Study Staff Research Articles

Acceptability and Feasibility of Remote PrEP Visits for Adolescent Girls and Young Women in South Africa.

The World Health Organization recommends differentiated service delivery (DSD) models for HIV prevention, including alternatives to clinic-based PrEP services. This study assessed the acceptability and feasibility of remote PrEP delivery-including HIV and pregnancy self-testing, and phone-based adherence counselling-among adolescent girls and young women (AGYW) in Johannesburg. The research was nested within the PrEP SMART trial (2019-2022), which evaluated scalable adherence support strategies for AGYW aged 18-25. During COVID-19 lockdowns, PrEP refills and testing kits were delivered to participants' homes, and counselling was provided by phone. Using a phenomenological qualitative method, we conducted in-depth interviews with AGYW (n = 14) who had the option to complete remote PrEP visits (accepting or declining), study staff (n = 12), and key informants (n = 10) involved in PrEP programming. Thematic analysis explored experiences of remote delivery, focusing on acceptability and feasibility. AGYW found remote PrEP visits convenient, empowering, and time-saving. Procedures such as self-testing and phone counselling were generally acceptable, though some expressed anxiety about performing tests incorrectly and concerns over privacy, stigma, and unintentional disclosure of PrEP use at home. About half still preferred clinic-based visits. Staff and key informants recognized benefits, but highlighted challenges related to cost, sustainability, and provider workload. Suggestions for improvement included integrating contraception and partnering with community organizations. In conclusion, remote PrEP delivery is acceptable and feasible for many AGYW but not universally suitable. These findings support the inclusion of remote PrEP options in DSD models, with attention to privacy concerns and support for self-testing in this age group.

Evaluating spoke facilitation costs of implementing TelePain in the Veterans Health Administration

BackgroundThe high prevalence and significant morbidity and mortality associated with chronic pain among veterans has made expansion of pain services within the Veterans Health Administration (VHA) a key priority. TelePain, in which services are provided via telehealth from central “hub” sites to patients at decentralized “spoke” sites, is one such model with positive implementation findings to date. However, the staff effort and cost of implementation have yet to be examined when considering TelePain or similar virtual hub-and spoke models of specialty pain care, information that is critical for expansion of services.MethodsUsing an established time-based activity tracker designed for implementation facilitation, study staff tracked minutes spent on implementation activities at 11 spoke sites. Annual salaries were extracted to calculate an average cost per minute for each personnel type. Costs per personnel minute were combined with activity data to calculate costs of implementation activities at spoke sites. Implementation reach outcomes for the first 36 months of implementation were extracted from the electronic health record. Service utilization data was combined with cost data to calculate cost per patient reached and per clinical encounter achieved at each site.ResultsTotal facilitation costs (range: $1,746-$7,978) and unique patients reached (range: 2–46) varied considerably across spoke sites and greater staff implementation efforts (measured in time or cost) were not associated with greater numbers of patients reached. Therefore, costs per patient reached also varied widely (range: $120–2,569) across spoke sites. Key challenges included high rurality and small clinic size; insufficient engagement of frontline providers; lack of referral options for high acuity patients; and lack of existing programming within which to situate pain services.ConclusionsAt spoke sites where patients were consistently referred and reached, costs were relatively modest, particularly compared to the high cost of untreated chronic pain, suggesting the potential impact of this model at scale. However, in spoke sites where referrals and encounters were low during initial implementation, cost per patient was high. Findings highlight the need for better methods for tailoring of facilitation interventions to spoke site’s individual needs to maximize impact.

Abstract 4907: Availability and characteristics of energy balance programs offered by NCI-designated cancer centers

