JMIR Research Protocols最新文献

{"title":"Vaping, Acculturation, and Social Media Use Among Mexican American College Students: Protocol for a Mixed Methods Web-Based Cohort Study.","authors":"Bara S Bataineh, C Nathan Marti, Dhiraj Murthy, David Badillo, Sherman Chow, Alexandra Loukas, Anna V Wilkinson","doi":"10.2196/63584","DOIUrl":"https://doi.org/10.2196/63584","url":null,"abstract":"<p><strong>Background: </strong>The tobacco industry has a history of targeting minority communities, including Hispanic individuals, by promoting vaping through social media. This marketing increases the risk of vaping among Hispanic young adults, including college students. In Texas, college enrollment among Mexican Americans has significantly increased over recent years. However, little research exists on the link between social media and vaping and the underlying mechanisms (ie, outcome expectations, attitudes, and beliefs) explaining how vaping-related social media impacts vaping among Mexican American college students. Moreover, there is limited knowledge about how acculturation moderates the association between social media and vaping. Hispanic individuals, particularly Mexican Americans, are the largest ethnic group in Texas colleges; thus, it is crucial to understand the impact of social media and acculturation on their vaping behaviors.</p><p><strong>Objective: </strong>We outline the mixed methods used in Project Vaping, Acculturation, and Media Study (VAMoS). We present descriptive analyses of the participants enrolled in the study, highlight methodological strengths, and discuss lessons learned during the implementation of the study protocol related to recruitment and data collection and management.</p><p><strong>Methods: </strong>Project VAMoS is being conducted with Mexican American students attending 1 of 6 Texas-based colleges: University of Texas (UT) Arlington, UT Dallas, UT El Paso, UT Rio Grande Valley, UT San Antonio, and the University of Houston System. This project has 2 phases. Phase 1 included an ecological momentary assessment (EMA) study and qualitative one-on-one interviews (years 1-2), and phase 2 includes cognitive interviews and a 4-wave web-based survey study (years 2-4) with objective assessments of vaping-related social media content to which participants are exposed. Descriptive statistics summarized participants' characteristics in the EMA and web-based survey.</p><p><strong>Results: </strong>The EMA analytic sample comprised 51 participants who were primarily female (n=37, 73%), born in the United States (n=48, 94%), of middle socioeconomic status (n=38, 75%), and aged 21 years on average (SD 1.7 years). The web-based survey cohort comprised 1492 participants self-identifying as Mexican American; Tejano, Tejana, or Tejanx; or Chicano, Chicana, or Chicanx heritage who were primarily female (n=1042, 69.8%), born in the United States (n=1366, 91.6%), of middle socioeconomic status (n=1174, 78.7%), and aged 20.1 years on average at baseline (SD 2.2 years). Of the baseline cohort, the retention rate in wave 2 was 74.7% (1114/1492).</p><p><strong>Conclusions: </strong>Project VAMoS is one of the first longitudinal mixed methods studies exploring the impact of social media and acculturation on vaping behaviors specifically targeting Mexican American college students. Its innovative approach to objectively measuring","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63584"},"PeriodicalIF":1.4,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143700447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Health System Readiness and Quality of Dementia Services in Peru: Protocol for a Qualitative Study With Stakeholder Interviews and Documentation Review.","authors":"Maria Lazo-Porras, Francisco Jose Tateishi-Serruto, Christopher Butler, María Sofía Cuba-Fuentes, Daniela Rossini-Vilchez, Silvana Perez-Leon, Miriam Lúcar-Flores, J Jaime Miranda, Antonio Bernabe-Ortiz, Francisco Diez-Canseco, Graham Moore, Filipa Landeiro, Maria Kathia Cardenas, Juan Carlos Vera Tudela, Lee White, Rafael A Calvo, William Whiteley, Jemma Hawkins","doi":"10.2196/60296","DOIUrl":"https://doi.org/10.2196/60296","url":null,"abstract":"<p><strong>Background: </strong>Dementia is a global health priority with significant challenges due to its complex nature and increasing prevalence. Health systems worldwide struggle to address chronic conditions like dementia, often providing fragmented care. However, information about how health systems respond to the needs of people with dementia and their carers, and the quality of care provided, is scarce in low- and middle-income countries.</p><p><strong>Objective: </strong>This study aims to assess the quality of the health system to provide diagnosis and care for people with dementia and their carers in Peru. In order to do this, the study will explore the response of the Peruvian health system to people with dementia and their carers, and explore the experiences of people with dementia of receiving their diagnosis, management, and quality of care for this condition.