Anna Larsen

Background: Fully remote online health research is vulnerable to fraudulent participation that can threaten data validity and divert study resources. Although fraud mitigation is increasingly necessary in online research, mitigation efforts are rarely described systematically or evaluated transparently across studies. Objective: This study demonstrates the application of the configure, assess, triage, corroborate, and hone (CATCH) framework to an ongoing remote mental health study and evaluates how structured mitigation procedures have affected participant progression and operational costs. Methods: This study was conducted within an ongoing, fully remote mental health study evaluating hallucinations through longitudinal digital data collection. Following detection of fraudulent activity, the CATCH framework was applied to organize mitigation procedures into stages and refine detection and verification workflows. New screening safeguards were configured, classification thresholds were recalibrated, enrolled participants were reassessed and triaged accordingly, and secondary corroboration through synchronous video verification was introduced when warranted. Procedures were honed through ongoing monitoring in response to emerging fraud patterns. We compared 2 temporally defined cohorts before (March-August 2025) and after (September 2025-January 2026) the implementation of the refined procedures. Primary outcomes included the stage at which fraudulent participants were identified and cost per eligible participant, decomposed into costs attributable to fraudulent participants, nonfraudulent participants, and fraud-mitigation technology. Participant-level costs were estimated using a stage-based model incorporating participant compensation and research staff effort. Sensitivity analyses examined alternative compensation and staffing scenarios to assess the generalizability of the proposed cost-accounting mechanism. Results: Following CATCH implementation, fraudulent participants were identified earlier in the study workflow, reducing progression to later study stages. Overall, 41.5% (161/388) of reassessed participants were discharged for suspected fraud, while 58.5% (227/388) were retained following adjudication. Among those flagged as high risk and invited to video verification, 1.8% (3/164) successfully confirmed their identity, providing a lower-bound estimate of the false-positive classification rate. The mean sunk cost per fraudulent participant decreased from US $12.75 (SD US $40.76) in the pre-CATCH cohort to US $3.29 (SD US $10.91) in the post-CATCH cohort. Total cost per eligible participant decreased from US $170.48 to US $134.90, driven by a substantial reduction in the fraud-related portion from US $80.46 to US $19.73. Sensitivity analyses showed reductions in fraud-related cost per eligible participant across all alternative costing scenarios. To our knowledge, this is the first empirical demonstration of a structured fraud-mitigation framework implemented and evaluated within an active health study. Conclusions: Structuring fraud mitigation using an explicit framework enabled systematic documentation of procedural adaptations and their operational consequences. Beyond study-specific findings, this work illustrates how organizing fraud mitigation into defined, reportable stages can promote transparency, reproducibility, and cumulative learning across remote health studies. Treating fraud mitigation as an integral methodological component is essential for safeguarding scientific integrity and legitimate resource expenditure in online research.

Vertical HIV transmission remains a public health challenge in high-burden areas. This cross-sectional study analyzed baseline data from 600 pregnant women without HIV in western Kenya who initiated preexposure prophylaxis (PrEP) between January 2022 and July 2023. We examined associations between participant characteristics, self-perceived HIV risk, and PrEP initiation motivations. Overall, 36.3% reported high HIV risk perception. High self-perceived risk was associated with having multiple sexual partners, high empiric risk scores, intimate partner violence (IPV), and anxiety. Unplanned pregnancies and IPV correlated with specific PrEP motivations. Findings highlight the need for tailored counseling, IPV screening, and integrated maternal and child health services to improve PrEP uptake and reduce vertical transmission.

