D; Adedimeji A; Edmonds A; From the Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.; Kalembelembe Pediatric Hospital, Kinshasa, Democratic Republic of the Congo.; Departments of Medicine and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY.; Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC.; Rwanda Military Hospital, Kigali, Rwanda.; Centre Hospitalo, Universitaire de Kamenge, Bujumbura, Burundi.; Institute for Implementation Science in Population Health, City University of New York, New York, NY.; Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.BACKGROUND: In some time-to-event analyses, it is unclear whether loss to follow up should be treated as a censoring event or competing event. Such ambiguity is particularly common in HIV research that uses routinely collected clinical data to report the timing of key milestones along the HIV care continuum. In this setting, loss to follow up may be viewed as a censoring event, under the assumption that patients who are "lost" from a study clinic immediately enroll in care elsewhere, or a competing event, under the assumption that people "lost" are out of care all together. METHODS: We illustrate an approach to address this ambiguity when estimating the 2-year risk of antiretroviral treatment initiation among 19,506 people living with HIV who enrolled in the IeDEA Central Africa cohort between 2006 and 2017, along with published estimates from tracing studies in Africa. We also assessed the finite sample properties of the proposed approach using simulation experiments. RESULTS: The estimated 2-year risk of treatment initiation was 69% if patients were censored at loss to follow up or 59% if losses to follow up were treated as competing events. Using the proposed approach, we estimated that the 2-year risk of antiretroviral therapy initiation was 62% (95% confidence interval: 61, 62). The proposed approach had little bias and appropriate confidence interval coverage under scenarios examined in the simulation experiments. CONCLUSIONS: The proposed approach relaxes the assumptions inherent in treating loss to follow up as a censoring or competing event in clinical HIV cohort studies.Item Improving HIV outreach testing yield at cross-border venues in East Africa.(2020-May-01) Edwards JK; Arimi P; Ssengooba F; Herce ME; Mulholland G; Markiewicz M; Babirye S; Ssendagire S; Weir SS; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; U.S. Agency for International Development, Kenya/East Africa Regional Mission, Nairobi, Kenya.; Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Institute for Global Health & Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Makerere University School of Public Health, Kampala, Uganda.OBJECTIVE: The aim of this study was to evaluate HIV testing yield under several candidate strategies for outreach testing at venues (i.e. places where people socialize and meet new sex partners) in East Africa cross-border areas. DESIGN: Population-based cross-sectional biobehavioural survey of people who had not been previously diagnosed with HIV found in venues. METHODS: We identified participants who would have been tested for HIV under each of 10 hypothetical outreach testing strategies and calculated the proportion who would have newly tested positive for HIV under each strategy. On the basis of this proportion, we calculated the 'number needed to test' (NNT) to identify one new case of HIV under each strategy. All estimates were obtained by applying survey sampling weights to account for the complex sampling design. RESULTS: If testing was performed at a random sample of venues, 35 people would need to be tested to identify one new case of HIV, but higher yield could be found by limiting testing to venues with specific characteristics. Strategies focusing on women had higher testing yield. Testing women employed by venues would result in highest yield of all strategies examined (NNT = 15), while testing men under age 24 would result in the lowest yield (NNT = 99). CONCLUSION: Quantitatively evaluating HIV testing strategies prior to implementation using survey data presents a new opportunity to refine and prioritize outreach testing strategies for the people and places most likely to result in high HIV testing yield.