Mental Health Disorder

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2). The primary aim is to assess any possible predictive effect of erectile function status on cardiac events. The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups. The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention. All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study. The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months. 3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse. The surveys include: IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale ) The objective scale we use: Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral ) The survey will take place in our institutions. The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event. Myocardial infarction causes significant changes in erectile function in a natural survey. The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.

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 prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations. Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed. The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice. This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.

BACKGROUND. The increasing prevalence of autism spectrum disorder (ASD), now at 1 in 36 children, highlights an urgent need for early interventions that are both effective and efficient, given the social and economic impact of the challenges experienced by individuals on the autism spectrum and their families. Several clinical trials have documented the benefits of parent-mediated interventions starting early in life, even before a formal autism diagnosis is established. Symptoms of autism manifest across the lifespan and can be diagnosed as early as 12 months of age. Although parents often identify concerns about their child's development during the first two years of life, the median age of diagnosis in the United States continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months. These cumulative waiting times often result in children receiving minimal early intervention prior to school entry. Additionally, health disparities disproportionally affect access to services for families from minoritized and socioeconomically disadvantaged backgrounds. Families who are low-income, have low parental educational attainment, or are from minoritized racial and ethnic backgrounds not only experience delays in receiving diagnoses, but are also less likely to receive high-quality services following diagnosis. These inequities have been exacerbated by the COVID-19 pandemic. Barriers to accessing diagnostic services limit the opportunity to receive autism-specific interventions at the age for which they are shown to be maximally beneficial. Children on the autism spectrum whose needs are not addressed in a timely fashion are at an increased risk of impairments in cognitive, adaptive, and social dimensions of well-being, as well as physical and mental health issues. Further, the 'passive waiting' time in the waitlist is harmful for parental wellbeing and mental health, with research reporting feelings of frustration, worry, and stress in parents experiencing the yearlong 'odyssey' from initial concerns to diagnosis and intervention referral. Importantly, such harmful delays in accessing autism-specific early interventions are potentially avoidable, as many caregivers of children later diagnosed with autism identify concerns about their child's development before her or his second birthday, often as early as 13 months of age. Many difficulties identified by parents during infancy and toddlerhood can be successfully addressed through evidence-based intervention practices. For example, early emerging differences in verbal and nonverbal communication are amenable to improvements through targeted parent-mediated interventions, with benefits documented across multiple dimensions of wellbeing (i.e., adaptive and social-communicative functioning). Despite advances in this area, the potential benefits of early interventions remain largely untapped, as wait times to receive a formal diagnosis of autism are such a significant barrier that they have been referred to as a "crisis" in the field, with parents reporting an average wait time of 1.2 years in the US. The American Academy of Pediatrics recommends simultaneous referrals for clinical diagnostic evaluation and early intervention for young children with suspected autism - however, most children without an autism diagnosis receive low-intensity, generic early interventions rather than autism-specific early intervention programs that rely on evidence-based practices. Accordingly, key stakeholders, including caregivers and providers, have voiced the need for facilitating earlier access to intervention options to counteract the harmful impact of the waitlist crisis. Accordingly, the current project focuses on circumventing the roadblock of delayed access to diagnosis and intervention by empowering caregivers to address their children's needs while they are waiting to be seen for a formal diagnosis. One viable option to accomplish this goal is the delivery of parent-mediated intervention programs that do not require a previous diagnosis or enrollment in formal early intervention services. In particular, recent research has shown the promise of self-directed online intervention programs for caregivers of autistic children. These programs involve independent access to online resources that caregivers can utilize at their own pace and individualize to their own children by selecting content relevant to the specific difficulties experienced by their children. Implementation of the intervention strategies might be exclusively self-directed (i.e., parents deliver the intervention strategy without any assistance from a provider) or based on a hybrid format, whereby a clinician is available to provide guidance and