Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Gross, Rachel; Thaweethai, Tanayott; Rosenzweig, Erika B; Chan, James; Chibnik, Lori B; Cicek, Mine S; Elliott, Amy J; Flaherman, Valerie J; Foulkes, Andrea S; Witvliet, Margot Gage; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L; Karlson, Elizabeth W; Katz, Stuart D; Kinser, Patricia A; Kleinman, Lawrence C; Lamendola-Essel, Michelle F; Milner, Joshua D; Mohandas, Sindhu; Mudumbi, Praveen C; Newburger, Jane W; Rhee, Kyung E; Salisbury, Amy L; Snowden, Jessica N; Stein, Cheryl R; Stockwell, Melissa S; Tantisira, Kelan G; Thomason, Moriah E; Truong, Dongngan T; Warburton, David; Wood, John C; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N; Anderson, Brett R; Aschner, Judy L; Atz, Andrew M; Aupperle, Robin L; Baker, Fiona C; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C; Bogie, Amanda L; Buchbinder, Natalie C; Bueler, Elliott; Bükülmez, Hülya; Casey, B J; Chang, Linda; Clark, Duncan B; Clifton, Rebecca G; Clouser, Katharine N; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dummer, Kirsten B; Elias, Matthew D; Esquenazi-Karonika, Shari; Evans, Danielle N; Faustino, E Vincent S; Fiks, Alexander G; Forsha, Daniel; Foxe, John J; Friedman, Naomi P; Fry, Greta; Gaur, Sunanda; Gee, Dylan G; Gray, Kevin M; Harahsheh, Ashraf S; Heath, Andrew C; Heitzeg, Mary M; Hester, Christina M; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K F; Horowitz, Carol R; Hsia, Daniel S; Huentelman, Matthew; Hummel, Kathy D; Iacono, William G; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L; Jone, Pei-Ni; Kaelber, David C; Kasmarcak, Tyler J; Kluko, Matthew J; Kosut, Jessica S; Laird, Angela R; Landeo-Gutierrez, Jeremy; Lang, Sean M; Larson, Christine L; Lim, Peter Paul C; Lisdahl, Krista M; McCrindle, Brian W; McCulloh, Russell J; Mendelsohn, Alan L; Metz, Torri D; Morgan, Lerraughn M; Müller-Oehring, Eva M; Nahin, Erica R; Neale, Michael C; Ness-Cochinwala, Manette; Nolan, Sheila M; Oliveira, Carlos R; Oster, Matthew E; Payne, R Mark; Raissy, Hengameh; Randall, Isabelle G; Rao, Suchitra; Reeder, Harrison T; Rosas, Johana M; Russell, Mark W; Sabati, Arash A; Sanil, Yamuna; Sato, Alice I; Schechter, Michael S; Selvarangan, Rangaraj; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M; Stevenson, Michelle D; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M; Teufel, Ronald J; Thacker, Deepika; Udosen, Mmekom M; Warner, Megan R; Watson, Sara E; Werzberger, Alan; Weyer, Jordan C; Wood, Marion J; Yin, H Shonna; Zempsky, William T; Zimmerman, Emily; Dreyer, Benard P
IMPORTANCE/UNASSIGNED:The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults. OBSERVATIONS/UNASSIGNED:cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science. CONCLUSIONS AND RELEVANCE/UNASSIGNED:RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions. CLINICAL TRIALSGOV IDENTIFIER/UNASSIGNED:Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
PMID: 37214806
CID: 5770522
Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial
Aifah, Angela A; Hade, Erinn M; Colvin, Calvin; Henry, Daniel; Mishra, Shivani; Rakhra, Ashlin; Onakomaiya, Deborah; Ekanem, Anyiekere; Shedul, Gabriel; Bansal, Geetha P; Lew, Daphne; Kanneh, Nafesa; Osagie, Samuel; Udoh, Ememobong; Okon, Esther; Iwelunmor, Juliet; Attah, Angela; Ogedegbe, Gbenga; Ojji, Dike
BACKGROUND:As people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria. DESIGN:In partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28-32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes. DISCUSSION:Given the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH. TRIAL REGISTRATION:Clinicaltrials.gov ( NCT05031819 ). Registered on 2nd September 2021.
