Medication Management

This is a randomized, double-blind, controlled trial that will compare ED, i.e. alternate day dosing to daily dosing i.e. TAU. Individuals will be randomized to ED or TAU using a permuted block design with a random number generator. The size will be fixed and study personnel blinded to the randomization block size. To maintain a double-blind design, our pharmacy will provide, on an individualized basis, APs at the appropriate dose and placebo where necessary in matching gelatin capsules, packaged in blister packs. The active tablet will be over-encapsulated, and matching placebo will be prepared using the same capsules (filled with lactose). Thus, from the individual subject's position, AP treatment is continued according to the same daily schedule. Further, if their current medication is prescribed in divided doses, this too will be employed during the study. The minimum and maximum doses for Risperidone will be 1 mg and 16mg respectively. The minimum and maximum doses for Olanzapine will be 5 mg and 20mg respectively. The minimum and maximum doses for Paliperidone will be 3 mg and 12mg respectively. Other psychotropic medications prescribed before the study will be permitted, with any changes in dosing during its course documented The trial is 1 year in duration. To prevent bias, the study code will remain blinded until the trial's completion. Study visits will be scheduled every 2 weeks over the first 6 months, in line with the earlier investigation. Thereafter, the visits will be decreased to every 4 weeks, aligning with the schedule routinely observed in our ambulatory clinics. The investigators are asking the following questions: 1. (Non-inferiority) Can additional confirmatory evidence support "extended" AP dosing (ED) as an alternative to continuous administration, i.e. is it as effective clinically? 2. (Superiority) Can the investigators establish clinical benefits (e.g. better tolerability, fewer side effects, such as decreased glucose dysregulation) with ED? Hypothesis: The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.

This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.