To broaden our understanding of energy balance programs (diet, physical activity, weight control available for cancer survivors in NCI-designated cancer centers across the United States, we reviewed the characteristics (program components, personalization, delivery mode) of programs using publicly available information on cancer center websites. All NCI-designated cancer centers (n=72 as of 4/24/2024) were included, and two coders reviewed their websites. Each cancer center’s website was searched and reviewed from June 2023 to April 2024. We applied the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, an implementation framework used for planning and evaluation of programs, to evaluate each cancer center’s energy balance programming. Information was extracted by each reviewer independently and then checked by a third study staff member for discrepancies. A total of 55 (76%) cancer centers had information on at least one energy balance program or resource posted on their website. These programs included diet/nutrition (n=41), physical activity (n=23), and weight control programs (n=3). Personalized programming was offered in 68% of diet/nutrition programs, 30% of physical activity programs, and 33% of weight control programs. Across all energy balancing behaviors, most programs offered individual sessions (76% diet/nutrition; 57% physical activity; 67% weight control). Group-based support was offered in less than half of programs across all behaviors (29% diet/nutrition; 40% physical activity; 33% weight control). In-person delivery was offered in 56% of diet/nutrition programs, 74% of physical activity programs, and 33% of weight control programs. Most of the programming for cancer survivors addressed diet/nutrition. Weight control programs were limited. Most physical activity programs were delivered in-person, which could limit reach and increase barriers to participation since the median of NCI-designated catchment areas is 26,500 square miles. There is a need for more consistency and availability of personalized support, particularly concerning exercise and weight control. Comprehensively addressing all energy balance components as part of cancer survivorship care is needed. Citation Format: Jean Miki Reading, Alexandra Rich, Aarifah Bandealy, Payton Solk, Julia Starikovsky, Allegra Frank, Kristina Hasanaj, Shirlene Wang, Siobhan M. Phillips. Availability and characteristics of energy balance programs offered by NCI-designated cancer centers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4907.

Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.

Deep brain stimulation (DBS) is well suited to target disorders with network dysregulation, as is the case in many neuropsychiatric diseases. While DBS is a well-established therapy for Parkinson's disease, essential tremor, dystonia, and medically refractory epilepsy, it is actively being studied in clinical trials for neuropsychiatric disorders including treatment-refractory major depressive disorder (MDD). Due to the nature of symptomology and participant characteristics, special care must be taken in the design and implementation of clinical trials testing DBS for neuropsychiatric disorders. In particular, these studies typically include multi-year relationships between participants and study staff with frequent interactions, high burden of study activities on participants, and disclosure by participants of sensitive information related to symptoms and disease state. Through our experience with six participants across more than 5 years of the Presidio clinical trial assessing personalized closed-loop DBS for treatment-refractory MDD, we have gathered experience and evidence to inform best practices for conducting these interaction-intensive clinical studies in a vulnerable population. Here, we present these Key Practices along with discussion, informed by multiple fundamental principles: The Belmont Report; emotional and physical safety for study participants and staff; and integrity and validity of scientific outcomes.

Testing a Machine Learning-Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial.

Individuals who are socioeconomically disadvantaged have high smoking rates and face barriers to participating in smoking cessation interventions. Computer-tailored health communication, which is focused on finding the most relevant messages for an individual, has been shown to promote behavior change. We developed a machine learning approach (the Adapt2Quit recommender system), and our pilot work demonstrated the potential to increase message relevance and smoking cessation effectiveness among individuals who are socioeconomically disadvantaged. This study protocol describes our randomized controlled trial to test whether the Adapt2Quit recommender system will increase smoking cessation among individuals from socioeconomically disadvantaged backgrounds who smoke. Individuals from socioeconomically disadvantaged backgrounds who smoke were identified based on insurance tied to low income or from clinical settings (eg, community health centers) that provide care for low-income patients. They received text messages from the Adapt2Quit recommender system for 6 months. Participants received daily text messages for the first 30 days and every 14 days until the end of the study. Intervention participants also received biweekly texting facilitation messages, that is, text messages asking participants to respond (yes or no) if they were interested in being referred to the quitline. Interested participants were then actively referred to the quitline by study staff. Intervention participants also received biweekly text messages assessing their current smoking status. Control participants did not receive the recommender messages but received the biweekly texting facilitation and smoking status assessment messages. Our primary outcome is the 7-day point-prevalence smoking cessation at 6 months, verified by carbon monoxide testing. We will use an inverse probability weighting approach to test our primary outcome. This involves using a logistic regression model to predict nonmissingness, calculating the inverse probability of nonmissingness, and using it as a weight in a logistic regression model to compare cessation rates between the two groups. The Adapt2Quit study was funded in April 2020 and is still ongoing. We have completed the recruitment of individuals (N=757 participants). The 6-month follow-up of all participants was completed in November 2024. The sample consists of 64% (486/757) female participants, 35% (265/757) Black or African American individuals, 51.1% (387/757) White individuals, and 16% (121/757) Hispanic or Latino individuals. In total, 52.6% (398/757) of participants reported having a high school education or being a high school graduate; 70% (529/757) smoked their first cigarette within 30 minutes of waking, and half (379/757, 50%) had stopped smoking for at least one day in the past year. Moreover, 16.6% (126/757) had called the quitline before study participation. We have recruited a diverse sample of individuals who are socioeconomically disadvantaged and designed a rigorous protocol to evaluate the Adapt2Quit recommender system. Future papers will present our main analysis of the trial. ClinicalTrials.gov NCT04720625; https://clinicaltrials.gov/study/NCT04720625. DERR1-10.2196/63693.