Background: Perinatal mood and anxiety disorders (PMAD) cause substantial morbidity and mortality globally. Kenya, like many low- and middle-income countries, experiences severe shortage of specialized mental healthcare workers and poor coverage of screening and management for PMAD. Provision of screening and treatment by lay and non-specialist providers in the context of routine maternal child health services may enhance access to mental health services and improve outcomes. Methods and analysis: In a hybrid type II cluster randomized clinical trial in 20 facilities in Western Kenya, we will evaluate the clinical, service delivery, and implementation outcomes of a stepped-care model integrating: 1) screening of all pregnant women for depression and anxiety symptoms, 2) Problem Management Plus (PM+) counseling delivered by trained lay providers, and 3) telepsychiatry for women with severe symptoms, suicidality, or inadequate response to PM + . The intervention package also includes a bundle of implementation strategies such as audit and feedback, process mapping, health educational health talks, and procurement of antidepressants for all sites. In addition, intervention sites will receive provider training, structured supervision and financial compensation for providers. Facilities will be randomized 1:1 to intervention and enhanced standard of care (basic screening and referral to specialist care), using restricted randomization. We will enroll a total of 2,970 women. Women will be eligible if they are pregnant and ≥20 weeks’ gestation, attending antenatal care at the facility, ≥ 14 years old, and screen positive for PMAD symptoms (Patient Health Questionnaire [PHQ]-2 ≥ 3 and/or Generalized Anxiety Disorder-[GAD]-2 ≥ 3). Assessments will be conducted at enrollment (pregnancy), 6 weeks, 14 weeks, and 6 months postpartum among participants in both study arms to align with routine well-baby visits. Primary outcomes are PMAD symptoms (PHQ-9 and GAD-7 score) change at 14 weeks postpartum using an intent-to-treat analysis. Secondary outcomes include quality of life at 14 weeks postpartum, PM+ mechanism of action, and adverse pregnancy outcomes at 6 weeks postpartum. Using mixed methods, we will evaluate acceptability and fidelity of the intervention and compare service delivery and other implementation outcomes (penetration, efficiency, equity, cost) across arms and alongside multilevel drivers of implementation success. Ethics and dissemination: The study protocol was approved by Kenyatta National Hospital/University of Nairobi (P425/04/2023) and the University of Washington (STUDY00017933). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences. Trial registration: Trial registration number NCT06456307 .

Background: Perinatal mood and anxiety disorders (PMAD) cause substantial morbidity and mortality globally. Kenya, like many low- and middle-income countries, experiences severe shortage of specialized mental healthcare workers and poor coverage of screening and management for PMAD. Provision of screening and treatment by lay and non-specialist providers in the context of routine maternal child health services may enhance access to mental health services and improve outcomes. Methods and analysis: In a hybrid type II cluster randomized clinical trial in 20 facilities in Western Kenya, we will evaluate the clinical, service delivery, and implementation outcomes of a stepped-care model integrating: 1) screening of all pregnant women for depression and anxiety symptoms, 2) Problem Management Plus (PM+) counseling delivered by trained lay providers, and 3) telepsychiatry for women with severe symptoms, suicidality, or inadequate response to PM+. The intervention package also includes a bundle of implementation strategies such as audit and feedback, process mapping, health educational health talks, and procurement of antidepressants for all sites. In addition, intervention sites will receive provider training, structured supervision and financial compensation for providers. Facilities will be randomized 1:1 to intervention and enhanced standard of care (basic screening and referral to specialist care), using restricted randomization. We will enroll a total of 2,970 women. Women will be eligible if they are pregnant and ≥20 weeks’ gestation, attending antenatal care at the facility, ≥14 years old, and screen positive for PMAD symptoms (Patient Health Questionnaire [PHQ]-2≥3 and/or Generalized Anxiety Disorder-[GAD]-2≥3). Assessments will be conducted at enrollment (pregnancy), 6 weeks, 14 weeks, and 6 months postpartum among participants in both study arms to align with routine well-baby visits. Primary outcomes are PMAD symptoms (PHQ-9 and GAD-7 score) change at 14 weeks postpartum using an intent-to-treat analysis. Secondary outcomes include quality of life at 14 weeks postpartum, PM+ mechanism of action, and adverse pregnancy outcomes at 6 weeks postpartum. Using mixed methods, we will evaluate acceptability and fidelity of the intervention and compare service delivery and other implementation outcomes (penetration, efficiency, equity, cost) across arms and alongside multilevel drivers of implementation success. Ethics and dissemination: The study protocol was approved by Kenyatta National Hospital/University of Nairobi (P425/04/2023) and the University of Washington (STUDY00017933). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences. Trial registration number: NCT06456307 Strengths and limitations of this study: Strengths include: This is among the first studies to evaluate a stepped care intervention for perinatal mental health that has been integrated into routine public maternal child health services in a low-resource setting This is among the first studies to evaluate telepsychiatry as part of an integrated care model in a low-resource setting. This study combines 3 evidence-based and resource-appropriate interventions, that have the potential to be scalable in this context The study will generate not only clinical effectiveness data but also data on implementation outcomes in the context of service provision by routine providers, which will enable holistic evaluation of the intervention’s potential This is a large randomized controlled trial conducted in a mix of rural and urban clinics in Kenya, increasing generalizability across geographical contexts Limitations include: PM+ is provided in-person and transportation barriers may prevent clients’ consistent attendance The implementation strategies used include financial support for providers and essential medications, limiting generalizability