</p><p><strong>Methods: </strong>This study is part of a research program called \"IMPACT Salud: Innovations using Mhealth for people with dementia and Co-morbidities,\" aimed at strengthening health systems to provide care for people with dementia and their carers. The study has a descriptive, cross-sectional design that uses a qualitative methodology, including stakeholder interviews and documentation review, and consists of 2 substudies, a health system assessment (HSA) and an exploration of the patient journey. The first substudy uses an HSA methodology suitable for low- and middle-income countries, conducting 160 structured interviews with 12 different stakeholder types across 3 levels of the health system (micro, meso, and macro) in 4 Peruvian regions, each with distinct geographical and urbanization profiles. The second substudy uses a patient journey methodology, which involves conducting 40 in-depth interviews with people with dementia, carers, and health care workers from the same 4 regions. The insights into the people with dementia patient and caregiver experience within the health system from the interviews will be used to produce a patient journey map. The analysis will be guided by the high-quality health system framework, and the findings from the HSA and patient journey will be structured using the domains included in the framework through the lens of quality of services.</p><p><strong>Results: </strong>Data collection began in March 2024. As of the end of September 2024, a total of 156 interviews from the HSA and 38 interviews from the patient journey study have been conducted across 4 regions.</p><p><strong>Conclusions: </strong>This study will provide a national, multilevel insight into the current operation of the Peruvian health system, including an analysis of the quality of services provided with regard to dementia diagnosis, management, and care from the perspectives of stakeholders, patients, and their carers.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60296.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60296"},"PeriodicalIF":1.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study.","authors":"Mengmeng Wang, Lianxin Wang, Fumei Liu, Renbo Chen, Zhifei Wang, Xin Cui, Yuanyuan Li, Yanming Xie","doi":"10.2196/65789","DOIUrl":"https://doi.org/10.2196/65789","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pudilan Xiaoyan oral liquid (PDL) is a proprietary Chinese medicine preparation widely used for upper respiratory tract infection, known for its significant therapeutic effects. However, the safety profiles reported in several observational studies vary, and these studies primarily focus on efficacy rather than specifically addressing safety concerns, thus representing inadequate safety monitoring.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to investigate the incidence of adverse drug reactions (ADRs) associated with PDL and explore the factors contributing to these reactions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study is a prospective, observational, multicenter, hospital-based surveillance study. A total of 17 hospitals from China are involved. The study is expected to enroll a large sample of 10,000 patients aged between 18 and 80 years with upper respiratory tract infection who were prescribed PDL. The patients' data, including demographics, medical history, diagnostic information, medication details, adverse events, and laboratory test results, will be monitored. The occurrence of ADRs will be recorded. The primary outcome is the incidence of ADR. Secondary outcomes are the ratio of patients whose body temperature return to the normal range (cases of body temperature normalization and the duration for achieving normal body temperature within a 3-day period will be documented) and changes in liver and kidney function (occurrence of drug-induced liver injury and acute kidney injury). Descriptive analyses will be performed for the primary and secondary outcomes. A cohort, nested, case-control study design will be used. If one patient has an ADR, then 4 patients without ADRs will be matched as the control group according to gender, age within 5 years, drug batch, and other factors, at a ratio of 1∶4 to compare the symptoms related to ADRs. The differences of ADR incidence among the possible influencing factors will be compared separately to find the factors with large differences. Then, synthetic minority oversampling technique and group least absolute shrinkage and selection operator methods will be used to identify factors influencing the occurrence of ADRs. Finally, propensity scoring methods will be used to control for confounding variables. The progress of each subcenter will be closely monitored, and the incidence of ADR will be systematically calculated. Furthermore, the characteristics and influencing factors of ADR will be analyzed, along with an investigation into its geographical distribution.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study began on July 17, 2019. Due to the limited number of eligible patients, missed follow-ups, and the huge clinical burden caused by public health events in 2019, the final case will be enrolled on August 30, 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will obtain safety results of PDL in the real world and provide guidance on the clinical safety of traditiona","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65789"},"PeriodicalIF":1.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial.","authors":"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","doi":"10.2196/68085","DOIUrl":"https://doi.org/10.2196/68085","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;While access to pre-exposure prophylaxis (PrEP) is an important tool for reducing HIV incidence in the United States, disparities in uptake by race, sex, socioeconomic status, and geography persist. In 2018, the US South accounted for more than half of all new HIV diagnoses but only one-third of PrEP users. PrEP use in North Carolina (NC) similarly lags, with uptake being the lowest among young, sexual and gender minority populations, who account for nearly two-thirds of the state's incident infections. The PrEP-to-need ratio, a metric of PrEP equity that measures PrEP uptake relative to new HIV diagnoses, highlights disparities in PrEP uptake among specific demographic groups such as women and Black, Hispanic, and Southern people, indicating that these groups are underserved relative to their epidemic need. Despite behavioral risk overlap of incident sexually transmitted infections (STIs) and HIV, in NC, PrEP is only offered at a few primarily urban health department-affiliated STI clinics. The lack of robust health care infrastructure in these areas presents challenges for HIV prevention services.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol describes a randomized controlled trial of a multilevel PrEP intervention recruiting from rural and periurban STI clinics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This trial aims to enroll up to 336 participants and randomly assign them 1:1 to either the intervention or control group. The intervention consists of access to a digital health app, linkage to a remote PrEP navigator, and the option of referral to telehealth-based PrEP services. Persons randomly assigned to the control condition will receive an enhanced standard of care, including access to a limited version of the digital health app. All participants will be followed up on quarterly for at least 3 months. The primary outcome is the initiation of PrEP within 3 months of an index STI clinic visit; secondary outcomes evaluate PrEP care engagement and adherence, incident HIV and bacterial STI infections, PrEP stigma, and cost-effectiveness. Binary outcome analyses will estimate the proportion of participants achieving an event (eg, PrEP uptake) in each arm and a probability difference and the corresponding 95% CI to compare the intervention versus control arm at each time point. Continuous end points will use nonparametric Wilcoxon rank sum tests comparing the intervention and control groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Enrollment opened on August 31, 2023, at 15 health departments in NC and subsequently expanded to 21 facilities in 20 counties by July 2024. Completion of the enrollment and data collection phases is expected by May 2025. Results will be published thereafter.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study directly addresses multiple barriers to PrEP use in rural and periurban areas of the Southeastern United States and can inform policy and programming that seek to expand PrEP access and promote use in","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68085"},"PeriodicalIF":1.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing and Implementing Provider-Training and Evidence-Based Tools to Support Pre-exposure Prophylaxis (PrEP) Decision-Making and Increase PrEP Adherence Among Young Men Who Have Sex With Men: Protocol for the PrEP Choice Longitudinal Cohort Study.","authors":"Crissi Rainer, Rebecca Schnall, Mary R Tanner, Carla A Galindo, Karen W Hoover, Sylvie Naar, Maeve Brin, Andres Martinez, Haomiao Jia, Maria Mendoza, Lisa Hightow-Weidman","doi":"10.2196/64186","DOIUrl":"https://doi.org/10.2196/64186","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Despite the availability of highly effective HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among young men who have sex with men (YMSM) remains low, limiting its impact on the prevention of HIV infection. Strategies that incorporate an array of prevention options and provide YMSM and their providers with tailored education and support tools, including tools to support shared decision-making, are needed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The goals of the Centers for Disease Control and Prevention (CDC)-funded PrEP Choice study include the development and deployment of CDC guideline-consistent PrEP provider training and the implementation of evidence-based provider- and client-facing PrEP education and support tools. Under this initiative, the CDC funded 2 research projects, Florida State University (the Expanding PrEP in Communities of Color [EPICC] project), and Columbia University (the mChoice project).