Evaluation of a Curriculum-Based Nutrition Education Intervention Protocol in Elementary Schools: Nonrandomized Feasibility Study.

Improving children's food literacy through school-based interventions can support developing healthy eating habits. However, teachers lack appropriate resources, time, and training to provide nutrition education in schools. Serious games, which are games designed for a purpose other than entertainment, have been demonstrated to improve children's food literacy and dietary intake and can address the barriers teachers face in providing nutrition education. Foodbot Factory (Arcand Lab) is a nutrition education intervention that is aligned with curricula and uses a serious game to provide nutrition education to students. Further evidence is needed to understand how serious games, including Foodbot Factory, can be researched in schools to support nutrition education. The objective of this study was to evaluate the feasibility of a research study protocol that implements the curriculum-based nutrition education intervention Foodbot Factory into a real-world classroom setting. The evaluation of the protocol included study processes, resources, and management feasibility outcomes, as well as a preliminary assessment of scientific outcomes relevant to the intervention. A nonrandomized study determined the feasibility of intervention implementation. Grade 4 and 4/5 classrooms were assigned to have nutrition education lessons for 5 days with either the Foodbot Factory or a control intervention. Outcomes were assessed in 4 feasibility domains of study processes (eg, recruitment and attrition rates), resources (eg, time taken to deliver the intervention), and management (eg, challenges with intervention delivery), and a preliminary assessment of scientific outcomes pertaining to the acceptability and impacts of the interventions. These outcomes were captured in semistructured field notes completed by study staff and a Nutrition Attitudes and Knowledge questionnaire and acceptability questionnaire completed by participants. Data were analyzed descriptively and using a paired t test to assess within-group changes in nutrition knowledge. In total, 4 classrooms participated in the feasibility study, with varying recruitment rates for schools (3/20, 15%), classrooms (4/4, 100%), parents (54/102, 53%), and children (49/54, 91%). The time required to implement the research protocol, including data collection and lesson plans, was sufficient and management of the intervention implementation was overall successful. Some challenges were experienced with classroom management during data collection, specifically with electronic data collection. After the intervention, participants reported a positive affective experience (26/41, 63%) and learning something new about healthy eating (31/41, 76%). Participants in both study groups improved their nutrition knowledge, but the changes were not statistically significant. The Foodbot Factory group had a statistically significant improvement in their knowledge of vegetables and fruit (P=.04) and protein foods (P=.03). These findings indicate that the study protocol is feasible to implement and evaluate Foodbot Factory in a representative sample with select modifications to improve recruitment and data collection procedures.

Perceptions of dietary sugar consumption among public housing residents using a modified qualitative photovoice methodology

BackgroundConsumption of dietary sugar (e.g. sugar-sweetened beverages and high sugar foods) is a predominant contributor to chronic health conditions, particularly in communities of low socio-economic position. Our objective was to explore social contextual influences on dietary sugar consumption among public housing residents in Boston, MA.MethodsThis study employed the use of photovoice, a qualitative technique involving participant photography and narratives. Due to the COVID-19 pandemic, we conducted photovoice methods using Zoom. Adult residents of two public housing developments were invited to participate in pairs of online group sessions. The first session provided training on photovoice methodology and a discussion of example photographs and written narratives. Over the ensuing two weeks, participants took or identified stock photos as visual examples of personally-experienced barriers and facilitators of avoiding sugary foods and beverages. During the second session, study staff facilitated development of verbal narratives via group discussion. A total of 18 sessions were audio recorded, transcribed, and double-coded for themes.ResultsParticipants (n = 49) were predominantly women and identified as either Hispanic (61.2%) or non-Hispanic Black (30.6%). Approximately half of participants (51.1%) reported consuming sugar-sweetened beverages at least once per day. Qualitative analysis revealed participant-identified influences on dietary sugar consumption across multiple domains of influence, including individual preferences, beliefs, or circumstance, the social environment, the physical environment, and the macro environment.ConclusionsThe multiple social contextual influences on dietary sugar consumption identified in this study, particularly centrality of the home, cultural influences, individual-level sabotaging factors, may be useful for development of culturally tailored health promotion messaging and intervention through multiple channels.