PMCID:10173657
PMID: 37165382
ISSN: 1748-5908
CID: 5503342
Neighborhood Built Environments and Sleep Health: A Longitudinal Study in Low-Income and Predominantly African-American Neighborhoods
Kim, Byoungjun; Troxel, Wendy M; Dubowitz, Tamara; Hunter, Gerald P; Ghosh-Dastidar, Bonnie; Chaix, Basile; Rudolph, Kara E; Morrison, Christopher N; Branas, Charles C; Duncan, Dustin T
The present study examined the associations between physical characteristics of neighborhoods and sleep health outcomes and assessed the mediating role of physical activity on these associations. A longitudinal study (PHRESH Zzz, n=1,051) was conducted in two low-income, predominately African-American neighborhoods with repeated measures of neighborhood characteristics and sleep health outcomes from 2013 to 2018. Built environment measures of walkability, urban design, and physical neighborhood disorder were captured from systematic field observations. Sleep health outcomes included insufficient sleep, sleep duration, wakefulness after sleep onset (WASO), and sleep efficiency measured from 7-day actigraphy data. G-computations based on structural nested mean models were used to examine the total effects of each built environment feature and causal mediation analyses were used to evaluate direct and indirect effects through physical activity. Urban design features were associated with decreased WASO (β: -1.26, 95% confidence interval [-4.31, -0.33]). Neighborhood disorder (β: -0.46, CI [-0.86, -0.07]) and crime rate (β: -0.54, CI [-0.93, -0.08]) were negatively associated with sleep efficiency. Neighborhood walkability was not associated with sleep outcomes. We did not find a strong and consistent mediating role of physical activity. Interventions to improve sleep should target modifiable factors, including urban design and neighborhood disorder.
PMID: 36691683
ISSN: 1476-6256
CID: 5403742
National cervical cancer burden estimation through systematic review and analysis of publicly available data in Pakistan
Chughtai, Novera; Perveen, Kausar; Gillani, Sehar Rahim; Abbas, Aamir; Chunara, Rumi; Manji, Afshan Ali; Karani, Salima; Noorali, Ali Aahil; Zakaria, Maheen; Shamsi, Uzma; Chishti, Uzma; Khan, Adnan A; Soofi, Sajid; Pervez, Shahid; Samad, Zainab
BACKGROUND:Cervical cancer is a major cause of cancer-related deaths among women worldwide. Paucity of data on cervical cancer burden in countries like Pakistan hamper requisite resource allocation. OBJECTIVE:To estimate the burden of cervical cancer in Pakistan using available data sources. METHODS:We performed a systematic review to identify relevant data on Pakistan between 1995 to 2022. Study data identified through the systematic review that provided enough information to allow age specific incidence rates and age standardized incidence rates (ASIR) calculations for cervical cancer were merged. Population at risk estimates were derived and adjusted for important variables in the care-seeking pathway. The calculated ASIRs were applied to 2020 population estimates to estimate the number of cervical cancer cases in Pakistan. RESULTS:A total of 13 studies reported ASIRs for cervical cancer for Pakistan. Among the studies selected, the Karachi Cancer Registry reported the highest disease burden estimates for all reported time periods: 1995-1997 ASIR = 6.81, 1998-2002 ASIR = 7.47, and 2017-2019 ASIR = 6.02 per 100,000 women. Using data from Karachi, Punjab and Pakistan Atomic Energy Cancer Registries from 2015-2019, we derived an unadjusted ASIR for cervical cancer of 4.16 per 100,000 women (95% UI 3.28, 5.28). Varying model assumptions produced adjusted ASIRs ranging from 5.2 to 8.4 per 100,000 women. We derived an adjusted ASIR of 7.60, (95% UI 5.98, 10.01) and estimated 6166 (95% UI 4833, 8305) new cases of cervical cancer per year. CONCLUSION:The estimated cervical cancer burden in Pakistan is higher than the WHO target. Estimates are sensitive to health seeking behavior, and appropriate physician diagnostic intervention, factors that are relevant to the case of cervical cancer, a stigmatized disease in a low-lower middle income country setting. These estimates make the case for approaching cervical cancer elimination through a multi-pronged strategy.
PMCID:10163779
PMID: 37147640
ISSN: 1471-2458
CID: 5495312