HIV care engagement is essential to optimize the health of Black women LWH. Black women LWH have poorer health outcomes due to exposures to poverty, substance use, and violence as well as constrained support resources derived from historically unjust social policies. Baltimore City has the highest prevalence rates of HIV in Maryland. In 2018, nearly 1 in 5 (18.7%) people living with HIV, the majority of whom are Black, were not engaged in HIV care and only two-thirds had achieved viral suppression. Two critical aspects of HIV care engagement include at least two HIV care visits in a 12-month period 90 days apart and a prescription for ART as early as possible after HIV diagnosis. HIV care engagement among Black women LWH can be challenging; and exposure to IPV is a well-established barrier. Black women LWH experience high rates of IPV victimization. Approximately 1 in 2 Black women report lifetime experiences of IPV compared to 1 in 3 White women. Women LWH and experiencing IPV are more likely to have a lower Clusters of differentiation 4(CD4) count and higher viral load; and delayed care poses heightened risks for ongoing HIV transmission in communities. Black women LWH also report higher rates of severe IPV, greater IPV frequency, and are more likely to be murdered by an abusive partner in the United States. Despite these stressors, fewer Black women experience IPV-related Post Traumatic Stress Disorder symptoms compared to White women, though they are also less likely to seek help from healthcare organizations. IPV impacts HIV care engagement among Black women LWH. Attending HIV care visits is a critical step to HIV care engagement because interactions with healthcare providers can increase access to life-preserving antiretroviral therapies and other resources to address IPV. However, Black women experiencing various types of IPV (psychological, physical, and sexual) are less likely to access HIV healthcare. Among women already engaged in healthcare, women experiencing IPV are also more likely to experience hospitalizations and longer care disruptions compared to women not experiencing IPV. Thus, Black women LWH have increased risks of clinical progression if IPV is a barrier to full HIV care engagement. Barriers to HIV visit attendance reported among individuals experiencing IPV in previous studies have included: psychological control of money and/or resources by abusive partners, fear of rejection or escalated violence in response to disclosure of HIV status, overall poor health, low self-esteem, low self-efficacy, and fears of stigma. The effects of stigma on HIV care engagement are pervasive among women experiencing HIV and IPV. The intersection of two socially devalued identities, HIV diagnosis and experiencing IPV, can cause psychological and emotional distress among BWLWHI. Factors driving stigmatization include societal beliefs that delegitimize BWLWHI, internalization of those beliefs, and fears about possible rejection if others know about their HIV status and IPV experiences. A recent systematic review found HIV-related stigma at multiple levels the most prevalent barrier to engaging in HIV care among Black women LWH. IPV stigma is a barrier to engaging with familial or friend networks for social support due to beliefs that women in violent relationships are irresponsible and unwise. Both of these societal stigmas are pervasive, and can affect individual decisions to employ IPV safety strategies and engage in HIV care. Black women use IPV safety strategies and build on existing sources of strength to overcome the effects of IPV and HIV. Several studies report Black women LWH and/or experiencing IPV draw on internal and external sources of strength and employ safety strategies to overcome stigmas and preserve or improve their health. Women experiencing IPV reported accessing sources of strength to gain motivation to change their situation, leave their abuser, or take care of their health. Internal sources of strength include spirituality/religion or belief in God and self-reliance or belief in oneself. External sources included accessing informal and formal resources for support. Examples of informal support resources included friends or family who cared about the woman. Among Black women LWH, social support from family members, friends, and peers were resources for resilience; fostering health promoting behaviors to cope with HIV. Formal support resources for Black women experiencing IPV were police or court systems, IPV organizations, and healthcare. Feelings of empowerment and resiliency derived from a shared identity, unique strategies for coping, and awareness of social and political meaning can preserve Black women's well-being in the face of adversity. Black women LWH identified healthcare providers as vital resources of resilience to maintaining health. Resilience is linked to higher quality of life, undetectable viral load, and improved medication adherence among this group. Identifying the numerous ways women cope with IPV and build on their existing capacities are characteristics of strengths-based intervention approaches using a resiliency-reintegration model. Strengths-based approaches engaging BWLWHI in care are lacking. Despite established links between IPV experiences and HIV care disengagement, few existing HIV care engagement interventions are tailored for Black women LWH nor do they address the effects of IPV on health. In fact, the majority of existing studies describe barriers and facilitators to care engagement but are not focused on interventions addressing these issues. The Living in the Face of Trauma (LIFT) intervention for women LWH found improved coping and reductions in traumatic stress 12 months after completing the intervention. However, this study did not focus on the role of current IPV. While strengths-based case management has been found to be a highly efficacious strategy to linking individuals to HIV care, it is resource-intensive and did not focus on the effects IPV can pose on this process. The negative influence of IPV experiences engagement in the distal outcomes of the HIV Care Continuum, i.e., medication adherence and viral suppression among Black women demonstrate potential areas for targeted intervention to address the effects of IPV and HIV-related stigma as barriers to HIV care visit attendance and receipt of ART. The 1MoreStep study refines and tests a 8-session cognitive behavioral approach intervention referred to as COPE. COPE is a mnemonic of the skills: Challenge negative and maladaptive thoughts, Options - internal and external sources of strength, Positive affirmations, and Establish a plan. The investigators expect that introducing COPE skills will lead to increased HIV care engagement