Understanding adaptations in a community-vetted COVID-19 testing program.

Adaptations are expected when complex public health interventions are implemented in dynamically and rapidly changing real-world settings, as seen for many programs during the COVID-19 pandemic. Systematic documentation of adaptations to intervention components and strategies are critical when assessing their impact on implementation. Here, we report processes used for tracking and evaluating adaptations made during the CO-CREATE project, which aimed to address COVID-19 testing disparities in the San Ysidro US/Mexico border community. The study utilized a longitudinal, prospective, mixed methods approach to systematically document and assess adaptations across the pre-implementation, early and mid/late-implementation phases of the project. Aggregated from a combination of sources (i.e., meeting notes, Advisory Board transcripts, and periodic reflections), adaptations were entered weekly into an electronic database that captured information on 16 characteristics and were validated by study staff. The impacts of the adaptations were determined using a team consensus approach and based on the outcomes from the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Each adaptation was evaluated to determine whether it increased, decreased, had no effect, or not applicable to the RE-AIM outcomes. Data were analyzed using descriptive statistics. 98 adaptations were identified, and most were identified by research staff (n = 79, 75.2%). Planned adaptations were defined as those discussed between at least two research team members prior to implementation. Unplanned adaptations were defined as a change made without shared discussion and agreement among at least 2 research team members. Most adaptations were planned (n = 93, 94.9%). Of those that were planned, (n = 21, 22.6%) occurred during pre-implementation, (n = 26, 28.0%) during early implementation, and (n = 46, 49.4%) during mid/late implementation. Of those that were unplanned, (n = 1, 20.0%) occurred during pre-implementation and (n = 4, 80.0%) occurred during implementation. Most adaptations (n = 45, 45.9%) had a positive impact (i.e., increase) on the efficiency of delivery of services, meaningful engagement of partners, and reach of community members through the program. This work describes our systematic and prospective approach to document and analyze adaptations over a two-year period and assesses the impact of these adaptations. Lessons learned from this work can be used to develop best practices for adapting interventions to ensure sustainable implementation and address disparities in public health and clinical programs.

A Comprehensive Auditing and Mapping of University Press Publications in Kenya from 2020-2023

Research publications are a fundamental requirement for university academics worldwide, shaping their tenure and promotion prospects. They represent the essential scholarly output that academics must produce to advance or maintain their careers. University presses bear the responsibility of disseminating research generated in institutions of higher learning. Thus, they play a crucial role in the scholarly communication ecosystem. This paper mapped and audited scholarly publications produced by university presses in Kenya. It specifically examines the types and quantities of scholarly publications produced by university presses and deposited in university libraries and bookshops in Kenya. The study was informed by revised Boyer’s Model of Scholarship. Conducted using a mixed methods research approach and survey research design, the study employed a census and purposive sampling to select key informants of the study and university press staff respectively. The target population was fifty-one respondents comprising 36 staff from university presses, 7 university librarians, 7 university press managers and one bookshop manager from the selected universities. Quantitative data was collected using questionnaires while qualitative data was collected using interviews and documentary review. Qualitative data was analysed thematically using Nvivo data management software version 12, while quantitative data was analysed using SPSS (IBM SPSS Statistics version 28.0.1.1). Quantitative data was presented statistically using tables and graphical representations, while qualitative data was presented using descriptive narratives and verbatim quotations. Findings revealed that university presses in Kenya produce more of non-scholarly publications than the scholarly ones. Additionally, the study revealed that these publications are hardly deposited in university bookshops and libraries. This limits their visibility and uptake. The study concludes that university presses in Kenya are not fully meeting their mandate of disseminating scholarly knowledge. The study recommends improved productivity of scholarly publications by university presses as a means of increasing their scholarly value. The study also recommends a regular auditing of university press publications to continually assess their quality and visibility within and beyond their parent institutions. The findings of this study may be used by university management to develop policies which systemise, promote and sustain their presses for better productivity and visibility.

ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears

BackgroundDegenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears.MethodsThe study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40–75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including—as indicated—bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.DiscussionThe ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.Trial registrationThe trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).

Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial.

Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial.

A qualitative, community-based needs assessment to inform the development of a radiology health equity curriculum.

A qualitative, community-based needs assessment to inform the development of a radiology health equity curriculum.

C.E.R.E.B.R.O.: A home-based physical activity study for older Latino adults.

C.E.R.E.B.R.O.: A home-based physical activity study for older Latino adults.

Impact of Platform Design and Usability on Adherence and Retention: Randomized Web- and Mobile-Based Longitudinal Study.

Low retention and adherence increase clinical trial costs and timelines. Burdens associated with participating in a clinical trial contribute to early study termination. Electronic patient-reported outcome (ePRO) tools reduce participant burden by allowing remote participation, and facilitate communication between researchers and participants. The Datacubed Health (DCH) mobile app is unique among ePRO platforms in its application of behavioral science principles (reward, motivation, identity, etc) in clinical trials to promote engagement, adherence, and retention. We evaluated the impact of platform design and usability on adherence and retention with a longitudinal study involving repeated patient-facing study instruments. We expected participants assigned to complete instruments in the DCH mobile app to stay in this study longer (increased retention) and complete more surveys while in this study (increased adherence) due to the enhanced motivational elements unique to the participant experience in the DCH app group, and this group's overall lower burden of participation. A total of 284 adult participants completed 24 weekly surveys via 1 of 4 modalities (DCH app vs DCH website vs third-party website vs paper) in a web-based and mobile longitudinal study. Participants were recruited from open access websites (eg, Craigslist or Facebook [Meta]), and a closed web-based user group. All participation occurred remotely. Study staff deliberately limited communications with participants to directly assess the main effects of survey administration modality; enrollment and study administration were largely automated. Participants assigned to the DCH app group experienced behavioral science-driven motivational elements related to reward and identity formation throughout their study journey. There was no homolog to this feature in any other tested platform. Participants assigned to the DCH app group accessed study measures using passcodes or smartphone biometrics (face or touch ID). Participants in the DCH website group logged into a website using a username and password. Participants in the third-party website group accessed web-based surveys via personalized emailed links with no need for password authentication. Paper arm participants received paper surveys in the mail. Mode of survey administration (DCH app vs DCH website vs third-party website vs paper) predicted study retention (F9,255=4.22, P<.001) and adherence (F9,162=5.5, P<.001). The DCH app group had greater retention than the paper arm (t=-3.80, P<.001), and comparable retention to the DCH website group. The DCH app group had greater adherence than all other arms (DCH web: t=-2.42, P=.02; third-party web: t=-3.56, P<.001; and paper arm: t=-4.53, P<.001). Using an ePRO platform in a longitudinal study increased retention and adherence in comparison to paper instruments. Incorporating behavioral science design in an ePRO platform resulted in further increase in adherence in a longitudinal study.

Application of point-of-care ultrasound-guided tip navigation combined with visualised directional high-frequency linear array probe compression to improve the success rate of umbilical venous catheterisation in critical neonates: protocol of a multicentre randomised controlled trial in neonatal units

IntroductionConventional umbilical venous catheterisation (UVC) relies on ‘blind’ insertion without ultrasound guidance, resulting in low success and high complication rates. While point-of-care ultrasound (POCUS)-based tip navigation and location has improved...