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Providers from both projects will complete the PrEP Choice online training, which was developed to educate providers on PrEP options and how to engage clients in open discussions around sexual health and PrEP options. EPICC project providers will also attend online tailored motivational interviewing (TMI) training sessions, and mChoice project providers will view a training video on cultural competency and humility in PrEP care. Following training, each project will enroll a cohort of 400 participants receiving care from study providers and follow them for 12-18 months. Participants will complete online surveys every 3 months and provide biomarkers to assess PrEP adherence. Electronic health record (EHR) data will be collected every 6 months to provide additional information on clinic attendance, PrEP prescriptions, and HIV/sexually transmitted infection (STI) testing. Each project will provide cohort participants with a unique digital health tool to support the PrEP choice and ongoing adherence. The study will assess the effectiveness of training and educational and support tools in practice and the critical factors associated with the successful uptake of and adherence to PrEP by participants. The study will also monitor patterns of PrEP use among YMSM, including types of PrEP and switching between types.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Formative work to develop and prepare the tools for implementation was completed in 2023. The EPICC project began provider training in early 2024, and the mChoice project began in spring 2024. Cohort enrollment for both projects began after provider training began.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Given the changing PrEP landscape, implementation of provider education and tools to maximize uptake and adherence is needed. By delivering culturally competent and interactive provider training on PrEP options, the study will help providers counsel and guide participants on the effective and safe use of PrEP. The digital health tool","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64186"},"PeriodicalIF":1.4,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission and Discharge (PHAROS): Protocol for a Quasi-Experimental Clinical Uncontrolled Trial.","authors":"Slavka Porubcova, Kristina Lajtmanova, Kristina Szmicsekova, Veronika Slezakova, Jan Tomka, Tomas Tesar","doi":"10.2196/60728","DOIUrl":"https://doi.org/10.2196/60728","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Patient safety is essential in pharmacotherapy, especially in surgical contexts, due to the elevated risk of drug-related complications. Vascular surgery patients are particularly susceptible because of their complex medication needs and underlying health conditions. Improved safety monitoring and targeted pharmaceutical care in collaboration with physicians are crucial to minimize these risks and enhance patient outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol evaluates whether structured pharmaceutical care interventions-including medication reconciliation, medication review, and patient education-can reduce the prevalence of drug-related problems at hospital admission and discharge in vascular surgery patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This prospective, uncontrolled study was conducted over 1 year in the Vascular Surgery Department at the National Institute of Cardiovascular Diseases in Bratislava, Slovakia. The study included adult patients with carotid artery disease or lower extremity artery disease who were on 3 or more medications, with an estimated sample size of approximately 100 patients. The primary intervention involved 3 key changes in practice: medication reconciliation at both admission and discharge, where hospital pharmacists review and verify medication lists; medication review to identify and address drug-related problems; and patient education at discharge. Pharmacist-proposed interventions were documented and communicated to the physician for treatment adjustments. The primary outcome is the change in drug-related problem prevalence from hospital admission to discharge. Secondary outcomes include the acceptance rate of pharmacist recommendations and patient understanding of pharmacotherapy. Data collection involved documenting the number, type, and frequency of drug-related problems; the anatomical therapeutic chemical classification of medications associated with drug-related problems; and patients' social, demographic, and clinical characteristics, with a focus on factors related to drug-related problems, comorbidities, and medication use. Data analysis will use the paired Wilcoxon signed-rank test to compare the prevalence of drug-related problems and medication counts between admission and discharge. Continuous variables will be presented as means (SDs), while categorical variables will be reported as counts and percentages. Patient understanding of pharmacotherapy will be evaluated using a 3-point scale, classifying understanding as good (2-3 points per medication), modest (1-2 points), or poor (0-1 point).