and use of IPV safety strategies in a sample of BWLWHI ages 18 and older. The investigative team has a strong record of recruiting and retaining samples of Black women in Baltimore. The CHAT study (R01MH66810) was a Randomized Control Trial (RCT) testing a peer-based HIV prevention intervention with a sample of predominantly Black women. CHAT stands for: 1) Choose the right time and place; 2) Hear what the person is saying; 3) Ask Questions; and 4) Talk with respect. The Prevention and Testing study was a RCT testing an intervention for people LWH, 40% were Black women. The Young Women's Healthy Relationship (YWHR) study (R25-MH087217) was a cross-sectional study examining mental, sexual, and reproductive health effects of IPV and reproductive coercion among Black young women age 18 to 24 in Baltimore. The BMore PrEP Her Way (BHPHW) study (R24HD042854) recruited over 100 IPV-exposed women living in Baltimore to examine acceptability of women-controlled methods for HIV prevention (i.e. pre-exposure prophylaxis (PrEP)) and pregnancy prevention (long-acting reversible contraceptives (LARC)). Black women were 85% of the sample and 5% of the 250 screened ineligible were HIV-positive. Finally, myPlan, the IPV risk assessment and safety planning tool, that facilitators will introduce in Session 4 of the intervention was tested in diverse samples (\>20% self-identified as Black women) and found to be an effective intervention for women experiencing IPV. This study is a randomized, two-arm pilot clinical trial to determine acceptability, feasibility and preliminary estimates of efficacy of a trauma-informed cognitive behavior change program with 3-month and 6-month follow-up visits of BWLWHI (N=100). Participants complete baseline assessments and attend group sessions at a community-based research clinic. Follow-up assessments (satisfaction survey, qualitative interviews to assess acceptability and feasibility) will be conducted post-treatment and 3 and 6 months. Experimental Condition: The intervention arm includes 7 small-group sessions and one individual session that meet weekly with facilitators who are paraprofessional women, one of whom is indigenous to the Black community in Baltimore and has experience implementing prior cognitive behavioral skills interventions in addition to several other HIV prevention and care RCTs with marginalized populations including Black women. Session 1: The first session is an introduction of the purpose of the training and includes an activity about the strengths of BWLWHI and an inventory of internal and external sources of strength. Session 2: The intervention uses a mnemonic (COPE) to teach cognitive and behavioral skills, develop strategies for safety from IPV and improve knowledge and motivation for engagement in HIV care. Session 3: Teaches women about U=U and using COPE to address HIV care engagement. A female HIV care navigator will describe services offered at numerous clinics in Baltimore including the Baltimore Rapid Start Collaborative that provide immediate antiretroviral therapy to people newly diagnosed and/or re-engaging in HIV care. Participants will set HIV care goals. Sessions 4-5: These sessions are focused on conducting a personalized danger assessment and learning IPV safety strategies. In session 4, participants will meet in a small-group to learn about IPV safety strategies, specifically: placating strategies (e.g. not arguing with partner), safety planning (e.g. hiding car keys, keeping money hidden, having supplies ready for escape), engaging informal resources (e.g. sending kids to relatives) and formal resources (e.g. talking to a pastor, calling crisis line). Participants will be introduced to the myPlan app, which is a secure, interactive, and personalized app that has been developed and tested with diverse women (18 years and older) to support decisions to increase safety and reduce barriers to services. The myPlan app allows users to define their personal safety priorities, assess the level of danger in their intimate or dating relationship, and formulates a personally-tailored safety plan with referrals to appropriate resources and services. For the proposed study, no data will be used from the app. The app is a resource that will be shared with participants who are interested in voluntarily using it. The group will practice communication strategies for responding to enacted stigma which include positive affirmations such as "I am a survivor and doing the best I can for me and my kids", "One of my goals is to stay healthy for my kids, so going to the doctor is part of my plan", "I am worthy, HIV does not define me". Session 5 is an individual format in which the participant will identify the IPV safety strategies that she is willing to try and goal setting for safety planning. Session 6: The facilitator will discuss peer engagement, community building, and ways to support other Black Women Living With HIV (BLWHI). Session 7: This session is focused on goal setting for the next 30 days and establishing cues to remind the participant to practice the COPE skills. Session 8: Reunion session 30 days post completion of the intervention. Comparison Condition: The Equal Attention Control/Standard of care control arm will consist of 7 group-based sessions that meet weekly and last 60-90 minutes. The control sessions provide both equal attention and psychotherapeutic experience of a support group where participants can talk about issues that are important in their lives, improving equal retention by study arm. Session 1 will include a video entitled "Personal stories of people living with HIV" created by the Positive Life Campaign. Participants will share their experiences living with HIV and staff will give HIV care resources. Session 2 will be a standard of care presentation of IPV resources, services, and shelters for women. Sessions 3-5 will address diet-related health disparities that affect Black women such as obesity, hypertension and diabetes. Women will watch videos about each topic and then discuss their reactions. Session 6 will address caregiving and its relationship to self-care. Session 7 will address COVID-19 (transmission risks, symptoms and prevention behaviors) and related services available including food resources, financial assistance, testing sites and childcare. The investigators chose these topics because they are relevant to BWLWHI but not associated with the health outcomes targeted by the intervention. Follow-up Assessments: All participants will be asked to complete a survey at 3 and 6 months post baseline. The follow-up surveys will assess changes in IPV safety strategies and HIV care linkage. Two participants per cohort will be asked to conduct an in-depth feedback interview.

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.

PRIMARY OBJECTIVE: I. Evaluate the feasibility of translating the low-Empirical Dietary Index for Hyperinsulinemia (EDIH) dietary pattern intervention from epidemiologic cohorts to the clinic in a single arm phase I trial among postmenopausal women at high risk for cancer and evaluate safety. SECONDARY OBJECTIVES: I. Determine the change in patient reported outcomes (PRO) under the Low-EDIH dietary pattern at 12 weeks from baseline. II. Evaluate the change in cardiometabolic biomarker profiles at 12 weeks from baseline (a) glycemic control and insulin response parameters measured using fasting glucose, insulin, hemoglobin A1C, C-peptide, HOMA-IR, HOMA-B and IGFBP-1, IGFBP-2, (b) lipid profiles (total cholesterol, triglycerides \[TG\], low density lipoprotein \[LDL\], higher high density lipoprotein \[HDL\]). III. Assess change in circulating biomarkers associated with risk of breast cancer and low-grade chronic inflammatory state including C-reactive protein (CRP), TNFalpha-R2, IL-6 and leptin/adiponectin ratio at 12 weeks from baseline. EXPLORATORY OBJECTIVES: I. Collect stool samples and process for subsequent assessment of changes in the fecal microbiome structure and function related to the low-EDIH dietary pattern intervention. II. Collect 24-hour urine samples and process for subsequent assessment of changes in targeted and non-targeted metabolomics and lipidomics alterations related to the low-EDIH dietary pattern intervention. OUTLINE: Participants receive the low-EDIH dietary pattern intervention consisting of 6 group nutrition education sessions focusing on foods to prioritize within each food group, food combinations, food preparation, discussion, simple cooking demonstrations, food tastings, smart shopping advising, and a question/answer period over 2 hours each at weeks 0, 1, 2, 3, 5, and 6. Participants also attend 3 in-person or virtual individual nutrition counseling and motivational interviewing sessions over 30 minutes each at weeks 3 and 5, between weeks 7 and 9, and between weeks 9 and 11. Participants also wear an activity tracker and undergo blood sample collection on the study. After completion of study intervention, participants are followed up in week 12.

In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat. Aim 1: To conduct formative evaluation interviews, guided by the i-PARHIS framework, with approximately 30 stakeholders (23 PrEP patients, 4 clinical staff, 3 clinic administrators) in order to adapt Viral Combat for diverse PrEP patient populations, and to identify individual, organizational, and structural factors associated with its implementation. Aim 2: To evaluate, in a Hybrid Type 1 effectiveness-implementation randomized controlled trial with 200 participants taking PrEP (15-34 years of age), the effectiveness of Viral Combat compared to a control group that receives a non-PrEP related game. The investigators will examine the impact of the intervention on: 2a: improving adherence to PrEP using a biological measure (tenofovir from DBS), clinic records, and self-report; 2b: the potential mediators of the intervention, such as knowledge, motivation, self-efficacy, and game metrics. Aim 3: To conduct summative evaluation interviews, following the RCT phase, with an additional 30 stakeholders ((23 PrEP patients, 4 clinical staff, 3 clinic administrators). Interviews will assess and summarize the i-PARIHS constructs relevant to the intervention's future implementation success.

Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psychosocial health and early mortality, among many other short- and long-term consequences. It is estimated that families of children with obesity need at least 26 hours of contact with the health care per year to make it possible for the children to reach a clinically relevant reduction in degree of obesity. Such visit frequency is difficult to carry out due to its cost for society and places great demands on families. A digital support system named Evira has newly been developed and is based on four cornerstones; a) daily self-monitoring of weight, b) a mobile app used by parents to easily follow weight development, c) a website on which clinicians view the same data as parents do and d) communication between clinicians and parents by text messages through the website and the mobile app. Hence, Evira enables close follow-up of treatment results and continuous communication between the healthcare and the families. The overall aim is to evaluate the effects of adding Evira, a digital support system for childhood obesity treatment and accompanying treatment manual, to the already locally used life-style treatment. Boys and girls aged 4-17 years old with obesity will be asked for participation. All patient who fulfills the inclusion criteria and have signed the informed consent form will be included and randomized into the study. Randomization means that the patient can either be randomized to intervention (Evira Care) or control (Standard Lifestyle Care) group. The study duration is 12 months. The Intervention group will receive Evira support (Evira Care) in combination with local standard treatment (Standard Lifestyle Care). During the first 2-4 weeks, they will receive information about the system and how to utilize the daily weighings and communication system. The families will be informed about possible lifestyle changes that may be effective. Furthermore, they will be informed that they are supposed to do lifestyle changes primarily regarding energy intake that they do consider feasible in their specific living situations. Within four weeks after randomization, the families will get one or two scales, depending on the family situation. The parent's will also have the mobile app installed in their smart phones and, depending on the age of the child, in the child's phone as well. The individual weight loss target curve for the first three months of treatment will be installed in the database and presented in the application. The control group will receive Standard Lifestyle Care without any restriction in visits or clinical support. The following clinical investigations will be completed in both groups: 1) Physical examination including puberty, cardio-respiratory, thyroid status, skin (e.g. acanthosis nigricans) and abdominal examinations, and 2) Weight, height, and blood pressure. Blood sampling in accordance with local routine can be reported at any time-point. In addition to the clinical investigation, all participants will be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction. Background information and negative side effects will be reported in the electronic case report form (e-crf).

In this study, patients diagnosed with mantle cell lymphoma who have achieved remission (CR or PR) by first-line immunochemotherapy, will be treated with Zanubrutinib monotherapy for 2 years (or until PD, intolerable toxicity, death, withdrawal, or study termination). This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of those patients, and explore the efficiency and safety.

Investigators are using a pseudo randomized yoked design and will include two groups: choice of intervention strategy or no-choice. If the individual is randomized to no choice, then the next person would get a choice and the no choice person would be assigned to the group yoked (matched) to the person with a choice. Participants assigned to the choice group will choose one of three intervention strategies provided; either Group A (receiving both nutrition and exercise simultaneously), B (starting with nutrition and receiving exercise sequentially followed by nutrition starting at 25 weeks) or C (starting with nutrition first and then introducing exercise sequentially at 25 weeks). All groups will follow the full NELIP until delivery. Participants in the no-choice group will be yoked (matched) to a participant in the choice group and receive the strategy that their yoked counterparts chose. Nutrition component of NELIP: This component is a modified gestational diabetic meal plan that has four general goals tailored to the participant: (1) to achieve approximately 2000 kcal of energy per day. The determination of the amount of kcal consumed per day will consider the participant's intake from the dietary assessment. There also must not be a restriction of calories that exceeds 30% of their total energy intake; (2) participants will consume approximately 200-250g/day of carbohydrates, accounting for approximately 40-55% of total energy intake. Carbohydrate intake will be distributed throughout three meals and four snacks daily. The nutritionist will educate participants about the importance of complex and low-glycemic index carbohydrates through the one-on-one session; (3) fat and protein intake will be approximately 30% and 20-30% of total energy intake, respectively; (4) achieve appropriate micronutrient and fluid intake for pregnancy. This will be monitored by a weekly 24 hour food intake record. Exercise component of NELIP: This is a walking program that comprises of 1 weekly supervised session on a treadmill or outside and participants will be recommended to walk 2 to 3 additional times per week. The walking program will start at 25 minutes per session, 3 to 4 times weekly, and increase by 2 minutes per week until 40 minutes and then maintained until delivery. This will be monitored by a wrist monitoring device. The primary outcome is adherence measured weekly using a published adherence protocol using a point system. Secondary outcomes are participant satisfaction to the program and health outcomes: weekly weight gain, calculated EGWG, and pregnancy outcomes (birth weight length, infant anthropometrics, APGAR scores and delivery complications). At 2, 6 and 12 months of age the maternal-infant dyad will return to the lab and infant morphometric measurements recorded from birth will be repeated.

The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement. The study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university. The project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC). To assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap. The GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning. Furthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.