Integrating mental health care into well-attended health services, such as maternal-child health (MCH), offers a promising approach to increasing access to mental health care. To inform integration, we assessed the current approach to screening and treatment of perinatal mood and anxiety disorders (PMAD) in MCH facilities in Western Kenya. We conducted a cross-sectional survey among the facility managers (“in-charges”) at 20 MCH facilities in Western Kenya. Trained data collectors administered questionnaires to assess facility infrastructure and human resources, perinatal mental health screening, psychological interventions, psychiatric medication availability, and level of perinatal mental health integration into standard MCH services. Across 20 MCH facilities, the majority were located in rural areas (16,80%), 2 peri-urban (10%), and 2 urban (10%). Facilities had a median of 37.5 medical staff (IQR: 31.0, 45.5); the most common cadre was nurses (median: 9.0, IQR: 6.0, 12.5). Under half of the facilities (8, 40%) screened for PMAD using a validated tool and documented results; most (19, 95%) reported diagnosing PMAD (not necessarily through a systematic approach), yet only half (10, 53%) documented the diagnosis. The most common psychotherapy reported across the sites was supportive counseling (15, 75%). Some facilities offered evidence-based psychotherapies (e.g., cognitive behavioral therapy, problem-solving therapy, etc.), but did not report on training, supervision or guidance from the evidence-based intervention manual. Across all facilities, the availability of mental health medications was limited. Only (12, 60%) had any antidepressant available, (16, 80%) had antiepileptics, (9, 45%) had antipsychotics, and (2, 10%) had mood stabilizers available. Mental health services in MCH clinics in Western Kenya are currently not offered in a structured and systematic manner to effectively alleviate PMAD. Available infrastructure and human resources offer an opportunity to integrate an evidence-based treatment model to improve perinatal mental health in the MCH clinics in Western Kenya.

Background: Youth experiencing early psychosis in West Africa often face delays in accessing evidence-based treatment. Digital mental health interventions may offer an acceptable and scalable approach to improve access to early psychosis care in West Africa; however, few data exist on the experiences and perspectives of patients with early psychosis and their caregivers to inform digital intervention development. Objective: This study aims to explore current experiences of early psychosis care, identify barriers and facilitators to in-person early psychosis care within health facilities, and identify opportunities for digital interventions to support patients with early psychosis and caregivers in Ghana. Methods: We conducted qualitative focus group discussions among patients with early psychosis, their caregivers, and their mental health care providers recruited at Accra Psychiatric Hospital in Accra, Ghana. Trained qualitative researchers facilitated discussions using a structured qualitative interview guide, exploring current care practices for early psychosis in Ghana, barriers and facilitators to facility-based care, and perceptions of digital mental health interventions. Transcripts were translated, transcribed, and analyzed thematically using a hybrid inductive and deductive approach grounded in the theoretical framework of acceptability. Results: Overall, we conducted 4 focus group discussions (N=31) among 7 patients with early psychosis (median age 28, IQR 21‐41 years), 6 caregivers (median age 58, IQR 29‐34 years), and 18 clinicians (median age 30, IQR 29‐34 years). Participants described current early psychosis care practices in Ghana, including seeking spiritual and traditional healing, the dearth of information and resources about psychosis, and the integral role of caregivers in facilitating treatment engagement and continuation (often at the cost of caregiver mental distress and burnout). Common barriers to facility-based mental health care included stigma associated with mental illness, lack of prior knowledge about early psychosis and treatment options, and practical constraints (eg, financial, logistical, and health care system limitations). Motivating factors for facility-based care included success stories from community members and strong rapport and trust in mental health clinicians. Technology (eg, mobile phones, laptops, radio, and television) was commonly used among participants in typical daily tasks, health information seeking, and stress reduction. Participants expressed support for digital tools that could deliver psychoeducation about early psychosis, support treatment adherence, and extend patient-provider communication between clinic visits. Conclusions: Digital mental health interventions have the potential to complement facility-based early psychosis services in Ghana by addressing misinformation, reducing access barriers, and supporting caregiver roles. These qualitative findings inform potential integration points, content, attributes, and strengths of digital modalities that could be leveraged to support patients with early psychosis and their caregivers in Ghana.