clarification related to the program's content, although without explicit coaching and feedback. Across formats, self-directed programs do not rely on diagnostic and intervention services for eligibility, insurance and billing purposes, providing a potential avenue for circumventing the roadblock of delayed access to diagnosis and intervention. Research has documented that despite not being coached by experienced clinicians, caregivers have expressed a high degree of acceptability and satisfaction with the self-directed format, demonstrated fidelity of implementation, experienced gains in knowledge and their use of the intervention strategies was associated with child improvements following parent completion of programs. However, substantial variation in outcomes in response to different self-directed programs was documented, and existing research only focuses on children who were already diagnosed. Therefore, the potential impact of a self-directed intervention program during families' enrolment in waitlists for a diagnostic evaluation remains unexplored. Against this background, our project focuses the implementation and evaluation of the "Online Parent Training in Early Behavioral Intervention" (OPT-In-Early), a self-directed online resource for caregivers of children with autism or high likelihood of autism which will be made available during their enrolment in waitlists for a diagnostic evaluation. Key features of Opt-In-Early include: (a) a comprehensive scope (i.e., multiple domains are addressed), (b) the use of a Naturalistic Developmental Behavioral Intervention approach, i.e., evidence-supported strategies that blend behavioral and developmental components to address the needs of autistic children and their families, (c) a combination of required and optional modules, so that caregivers can learn autism-specific strategies and focus on areas most relevant to their specific child's needs, and (d) a hybrid format including access to web-based materials designed for self-directed implementation, as well as optional access to remote consultation with a clinician for advice, clarification and support (e.g., selection of appropriate modules). APPROACH. The overarching goal of our project is to evaluate the utility of the OPT-In-Early program for caregivers of toddlers who are on a waitlist for receiving diagnostic services. The OPT-In-Early program centers on the use of naturalistic, developmental, and behavioral principles to increase motivation and engagement, teach skills, and generalize skills across settings. The program emphasizes the importance of utilizing the parent-child relationship, the child's interests, and daily routines to facilitate skill acquisition, and to create developmentally appropriate learning experiences, to value small gains, and to use evidence-based applied behavior analytic principles including task analysis, prompting and prompt fading, and contingent reinforcement. Optional modules focus on specific needs, such as toilet training and picky eating. To evaluate whether the OPT-In-Early program is an acceptable and effective tool for caregivers who are on a waitlist for receiving diagnostic services, the following specific aims will be addressed: 1. Comparing outcomes for 120 toddlers aged 16-48 months whose caregivers are on a waitlist to receive a formal autism diagnosis, randomly assigned to receive either OPT-In-Early or no intervention for six months period. The investigators hypothesize that children randomized to the OPT-In-Early condition will have superior gains. 2. Examining feasibility and acceptability of the intervention (both hypothesized to be high). 3. As an exploratory aim, the investigators will examine theoretically- and empirically- motivated factors associated with intervention engagement and child outcomes. Participants and Setting. Participants will be 120 toddler-caregiver dyads (with each dyad including one toddler and one caregiver) who are on a waitlist to receive a formal diagnostic evaluation due to autism concerns identified by either parents or professionals. As the study does not involve in-person contact between investigators and participants, participants will be recruited across any geographical area. Inclusion criteria include (a) age between 16-48 months, (b) parental consent, (c) being on a waitlist to receive a formal diagnostic evaluation at the time of parent consent due to autism concerns, (d) parents speak English, (e) an initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F) as an indication of autism likelihood. Exclusion criteria include (a) having already received a formal diagnosis of autism, (b) enrolment in early intervention programs delivering more than 5 h per week of evidence-based autism-specific interventions at the time of consent, (c) child has a gestational age less than 36 weeks associated with a birth weight less than 2500 g, (d) the child is not yet walking, or has severe hearing and/or vision impairment that is uncorrected with aids, or known neurological disorder or genetic syndrome (e.g., Down syndrome). Research Design. Our aims will be addressed using an intent-to-treat randomized controlled trial, with participants randomized to either the OPT-In-Early intervention or a waitlist control condition, stratified by age, language level and parental education. Data will be collected from each family prior to random assignment (baseline) and following completion of the 6-month trial period (or earlier for families electing to discontinuing their participation from the trial). The investigators will use REDCap, a HIPAA-compliant data management software to store data. To ensure data accuracy, data will be doubled entered by independent research team members, when not collected directly via REDCap. Study flow. The study flow is articulated in the 5 steps. In step 1 participants will be recruited through our extensive network of hospitals and