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1.  Proceedings of the 3rd Biennial Conference of the Society for Implementation Research Collaboration (SIRC) 2015: advancing efficient methodologies through community partnerships and team science 
Lewis, Cara | Darnell, Doyanne | Kerns, Suzanne | Monroe-DeVita, Maria | Landes, Sara J. | Lyon, Aaron R. | Stanick, Cameo | Dorsey, Shannon | Locke, Jill | Marriott, Brigid | Puspitasari, Ajeng | Dorsey, Caitlin | Hendricks, Karin | Pierson, Andria | Fizur, Phil | Comtois, Katherine A. | Palinkas, Lawrence A. | Chamberlain, Patricia | Aarons, Gregory A. | Green, Amy E. | Ehrhart, Mark. G. | Trott, Elise M. | Willging, Cathleen E. | Fernandez, Maria E. | Woolf, Nicholas H. | Liang, Shuting Lily | Heredia, Natalia I. | Kegler, Michelle | Risendal, Betsy | Dwyer, Andrea | Young, Vicki | Campbell, Dayna | Carvalho, Michelle | Kellar-Guenther, Yvonne | Damschroder, Laura J. | Lowery, Julie C. | Ono, Sarah S. | Carlson, Kathleen F. | Cottrell, Erika K. | O’Neil, Maya E. | Lovejoy, Travis L. | Arch, Joanna J. | Mitchell, Jill L. | Lewis, Cara C. | Marriott, Brigid R. | Scott, Kelli | Coldiron, Jennifer Schurer | Bruns, Eric J. | Hook, Alyssa N. | Graham, Benjamin C. | Jordan, Katelin | Hanson, Rochelle F. | Moreland, Angela | Saunders, Benjamin E. | Resnick, Heidi S. | Stirman, Shannon Wiltsey | Gutner, Cassidy A. | Gamarra, Jennifer | Vogt, Dawne | Suvak, Michael | Wachen, Jennifer Schuster | Dondanville, Katherine | Yarvis, Jeffrey S. | Mintz, Jim | Peterson, Alan L. | Borah, Elisa V. | Litz, Brett T. | Molino, Alma | McCaughan, Stacey Young | Resick, Patricia A. | Pandhi, Nancy | Jacobson, Nora | Serrano, Neftali | Hernandez, Armando | Schreiter, Elizabeth Zeidler- | Wietfeldt, Natalie | Karp, Zaher | Pullmann, Michael D. | Lucenko, Barbara | Pavelle, Bridget | Uomoto, Jacqueline A. | Negrete, Andrea | Cevasco, Molly | Kerns, Suzanne E. U. | Franks, Robert P. | Bory, Christopher | Miech, Edward J. | Damush, Teresa M. | Satterfield, Jason | Satre, Derek | Wamsley, Maria | Yuan, Patrick | O’Sullivan, Patricia | Best, Helen | Velasquez, Susan | Barnett, Miya | Brookman-Frazee, Lauren | Regan, Jennifer | Stadnick, Nicole | Hamilton, Alison | Lau, Anna | Regan, Jennifer | Hamilton, Alison | Stadnick, Nicole | Barnett, Miya | Lau, Anna | Brookman-Frazee, Lauren | Stadnick, Nicole | Lau, Anna | Barnett, Miya | Regan, Jennifer | Roesch, Scott | Brookman-Frazee, Lauren | Powell, Byron J. | Waltz, Thomas J. | Chinman, Matthew J. | Damschroder, Laura | Smith, Jeffrey L. | Matthieu, Monica M. | Proctor, Enola K. | Kirchner, JoAnn E. | Waltz, Thomas J. | Powell, Byron J. | Chinman, Matthew J. | Damschroder, Laura J. | Smith, Jeffrey L. | Matthieu, Monica J. | Proctor, Enola K. | Kirchner, JoAnn E. | Matthieu, Monica M. | Rosen, Craig S. | Waltz, Thomas J. | Powell, Byron J. | Chinman, Matthew J. | Damschroder, Laura J. | Smith, Jeffrey L. | Proctor, Enola K. | Kirchner, JoAnn E. | Walker, Sarah C. | Bishop, Asia S. | Lockhart, Mariko | Rodriguez, Allison L. | Manfredi, Luisa | Nevedal, Andrea | Rosenthal, Joel | Blonigen, Daniel M. | Mauricio, Anne M. | Dishion, Thomas D. | Rudo-Stern, Jenna | Smith, Justin D. | Locke, Jill | Wolk, Courtney Benjamin | Harker, Colleen | Olsen, Anne | Shingledecker, Travis | Barg, Frances | Mandell, David | Beidas, Rinad S. | Hansen, Marissa C. | Aranda, Maria P. | Torres-Vigil, Isabel | Hartzler, Bryan | Steinfeld, Bradley | Gildred, Tory | Harlin, Zandrea | Shephard, Fredric | Ditty, Matthew S. | Doyle, Andrea | Bickel, John A. | Cristaudo, Katharine | Fox, Dan | Combs, Sonia | Lischner, David H. | Van Dorn, Richard A. | Tueller, Stephen J. | Hinde, Jesse M. | Karuntzos, Georgia T. | Monroe-DeVita, Maria | Peterson, Roselyn | Darnell, Doyanne | Berliner, Lucy | Dorsey, Shannon | Murray, Laura K. | Botanov, Yevgeny | Kikuta, Beverly | Chen, Tianying | Navarro-Haro, Marivi | DuBose, Anthony | Korslund, Kathryn E. | Linehan, Marsha M. | Harker, Colleen M. | Karp, Elizabeth A. | Edmunds, Sarah R. | Ibañez, Lisa V. | Stone, Wendy L. | Andrews, Jack H. | Johnides, Benjamin D. | Hausman, Estee M. | Hawley, Kristin M. | Prusaczyk, Beth | Ramsey, Alex | Baumann, Ana | Colditz, Graham | Proctor, Enola K. | Botanov, Yevgeny | Kikuta, Beverly | Chen, Tianying | Navarro-Haro, Marivi | DuBose, Anthony | Korslund, Kathryn E. | Linehan, Marsha M. | Harker, Colleen M. | Karp, Elizabeth A. | Edmunds, Sarah R. | Ibañez, Lisa V. | Stone, Wendy L. | Choy-Brown, Mimi | Andrews, Jack H. | Johnides, Benjamin D. | Hausman, Estee M. | Hawley, Kristin M. | Prusaczyk, Beth | Ramsey, Alex | Baumann, Ana | Colditz, Graham | Proctor, Enola K. | Meza, Rosemary D. | Dorsey, Shannon | Wiltsey-Stirman, Shannon | Sedlar, Georganna | Lucid, Leah | Dorsey, Caitlin | Marriott, Brigid | Zounlome, Nelson | Lewis, Cara | Gutner, Cassidy A. | Monson, Candice M. | Shields, Norman | Mastlej, Marta | Landy, Meredith SH | Lane, Jeanine | Stirman, Shannon Wiltsey | Finn, Natalie K. | Torres, Elisa M. | Ehrhart, Mark. G. | Aarons, Gregory A. | Malte, Carol A. | Lott, Aline | Saxon, Andrew J. | Boyd, Meredith | Scott, Kelli | Lewis, Cara C. | Pierce, Jennifer D. | Lorthios-Guilledroit, Agathe | Richard, Lucie | Filiatrault, Johanne | Hallgren, Kevin | Crotwell, Shirley | Muñoz, Rosa | Gius, Becky | Ladd, Benjamin | McCrady, Barbara | Epstein, Elizabeth | Clapp, John D. | Ruderman, Danielle E. | Barwick, Melanie | Barac, Raluca | Zlotkin, Stanley | Salim, Laila | Davidson, Marnie | Bunger, Alicia C. | Powell, Byron J. | Robertson, Hillary A. | Botsko, Christopher | Landes, Sara J. | Smith, Brandy N. | Rodriguez, Allison L. | Trent, Lindsay R. | Matthieu, Monica M. | Powell, Byron J. | Proctor, Enola K. | Harned, Melanie S. | Navarro-Haro, Marivi | Korslund, Kathryn E. | Chen, Tianying | DuBose, Anthony | Ivanoff, André | Linehan, Marsha M. | Garcia, Antonio R. | Kim, Minseop | Palinkas, Lawrence A. | Snowden, Lonnie | Landsverk, John | Sweetland, Annika C. | Fernandes, Maria Jose | Santos, Edilson | Duarte, Cristiane | Kritski, Afrânio | Krawczyk, Noa | Nelligan, Caitlin | Wainberg, Milton L. | Aarons, Gregory A. | Sommerfeld, David H. | Chi, Benjamin | Ezeanolue, Echezona | Sturke, Rachel | Kline, Lydia | Guay, Laura | Siberry, George | Bennett, Ian M. | Beidas, Rinad | Gold, Rachel | Mao, Johnny | Powers, Diane | Vredevoogd, Mindy | Unutzer, Jurgen | Schroeder, Jennifer | Volpe, Lane | Steffen, Julie | Dorsey, Shannon | Pullmann, Michael D | Kerns, Suzanne E. U. | Jungbluth, Nathaniel | Berliner, Lucy | Thompson, Kelly | Segell, Eliza | McGee-Vincent, Pearl | Liu, Nancy | Walser, Robyn | Runnals, Jennifer | Shaw, R. Keith | Landes, Sara J. | Rosen, Craig | Schmidt, Janet | Calhoun, Patrick | Varkovitzky, Ruth L. | Landes, Sara J. | Drahota, Amy | Martinez, Jonathan I. | Brikho, Brigitte | Meza, Rosemary | Stahmer, Aubyn C. | Aarons, Gregory A. | Williamson, Anna | Rubin, Ronnie M. | Powell, Byron J. | Hurford, Matthew O. | Weaver, Shawna L. | Beidas, Rinad S. | Mandell, David S. | Evans, Arthur C. | Powell, Byron J. | Beidas, Rinad S. | Rubin, Ronnie M. | Stewart, Rebecca E. | Wolk, Courtney Benjamin | Matlin, Samantha L. | Weaver, Shawna | Hurford, Matthew O. | Evans, Arthur C. | Hadley, Trevor R. | Mandell, David S. | Gerke, Donald R. | Prusaczyk, Beth | Baumann, Ana | Lewis, Ericka M. | Proctor, Enola K. | McWilliam, Jenna | Brown, Jacquie | Tucker, Michelle | Conte, Kathleen P | Lyon, Aaron R. | Boyd, Meredith | Melvin, Abigail | Lewis, Cara C. | Liu, Freda | Jungbluth, Nathaniel | Kotte, Amelia | Hill, Kaitlin A. | Mah, Albert C. | Korathu-Larson, Priya A. | Au, Janelle R. | Izmirian, Sonia | Keir, Scott | Nakamura, Brad J. | Higa-McMillan, Charmaine K. | Cooper, Brittany Rhoades | Funaiole, Angie | Dizon, Eleanor | Hawkins, Eric J. | Malte, Carol A. | Hagedorn, Hildi J. | Berger, Douglas | Frank, Anissa | Lott, Aline | Achtmeyer, Carol E. | Mariano, Anthony J. | Saxon, Andrew J. | Wolitzky-Taylor, Kate | Rawson, Richard | Ries, Richard | Roy-Byrne, Peter | Craske, Michelle | Simmons, Dena | Torrente, Catalina | Nathanson, Lori | Carroll, Grace | Smith, Justin D. | Brown, Kimbree | Ramos, Karina | Thornton, Nicole | Dishion, Thomas J. | Stormshak, Elizabeth A. | Shaw, Daniel S. | Wilson, Melvin N. | Choy-Brown, Mimi | Tiderington, Emmy | Smith, Bikki Tran | Padgett, Deborah K. | Rubin, Ronnie M. | Ray, Marilyn L. | Wandersman, Abraham | Lamont, Andrea | Hannah, Gordon | Alia, Kassandra A. | Hurford, Matthew O. | Evans, Arthur C. | Saldana, Lisa | Schaper, Holle | Campbell, Mark | Chamberlain, Patricia | Shapiro, Valerie B. | Kim, B.K. Elizabeth | Fleming, Jennifer L. | LeBuffe, Paul A. | Landes, Sara J. | Lewis, Cara C. | Rodriguez, Allison L. | Marriott, Brigid R. | Comtois, Katherine Anne | Lewis, Cara C. | Stanick, Cameo | Weiner, Bryan J. | Halko, Heather | Dorsey, Caitlin