Background: Evidence gaps remain regarding the influence of perinatal depression on mother–child engagement and child social–emotional development. Objectives: We assessed relationships between perinatal depression, mother–child engagement and child social–emotional development among Kenyan mother–child pairs. Methods: Mother–child pairs attending maternal‐child health services in four sites in Western Kenya were followed from pregnancy through early childhood. Study nurses serially assessed perinatal depression (pregnancy, 6 weeks, and 9 months postpartum with the Center for Epidemiologic Studies Depression scale, CESD‐10 scores ≥ 10), mother–child engagement activities (6‐monthly, 24 to 60 months post‐delivery with UNICEF Multiple Indicator Cluster Surveys) and child social–emotional delay (6‐monthly, 30 to 60 months post‐delivery with Ages and Stages Questionnaires). We estimated prevalence and correlates of low mother–child engagement and social–emotional delay. Results: Among 884 mothers, the median age was 26 years (IQR 22.0, 30.3), 91.6% were married, and 36.8% had perinatal depression. High mother–child engagement (≥ 4 activities in the prior 3 days) ranged from 27.1% to 94.1% from 24 to 60 months post‐delivery. The frequency of child social–emotional delay ranged from 26.6% at 30 months to 4.4% at 60 months. Low mother–child engagement at any point (< 4 activities) was more common among women with perinatal depression (adjusted relative risk [RR] 1.20, 95% confidence interval [CI] 1.08, 1.33) and was associated with twice the risk of child social–emotional delay (RR 2.22, 95% CI 1.78, 2.77). Mothers who reported adverse childhood experiences (ACES) (RR 1.08, 95% CI 1.04, 1.11) and intimate partner violence (IPV) (RR 1.28, 95% CI 1.11, 1.47) interacted less frequently with their children than women without these experiences. Conclusion: In this cohort of Kenyan mother–child pairs followed from pregnancy through childhood, perinatal depressive symptoms were associated with lower mother–child engagement, which was associated with double the risk of child social–emotional delay.

BACKGROUND Fully remote online health research is vulnerable to fraudulent participation that can threaten data validity and divert study resources. Although fraud mitigation is increasingly necessary in online research, mitigation efforts are rarely described systematically or evaluated transparently across studies. OBJECTIVE This study demonstrates the application of the configure, assess, triage, corroborate, and hone (CATCH) framework to an ongoing remote mental health study and evaluates how structured mitigation procedures have affected participant progression and operational costs. METHODS This study was conducted within an ongoing, fully remote mental health study evaluating hallucinations through longitudinal digital data collection. Following detection of fraudulent activity, the CATCH framework was applied to organize mitigation procedures into stages and refine detection and verification workflows. New screening safeguards were configured, classification thresholds were recalibrated, enrolled participants were reassessed and triaged accordingly, and secondary corroboration through synchronous video verification was introduced when warranted. Procedures were honed through ongoing monitoring in response to emerging fraud patterns. We compared 2 temporally defined cohorts before (March-August 2025) and after (September 2025-January 2026) the implementation of the refined procedures. Primary outcomes included the stage at which fraudulent participants were identified and cost per eligible participant, decomposed into costs attributable to fraudulent participants, nonfraudulent participants, and fraud-mitigation technology. Participant-level costs were estimated using a stage-based model incorporating participant compensation and research staff effort. Sensitivity analyses examined alternative compensation and staffing scenarios to assess the generalizability of the proposed cost-accounting mechanism. RESULTS Following CATCH implementation, fraudulent participants were identified earlier in the study workflow, reducing progression to later study stages. Overall, 41.5% (161/388) of reassessed participants were discharged for suspected fraud, while 58.5% (227/388) were retained following adjudication. Among those flagged as high risk and invited to video verification, 1.8% (3/164) successfully confirmed their identity, providing a lower-bound estimate of the false-positive classification rate. The mean sunk cost per fraudulent participant decreased from US $12.75 (SD US $40.76) in the pre-CATCH cohort to US $3.29 (SD US $10.91) in the post-CATCH cohort. Total cost per eligible participant decreased from US $170.48 to US $134.90, driven by a substantial reduction in the fraud-related portion from US $80.46 to US $19.73. Sensitivity analyses showed reductions in fraud-related cost per eligible participant across all alternative costing scenarios. To our knowledge, this is the first empirical demonstration of a structured fraud-mitigation framework implemented and evaluated within an active health study. CONCLUSIONS Structuring fraud mitigation using an explicit framework enabled systematic documentation of procedural adaptations and their operational consequences. Beyond study-specific findings, this work illustrates how organizing fraud mitigation into defined, reportable stages can promote transparency, reproducibility, and cumulative learning across remote health studies. Treating fraud mitigation as an integral methodological component is essential for safeguarding scientific integrity and legitimate resource expenditure in online research.

Objectives: Mobile health (mHealth) interventions are increasingly used to support illness self-management for individuals with schizophrenia spectrum disorders (SSD). Yet limited research explores how symptom patterns that vary throughout an intervention period can be used to identify individuals who may benefit from tailored support. Leveraging daily self-ratings from FOCUS, an mHealth intervention for SSD, we identified and characterized distinct self-reported symptom patterns. Methods: We conducted a prospective cohort study as a secondary analysis using data from a hybrid type 3 effectiveness–implementation trial of FOCUS across 23 community mental health programs. Participants used FOCUS for up to 90 days and provided daily self-ratings on mood, sleep, and/or auditory hallucinations. Group-Based Trajectory Modeling (GBTM) was used to identify longitudinal trajectories for each domain. We examined demographic, psychiatric, and functioning correlates of trajectory group membership. Results: Overall, 190 participants provided daily self-ratings for mood, sleep, or hallucinations. Participants provided a median of 33 ratings (IQR: 10, 84) across a median 82 days (IQR: 50, 88). For each domain, five distinct trajectory groups emerged. Mood ratings were largely stable over time, with one improving group. Sleep domain showed a unique worsening trajectory. Multiple groups improved in hallucinations self-ratings. Higher early self-rating response rates were associated with improving mood trajectories. Conclusions: Individuals with SSD exhibited distinct symptom expression trajectories over the course of treatment with an mHealth intervention. Trajectory-based approaches may inform adaptive mHealth designs and more targeted allocation of mHealth and clinical support resources.

Background: Integrating mental health care into well-attended health services, such as maternal-child health (MCH), offers a promising approach to increasing access to mental health care. To inform integration, we assessed the current approach to screening and treatment of perinatal mood and anxiety disorders (PMAD) in MCH facilities in Western Kenya. Methods: We conducted a cross-sectional survey among the facility managers (“in-charges”) at 20 MCH facilities in Western Kenya. Trained data collectors administered questionnaires to assess facility infrastructure and human resources, perinatal mental health screening, psychological interventions, psychiatric medication availability, and level of perinatal mental health integration into standard MCH services. Results: Across 20 MCH facilities, the majority were located in rural areas (16,80%), 2 peri-urban (10%), and 2 urban (10%). Facilities had a median of 37.5 medical staff (IQR: 31.0, 45.5); the most common cadre was nurses (median: 9.0, IQR: 6.0, 12.5). Under half of the facilities (8, 40%) screened for PMAD using a validated tool and documented results; most (19, 95%) reported diagnosing PMAD, yet only half (10, 53%) documented the diagnosis. The most common psychotherapy reported across the sites was supportive counseling (15, 75%). Some facilities offered evidence-based psychotherapies (e.g., cognitive behavioral therapy, problem-solving therapy, etc.), but did not report on training, supervision or guidance from the evidence-based intervention manual. Across all facilities, the availability of mental health medications was limited. Only (12, 60%) had any antidepressant available, (16, 80%) had antiepileptics, (9, 45%) had antipsychotics, and (2, 10%) had mood stabilizers available. Conclusion: Mental health services in MCH clinics in Western Kenya are currently not offered in a structured and systematic manner to effectively alleviate PMAD. Available infrastructure and human resources offer an opportunity to integrate an evidence-based treatment model to improve perinatal mental health in the MCH clinics in Western Kenya.