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment began in September 2021 and concluded in August 2022. Data collection occurred continuously during hospital stays, capturing demographics, comorbidities, pharmacotherapy, and drug-related problems at admission and discharge. Important milestones included the initial data review, which began in August 2023 to assess recruitment","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60728"},"PeriodicalIF":1.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integration of a Patient-Centered mHealth Intervention (Support-Moms) Into Routine Antenatal Care to Improve Maternal Health Among Pregnant Women in Southwestern Uganda: Protocol for a Randomized Controlled Trial.","authors":"Esther Cathyln Atukunda, Godfrey Rwambuka Mugyenyi, Jessica E Haberer, Mark J Siedner, Angella Musiimenta, Josephine N Najjuma, Celestino Obua, Lynn T Matthews","doi":"10.2196/67049","DOIUrl":"10.2196/67049","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Mobile health (mHealth) interventions that leverage social support (SS) can improve partner involvement and pregnancy experiences and promote antenatal care (ANC) attendance and skilled births. In our previous studies, we used behavioral frameworks to develop a user-centered mHealth-based, audio SMS text messaging app to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). In our pilot study, we observed high intervention uptake, acceptability, and feasibility, as well as increased ANC attendance and skilled births.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;With the promising pilot data, we propose a type 1 hybrid implementation-effectiveness trial to test if this novel patient-centered automated and customized mHealth-based SS intervention is effective and cost-effective enough to warrant future large-scale implementation into Uganda's routine maternity care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will physically recruit 824 pregnant women at &lt;20 weeks of gestation living in Mbarara and Mitooma districts, southwestern Uganda, and randomize them (1:1) to receive standard of care or the Support-Moms app, with at least 2 of their identified social supporters. Our primary outcome will be the proportion of skilled births. Secondary outcomes will include number of ANC visits&lt;strong&gt;,&lt;/strong&gt; institution-based delivery, mode of infant delivery, preterm birth, birth weight, SS, obstetric complications, and deaths (maternal, fetal, and newborn). We will assess other implementation, service, and client outcomes through study records, the mHealth platform, and questionnaires with all women in the intervention, their social supporters, health care providers (HCPs), and managers from participating facilities. We will conduct face-to-face in-depth exit interviews with 30 purposively selected intervention participants and 15 facility HCPs and managers to explore implementation strategies for scale-up. Annual maternity resource allocations, costs, number of ANC visits, and deliveries will be assessed from facility records up to 36 months after implementation. We will estimate incremental cost-effectiveness ratios concerning cost per additional HCP-led delivery, per death averted, and per quality-adjusted life year gained as cost-effectiveness measures.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in September 2023. Ethics approval was obtained in February 2024, and actual data collection started in March 2024. As of January 2025, 75% (618/824) of all projected study participants provided consent and were recruited into the study. Participants are expected to be followed up until delivery, and 15% (124/824) have so far exited. Data analysis for the trial is expected to start as soon as the last participant exits from the study. The qualitative interviews will start in April 2025, and data will be analyzed and published as soon as data collection is done, which is expected in March 2027.&lt;/p&gt;","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67049"},"PeriodicalIF":1.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Evaluation of Effectiveness of Standard of Care Alone and in Combination With Homoeopathic Treatment in COVID-19-Related Rhino-Orbito-Cerebral Mucormycosis (ROCM): Protocol for a Single Blind, Randomized Controlled Trial.","authors":"Harleen Kaur, Jyoti Sachdeva, Ramesh Bawaskar, Twinkle Goyal","doi":"10.2196/57905","DOIUrl":"https://doi.org/10.2196/57905","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Rhino-orbital-cerebral mucormycosis (ROCM) is the most common (45%-74%) mucormycosis in India. With contemporary medical care, ROCM has a mortality rate of 40%-50% and 70% of survivors are left with residual defects. Recently, several cases of mucormycosis in people with COVID-19 have been increasingly reported worldwide, from India, due to immune dysregulation caused by SARS-CoV-2. To reduce the high mortality rate and residual defect in most survivors under the guidelines of the Ministry of AYUSH, the Government of India recommended homoeopathy as an add-on therapy to maximize the effectiveness of standard treatment in conventional therapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to evaluate the role of existing homoeopathic treatment as an adjuvant therapy in patients with COVID-19-related ROCM and enhancing the survival of the patients hospitalized due to COVID-19 infection and to access the initial treatment response and duration required for significant or complete recovery in patients receiving adjuvant treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This superiority, randomized controlled clinical trial would include two parallel comparator groups A and B. Group A would be the experimental group and would receive homoeopathic treatment along with the standard line of treatment as per investigational medicinal product (IMP) and group B would be the control arm and would receive standard line of treatment as per IMP along with identical placebo. Allocation would be 1:1 through randomization. Based on the inclusion and exclusion criteria, 36 participants per arm would be screened. Participants would be assessed clinically twice a day and magnetic resonance imagery or endoscopy cum-biopsy would be assessed on days 1, 14, and 28. Laboratory investigations may vary as per demand of disease conditions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In India, the COVID-19 pandemic, particularly during the second wave, resulted in a surge of mucormycosis cases among patients with COVID-19. At the time this protocol was being developed, there was a significant spike in mucormycosis cases in India, particularly in Mumbai (June 2021). However, by the time the Central Council for Research in Homoeopathy obtained the necessary approvals and ethical clearance for the study, the incidence of mucormycosis had drastically declined (September 2021). As a result, the study was not initiated and registered. The authors feel it is their ethical responsibility to share the reviewed protocol with the medical community as a reference for future work.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study aims to evaluate the role of existing homoeopathic medicines as an adjuvant therapy in managing COVID-19-related ROCM, potentially contributing to the use of homoeopathy as an evidence-based medical approach. The protocol can also serve as a valuable resource for clinicians and researchers addressing mucormycosis cases unrelated to COVID-19, partic","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e57905"},"PeriodicalIF":1.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a Smartphone-Based Weight Loss Intervention with Telephone Support for Merchant Women With Obesity in Côte d'Ivoire: Protocol for a Randomized Controlled Trial.","authors":"Rui Usui, Maki Aomori, Shogo Kanamori, Setsuko Watabe, Bi Tra Jamal Sehi, Kei Kawano, Yuka Kanoya","doi":"10.2196/69264","DOIUrl":"https://doi.org/10.2196/69264","url":null,"abstract":"<p><strong>Background: </strong>The obesity rate among women in Côte d'Ivoire is rising, particularly in urban areas. Merchantry is the leading occupation for women in the country, and merchant women face a high risk of obesity owing to their sedentary lifestyle. A previous survey indicated that the obesity rate among merchant women was 30%, double the national average. Furthermore, 82.2% of merchant women with obesity were unaware of their condition, and 40.1% expressed no interest in losing weight. While most weight loss programs target individuals ready to lose weight, community interventions should also address those with minimal readiness. Additionally, low-cost weight-loss interventions that do not require health professionals are needed in countries with limited medical resources. Smartphones could offer a cost-effective solution as they enable self-monitoring and remote communication.</p><p><strong>Objective: </strong>This study will evaluate a low-cost smartphone-based intervention that targets individuals who are not ready to lose weight without the involvement of health professionals.