RCTs - Protocols/Proposals (funded, already peer-reviewed, non-eHealth)

Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial

Sarah E Rutstein, Ella Ferguson, Odai Mansour, Nicole Brown, Jacob B Stocks, Anja Washington, Victoria Mobley, Shannon Dowler, Jessie Edwards, Lisa B Hightow-Weidman, Christopher B Hurt, Brian Pence, Kathryn E Muessig

JMIR Res Protoc 2025 (Mar 21); 14:e68085

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Frontal Pole Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-Occurring Mental Health Conditions: Protocol for a Pilot Randomized Controlled Trial

Alyssa Bernanke, Rebecca Hasley, Niki Sabetfakhri, Harriet de Wit, Bridget M Smith, Lei Wang, Lisa A Brenner, Colleen Hanlon, Noah S Philip, Olusola Ajilore, Amy Herrold, Alexandra Aaronson

JMIR Res Protoc 2024 (Dec 13); 13:e58206

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Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial

Dorian K Rose, Gina Brunetti, Kathryn Cavka, J Brooke Hoisington, Hannah Snyder, Wei Xue, Barbara K Smith

JMIR Res Protoc 2024 (Nov 27); 13:e59749

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Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial—Protocol for a Mixed Methods Study

Emilie Mosnier, Olivier Ségéral, Sansothy Neth, Luis Sagaon-Teyssier, Dyna Khuon, Chan Leakhena Phoeung, Sovatha Mam, Chhingsrean Chhay, Kimeang Heang, Jean Charles Duclos-Vallée, Vonthanak Saphonn

JMIR Res Protoc 2024 (Nov 20); 13:e63376

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Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial

Heidi M Munger Clary, Beverly M Snively, Christian Cagle, Richard Kennerly, James N Kimball, Halley B Alexander, Gretchen A Brenes, Justin B Moore, Robin A Hurley

JMIR Res Protoc 2024 (Nov 13); 13:e59329

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Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial

J Margo Brooks Carthon, Heather Brom, Kelvin Eyram Amenyedor, Michael O Harhay, Marsha Grantham-Murillo, Jacqueline Nikpour, Karen B Lasater, Daniela Golinelli, Pamela Z Cacchione, Amanda P Bettencourt

JMIR Res Protoc 2024 (Nov 12); 13:e64575

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Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial

Ingrid Kvestad, Frode Adolfsen, Renira Corinne Angeles, Oda Lekve Brandseth, Kyrre Breivik, Janne Grete Evertsen, Irene Kvåle Foer, Morten Haaland, Birgit Millerjord Homola, Gro Elisabeth Hoseth, Josefine Jonsson, Egil Kjerstad, Henriette Kyrrestad, Monica Martinussen, Annelene Moberg, Karianne Moberg, Anita Skogstrand, Line Remme Solberg, Merete Aasheim

JMIR Res Protoc 2024 (Oct 24); 13:e60626

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Education Program for Enhancing Health Care Students’ Attitudes Toward People Living With Dementia: Protocol for a Single-Arm Pre-Post Study

Dianis Wulan Sari, Haruna Kugai, Ayumi Igarashi, Manami Takaoka, Hiroshige Matsumoto, Haruno Suzuki, Jinyan Wu, Rizki Fitryasari, Ike Ayunda Nasifah, Eka Mishbahatul M Has, Noriko Yamamoto-Mitani

JMIR Res Protoc 2024 (Sep 18); 13:e62654

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Effect of Semaglutide on Physical Function, Body Composition, and Biomarkers of Aging in Older Adults With Overweight and Insulin Resistance: Protocol for an Open-Labeled Randomized Controlled Trial

Tiffany M Cortes, Libia Vasquez, Monica C Serra, Ronna Robbins, Allison Stepanenko, Kevin Brown, Hannah Barrus, Annalisa Campos, Sara E Espinoza, Nicolas Musi

JMIR Res Protoc 2024 (Sep 13); 13:e62667

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Quantification of Urinary Exosomal Prostate-Specific Antigen for the Diagnosis of Prostate Cancer Using Clinical Laboratory–Based Techniques: Protocol for a Case-Control Study

Guorong Li, Yannick Tholance, Nora Mallouk, Louis Waeckel, Pascale Flandrin, Bruno Bali, Lionel Badet, Pierre Cornillon

JMIR Res Protoc 2024 (Sep 11); 13:e63551

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Effectiveness of an mHealth App That Uses Financial Incentives and Gamification to Promote Health Behavior Change in Adolescents and Caregivers: Protocol for a Clinic-Based Randomized Controlled Trial

Amy Braddock, Parijat Ghosh, Emma Montgomery, Crystal Lim, Jaya Ghosh, Nicole Henry, Mihail Popescu, Kimberly Kimchi, Congyu Guo, K Taylor Bosworth, Richelle J Koopman

JMIR Res Protoc 2024 (Sep 10); 13:e63505

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Effectiveness of Aerobic Training for Adverse Symptoms Related to Chemotherapy During Treatment: Protocol for a Randomized Controlled Trial With Cost-Effectiveness Assessment

William de Lima Selles, Gisela Cristiane Miyamoto, Elinaldo da Conceição Santos, Cibelle Regina Lima Carmo, Giovanni Marini Moura, Giovanna Marques Frascoli Santos, Giovanna dos Santos Lopes, Diego Wisnieski Silva, Leticia Jeremias Ferreira Pereira, Adriana Claudia Lunardi

JMIR Res Protoc 2024 (Aug 20); 13:e60828

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The Effect of Prebedtime Behaviors on Sleep Duration and Quality in Children: Protocol for a Randomized Crossover Trial

Rosie Jackson, Chao Gu, Jillian Haszard, Kim Meredith-Jones, Barbara Galland, Justine Camp, Deirdre Brown, Rachael Taylor

JMIR Res Protoc 2024 (Aug 20); 13:e63692

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Social Transfers for Exclusive Breastfeeding (STEB) Intervention in Lao People’s Democratic Republic: Protocol for a Randomized Controlled Trial

Souliviengkham Sonephet, Sengchanh Kounnavong, Lucienne Zinsstag, Pascale Vonaesch, Somphou Sayasone, Latsamy Siengsounthone, Peter Odermatt, Günther Fink, Jordyn Tinka Wallenborn

JMIR Res Protoc 2024 (May 03); 13:e54768

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Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Limb Loss Using Dynamic Stereo X-Ray: Protocol for a Lower Limb Loss Cadaver and Clinical Study

Jason T Maikos, John M Chomack, David V Herlihy, David N Paglia, Charlene Wetterstrand, J Patrick O'Connor, Michael J Hyre, J Peter Loan, Susan E D'Andrea

JMIR Res Protoc 2024 (Apr 26); 13:e57329

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Psychotherapy for Ketamine’s Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial

Akash Goel, Bhavya Kapoor, Hillary Chan, Karim Ladha, Joel Katz, Hance Clarke, Janneth Pazmino-Canizares, Zaaria Thomas, Kaylyssa Philip, Gabriella Mattina, Paul Ritvo

JMIR Res Protoc 2024 (Apr 17); 13:e54406

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Enhancing Psychotherapy Outcomes by Encouraging Patients to Regularly Self-Monitor, Reflect on, and Share Their Affective Responses Toward Their Therapist: Protocol for a Randomized Controlled Trial

Alberto Stefana, Eduard Vieta, Paolo Fusar-Poli, Eric A Youngstrom

JMIR Res Protoc 2024 (Apr 08); 13:e55369

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High-Flow Humidified Oxygen as an Early Intervention in Children With Acute Severe Asthma: Protocol for a Feasibility Randomized Controlled Trial

Hector Rojas-Anaya, Akshat Kapur, Graham Roberts, Damian Roland, Atul Gupta, Michaela Lazner, Jane Bayreuther, John Pappachan, Christina Jones, Stephen Bremner, Fleur Cantle, Paul Seddon

JMIR Res Protoc 2024 (Mar 28); 13:e54081

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Equity-Centered Postdischarge Support for Medicaid-Insured People: Protocol for a Type 1 Hybrid Effectiveness-Implementation Stepped Wedge Cluster Randomized Controlled Trial

J Margo Brooks Carthon, Heather Brom, Marsha Grantham-Murrillo, Kathy Sliwinski, Aleigha Mason, Mindi Roeser, Donna Miles, Dianne Garcia, Jovan Bennett, Michael O Harhay, Emilia Flores, Kelvin Amenyedor, Rebecca Clark

JMIR Res Protoc 2024 (Mar 26); 13:e54211

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A Web-Based Physical Activity Promotion Intervention for Inactive Parent-Child Dyads: Protocol for a Randomized Controlled Trial

Daniel Phipps, Weldon Thomas Green, Reetta Aho, Eeva Kettunen, Stuart Biddle, Kyra Hamilton, Arto Laukkanen, Kaisa Aunola, Derwin King Chan, Nelli Hankonen, Mary Hassandra, Tommi Kärkkäinen, Virpi-Liisa Kykyri, Juho Polet, Ryan Rhodes, Montse C Ruiz, Arja Sääkslahti, Jekaterina Schneider, Hanna-Mari Toivonen, Taru Lintunen, Martin Hagger, Keegan Knittle

JMIR Res Protoc 2024 (Mar 21); 13:e55960

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