Implementation Science : IS  2016;11(Suppl 1):85.
Table of contents
Introduction to the 3rd Biennial Conference of the Society for Implementation Research Collaboration: advancing efficient methodologies through team science and community partnerships
Cara Lewis, Doyanne Darnell, Suzanne Kerns, Maria Monroe-DeVita, Sara J. Landes, Aaron R. Lyon, Cameo Stanick, Shannon Dorsey, Jill Locke, Brigid Marriott, Ajeng Puspitasari, Caitlin Dorsey, Karin Hendricks, Andria Pierson, Phil Fizur, Katherine A. Comtois
A1: A behavioral economic perspective on adoption, implementation, and sustainment of evidence-based interventions
Lawrence A. Palinkas
A2: Towards making scale up of evidence-based practices in child welfare systems more efficient and affordable
Patricia Chamberlain
A3: Mixed method examination of strategic leadership for evidence-based practice implementation
Gregory A. Aarons, Amy E. Green, Mark. G. Ehrhart, Elise M. Trott, Cathleen E. Willging
A4: Implementing practice change in Federally Qualified Health Centers: Learning from leaders’ experiences
Maria E. Fernandez, Nicholas H. Woolf, Shuting (Lily) Liang, Natalia I. Heredia, Michelle Kegler, Betsy Risendal, Andrea Dwyer, Vicki Young, Dayna Campbell, Michelle Carvalho, Yvonne Kellar-Guenther
A3: Mixed method examination of strategic leadership for evidence-based practice implementation
Gregory A. Aarons, Amy E. Green, Mark. G. Ehrhart, Elise M. Trott, Cathleen E. Willging
A4: Implementing practice change in Federally Qualified Health Centers: Learning from leaders’ experiences
Maria E. Fernandez, Nicholas H. Woolf, Shuting (Lily) Liang, Natalia I. Heredia, Michelle Kegler, Betsy Risendal, Andrea Dwyer, Vicki Young, Dayna Campbell, Michelle Carvalho, Yvonne Kellar-Guenther
A5: Efficient synthesis: Using qualitative comparative analysis and the Consolidated Framework for Implementation Research across diverse studies
Laura J. Damschroder, Julie C. Lowery
A6: Establishing a veterans engagement group to empower patients and inform Veterans Affairs (VA) health services research
Sarah S. Ono, Kathleen F. Carlson, Erika K. Cottrell, Maya E. O’Neil, Travis L. Lovejoy
A7: Building patient-practitioner partnerships in community oncology settings to implement behavioral interventions for anxious and depressed cancer survivors
Joanna J. Arch, Jill L. Mitchell
A8: Tailoring a Cognitive Behavioral Therapy implementation protocol using mixed methods, conjoint analysis, and implementation teams
Cara C. Lewis, Brigid R. Marriott, Kelli Scott
A9: Wraparound Structured Assessment and Review (WrapSTAR): An efficient, yet comprehensive approach to Wraparound implementation evaluation
Jennifer Schurer Coldiron, Eric J. Bruns, Alyssa N. Hook
A10: Improving the efficiency of standardized patient assessment of clinician fidelity: A comparison of automated actor-based and manual clinician-based ratings
Benjamin C. Graham, Katelin Jordan
A11: Measuring fidelity on the cheap
Rochelle F. Hanson, Angela Moreland, Benjamin E. Saunders, Heidi S. Resnick
A12: Leveraging routine clinical materials to assess fidelity to an evidence-based psychotherapy
Shannon Wiltsey Stirman, Cassidy A. Gutner, Jennifer Gamarra, Dawne Vogt, Michael Suvak, Jennifer Schuster Wachen, Katherine Dondanville, Jeffrey S. Yarvis, Jim Mintz, Alan L. Peterson, Elisa V. Borah, Brett T. Litz, Alma Molino, Stacey Young McCaughanPatricia A. Resick
A13: The video vignette survey: An efficient process for gathering diverse community opinions to inform an intervention
Nancy Pandhi, Nora Jacobson, Neftali Serrano, Armando Hernandez, Elizabeth Zeidler- Schreiter, Natalie Wietfeldt, Zaher Karp
A14: Using integrated administrative data to evaluate implementation of a behavioral health and trauma screening for children and youth in foster care
Michael D. Pullmann, Barbara Lucenko, Bridget Pavelle, Jacqueline A. Uomoto, Andrea Negrete, Molly Cevasco, Suzanne E. U. Kerns
A15: Intermediary organizations as a vehicle to promote efficiency and speed of implementation
Robert P. Franks, Christopher Bory
A16: Applying the Consolidated Framework for Implementation Research constructs directly to qualitative data: The power of implementation science in action
Edward J. Miech, Teresa M. Damush
A17: Efficient and effective scaling-up, screening, brief interventions, and referrals to treatment (SBIRT) training: a snowball implementation model
Jason Satterfield, Derek Satre, Maria Wamsley, Patrick Yuan, Patricia O’Sullivan
A18: Matching models of implementation to system needs and capacities: addressing the human factor
Helen Best, Susan Velasquez
A19: Agency characteristics that facilitate efficient and successful implementation efforts
Miya Barnett, Lauren Brookman-Frazee, Jennifer Regan, Nicole Stadnick, Alison Hamilton, Anna Lau
A20: Rapid assessment process: Application to the Prevention and Early Intervention transformation in Los Angeles County
Jennifer Regan, Alison Hamilton, Nicole Stadnick, Miya Barnett, Anna Lau, Lauren Brookman-Frazee
A21: The development of the Evidence-Based Practice-Concordant Care Assessment: An assessment tool to examine treatment strategies across practices
Nicole Stadnick, Anna Lau, Miya Barnett, Jennifer Regan, Scott Roesch, Lauren Brookman-Frazee
A22: Refining a compilation of discrete implementation strategies and determining their importance and feasibility
Byron J. Powell, Thomas J. Waltz, Matthew J. Chinman, Laura Damschroder, Jeffrey L. Smith, Monica M. Matthieu, Enola K. Proctor, JoAnn E. Kirchner
A23: Structuring complex recommendations: Methods and general findings
Thomas J. Waltz, Byron J. Powell, Matthew J. Chinman, Laura J. Damschroder, Jeffrey L. Smith, Monica J. Matthieu, Enola K. Proctor, JoAnn E. Kirchner
A24: Implementing prolonged exposure for post-traumatic stress disorder in the Department of Veterans Affairs: Expert recommendations from the Expert Recommendations for Implementing Change (ERIC) project
Monica M. Matthieu, Craig S. Rosen, Thomas J. Waltz, Byron J. Powell, Matthew J. Chinman, Laura J. Damschroder, Jeffrey L. Smith, Enola K. Proctor, JoAnn E. Kirchner
A25: When readiness is a luxury: Co-designing a risk assessment and quality assurance process with violence prevention frontline workers in Seattle, WA
Sarah C. Walker, Asia S. Bishop, Mariko Lockhart
A26: Implementation potential of structured recidivism risk assessments with justice- involved veterans: Qualitative perspectives from providers
Allison L. Rodriguez, Luisa Manfredi, Andrea Nevedal, Joel Rosenthal, Daniel M. Blonigen
A27: Developing empirically informed readiness measures for providers and agencies for the Family Check-Up using a mixed methods approach
Anne M. Mauricio, Thomas D. Dishion, Jenna Rudo-Stern, Justin D. Smith
A28: Pebbles, rocks, and boulders: The implementation of a school-based social engagement intervention for children with autism
Jill Locke, Courtney Benjamin Wolk, Colleen Harker, Anne Olsen, Travis Shingledecker, Frances Barg, David Mandell, Rinad S. Beidas
A29: Problem Solving Teletherapy (PST.Net): A stakeholder analysis examining the feasibility and acceptability of teletherapy in community based aging services
Marissa C. Hansen, Maria P. Aranda, Isabel Torres-Vigil
A30: A case of collaborative intervention design eventuating in behavior therapy sustainment and diffusion
Bryan Hartzler
A31: Implementation of suicide risk prevention in an integrated delivery system: Mental health specialty services
Bradley Steinfeld, Tory Gildred, Zandrea Harlin, Fredric Shephard
A32: Implementation team, checklist, evaluation, and feedback (ICED): A step-by-step approach to Dialectical Behavior Therapy program implementation
Matthew S. Ditty, Andrea Doyle, John A. Bickel III, Katharine Cristaudo
A33: The challenges in implementing muliple evidence-based practices in a community mental health setting
Dan Fox, Sonia Combs
A34: Using electronic health record technology to promote and support evidence-based practice assessment and treatment intervention
David H. Lischner
A35: Are existing frameworks adequate for measuring implementation outcomes? Results from a new simulation methodology
Richard A. Van Dorn, Stephen J. Tueller, Jesse M. Hinde, Georgia T. Karuntzos
A36: Taking global local: Evaluating training of Washington State clinicians in a modularized cogntive behavioral therapy approach designed for low-resource settings
Maria Monroe-DeVita, Roselyn Peterson, Doyanne Darnell, Lucy Berliner, Shannon Dorsey, Laura K. Murray
A37: Attitudes toward evidence-based practices across therapeutic orientations
Yevgeny Botanov, Beverly Kikuta, Tianying Chen, Marivi Navarro-Haro, Anthony DuBose, Kathryn E. Korslund, Marsha M. Linehan
A38: Predicting the use of an evidence-based intervention for autism in birth-to-three programs
Colleen M. Harker, Elizabeth A. Karp, Sarah R. Edmunds, Lisa V. Ibañez, Wendy L. Stone
A39: Supervision practices and improved fidelity across evidence-based practices: A literature review
Mimi Choy-Brown
A40: Beyond symptom tracking: clinician perceptions of a hybrid measurement feedback system for monitoring treatment fidelity and client progress
Jack H. Andrews, Benjamin D. Johnides, Estee M. Hausman, Kristin M. Hawley
A41: A guideline decision support tool: From creation to implementation
Beth Prusaczyk, Alex Ramsey, Ana Baumann, Graham Colditz, Enola K. Proctor
A42: Dabblers, bedazzlers, or total makeovers: Clinician modification of a common elements cognitive behavioral therapy approach
Rosemary D. Meza, Shannon Dorsey, Shannon Wiltsey-Stirman, Georganna Sedlar, Leah Lucid
A43: Characterization of context and its role in implementation: The impact of structure, infrastructure, and metastructure
Caitlin Dorsey, Brigid Marriott, Nelson Zounlome, Cara Lewis
A44: Effects of consultation method on implementation of cognitive processing therapy for post-traumatic stress disorder
Cassidy A. Gutner, Candice M. Monson, Norman Shields, Marta Mastlej, Meredith SH Landy, Jeanine Lane, Shannon Wiltsey Stirman
A45: Cross-validation of the Implementation Leadership Scale factor structure in child welfare service organizations
Natalie K. Finn, Elisa M. Torres, Mark. G. Ehrhart, Gregory A. Aarons
A46: Sustainability of integrated smoking cessation care in Veterans Affairs posttraumatic stress disorder clinics: A qualitative analysis of focus group data from learning collaborative participants
Carol A. Malte, Aline Lott, Andrew J. Saxon
A47: Key characteristics of effective mental health trainers: The creation of the Measure of Effective Attributes of Trainers (MEAT)
Meredith Boyd, Kelli Scott, Cara C. Lewis
A48: Coaching to improve teacher implementation of evidence-based practices (EBPs)
Jennifer D. Pierce
A49: Factors influencing the implementation of peer-led health promotion programs targeting seniors: A literature review
Agathe Lorthios-Guilledroit, Lucie Richard, Johanne Filiatrault
A50: Developing treatment fidelity rating systems for psychotherapy research: Recommendations and lessons learned
Kevin Hallgren, Shirley Crotwell, Rosa Muñoz, Becky Gius, Benjamin Ladd, Barbara McCrady, Elizabeth Epstein
A51: Rapid translation of alcohol prevention science
John D. Clapp, Danielle E. Ruderman
A52: Factors implicated in successful implementation: evidence to inform improved implementation from high and low-income countries
Melanie Barwick, Raluca Barac, Stanley Zlotkin, Laila Salim, Marnie
Davidson
A53: Tracking implementation strategies prospectively: A practical approach
Alicia C. Bunger, Byron J. Powell, Hillary A. Robertson
A54: Trained but not implementing: the need for effective implementation planning tools
Christopher Botsko
A55: Evidence, context, and facilitation variables related to implementation of Dialectical Behavior Therapy: Qualitative results from a mixed methods inquiry in the Department of Veterans Affairs
Sara J. Landes, Brandy N. Smith, Allison L. Rodriguez, Lindsay R. Trent, Monica M. Matthieu
A56: Learning from implementation as usual in children’s mental health
Byron J. Powell, Enola K. Proctor
A57: Rates and predictors of implementation after Dialectical Behavior Therapy Intensive Training
Melanie S. Harned, Marivi Navarro-Haro, Kathryn E. Korslund, Tianying Chen, Anthony DuBose, André Ivanoff, Marsha M. Linehan
A58: Socio-contextual determinants of research evidence use in public-youth systems of care
Antonio R. Garcia, Minseop Kim, Lawrence A. Palinkas, Lonnie Snowden, John Landsverk
A59: Community resource mapping to integrate evidence-based depression treatment in primary care in Brazil: A pilot project
Annika C. Sweetland, Maria Jose Fernandes, Edilson Santos, Cristiane Duarte, Afrânio Kritski, Noa Krawczyk, Caitlin Nelligan, Milton L. Wainberg
A60: The use of concept mapping to efficiently identify determinants of implementation in the National Institute of Health--President’s Emergent Plan for AIDS Relief Prevention of Mother to Child HIV Transmission Implementation Science Alliance
Gregory A. Aarons, David H. Sommerfeld, Benjamin Chi, Echezona Ezeanolue, Rachel Sturke, Lydia Kline, Laura Guay, George Siberry
A61: Longitudinal remote consultation for implementing collaborative care for depression
Ian M. Bennett, Rinad Beidas, Rachel Gold, Johnny Mao, Diane Powers, Mindy Vredevoogd, Jurgen Unutzer
A62: Integrating a peer coach model to support program implementation and ensure long- term sustainability of the Incredible Years in community-based settings
Jennifer Schroeder, Lane Volpe, Julie Steffen
A63: Efficient sustainability: Existing community based supervisors as evidence-based treatment supports
Shannon Dorsey, Michael D Pullmann, Suzanne E. U. Kerns, Nathaniel Jungbluth, Lucy Berliner, Kelly Thompson, Eliza Segell
A64: Establishment of a national practice-based implementation network to accelerate adoption of evidence-based and best practices
Pearl McGee-Vincent, Nancy Liu, Robyn Walser, Jennifer Runnals, R. Keith Shaw, Sara J. Landes, Craig Rosen, Janet Schmidt, Patrick Calhoun
A65: Facilitation as a mechanism of implementation in a practice-based implementation network: Improving care in a Department of Veterans Affairs post-traumatic stress disorder outpatient clinic
Ruth L. Varkovitzky, Sara J. Landes
A66: The ACT SMART Toolkit: An implementation strategy for community-based organizations providing services to children with autism spectrum disorder
Amy Drahota, Jonathan I. Martinez, Brigitte Brikho, Rosemary Meza, Aubyn C. Stahmer, Gregory A. Aarons
A67: Supporting Policy In Health with Research: An intervention trial (SPIRIT) - protocol and early findings
Anna Williamson
A68: From evidence based practice initiatives to infrastructure: Lessons learned from a public behavioral health system’s efforts to promote evidence based practices
Ronnie M. Rubin, Byron J. Powell, Matthew O. Hurford, Shawna L. Weaver, Rinad S. Beidas, David S. Mandell, Arthur C. Evans
A69: Applying the policy ecology model to Philadelphia’s behavioral health transformation efforts
Byron J. Powell, Rinad S. Beidas, Ronnie M. Rubin, Rebecca E. Stewart, Courtney Benjamin Wolk, Samantha L. Matlin, Shawna Weaver, Matthew O. Hurford, Arthur C. Evans, Trevor R. Hadley, David S. Mandell
A70: A model for providing methodological expertise to advance dissemination and implementation of health discoveries in Clinical and Translational Science Award institutions
Donald R. Gerke, Beth Prusaczyk, Ana Baumann, Ericka M. Lewis, Enola K. Proctor
A71: Establishing a research agenda for the Triple P Implementation Framework
Jenna McWilliam, Jacquie Brown, Michelle Tucker
A72: Cheap and fast, but what is “best?”: Examining implementation outcomes across sites in a state-wide scaled-up evidence-based walking program, Walk With Ease
Kathleen P Conte
A73: Measurement feedback systems in mental health: Initial review of capabilities and characteristics
Aaron R. Lyon, Meredith Boyd, Abigail Melvin, Cara C. Lewis, Freda Liu, Nathaniel Jungbluth
A74: A qualitative investigation of case managers’ attitudes toward implementation of a measurement feedback system in a public mental health system for youth
Amelia Kotte, Kaitlin A. Hill, Albert C. Mah, Priya A. Korathu-Larson, Janelle R. Au, Sonia Izmirian, Scott Keir, Brad J. Nakamura, Charmaine K. Higa-McMillan
A75: Multiple pathways to sustainability: Using Qualitative Comparative Analysis to uncover the necessary and sufficient conditions for successful community-based implementation
Brittany Rhoades Cooper, Angie Funaiole, Eleanor Dizon
A76: Prescribers’ perspectives on opioids and benzodiazepines and medication alerts to reduce co-prescribing of these medications
Eric J. Hawkins, Carol A. Malte, Hildi J. Hagedorn, Douglas Berger, Anissa Frank, Aline Lott, Carol E. Achtmeyer, Anthony J. Mariano, Andrew J. Saxon
A77: Adaptation of Coordinated Anxiety Learning and Management for comorbid anxiety and substance use disorders: Delivery of evidence-based treatment for anxiety in addictions treatment centers
Kate Wolitzky-Taylor, Richard Rawson, Richard Ries, Peter Roy-Byrne, Michelle Craske
A78: Opportunities and challenges of measuring program implementation with online surveys
Dena Simmons, Catalina Torrente, Lori Nathanson, Grace Carroll
A79: Observational assessment of fidelity to a family-centered prevention program: Effectiveness and efficiency
Justin D. Smith, Kimbree Brown, Karina Ramos, Nicole Thornton, Thomas J. Dishion, Elizabeth A. Stormshak, Daniel S. Shaw, Melvin N. Wilson
A80: Strategies and challenges in housing first fidelity: A multistate qualitative analysis
Mimi Choy-Brown, Emmy Tiderington, Bikki Tran Smith, Deborah K. Padgett
A81: Procurement and contracting as an implementation strategy: Getting To Outcomes® contracting
Ronnie M. Rubin, Marilyn L. Ray, Abraham Wandersman, Andrea Lamont, Gordon Hannah, Kassandra A. Alia, Matthew O. Hurford, Arthur C. Evans
A82: Web-based feedback to aid successful implementation: The interactive Stages of Implementation Completion (SIC)TM tool
Lisa Saldana, Holle Schaper, Mark Campbell, Patricia Chamberlain
A83: Efficient methodologies for monitoring fidelity in routine implementation: Lessons from the Allentown Social Emotional Learning Initiative
Valerie B. Shapiro, B.K. Elizabeth Kim, Jennifer L. Fleming, Paul A. LeBuffe
A84: The Society for Implementation Research Collaboration (SIRC) implementation development workshop: Results from a new methodology for enhancing implementation science proposals
Sara J. Landes, Cara C. Lewis, Allison L. Rodriguez, Brigid R. Marriott, Katherine Anne Comtois
A85: An update on the Society for Implementation Research Collaboration (SIRC) Instrument Review Project
doi:10.1186/s13012-016-0428-0
PMCID: PMC4928139  PMID: 27357964
2.  Pregnant and Postpartum Women's Experiences and Perspectives on the Acceptability and Feasibility of Copackaged Medicine for Antenatal Care and PMTCT in Lesotho 
AIDS Research and Treatment  2015;2015:435868.
Objective. To improve PMTCT and antenatal care-related service delivery, a pack with centrally prepackaged medicine was rolled out to all pregnant women in Lesotho in 2011. This study assessed acceptability and feasibility of this copackaging mechanism for drug delivery among pregnant and postpartum women. Methods. Acceptability and feasibility were assessed in a mixed method, cross-sectional study through structured interviews (SI) and semistructured interviews (SSI) conducted in 2012 and 2013. Results. 290 HIV-negative women and 437 HIV-positive women (n = 727) participated. Nearly all SI participants found prepackaged medicines acceptable, though modifications such as size reduction of the pack were suggested. Positive experiences included that the pack helped women take pills as instructed and contents promoted healthy pregnancies. Negative experiences included inadvertent pregnancy disclosure and discomfort carrying the pack in communities. Implementation was also feasible; 85.2% of SI participants reported adequate counseling time, though 37.8% felt pack use caused clinic delays. SSI participants reported improvement in service quality following pack introduction, due to more comprehensive counseling. Conclusions. A prepackaged drug delivery mechanism for ANC/PMTCT medicines was acceptable and feasible. Findings support continued use of this approach in Lesotho with improved design modifications to reflect the current PMTCT program of lifelong treatment for all HIV-positive pregnant women.
doi:10.1155/2015/435868
PMCID: PMC4663282  PMID: 26649193
3.  Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics 
PLoS ONE  2015;10(8):e0135744.
Introduction
Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers.
Methods
Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19).
Results
After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; p<0.0001). A generally good acceptability for point-of-care testing was seen among health workers.
Conclusions
Point-of-care CD4+ T-cell enumeration resulted in a decreased time to initiation of antiretroviral therapy among treatment eligible women, without significant increase in testing coverage. Overall hemoglobin and syphilis screening increased. Despite the perception that point-of-care technologies increase access to health services, the variability in results indicate the potential for detrimental effects in some settings. Local context needs to be considered and services restructured to accommodate innovative technologies in order to improve service delivery to expectant mothers.
doi:10.1371/journal.pone.0135744
PMCID: PMC4550242  PMID: 26308345
4.  Immunogenicity of ALVAC-HIV vCP1521 in Infants of HIV-1 Infected Women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa 
Objective
Maternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1 infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.
Design
HPTN 027 was a randomized, double blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1 infected mothers with CD4 counts > 500 cell/μL that were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag and protease gene products.
Methods
Infants were vaccinated at birth, 4, 8 and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using IFN-γ ELISpot, CFSE proliferation, intracellular cytokine staining, binding and neutralizing antibody assays. Fisher's exact test was used to compare positive responses between study arms.
Results
Low levels of antigen specific CD4 and CD8 T cell responses (intracellular cytokine assay) were detected at 24 months (CD4 – 6/36 vaccine vs. 1/9 placebo; CD8 – 5/36 vaccine vs. 0/9 placebo) of age. There was a non-significant trend toward higher cellular immune response rates in vaccine recipients compared to placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.
Conclusions
HIV-1 exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.
doi:10.1097/01.qai.0000435600.65845.31
PMCID: PMC4171956  PMID: 24091694
HIV vaccine; infants; immunogenicity; Africa; HIV prevention
5.  High Rates of HIV Seroconversion in Pregnant Women and Low Reported Levels of HIV Testing among Male Partners in Southern Mozambique: Results from a Mixed Methods Study 
PLoS ONE  2014;9(12):e115014.
Introduction
Prevention of acute HIV infections in pregnancy is required to achieve elimination of pediatric HIV. Identification and support for HIV negative pregnant women and their partners, particularly serodiscordant couples, are critical. A mixed method study done in Southern Mozambique estimated HIV incidence during pregnancy, associated risk factors and factors influencing partner's HIV testing.
Methods
Between April 2008 and November 2011, a prospective cohort of 1230 HIV negative pregnant women was followed during pregnancy. A structured questionnaire, HIV testing, and collection of dried blood spots were done at 2–3 scheduled visits. HIV incidence rates were calculated by repeat HIV testing and risk factors assessed by Poisson regression. A qualitative study including 37 individual interviews with men, women, and nurses and 11 focus group discussions (n = 94) with men, women and grandmothers explored motivators and barriers to uptake of male HIV testing.
Results
HIV incidence rate was estimated at 4.28/100 women-years (95%CI: 2.33–7.16). Significant risk factors for HIV acquisition were early sexual debut (RR 3.79, 95%CI: 1.04–13.78, p = 0.04) and living in Maputo Province (RR 4.35, 95%CI: 0.97–19.45, p = 0.05). Nineteen percent of women reported that their partner had tested for HIV (93% knew the result with 8/213 indicating an HIV positive partner), 56% said their partner had not tested and 19% did not know their partner test status. Of the 14 seroconversions, only one reported being in a serodiscordant relationship. Fear of discrimination or stigma was reported as a key barrier to male HIV testing, while knowing the importance of getting tested and receiving care was the main motivator.
Conclusions
HIV incidence during pregnancy is high in Southern Mozambique, but knowledge of partners' HIV status remains low. Knowledge of both partners' HIV status is critical for maximal effectiveness of prevention and treatment services to reach elimination of pediatric HIV/AIDS.
doi:10.1371/journal.pone.0115014
PMCID: PMC4277288  PMID: 25542035
6.  Long Term Follow-up of Children in the HIVNET 012 Perinatal HIV Prevention Trial: Five-Year Growth and Survival 
Objectives
To describe five year growth, survival and long-term safety among children exposed to nevirapine or zidovudine in an African perinatal prevention trial, HIVNET 012.
Methods
All study children who were alive at eighteen months of age were eligible for an extended follow-up study. Children whose families consented were enrolled and evaluated every six months from 24 to 60 months. At each visit, history, physical exam and growth measures were taken. From these measurements Z scores based on World Health Organization (WHO) standards were computed. Serious adverse event data were collected. Data from the initial and extended follow-up cohorts were included in the analysis.
Results
528 study children were alive at age 18 months, and 491 (426 HIV uninfected; 65 infected) were enrolled into the follow-up study. Both exposed but uninfected children and HIV infected children were substantially below WHO growth standards for weight and height. Head circumference Z scores for uninfected children were comparable to WHO norms. Five-year survival rates were 93% for uninfected children versus 43% for infected children. Long-term safety and growth outcomes in the two study arms were similar.
Conclusions
Both infected and uninfected children in the five-year HIVNET 012 follow-up showed poor height and weight growth outcomes, underscoring the need for early nutritional interventions to improve long-term growth of all infants born to HIV-infected women in resource limited settings. Likewise, the low five year survival among HIV infected children support the importance of early initiation of antiretroviral therapy. Both peripartum nevirapine and zidovudine were safe.
doi:10.1097/QAI.0000000000000015
PMCID: PMC4172334  PMID: 24121753
7.  Access to HIV prevention and care for HIV-exposed and HIV-infected children: a qualitative study in rural and urban Mozambique 
BMC Public Health  2014;14:1240.
Background
Follow-up of HIV-exposed children for the delivery of prevention of mother-to-child transmission services and for early diagnosis and treatment of HIV infection is critical to their survival. Despite efforts, uptake of postnatal care for these children remains low in many sub-Saharan African countries.
Methods
A qualitative study was conducted in three provinces in Mozambique to identify motivators and barriers to improve uptake of and retention in HIV prevention, care and treatment services for HIV-exposed and HIV-infected children. Participant recommendations were also gathered. Individual interviews (n = 79) and focus group discussions (n = 32) were conducted with parents/caregivers, grandmothers, community leaders and health care workers. Using a socioecological framework, the main themes identified were organized into multiple spheres of influence, specifically at the individual, interpersonal, institutional, community and policy levels.
Results
Study participants reported factors such as seeking care outside of the conventional health system and disbelief in test results as barriers to use of HIV services. Other key barriers included fear of disclosure at the interpersonal level and poor patient flow and long waiting time at the institutional level. Key facilitators for accessing care included having hope for children’s future, symptomatic illness in children, and the belief that health facilities were the appropriate places to get care.
Conclusions
The results suggest that individual-level factors are critical drivers that influence the health-seeking behavior of caregivers of HIV-exposed and HIV-infected children in Mozambique. Noted strategies are to provide more information and awareness on the benefits of early pediatric testing and treatment with positive messages that incorporate success stories, to reach more pregnant women and mother-child pairs postpartum, and to provide counseling during tracing visits. Increasing uptake and retention may be achieved by improving patient flow at the institutional level at health facilities, by addressing concerns with family decision makers, and by working with community leaders to support the uptake of services for HIV-exposed children for essential preventive care.
doi:10.1186/1471-2458-14-1240
PMCID: PMC4265432  PMID: 25467030
Prevention of mother-to-child transmission; Barriers; Motivators; Pediatric HIV; Mozambique; HIV-exposed children; Infant HIV testing; Early infant diagnosis
8.  Feasibility and Safety of ALVAC-HIV vCP1521 Vaccine in HIV- exposed Infants in Uganda: Results from the First HIV Vaccine Trial in Infants in Africa 
Background
The development of a safe and effective vaccine against human immunodeficiency virus type 1 (HIV-1) for prevention mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from Phase I, randomized, double blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV-1-infected women in Uganda are reported.
Methods
HIV exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8 and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination, and days 1 and 2 post-vaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA PCR.
Findings
From October 2006 to May 2007, 60 infants (48 vaccine, 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by Diptheria, Polio, Hepatitis B and Heamophilus influenzae type B and measles vaccination were similar in the two arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine, 1 placebo) and one in vaccine arm at 2 weeks of age].
Interpretation
The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high quality infant HIV vaccine trials is achievable in Africa.
doi:10.1097/QAI.0b013e31827f1c2d
PMCID: PMC3625520  PMID: 23221981
HIV vaccine; ALVAC; infants; Africa; breast milk transmission
9.  High HIV incidence in the postpartum period sustains vertical transmission in settings with generalized epidemics: a cohort study in Southern Mozambique 
Introduction
Acute infection with HIV in the postpartum period results in a high risk of vertical transmission through breastfeeding. A study was done to determine the HIV incidence rate and associated risk factors among postpartum women in Southern Mozambique, where HIV prevalence among pregnant women is 21%.
Methods
A prospective cohort study was conducted in six rural health facilities in Gaza and Maputo provinces from March 2008 to July 2011. A total of 1221 women who were HIV-negative on testing at delivery or within two months postpartum were recruited and followed until 18 months postpartum. HIV testing, collection of dried blood spot samples and administration of a structured questionnaire to women were performed every three months. Infant testing by DNA-PCR was done as soon as possible after identification of a new infection in women. HIV incidence was estimated, and potential risk factors at baseline were compared using Poisson regression.
Results
Data from 957 women were analyzed with follow-up after the enrolment visit, with a median follow-up of 18.2 months. The HIV incidence in postpartum women is estimated at 3.20/100 women-years (95% CI: 2.30–4.46), with the highest rate among 18- to 19-year-olds (4.92 per 100 women-years; 95% CI: 2.65–9.15). Of the new infections, 14 (34%) were identified during the first six months postpartum, 11 (27%) between 6 and 12 months and 16 (39%) between 12 and 18 months postpartum. Risk factors for incident HIV infection include young age, low number of children, higher education level of the woman's partner and having had sex with someone other than one's partner. The vertical transmission was 21% (95% CI: 5–36) among newly infected women.
Conclusions
Incidence of HIV is high among breastfeeding women in Southern Mozambique, contributing to increasing numbers of HIV-infected infants. Comprehensive primary prevention strategies targeting women of reproductive age, particularly pregnant and postpartum women and their partners, will be crucial for the elimination of paediatric AIDS in Africa.
doi:10.7448/IAS.17.1.18808
PMCID: PMC3946505  PMID: 24629842
PMTCT; breastfeeding; incidence; HIV; elimination paediatric HIV; Mozambique
10.  Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial 
Lancet  2011;379(9812):221-228.
Summary
Background
Nevirapine given once-daily for the first 6, 14, or 28 weeks of life to infants exposed to HIV-1via breastfeeding reduces transmission through this route compared with single-dose nevirapine at birth or neonatally. We aimed to assess incremental safety and efficacy of extension of such prophylaxis to 6 months.
Methods
In our phase 3, randomised, double-blind, placebo-controlled HPTN 046 trial, we assessed the incremental benefit of extension of once-daily infant nevirapine from age 6 weeks to 6 months. We enrolled breastfeeding infants born to mothers with HIV-1 in four African countries within 7 days of birth. Following receipt of nevirapine from birth to 6 weeks, infants without HIV infection were randomly allocated (by use of a computer-generated permuted block algorithm with random block sizes and stratified by site and maternal antiretroviral treatment status) to receive extended nevirapine prophylaxis or placebo until 6 months or until breastfeeding cessation, whichever came first. The primaryefficacy endpoint was HIV-1 infection in infants at 6 months and safety endpoints were adverse reactions in both groups. We used Kaplan-Meier analyses to compare differences in the primary outcome between groups. This study is registered with ClinicalTrials.gov, number NCT00074412.
Findings
Between June 19, 2008, and March 12, 2010, we randomly allocated 1527 infants (762 nevirapine and 765 placebo); five of whom had HIV-1 infection at randomisation and were excluded from the primary analyses. In Kaplan-Meier analysis, 1.1% (95% CI 0.3–1.8) of infants who received extended nevirapine developed HIV-1 between 6 weeks and 6 months compared with 2.4% (1.3–3.6) of controls (difference 1.3%, 95% CI 0–2.6), equating to a 54% reduction in transmission (p=0.049). However, mortality (1.2% for nevirapine vs 1.1% for placebo; p=0.81) and combined HIV infection and mortality rates (2.3% vs 3.2%; p=0.27) did not differ between groups at 6 months. 125 (16%) of 758 infants given extended nevirapine and 116 (15%) of 761 controls had serious adverse events, but frequency of adverse events, serious adverse events, and deaths did not differ significantly between treatment groups.
Interpretation
Nevirapine prophylaxis can safely be used to provide protection from mother-to-child transmission of HIV-1 via breastfeeding for infants up to 6 months of age.
Funding
US National Institutes of Health.
doi:10.1016/S0140-6736(11)61653-X
PMCID: PMC3539769  PMID: 22196945
11.  Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY) 
Background
This phase III randomized clinical trial compared single dose nevirapine (sdNVP) plus HIV immunoglobulin (HIVIGLOB) to sdNVP alone for preventing maternal-to-child transmission (PMTCT) of HIV.
Primary objectives were to determine rates of HIV infection among infants, and to assess the safety of HIVIGLOB in combination with sdNVP in HIV-infected Ugandan pregnant women and their infants.
Methods
Mother-infant pairs were randomized to receive 200mg of NVP to women in labor and 2mg/kg NVP to newborns within 72 hours after birth (sdNVP arm) or to receive sdNVP plus a single intravenous 240ml dose of HIVIGLOB given to women at 36-38 weeks gestation and a single intravenous 24ml dose to newborns within 18 hours of birth (HIVIGLOB/sdNVP arm). Risk of HIV infection was determined using Kaplan-Meier and risk ratio estimates at birth, 2, 6, 14 weeks, 6 and 12 months of age.
Results
Intent-to-treat analysis included 198 HIVIGLOB/sdNVP and 294 sdNVP mother-infant pairs. At 6 months of age, the primary endpoint, there was no statistically significant difference in HIV transmission in the HIVIGLOB/sdNVP arm versus the sdNVP arm (18.7% vs.15.0%; RR =1.240 [95% CI: 0.833-1.846]; p= 0.290). Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively for mothers (18.9% vs. 19.3%; p= 0.91) and infants (62.6% vs. 59.5%; p=0.51), were not significantly different.
Conclusion
Giving mother-infant pairs an infusion of peripartum HIV hyperimmunoglobulin in addition to sdNVP for PMTCT was as safe as sdNVP alone, but was no more effective than sdNVP alone in preventing HIV transmission.
doi:10.1097/QAI.0b013e31822f8914
PMCID: PMC3204156  PMID: 21826009
HIV; HIVIGLOB; sdNVP; breastfeeding; PMTCT; Uganda
12.  Analysis of HIV tropism in Ugandan infants 
Current HIV research  2010;8(7):498-503.
HIV-infected infants may have CXCR4-using (X4-tropic) HIV, CCR5-using (R5-tropic) HIV, or a mixture of R5-tropic and X4-tropic HIV (dual/mixed, DM HIV). The level of infectivity for R5 virus (R5-RLU) varies among HIV-infected infants. HIV tropism and R5-RLU were measured in samples from HIV-infected Ugandan infants using a commercial assay. DM HIV was detected in 7/72 (9.7%) infants at the time of HIV diagnosis (birth or 6–8 weeks of age, 4/15 (26.7%) with subtype D, 3/57 (5.3 %) with other subtypes, P=0.013). A transition from R5-tropic to DM HIV was observed in only two (6.7%) of 30 infants over 6–12 months. Six (85.7%) of seven infants with DM HIV died, compared to 21/67 (31.3%) infants with R5-tropic HIV (p=0.09). Higher R5-RLU at 6–8 weeks was not associated with decreased survival. Infants with in utero infection had a higher median R5-RLU than infants who were HIV-uninfected at birth (p=0.025).
PMCID: PMC3075545  PMID: 21073438
CCR5; CXCR4; HIV-1; infant; survival; transmission; tropism
13.  Analysis of HIV Diversity Using a High-Resolution Melting Assay 
Abstract
HIV viruses are usually genetically homogeneous shortly after infection, and become more heterogeneous over time. We developed a high-resolution melting (HRM) assay to analyze HIV diversity without sequencing. Plasma samples from the HIVNET 012 trial were obtained from nine Ugandan mother–infant pairs. DNA amplified from the HIV gag region was analyzed to determine the number of degrees over which the DNA melted (HRM score). HRM gag DNA was also cloned and sequenced (50 clones/mother; 20 clones/infant). The median HRM score for infants (4.3, range 4.2–5.3) was higher than that for control plasmids (3.4, range 3.2–3.8, p < 0.001) and lower than that for mothers (5.7, range 4.4–7.7, p = 0.005, exact Wilcoxon rank sum test). The intraclass correlation coefficient reflecting assay reproducibility was 94% (95% CI: 89–98%). HRM scores were also compared to sequenced-based measures of HIV diversity; higher HRM scores were associated with higher genetic diversity (p < 0.001), complexity (p = 0.009), and Shannon entropy (p = 0.022), but not with length variation (p = 0.111). The HRM assay provides a novel, rapid method for assessing HIV diversity without sequencing. This assay could be applied to any region of the HIV genome or to other genetic systems that exhibit DNA diversity.
doi:10.1089/aid.2009.0259
PMCID: PMC2920076  PMID: 20666583
14.  Early Weaning of HIV-Exposed Uninfected Infants and Risk of Serious Gastroenteritis: Findings from Two Perinatal HIV Prevention Trials in Kampala, Uganda 
Objective
To assess serious gastroenteritis risk and mortality associated with early cessation of breastfeeding in infants enrolled in two prevention-of-maternal-to-child-HIV-transmission trials in Uganda.
Methods
We used hazard rates to evaluate serious gastroenteritis events by month of age and mortality among HIV-exposed uninfected infants enrolled in the HIVNET 012 (1997-2001) and HIVIGLOB/NVP (2004-2007) trials. HIV-infected mothers were counseled using local infant feeding guidelines current at the time.
Results
Breastfeeding cessation occurred earlier in HIVIGLOB/NVP compared to HIVNET 012 (median 4.0 vs. 9.3 months, p<0.001). Rates of serious gastroenteritis were higher in HIVIGLOB/NVP (8.0/1000 child-months) compared to HIVNET 012 (3.1/1000 child-months; p < 0.001). Serious gastroenteritis events also peaked earlier at 3-4 and 7-8 months (16.2/1000 and 15.0/1000 child-months, respectively) compared to HIVNET 012 at 9 to10 months (20.8/1000 child-months). All cause-infant mortality did not statistically differ between the HIVIGLOB/NVP and the HIVNET 012 trials [3.2/1000 versus 2.0/1000 child-months respectively, (p=0.10)]
Conclusion
Early breastfeeding cessation seen in the HIVIGLOB/NVP trial was associated with increased risk of serious gastroenteritis among HIV-exposed uninfected infants when compared to later breastfeeding cessation in the HIVNET 012 trial. Testing interventions which could decrease HIV transmission through breastfeeding and allow safe breastfeeding into the second year of life are urgently needed.
doi:10.1097/QAI.0b013e3181bdf68e
PMCID: PMC2888913  PMID: 19779355
HIV; infants; breastfeeding cessation; serious gastroenteritis; mortality; Uganda
15.  Considerations in Using US-Based Laboratory Toxicity Tables to Evaluate Laboratory Toxicities Among Healthy Malawian and Ugandan Infants 
Objectives
To determine normal hematologic and selected blood chemistry values among healthy, full-term, non–HIV-exposed infants in Uganda and Malawi, and to determine the proportion of healthy babies with an apparent laboratory toxicity based on Division of AIDS toxicity tables.
Design
This was a cross-sectional laboratory study of infants from birth to 6 months of age.
Methods
Blood samples were collected from a total of 561 infants and analyzed according to age categories similar to those in the 2004 Division of AIDS toxicity tables. Select chemistry and hematology parameters were determined and values compared with those in the toxicity tables.
Results
In the first 56 days of life, there were few graded toxicities except for neutropenia in 2 of 10 (20%) Ugandan and 13 of 45 (29%) Malawian infants at birth. After 7 days, about 20% of the infants in Uganda and Malawi would have been classified as having a neutropenia whereas 47% and 53% of those more than 2 months of age in Uganda and Malawi respectively, would have been reported as having an abnormal hemoglobin. Chemistry findings were not different from US norms.
Conclusions
These findings underscore the importance of establishing relevant local laboratory norms for infants.
doi:10.1097/QAI.0b013e3181db059d
PMCID: PMC3033212  PMID: 20588184
Division of AIDS; normal laboratory reference values; non–HIV-exposed; toxicity tables; Ugandan; Malawian; infants
16.  Pregnancy Does Not Affect HIV Incidence Test Results Obtained Using the BED Capture Enzyme Immunoassay or an Antibody Avidity Assay 
PLoS ONE  2010;5(10):e13259.
Background
Accurate incidence estimates are needed for surveillance of the HIV epidemic. HIV surveillance occurs at maternal-child health clinics, but it is not known if pregnancy affects HIV incidence testing.
Methods
We used the BED capture immunoassay (BED) and an antibody avidity assay to test longitudinal samples from 51 HIV-infected Ugandan women infected with subtype A, C, D and intersubtype recombinant HIV who were enrolled in the HIVNET 012 trial (37 baseline samples collected near the time of delivery and 135 follow-up samples collected 3, 4 or 5 years later). Nineteen of 51 women were also pregnant at the time of one or more of the follow-up visits. The BED assay was performed according to the manufacturer's instructions. The avidity assay was performed using a Genetic Systems HIV-1/HIV-2 + O EIA using 0.1M diethylamine as the chaotropic agent.
Results
During the HIVNET 012 follow-up study, there was no difference in normalized optical density values (OD-n) obtained with the BED assay or in the avidity test results (%) when women were pregnant (n = 20 results) compared to those obtained when women were not pregnant (n = 115; for BED: p = 0.9, generalized estimating equations model; for avidity: p = 0.7, Wilcoxon rank sum). In addition, BED and avidity results were almost exactly the same in longitudinal samples from the 18 women who were pregnant at only one study visit during the follow-up study (p = 0.6, paired t-test).
Conclusions
These results from 51 Ugandan women suggest that any changes in the antibody response to HIV infection that occur during pregnancy are not sufficient to alter results obtained with the BED and avidity assays. Confirmation with larger studies and with other HIV subtypes is needed.
doi:10.1371/journal.pone.0013259
PMCID: PMC2952593  PMID: 20949006
17.  Short Communication: In Utero HIV Infection Is Associated with an Increased Risk of Nevirapine Resistance in Ugandan Infants Who Were Exposed to Perinatal Single Dose Nevirapine 
Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis. We combined results from four clinical trials to analyze predictors of NVP resistance in sdNVP-exposed Ugandan infants. Samples were tested with the ViroSeq HIV Genotyping System and a sensitive point mutation assay (LigAmp, for detection of K103N, Y181C, and G190A). NVP resistance was detected at 6–8 weeks in 36 (45.0%) of 80 infants using ViroSeq and 33 (45.8%) of 72 infants using LigAmp. NVP resistance was more frequent among infants who were infected in utero than among infants who were diagnosed with HIV infection after birth by 6–8 weeks of age. Detection of NVP resistance at 6–8 weeks was not associated with HIV subtype (A vs. D), pre-NVP maternal viral load or CD4 cell count, infant viral load at 6–8 weeks, or infant sex. NVP resistance was still detected in some infants 6–12 months after sdNVP exposure. In this study, in utero HIV infection was the only factor associated with detection of NVP resistance in infants 6–8 weeks after sdNVP exposure.
doi:10.1089/aid.2009.0003
PMCID: PMC2752753  PMID: 19552593
18.  Comparison of Laboratory Methods for Analysis of Non-nucleoside Reverse Transcriptase Inhibitor Resistance in Ugandan Infants 
Abstract
Detailed comparisons of HIV drug resistance assays are needed to identify the most useful assays for research studies, and to facilitate comparison of results from studies that use different methods. We analyzed nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance in 40 HIV-infected Ugandan infants who had received nevirapine (NVP)-based prophylaxis using the following assays: an FDA-cleared HIV genotyping assay (the ViroSeq HIV-1 Genotyping System v2.0), a commercially available HIV genotyping assay (GeneSeq HIV), a commercially available HIV phenotyping assay (PhenoSense HIV), and a sensitive point mutation assay (LigAmp). ViroSeq and GeneSeq HIV results (NVP resistance yes/no) were similar for 38 (95%) of 40 samples. In 6 (15%) of 40 samples, GeneSeq HIV detected mutations in minor subpopulations that were not detected by ViroSeq, which identified two additional infants with NVP resistance. LigAmp detected low-level mutations in 12 samples that were not detected by ViroSeq; however, LigAmp testing identified only one additional infant with NVP resistance. GeneSeq HIV and PhenoSense HIV determinations of susceptibility differed for specific NNRTIs in 12 (31%) of the 39 samples containing mixtures at relevant mutation positions. PhenoSense HIV did not detect any infants with NVP resistance who were not identified with GeneSeq HIV testing. In this setting, population sequencing-based methods (ViroSeq and GeneSeq HIV) were the most informative and had concordant results for 95% of the samples. LigAmp was useful for the detection and quantification of minority variants. PhenoSense HIV provided a direct and quantitative measure of NNRTI susceptibility.
doi:10.1089/aid.2008.0235
PMCID: PMC2799186  PMID: 19621988
19.  Short Communication: In Utero HIV Infection Is Associated with an Increased Risk of Nevirapine Resistance in Ugandan Infants Who Were Exposed to Perinatal Single Dose Nevirapine 
Abstract
Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis. We combined results from four clinical trials to analyze predictors of NVP resistance in sdNVP-exposed Ugandan infants. Samples were tested with the ViroSeq HIV Genotyping System and a sensitive point mutation assay (LigAmp, for detection of K103N, Y181C, and G190A). NVP resistance was detected at 6–8 weeks in 36 (45.0%) of 80 infants using ViroSeq and 33 (45.8%) of 72 infants using LigAmp. NVP resistance was more frequent among infants who were infected in utero than among infants who were diagnosed with HIV infection after birth by 6–8 weeks of age. Detection of NVP resistance at 6–8 weeks was not associated with HIV subtype (A vs. D), pre-NVP maternal viral load or CD4 cell count, infant viral load at 6–8 weeks, or infant sex. NVP resistance was still detected in some infants 6–12 months after sdNVP exposure. In this study, in utero HIV infection was the only factor associated with detection of NVP resistance in infants 6–8 weeks after sdNVP exposure.
doi:10.1089/aid.2009.0003
PMCID: PMC2752753  PMID: 19552593
20.  Comparison of Laboratory Methods for Analysis of Non-nucleoside Reverse Transcriptase Inhibitor Resistance in Ugandan Infants 
Detailed comparisons of HIV drug resistance assays are needed to identify the most useful assays for research studies, and to facilitate comparison of results from studies that use different methods. We analyzed nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance in 40 HIV-infected Ugandan infants who had received nevirapine (NVP)-based prophylaxis using the following assays: an FDA-cleared HIV genotyping assay (the ViroSeq HIV-1 Genotyping System v2.0), a commercially available HIV genotyping assay (GeneSeq HIV), a commercially available HIV phenotyping assay (PhenoSense HIV), and a sensitive point mutation assay (LigAmp). ViroSeq and GeneSeq HIV results (NVP resistance yes/no) were similar for 38 (95%) of 40 samples. In 6 (15%) of 40 samples, GeneSeq HIV detected mutations in minor subpopulations that were not detected by ViroSeq, which identified two additional infants with NVP resistance. LigAmp detected low-level mutations in 12 samples that were not detected by ViroSeq; however, LigAmp testing identified only one additional infant with NVP resistance. GeneSeq HIV and PhenoSense HIV determinations of susceptibility differed for specific NNRTIs in 12 (31%) of the 39 samples containing mixtures at relevant mutation positions. PhenoSense HIV did not detect any infants with NVP resistance who were not identified with GeneSeq HIV testing. In this setting, population sequencing-based methods (ViroSeq and GeneSeq HIV) were the most informative and had concordant results for 95% of the samples. LigAmp was useful for the detection and quantification of minority variants. PhenoSense HIV provided a direct and quantitative measure of NNRTI susceptibility.
doi:10.1089/aid.2008.0235
PMCID: PMC2799186  PMID: 19621988
21.  Predictors of Early and Late Mother-to-Child Transmission of HIV in a Breastfeeding Population: HIV Network for Prevention Trials 012 Experience, Kampala, Uganda 
Objective:
To determine the predictors for early versus later (breastfeeding) transmission of HIV-1.
Methods:
Secondary data analysis was performed on HIV Network for Prevention Trials 012, a completed randomized clinical trial assessing the relative efficacy of nevirapine (NVP) versus zidovudine in reducing mother-to-child transmission (MTCT) of HIV-1. We used Cox regression analysis to assess risk factors for MTCT. The ViroSeq HIV genotyping and a sensitive point mutation assay were used to detect NVP resistance mutations.
Results:
In this subset analyses, 122 of 610 infants were HIV infected, of whom 99 (81.1%) were infected early (first positive polymerase chain reaction ≤56 days). Incidence of MTCT after 56 days was low [0.7% per month (95% confidence interval, CI: 0.4 to 1.0)], but continued through 18 months. In multivariate analyses, early MTCT “factors” included NVP versus zidovudine (hazard ratio (HR) = 0.57, 95% CI: 0.38 to 0.86), pre-entry maternal viral load (VL, HR = 1.76, 95% CI: 1.28 to 2.41), and CD4 cell count (HR = 1.16, 95% CI: 1.05 to 1.28). Maternal VL (6–8 weeks) was associated with late MTCT (HR = 3.66, 95% CI: 1.78 to 7.50), whereas maternal NVP resistance (6–8 weeks) was not.
Conclusions:
Maternal VL was the best predictor of both early and late transmission. Maternal NVP resistance at 6–8 weeks did not predict late transmission.
doi:10.1097/QAI.0b013e3181afd352
PMCID: PMC2767188  PMID: 19617849
early/late postnatal; MTCT; HIV-1
22.  Vertical transmission of X4-tropic and dual-tropic HIV-1 in five Ugandan mother–infant pairs 
AIDS (London, England)  2009;23(14):1903-1908.
Background
We previously reported the existence of CXCR4-using HIV-1 in 6–14 week-old Ugandan infants. Whether these viruses were transmitted from the mother perinatally or evolved after transmission is not known. In the current study, we investigated the origin of the CXCR4-using viruses in these infants by comparing HIV-1 envelope clones from the infants to those from their mothers at or near the time of delivery.
Methods
Envelope clones were isolated from five Ugandan infant plasma samples that harbored CXCR4-using viruses, collected at the time of HIV diagnosis (four at birth, one at week 6), and from their mothers at delivery. Coreceptor usage and phylogenetic relatedness of HIV-1 populations in mother–infant pairs were analyzed in detail using the Trofile assay and sequence analysis of envelope clones, respectively.
Results
X4-tropic clones were identified in two mother–infant pairs and dual-tropic clones were found in three pairs, either alone or in combination with R5-tropic viruses. Dual-tropic clones varied in their ability to infect CXCR4-expressing cells. In each mother–infant pair, X4-tropic or dual-tropic clones shared similar phenotypic profiles and V3 sequence patterns; gp160 sequences of X4-tropic and dual-tropic clones from infants were phylogenetically indistinguishable from those of their mothers. The virus populations were phylogenetically homogenous in three infants and segregated according to coreceptor tropism in the remaining two infants.
Conclusions
This study demonstrates that X4-tropic and dual-tropic HIV-1 can be transmitted from mother to infant, before, during or shortly after delivery, and establishes vertical transmission as an important source of CXCR4-using viruses in infants.
doi:10.1097/QAD.0b013e32832f1802
PMCID: PMC2764460  PMID: 19593079
coreceptor tropism; CXCR4; HIV; mother-to-child; transmission; X4
23.  Total Lymphocyte Count: not a surrogate marker for risk of death in HIV infected Ugandan children 
Objectives
To determine the utility of Total Lymphocyte Count (TLC) in predicting the 12 month mortality in HIV infected Ugandan children; to correlate TLC and CD4 cell %.
Design
This is a retrospective data analysis of clinical and laboratory data collected prospectively on 128 HIV infected children in the HIVNET 012 trial.
Methods
TLC and CD4 cell % measurements were obtained at birth, 14 weeks and 12, 24, 36, 48, and 60 months of age and assessed with respect to risk of death within 12 months.
Results
Median TLC/ul (CD4 cell %) were 4150 (41%) at birth, 4900 (24%) at 12 months, 4300 (19%) at 24 months, 4150 (19 %) at 36 months, 4100 (18%) at 48 months and 3800 (20%) at 60 months. The highest risk of mortality within 12 months was 34–37% at birth and declined to 13–15% at 24 months regardless of TLC measurement. The correlation between CD4 cell % and TLC was extremely low overall (r = 0.01).
Conclusion
The TLC did not predict a risk of progression to death within 12 months and therefore TLC alone may not be a useful surrogate marker for determining those children in greatest need for antiretroviral therapy in HIV infected Ugandan children.
doi:10.1097/QAI.0b013e318183a92a
PMCID: PMC2721476  PMID: 18769352
Total Lymphocyte Count; HIV; Africa; children
24.  Analysis of nevirapine (NVP) resistance in Ugandan infants who were HIV-infected despite receiving single dose (SD) nevirapine (NVP) vs. SD NVP plus daily NVP up to 6-weeks of age to prevent HIV vertical transmission 
The Journal of infectious diseases  2008;198(7):1075-1082.
Background
Single dose (SD) nevirapine (NVP) at birth plus NVP to the infant up to 6 weeks of age is superior to SD NVP alone for prevention of HIV vertical transmission through breastfeeding. We analyzed NVP resistance in HIV-infected Ugandan infants who received either SD NVP or extended NVP prophylaxis.
Methods
We tested plasma HIV using a genotyping assay (ViroSeq), a phenotypic resistance assay (PhenoSense), and sensitive point mutation assay (LigAmp, for K103N, Y181C, G190A).
Results
At 6 weeks, NVP resistance was detected by ViroSeq in a higher proportion of infants in the extended NVP arm than in the SD NVP arm (21/25=84% vs. 12/24=50%, p=0.01). Similar results were obtained with LigAmp and PhenoSense. Infants who were HIV-infected at birth had high rates of resistance in both study arms. In contrast, infants who were HIV-infected after birth were more likely to have resistance detected at 6 weeks in the extended NVP arm. Use of extended NVP prophylaxis was also associated with detection of NVP resistance by ViroSeq at 6 months (7/7=100% extended NVP arm vs. 1/6=16.7% SD NVP arm, p=0.005).
Conclusions
Use of extended NVP prophylaxis was associated with increased selection and persistence of NVP resistance in HIV-infected Ugandan infants.
doi:10.1086/591503
PMCID: PMC2587235  PMID: 18684096
HIV-1; infant; mother-to-child transmission; nevirapine; resistance
25.  Associations of Chemokine Receptor Polymorphisms With HIV-1 Mother-to-Child Transmission in Sub-Saharan Africa: Possible Modulation of Genetic Effects by Antiretrovirals 
Background
HIV-1 mother-to-child transmission (MTCT) remains an important route of infection in sub-Saharan Africa.
Methods
Genetic variants in CCR5 promoter, CCR2, CX3CR1, and Stromal cell-derived factor-1 (SDF-1) genes were determined in 980 infants from sub-Saharan Africa using real-time polymerase chain reaction to determine association with MTCT.
Results
In antiretroviral-naive mother–infant pairs (n = 637), CCR5 promoter polymorphisms at positions 59029: A allele vs. G/G [odds ratio (OR): 1.61, 95% confidence interval (CI): 1.04 to 2.48; P = 0.032] and 59356: T allele vs. C/C (OR: 0.63, 95% CI: 0.41 to 0.96; P = 0.033) and CCR2-180: G allele vs. A/A (OR: 3.32, 95% CI: 1.13 to 9.73; P = 0.029) were associated with risk of MTCT. Treatment of HIV-1–infected mothers and infants with single-dose nevirapine or perinatal zidovudine altered but did not eliminate the association of genetic variants with MTCT.
Conclusions
CCR5 promoter, CCR2, and CX3CR1 polymorphisms were associated with risk of MTCT likely through their role as an HIV-1 coreceptor or by modulating the early immune response. Host genetics may continue to alter MTCT when short-course interventions that only partially suppress virus are used. These findings will need to be confirmed in validation cohorts with a large number of infected infants.
doi:10.1097/QAI.0b013e318186eaa4
PMCID: PMC2748918  PMID: 18845960
mother-to-child transmission; HIV-1; chemokine/chemokine receptor genotypes; antiretrovirals

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