</p><p><strong>Methods: </strong>The intervention will run for 6 months, and its efficacy will be assessed in an unblinded, parallel-group, randomized controlled trial with 108 participants per group. All direct interventions for participants in this study will be carried out by staff without medical qualifications. The intervention group will receive weighing scales and be encouraged to record their weight with a smartphone app. Health education will be provided via weekly group messages and monthly phone calls. The evaluation will be conducted face-to-face. The primary outcome will be the weight change, and the secondary outcome will be differences in body fat percentage, abdominal circumference, and stage of behavioral change in weight loss behaviors from baseline to 3, 6, and 12 months.</p><p><strong>Results: </strong>In accordance with this protocol, the recruitment of participants started on August 26, 2024. A total of 216 participants were allocated, with 108 in the intervention group and 108 in the control group. The baseline survey began on November 15, 2024, and is currently ongoing as of the end of November 2024.</p><p><strong>Conclusions: </strong>This study will be the first in sub-Saharan African countries to implement a smartphone app-based weight loss program in sub-Saharan Africa that does not require direct intervention by health care professionals but specifically targets communities. Furthermore, if the effectiveness of this program is confirmed, it has the potential to serve as a low-cost sustainable weight loss model at the policy level.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/69264.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69264"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Multicomponent Strategy to Improve HIV Pre-Exposure Prophylaxis in a Southern US Jail: Protocol for a Type 3 Hybrid Implementation-Effectiveness Trial.","authors":"Ank E Nijhawan, Jana Kholy, Julia L Marcus, Timothy P Hogan, Robin T Higashi, Jacqueline Naeem, Laura Hansen, Brynn Torres, Barry-Lewis Harris, Song Zhang, Douglas Krakower","doi":"10.2196/64813","DOIUrl":"https://doi.org/10.2196/64813","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pre-exposure prophylaxis (PrEP) is an effective approach for preventing HIV infection, but it is underutilized by populations who may benefit the most, including people living in the Southern United States and those involved in the criminal legal (CL) system. Improving the access and use of PrEP for these groups could decrease HIV-related health disparities. Beyond individual outcomes, HIV prevention for CL-involved people can have a significant public health impact on HIV incidence due to a high turnover between jails and the community.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We will develop, implement, and evaluate a multicomponent PrEP implementation strategy for the Dallas County Jail (DCJ) to increase the initiation of this HIV-preventive intervention for CL-involved individuals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a type 3 hybrid implementation-effectiveness study that takes a combined approach by assessing the implementation of a strategy to identify candidates for PrEP at the DCJ and linking them to PrEP providers upon community re-entry while also gathering information about clinical outcomes. The approach is guided by the EPIS (exploration, preparation, implementation, sustainment) framework. Initial formative work (exploration) involves qualitative interviews of diverse key stakeholders to identify factors that may influence linkage to PrEP after jail release. These findings will undergo rapid qualitative analysis (preparation) to inform the adaptation of a multicomponent jail PrEP implementation strategy protocol. This approach, which will include an electronic health record (EHR) prediction model and integration of a PrEP patient navigator into the jail health team, will allow medical providers and the navigator at the DCJ to engage individuals most likely to benefit in shared decision-making about PrEP and navigate them to community PrEP care (implementation) in a process that begins before release from jail and ends with successful care linkage. Regular quantitative and qualitative evaluations of this approach will allow for ongoing stakeholder input, refinement of the implementation strategy, and maintenance of the program (sustainment).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Findings from 26 qualitative interviews (9 formerly incarcerated individuals, 9 county jail staff, and 8 employees of community organizations) have been obtained, analyzed, and mapped to an implementation strategy formalized in a jail PrEP protocol. An HIV risk prediction model based on EHR data to identify individuals most likely to benefit from PrEP has been developed and internally validated and is ready to be deployed. We anticipate the availability of preliminary study findings in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will provide key insights into the feasibility and effectiveness of a PrEP implementation strategy among people at increased risk of HIV acquisition in an urban jail in Southern United States. This prac","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64813"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}