clinical centers who provide diagnostic evaluations for autism, who will show study flyers in their waiting rooms and websites and inform families enrolled in their waitlist about the opportunity to participate. Interested caregivers will complete a phone screen to learn more about the study and to confirm eligibility. In step 2 caregivers who are invited and consented to the RCT will complete baseline assessments prior to randomization through an online procedure that includes completing online forms and phone interviews conducted by a clinician blind to group allocation and study hypotheses. Assessment measures will include standardized measures indexing broad adaptive functioning and severity of autism symptoms, as well as an idiographic measure capturing goals specific for each dyad. During the baseline assessment, a detailed description of the specific goals that each participant family wants to achieve with their child (e.g., addressing difficulties with verbal communication, toilet training, food refusal) will be obtained using Goal Attainment Scaling procedures. As part of the process, parents will be also asked to provide 3 to 5 "baseline goal" videos of 5- to 20-min in length illustrating the current level of performance in the skill that they are planning to address (one video for each goal) - such as, for example, a video illustrating lack of responsiveness to the child's name being called, a second video illustrating food refusal during lunch, and a third video illustrating the child having a tantrum when asked to brush her teeth. The study coordinator will provide guidance on the videos (e.g., duration, camera angle) to ensure consistency across participants. These videos will be used for later coding of change occurring from baseline to post-intervention. In step 3 each child-parent dyad will be randomly assigned to either the OPT-In-Early condition or the waitlist condition using the online randomization program randomize.net. Randomization will be concealed from clinicians assessing outcomes and stratified by child age (older than vs. equal to or younger than 24 months) language level (expressive language age equivalence score on the Vineland older than vs. equal to or younger than 18 months, reflecting benchmarks of pre-verbal vs. verbal functioning) and parental education (dichotomized as "some college or less" vs "bachelor's degree or more"), based on the literature suggesting that these factors are associated with response to early intervention. In step 4, child-parent dyads randomly assigned to the OPT-In-Early condition will be granted access to the online password-protected OPT-In-Early website for up to 6 months, and provided guidance on the selection of modules within OPT-In-Early that are relevant to the goals caregivers indicated as their priorities during the baseline assessment. The OPT-In-Early program includes 14 modules (6 mandatory, 8 optional) comprising text and video demonstrations to teach caregivers effective methods for improving their children's language, social, and adaptive skills (e.g., using utensils, toilet training), and reducing their children's disruptive behavior. Parents are taught how to facilitate joint attention, imitation, pretend play, language, sharing, emotional engagement, social play, and self-help skills such as feeding and dressing in their child using behavioral principles (e.g. prompting, shaping and fading) during play and naturalistic daily routines. The optional modules cover such topics as picky eating and toilet training. Parents in the OPT-In-Early condition will be also offered the option to schedule brief (i.e.,15-30 min) support calls with a clinician with a BCBA credential and expertise in each module's content (e.g., PECS, behavior assessment) for the duration of the 6-month trial, with a limit of three calls per week. These optional support calls are designed to provide parents with clarification and guidance on how to navigate the website materials, including selection of the appropriate modules. However, no instruction or feedback on how the parents are implementing the strategies (i.e., fidelity monitoring) will be provided, consistent with the self-directed nature of the intervention. Child-parent dyads randomly assigned to the waitlist group will receive access to the OPT-In-Early website immediately after their second (i.e., "post-intervention") assessment. Therefore, all participants will be given access to the intervention, with the only difference being that access will be given after a 6-month wait time for dyads assigned to the waitlist group (although intervention outcomes will not be assessed for those assigned to the waitlist group after receiving OPT-In). In step 5, post-intervention outcomes will be assessed by clinicians who will be blind to group assignment after 6 months from the baseline assessments. A group comparison approach was favored over a cross-over design due to the risk of carry-over effects. The post- intervention evaluation will include the same measures administered at baseline. MEASURES The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) is a 20-item (yes/no) parent-report, autism-specific screener; although initially validated for ages 16-30m, evidence supports use to 48 m. The M-CHAT-R/F provides scores that are indicative of "low likelihood" (\< 3), "high likelihood" (≥8), or "moderate likelihood" (3-7) for autism. Moderate likelihood scores trigger the structured Follow-Up questions, with two at-risk items on the follow-up signaling the need for evaluation referral. Initial M-CHAT-R items requires 5 min to complete and follow-up questions require an additional 10 min. The M-CHAT-R/F will be used to determine eligibility, based on the presence of clinical concerns operationalized as an initial score of 8 or greater or follow-up score of 2 or greater, and to quantify the degree of clinical concerns at baseline. The M-CHAT-R/F will be also used to characterize participants at baseline and will not be repeated at post-intervention as it is not used as an outcome measure. The Goal Attainment Scaling (GAS) will be used as a proximal measure of intervention response, i.e., a measure that captures changes in the specific goals selected for each participant. The GAS is designed to assess an individual's progress on a goal in relation to their baseline performance, and has been successfully utilized to capture proximal response to interventions for individuals on the autism spectrum, particularly for interventions that include different targets for different participants. Stakeholders have increasingly endorsed measurement of goals relevant to the needs of specific individuals within the autism population. Additionally, the GAS was selected to account for the heterogeneity of intervention targets within the OPT-In-Early intervention, whereby selection of modules and targets differ across participants. The GAS includes standardized procedures to generate a common metric of intervention change across participants who have different intervention goals, as articulated below. GAS Baseline assessment and goal setting. For each participant, goals will be developed based on detailed information obtained in a parent interview at the baseline assessment. Each goal is designed to identify an area in which the child is experiencing difficulties (e.g., picky eating, toilet training, self-injurious behavior) that caregivers want to address by teaching specific skills. Caregivers will be encouraged to identify three to five goals that are priorities for their family. The number of goals will vary across participants but is not expected to differ across groups, as goals will be established prior to randomization - however the number of goals targeted for each participant will be considered in the statistical analyses. The stringent standardization criteria detailed in Ruble et al., 2012 will be used to ensure that the goals are unambiguously operationalized and measurable based on: (1) the description of the skill planned to be targeted, (2) the prompt level required by the child for engaging in the targeted skill, and (3) the criterion for success. Caregivers will be asked to provide a set of 5- to 20-min videos (one for each to-be-targeted skill) illustrating their child's current level of performance in the skills that they are planning to target. GAS post-intervention outcome assessment. At the post intervention evaluation, caregivers will be asked to provide a second set of videos, one for each targeted goal, capturing their child's behavior in relation to the same situations/behaviors videotaped at baseline, so that change in relation to the specific goals identified by caregivers can be examined. GAS video collection procedures. For both phases of video collection, caregivers will be provided guidance by study personnel and asked to provide videos that capture the average or typical performance/ behavior currently displayed by their child with reference to the target goal, rather than the child's 'best' behavior. Previous research has shown that intervention participants typically do not use unrepresentative behavior samples in their selections of videos to be submitted for coding of goal attainment. Given the heterogeneity of needs in this population, the investigators expect different caregivers to identify different goals important to them, and to select different OPT-In-Early modules accordingly (e.g., the 'picky eating' module for a child displaying severe food refusal, or the 'toilet training' module for a child experiencing challenges in that domain). Consistent with the idiographic nature of the Goal Attainment Scaling, this will result in specific content and different quantity of videos from each participant. GAS rating. Following previous research, videos will be rated according to the GAS standard procedures whereby goals at baseline are assigned a score of -2 and are then scored on a 5-point scale at post-treatment with positive changes in score from baseline indicating increasingly positive benchmarks of improvement from the baseline to post-intervention. Consistent with previous trials that have used the GAS as an outcome measure, a trained clinician blind to study group and hypotheses will complete the ratings. A coding manual will be developed following Ruble et al., and 20% of videos will be coded by a senior rater (co-I de Marchena) to establish interrater reliability. Participant GAS scores will be averaged across modules to derive an overall score of goal attainment. The following measures will be used as secondary distal outcome measures . The Vineland Scales of Adaptive Behavior-3 (VABS-3), a standardized measure of adaptive functioning, will be administered to all participants at pre- and post-treatment to evaluate change occurring in adaptive behavior across groups. Previous research has documented that this measure has robust psychometric properties, is sensitive to change in response to early intervention, and captures dimensions that are highly valued by stakeholders. Participants' caregivers will also complete the Parenting Stress Index-4, Short-Form (PSI), a standardized measure of parental wellbeing with robust psychometric properties, which has been used in previous research with a similar population. The PSI will be completed at baseline and post-intervention to quantify intervention-related changes in stress. A focus on parenting stress has been endorsed as a top priority by autistic advocates as well as caregivers. The Autism Impact Measure (AIM) is a caregiver-report questionnaire that focuses on the frequency and impact of autism-associated challenges in social interaction, communication, peer interaction as well as repetitive and unusual behaviors. It will be administered at baseline and post-intervention to assess changes in social and communication functioning across groups. The AIM has been shown to have robust psychometric properties. The following measures will be administered to measure intervention feasibility and acceptability. Caregivers of participants randomized to the OPT-In condition will be administered the Acceptability of Intervention Measure and the Feasibility of Intervention Measure. These two standardized measures assess the extent to which end-users believe the intervention was acceptable and could be successfully carried out. To gain insight on feasibility and acceptability issues related to specific modules, participants will be asked to rate the program overall as well as each specific module they utilized. Both scales demonstrated robust discriminant validity and reliability. From onset of intervention until completion of post-intervention evaluation, caregivers will complete a monthly update either electronically or by phone (based on their preferences). Caregivers across conditions will report details about all interventions, services and supports the child is receiving outside the OPT-In-Early program. In addition, caregivers will be asked about any new medical conditions, medical updates, and updates on diagnostic evaluations. These factors will be accounted for in our analyses of the OPT-In-Early program. Finally, Opt-In-Early website usage analytics, including the frequency of access and the specific modules being accessed will be used to provide a measure of the caregivers' engagement with the website content. This information, together with a detailed log on the frequency of optional support calls by participants, will be used to examine the link between usage of the available resources and outcomes. ANALYTIC APPROACH Power analysis. The primary aim is to compare changes in the GAS rating in the OPT-In-Early intervention group to changes in the waitlist group from baseline to after 6 months. Although no research to our knowledge has used the GAS for this population, previous studies that have used the GAS to measure intervention-related change in children on the autism spectrum documented an improvement of 2.1 GAS units with a standard deviation of 0.79. Given our study population and goals, the investigators calculated the sample sizes required to detect change in GAS rating ranging from 0.5 to 2. The power table calculations are based on a mixed-model analysis with 2 observations per participant (e.g., baseline and 6 months). For example, to detect a difference in change in GAS rating in the OPT-In group compared to the waitlist group of 1.0, 76 participants (38 per group) are needed to achieve 80% power with a standard deviation of 1.0, within-subject correlation of 0.01, and significance level (alpha) of 0.025. Given the possibility of 30% dropout, a conservative enrollment plan of 120 participants (60 per group) will be implemented to ensure detection of a minimum difference of 1.0 in GAS rating. Statistical Plan. The investigators will employ best practices for collecting, verifying, managing, and analyzing data. Data will be examined to identify outliers, batch effects, and significant departures from normality for continuous outcomes. Accuracy and explanation for any identified outliers will be explored and dealt with accordingly. Analyses will be performed with and without extreme scores to evaluate their influence on the results. As some attrition is inevitable, baseline data also will be used to assess for non-equivalent attrition between groups and to subsequently support statistically controlling for any bias in attrition. This is consistent with our goal of conducting intent-to-treat analyses for all specific and exploratory aims discussed below. Aim 1 - Primary outcome. The investigators will employ a linear mixed effects modeling approach to compare change (baseline to 6 months) in GAS rating in the OPT-In-Early group to change in the waitlist group. The model will include participant-level random intercepts. Fixed effects in the model will include time (baseline, 6 months), treatment group, and the interaction between time and treatment group. Our model will include age, language level (as measured via the Vineland), M-CHAT-R/F score (as an indicator of clinical severity at baseline), and parental education as fixed effects. Given the RCT study design, the investigators expect balance at baseline on most covariates. However, the investigators will examine balance on other relevant variables - including family size, and other interventions received during the trial - and consider their inclusion in the model accordingly. Using this model, the investigators will estimate mean and 95% confidence intervals for GAS rating at baseline and 6 months. From these means, the investigators will estimate the change in GAS rating in the OPT-In-Early group and the waitlist group. Next, the investigators will contrast those changes with one another to quantify the intervention effect. Secondary distal outcomes. To investigate differences in VABS-3, PSI-4 and AIM score, the investigators will use a similar statistical approach to the one outlined for the primary proximal outcome. Mixed effects models will be used to estimate and contrast outcome changes in the OPT-In-Early group to changes in the waitlist group. Aim 2 - Feasibility and acceptability of the OPT-In-Early content and format will be investigated using the Acceptability of Intervention Measure and Feasibility of Intervention Measure, which use a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The investigators will classify participant agreement on feasibility and acceptability using as "in agreement" (average response score of ≥ 4) or "not in agreement" (average response score \< 4). Responses will be summarized using counts and percentages. The investigators will test whether at least 80% of participants are in agreement on each metric using one-sample tests of proportion. Aim 3 - In an exploratory analysis, the investigators will investigate theoretically and empirically motivated factors that may affect intervention engagement and child outcomes. Exploratory outcomes: engagement. Engagement outcomes will include engagement with program content (frequency of module access) and use of support calls (frequency of calls), evaluated separately. Explanatory variables of interest (i.e. putative predictors) will include diagnosis during participation in the trial, chronological age, baseline adaptive behavior and social communication functioning, and demographic factors (including parental education, employment status and family size). The investigators will model the relationship between these explanatory variables and rate of each of the outcomes using Poisson regression models. These models will be used to estimate and contrast the average rate of module access or rate of support calls by predictor group. Exploratory outcomes: child change. The investigators will examine whether putative predictors including program engagement (frequency of module access and frequency of calls), baseline adaptive behavior and social communication, chronological age, M-CHAT-R/F score, presence/absence of a diagnosis of autism during the trial, other interventions received during the trial, and demographic factors will affect change in GAS rating, assessed using a mixed effects modeling approach based on the approach described for Aim 1 (substituting the predictor variables for treatment group). Examining whether accessing and using OPT-In-Early during waitlist time is a viable alternative to the current "first diagnosis then intervention" format (for all children, or for children with specific profiles and needs) can be a critical step toward promoting a more efficient delivery model intervention, bridging the gap between timing of parental concerns and availability of intervention practices designed to target such concerns.

The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries. Study Design: The study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points. Intervention: The core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include: Identification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing. Audit \& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action. Education \& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care. Enabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence. Linkage to prevention: Improving linkage to the locally available preventive services. The intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap. Endpoints and Outcome Measures: Primary Endpoint: The change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams. Key Secondary Endpoints: The change in the incidence of new HIV diagnoses among patients with HIV indicator conditions. Variations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time. Assessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing. Evaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services. Changes in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV. Implementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention. Analysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM. Impact: By introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates. This project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.

Rationale: While the adverse effects of domestic violence on victimized parents and children have been extensively documented, there is still little knowledge on effective intervention approaches for these families. Both parents and children are at risk to develop trauma-related psychopathology after domestic violence. In addition, victimized parents are likely to show disrupted parenting due to their own traumatization (resulting from domestic violence and often also from their own traumatic childhood). This increases the risk for developing a disturbed attachment relationship for the child. Treatment should thus focus at improvement on three levels (parenting behavior and post-traumatic stress (PTSD) symptoms of the parent and the child), and can consist of trauma therapy for parent and child and attachment-based therapy. Since the symptoms in different families may exhibit in different ways, and can interact with each other in a different way, an individualized treatment trajectory that takes these interactions in account may be necessary to allow for maximum symptom reduction. Study design: The hypotheses will be tested using a single case experimental design (SCED) study, with a non-concurrent, randomized multiple baseline design. Families who receive treatment after experiencing severe domestic violence will be randomly assigned to a baseline length of 3, 4, 5, 6, 7 or 8 weeks (phase 1), and randomization will occur for two sets of five participants. After the end of the baseline phase, the intervention phase will start, during which dyads will follow an individualized treatment trajectory, consisting of different treatments (phase 2), including EMDR therapy for parent and child to reduce their PTSD symptoms and NIKA to reduce disrupted parenting behavior and increase sensitive parenting behavior. The dyads will participate in weekly appointments throughout the whole duration of the study (both baseline and treatment phase). Study population: This study will include 10 parent-child dyads who are residing at a community shelter location in the Netherlands after experiencing domestic violence. Parents with children aged between 4-6 years old will be included if both the parent and the child experience clinically important PTSD-symptoms (based on self-report of the parent). In case that not enough parent-child dyads can be recruited, based on the eligible age range of the child, the age range for the children will be widened, so that children aged between 3-6 years can participate.

The investigators conduct a randomized controlled trial to evaluate the (cost-)effectiveness of ABFT compared to Treatment As Usual (TAU) on suicidality, as delivered in daily practice. The hypothesis is that, compared to TAU, ABFT will lead to a stronger reduction of suicidal ideation and suicidal behavior, and will be more cost-effective, will improve family functioning and young adult attachment, and that this effect will hold at follow-up. The primary objective is change in suicidality, that is, suicidal ideation, attempts and suicide as assessed by the Suicidal Ideation Questionnaire Junior (SIQ-JR), and as reported by therapists during treatment. Secondary objectives are cost-effectiveness, process, working alliance and adherence during treatment, and change in young adult depressive symptoms, family functioning, and young adult attachment. Attachment Based Family Therapy (ABFT): ABFT is a manualized treatment, that emerges from interpersonal theories that suggest suicide can be precipitated, exacerbated, or buffered against by the quality of family relationships. Therefore, ABFT focuses on strengthening parent-child attachment bonds to create a protective and secure base for young adult development. Sessions are scheduled weekly, and the intervention lasts on average 16 weeks. Treatment as usual (TAU): Participants in both arms will receive TAU, in the experimental condition ABFT will be delivered as an add-on. Most treatment centres' clinical practices rely heavily on the use of antidepressants and/or CBT or DBT. All regular interventions are allowed in TAU, except for systemic family therapy of more than 4 sessions in total. Parents are allowed to be involved in the treatment, which is part of treatment as usual, and can comprise for instance psycho-education or parental support or skill training.

Introduction Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses. Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, research to date has predominantly been single-group designs with a lack of a control group and randomization. This contributes to limitations in the confidence and quality of the implications drawn from the synthesized studies. Indeed, within a post-secondary context, most studies are noted as poor quality and lack critical information regarding how they are designed, delivered, and made accessible to students. Second, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology reduction) and secondary (i.e., social support, social connectedness) outcomes. Importantly, group-based physical activity, in comparison to 1:1 delivered physical activity, may provide a less costly and less resource intensive intervention option, and may have unique benefits associated with exercising with others and peer-to-peer support (e.g., social support, a sense of belonging, expanded social networks). Third, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. As such, conclusions concerning achieving lasting change to mental health and sustained physical activity involvement are not possible. Lastly, limited research has explored contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of such programming opportunities. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. Objectives and Hypotheses This randomized controlled trial study will assess the immediate (post-intervention, 6 weeks) and follow-up (4 weeks after post-intervention) maintenance effects of 1:1 supervised physical activity and group-based physical activity in comparison to a 10-week waitlist control group in reducing symptoms of poor mental health, supporting social well-being outcomes, and facilitating physical activity behaviour among post-secondary students experiencing poor mental health. The primary outcomes will be the immediate change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress). The secondary outcomes will include follow-up change in symptoms of poor mental health (anxiety symptoms, depression symptoms, psychological distress) as well as the immediate and follow-up change in social well-being outcomes (social connectedness, social support), and physical activity behaviour. The aims of the study include: (1) examining group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes; and (2) grounded in process evaluation recommendations, to explore contextual factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. Study Setting The trial will be delivered in the post-secondary setting of a large metropolitan university. Importantly, post-secondary contexts offer natural advantages for large-scale implementation of physical activity programs for student mental health because they offer essential infrastructure (e.g., an integrated setting with access to sport and recreation facilities and mental health services) and practical support (e.g., experts in diverse fields) to develop, evaluate, and disseminate sustainable and scalable programs. Aligning with this perspective, the current study will employ a collaborative implementation approach, whereby the research team will work with on-campus sport and recreation professionals (i.e., for the provision of certified coaches with standard training in behavior change coaching and physical activity delivery) and mental health professionals in the post-secondary community (i.e., for program design, recruitment and implementation, and evaluation). In addition, purposeful efforts (e.g., through advocating for targeted referrals to the program and delivering targeted information sessions) will be made to promote the program among professionals (e.g., accessibility services, student-life services, health and wellness services) involved with providing mental health support or referrals to on-campus support services- an important approach for facilitating collaboration across disciplines and sectors in the campus community. Participant Timeline The university research ethics board (REB) has approved this study (protocol # 00045228). Students who meet eligibility and who have provided informed consent will be contacted to schedule an intake session with a program coordinator for the trial. Students who do not meet eligibility will be notified via email by the program coordinator and will be provided with a mental health resource sheet outlining alternative health and wellness programs and resources available to participate in. Intake sessions will be scheduled in-person in a private research space conveniently located in the campus athletics and recreation centre. During the intake session, participants will complete the baseline assessment (T1), and randomization will be conducted. Following completion of the intake session, participants in the experimental arms will complete the 6-week physical activity program (either 1:1 physical activity delivery or group-based physical activity delivery). In the experimental arms and control condition, study outcomes will be assessed at baseline (T1), 6-weeks post baseline (T2), and at 1-month follow-up (T3). Sample Size A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures design would require 25 participants per group assuming a moderate effect size of .30, a power level of .80, an alpha of .05, and expected correlations between timepoints of r = .50. To account for a loss to follow-up rate of 25%, the final targeted sample size is 93 post-secondary students. Participants will be randomly assigned to equal groups of approximately 31 students. Recruitment Purposive and snowball sampling procedures will be used to recruit post-secondary students who are physically inactive and experiencing poor mental health. Post-secondary students will be recruited and referred to the intervention through the team's research and professional networks (e.g., health and wellness and student support services; student life listservs; campus mental health listservs; the research team's social media platforms including Twitter and Instagram). Digital recruitment materials (including email scripts and poster advertisements) outlining the purpose of the intervention, intervention procedures, eligibility criteria, and a link to the screening questionnaire will be shared. The screening questionnaire will be administered through REDCap and allow participants to "sign up" up for the intervention through providing their email address and completing several screening questions to confirm eligibility. The program coordinator will contact eligible participants through their provided email address to confirm involvement in the study and to schedule an intake meeting. Data Collection Methods Statistical Methods Preliminary analyses will include descriptive statistics (including mean scores for study variables, standard deviations, frequency counts for categorical variables and bivariate correlations) to examine the relationships between study variables and to describe participant characteristics. A 3 (group, individual, control) by 3 (T1, T2, T3) repeated measures ANOVA will be used to examine whether there are group differences between 1:1 physical activity delivery, group-based physical activity delivery, and the 10-week waitlist control group on the primary and secondary outcomes. Lastly, the implementation process evaluation outcomes will be assessed analyzing the responses to the closed-ended and open-ended questions. Closed-ended questions will be analyzed using descriptive statistics and open-ended questions will be analyzed using inductive thematic analysis. Methods Monitoring Harms There are minimal risks or harms associated with participating in the research trial. Nonetheless, the current sample represents a population with relevant group vulnerability due to self-reported mental health concerns. There are also inherent risks associated with engaging in physical activity. First, it is possible that the self-report assessments may provoke negative emotions or may elicit uncomfortable thoughts and/or feelings. To mitigate emotional risks, participants will be informed of their right to not answer questions they feel uncomfortable answering, and all participants will be provided with a mental health resource sheet following completion of the intake meeting. Participants will also be informed of their right to withdraw from the trial without any penalty to their involvement in the 6-week physical activity intervention. Second, physical risks are rare but include cardiac events and musculoskeletal injuries. To reduce the risk of injury, the physical activity sessions will be delivered by certified sport and recreation coaches who have received standard training in behaviour change coaching and physical activity program delivery. Participants will also receive clearance for physical activity engagement using the PAR-Q+ and will be informed to refrain from engaging in any physical activity causing sharp pain, nausea, dizziness, or light-headedness. Bi-weekly meetings with the research team and sport and recreation coaches to mitigate any risks or concerns for participant vulnerability throughout the duration of the study will be held. Ethics and Dissemination Protocol Amendments Protocol amendments, including but not limited to changes in the study objectives, the eligibility criteria, samples size, the outcomes, or statistical analyses will be submitted to appropriate REB review. Substantive changes will also be documented as amendments to the published study protocol and to the trial registry. Confidentiality All information collected for this trial will be kept strictly confidential. The information will be stored electronically in secure, password-protected folders only accessible to members of the research team. All data will be collected through a secure online data capture program (REDCap), where identifying information (i.e., email address, participant name) will be removed prior to data analysis. Data will be coded by participant ID and presented as aggregate-level data to maintain confidentiality and anonymity of the data.

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.