Diagnostic accuracy of an antigen-based point-of-care test versus nucleic acid amplification testing for genital trichomoniasis among pregnant women attending antenatal care facilities in Zambia

BackgroundInfection with Trichomonas vaginalis (TV) is the most prevalent curable sexually transmitted infection (STI) globally and is associated with prelabour rupture of membranes, preterm delivery, and low birthweight. Point-of-care (POC) testing for TV during pregnancy may facilitate rapid antenatal case detection and treatment. This study, part of the World Health Organization’s global ProSPeRo study, aimed to evaluate the performance of OSOM® Trichomonas Rapid Test, an antigen-based POC test, against a reference nucleic acid amplification test (NAAT) among pregnant women in Zambia. We also assessed the operational characteristics and patient acceptability of the POC test, within the context of WHO’s target product profiles for STI POC tests.MethodsWe enrolled pregnant women attending four health centres in Nchelenge, Zambia, for antenatal care between 15 February and 26 May 2023. Vaginal swabs for the TV POC test and a reference NAAT (Aptima® Trichomonas vaginalis assay) were obtained. POC test results were read independently by two study staff members. Study staff filled a questionnaire on the operational characteristics of the POC test, and participants were asked about their willingness to wait for results.ResultsPaired POC and reference test samples were collected from 1,015 participants. Overall, 23.0% (233/1015) tested positive for TV by NAAT, and 15.3% (155/1015) tested positive by the POC test, with three inconclusive results. The overall sensitivity and specificity of the POC test were 66.4% (95% confidence intervals [CI] 57.7–74.1%) and 99.6% (95% CI: 98.8–99.9%), respectively. Sensitivity was higher among those with TV-associated symptoms compared to those without (83.6% versus 60.4%, relative ratio 1.39, 95% CI 1.14–1.68). Inter-rater agreement was 99.7% (Cohen’s Kappa 0.989). The study staff (n = 14) found the test easy to use and interpret, with most staff (12/14) reporting results were available within 25 min.ConclusionOverall, the TV POC test showed lower sensitivity than WHO’s 85% target, but exceeded the 99% specificity target. Among symptomatic pregnant women, sensitivity nearly reached the WHO target. The assay was user-friendly, required minimal training, and delivered results quickly. Further studies are needed to determine the optimal antenatal settings for this technology.Trial registrationPACTR202302766902029.

Circadian rhythmicity of symptomatic phenotypes in multiple sclerosis: the CircaMS study protocol and feasibility of biomarker collection

IntroductionMultiple sclerosis (MS) is a chronic autoimmune neurological disease with a variable prognosis and unpredictable course. Fatigue, pain and low mood are common symptoms that tend to fluctuate in people...

A comparison of acceptability of contraceptive vaginal rings, pills, and injectables among cisgender women in Kenya and Zimbabwe: protocol for a mixed-methods study.

Expanding contraceptive options could better meet users' diverse needs and preferences. Annovera ® is a contraceptive vaginal ring that provides a year of pregnancy prevention while remaining under user control and allowing for regular menstrual cycles. This method may also help to reduce burdens on some health care and supply chain systems. However, knowledge gaps exist regarding initial and ongoing acceptability of contraceptive vaginal rings in African settings. We will undertake an open-label, non-randomized, two-arm, parallel clinical acceptability study with an embedded qualitative component, based in clinics providing contraceptive services in Kenya and Zimbabwe. Women aged 18-45 interested in newly initiating or switching contraception will choose from among all available contraceptive options, including Annovera. We aim to enroll 200 participants selecting Annovera and 200 participants selecting either contraceptive injectables or pills. We will compare method uptake, continuation, and satisfaction over one year. Participants will complete questionnaires administered by study staff during two in-person visits (a screening/enrollment visit, and an end of study visit after 52 weeks of method use or at discontinuation) and four phone appointments (at 4, 12, 24, and 36 weeks of use). We will evaluate used rings for discoloration and residual drug levels. The qualitative component involve in-depth interviews with women in the clinical study, their sexual partners, and their service providers, to further examine drivers of and barriers to interest in and use of contraceptive vaginal rings. This study will explore acceptability of contraceptive vaginal rings in 'real-world' contraceptive service settings in two African countries. Findings will be based on actual ring use and contextualized via comparison to two other commonly available methods. As vaginal rings are being considered for multiple reproductive health indications, this work can fill key knowledge gaps and empower decision-makers with information needed to inform future investments in reproductive health.

Immunogenicity and safety of a measles and rubella-containing vaccine at age 6 and 9 months in Bangladesh: an open-label, randomised trial.

Immunogenicity and safety of a measles and rubella-containing vaccine at age 6 and 9 months in Bangladesh: an open-label, randomised trial.

A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers.

A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers.