[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525086":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":38,"armGroups":47,"interventions":54,"overallOfficials":62,"centralContacts":66,"locations":72,"responsibleParty":91,"collaborators":93,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":38,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":38,"enrollmentInfo":108,"targetDuration":38,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":75,"whyStopped":38,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":38},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Proportion of women who recovered from probable depression at 12 months postpartum","The depression score is calculated and severity assessed through a brief screener, the Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding the score for each question (total points). A total score of 0-4 suggests none to minimal depression severity, a score of 5-9 mild depression severity, a score of 10-19 moderate depression severity, and a score of 20-27 severe depression. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N).","Baseline, 12 months postpartum",{"measure":14,"description":15,"timeFrame":12},"Proportion of women who recovered from probable anxiety at 12 months postpartum","The anxiety score is calculated and severity assessed through a brief screener, Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 score is obtained by adding a score for each question (total points). A total score of 0-4 suggests none to minimal anxiety severity, a score of 5-9 mild anxiety severity, a score of 10-14 moderate anxiety severity, and a score of 15-21 severe anxiety. Recovery from the anxiety of pregnant and postpartum women living with HIV will be assessed as the change of a total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) less than 10 points at 12 months postpartum (anxiety not detected and coded as N).",{"measure":17,"description":18,"timeFrame":12},"Proportion of women who recovered from probable depression and\u002For anxiety at 12 months postpartum","Composite variable of recovery from common mental health conditions: Out of women with depression and\u002For anxiety at baseline, Y=recovery if depression and anxiety are both coded as N at the follow-up point; N = if at least one of the variables (depression, anxiety) is coded as Y at the follow-up point. Recovery from depression of pregnant and postpartum women living with HIV will be assessed as the change of a total PHQ-9 score from ≥10 points (depressed and coded as Y) at baseline to less than 10 points 12 months postpartum (not depressed and coded as N). Recovery from anxiety in pregnant and postpartum women living with HIV will be assessed as the change in total GAD-7 score from ≥10 points at baseline (anxiety detected and coded as Y) to less than 10 points at 12 months postpartum (anxiety not detected and coded as N).",{"measure":20,"description":21,"timeFrame":22},"Proportion of women with combined HIV care retention and treatment success outcome up to 12 months postpartum","Composite variable based on medical records: Y=if all described variables coded as Y, N=if at least one of the following variable coded as N: (1) Y=if a woman was retained in HIV care (didn't miss any HIV care appointment by 14 or more days after baseline up to 12 months postpartum), N=if a woman missed at least one HIV care appointment after baseline up to 12 months postpartum; (2) Y=woman had sustained suppressed HIV RNA (\\\u003C400 copies\u002Fml) after baseline up to 12 months postpartum, N=woman had at least one unsuppressed HIV RNA (≥400 copies\u002Fml) during the period after baseline up to 12 months postpartum. Variables assessed through monthly abstraction of medical records among pregnant and postpartum women living with HIV between baseline and up to 12 months postpartum.","Between baseline and up to 12 months PP",[24,28,31,35],{"measure":25,"description":26,"timeFrame":27},"Proportion of infants with low birth weight out of live births","A birth weight, measured in grams, and based on monthly abstraction of medical records, and categorized into normal weight (≥ 2500 grams at birth, coded as N) and low birth weight (\\\u003C2500 grams at birth, coded as Y).","Birth",{"measure":29,"description":30,"timeFrame":27},"Proportion of women with preterm delivery out of live births","The proportion of women who experienced a preterm delivery based on medical records. Coded as Y if woman delivered \\\u003C37 weeks of pregnancy and coded as N if delivered ≥37 weeks of pregnancy.",{"measure":32,"description":33,"timeFrame":34},"Infant HIV free survival","Proportion of infants alive and HIV-free at 12 months after birth. This is assessed in a brief interview and confirmed through medical records. Coded as Y if infant is alive and HIV-free at 12 months after birth, and coded as N if infant is not alive or HIV free at 12 months after birth.","Birth, 12 months",{"measure":36,"description":37,"timeFrame":34},"Infant retention in HIV care for infants who tested HIV+ among women completing 12 months postpartum","The proportion of infants who tested HIV-positive who remained enrolled in HIV care at 12 months, assessed in a brief interview and confirmed through medical records. Coded as Y if HIV+ infant is retained in care at 12 months after birth, and coded as N if infant is not retained in HIV care at 12 months after birth.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"NA","SINGLE_GROUP","A type 2 hybrid effectiveness-implementation trial with a stepped-wedge design","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":38,"whoMasked":38},"NONE","Common mental disorders (CMD) of depression and anxiety are prevalent and largely untreated among Kenyan pregnant and postpartum women living with HIV (PPWH). CMD lead to poor maternal and child health outcomes and contribute to lack of HIV care engagement and virologic failure in PPWH. While efficacious treatments for CMD exist, scaling treatment within routine health care in low- and middle-income (LMIC) settings will require stakeholder engagement and both effectiveness and implementation data to inform scale up and sustainability. The study team has integrated other efficacious interventions into antenatal (ANC) and HIV care in Kenya. The investigators now propose to integrate proven mental health services using a collaborative care model, combined with a low intensity evidence-based intervention (problem solving therapy), while targeting known social determinants of HIV-related health for PPWH (stigma and IPV). Building on the current multidisciplinary approach for HIV care in Kenya, the proposed Collaborative Care Model (CCM) will utilize existing peer mentor mothers, non-specialist behavioral care managers, and psychiatric nurses; and will incorporate a consultant psychiatrist into the ANC\u002FHIV care team. Guided by the EPIS (Exploration-Preparation-Implementation-Sustainment) framework, the overall study goal is to integrate collaborative care for perinatal CMD within routine ANC\u002FHIV services in Kenya, assess the costs and cost-effectiveness of this approach, and work with policy and decision makers to determine key considerations for scale-up. Specifically, in Aim 1, the investigators will identify contextual barriers and facilitators to refine an optimal integration model for delivering collaborative care model using multimethod data collection (focus groups with providers, in-depth interviews with key informants, and a clinic readiness checklist). A workshop with the study Advisory Board comprising of both county and national level stakeholders, will allow investigators to translate findings into a locally relevant CCM. In Aim 2, the investigators will test CCM in antenatal care for PPWH in a hybrid type 2 implementation-effectiveness trial using a stepped wedge design at 15 primary health care facilities in southwestern Kenya. The investigators will introduce CCM care for PPWH diagnosed with CMD during antenatal care. The co-primary health outcomes at 12 months postpartum will be (1) recovery from depression or anxiety symptoms in PPWH, and (2) proportion PPWH with sustained viral suppression and retention in HIV care. Key implementation outcomes are feasibility and acceptability. Finally, in Aim 3, the investigators will refine CCM implementation strategies through cost-effectiveness and dissemination research. The investigators will carry out costing and cost-effectiveness analysis and invite policy and decision-makers to participate in a nominal group technique process to elucidate factors for further scale up and sustainment of the CCM approach. Findings from this study will guide the development of a scalable model adaptable to other LMIC settings, contributing to global HIV and maternal health goals while addressing the burden of untreated CMD.",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Collaborative Care Model (CCM)","EXPERIMENTAL","The investigators propose a CCM called Tunawiri, meaning \"thrive\" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication.",[53],"Behavioral: Collaborative Care Model",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"BEHAVIORAL","Collaborative Care Model","The investigators propose a CCM called Tunawiri, meaning \"thrive\" in Kiswahili, that will be integrated within an existing multidisciplinary team of clinicians, mentor mothers, and other clinic staff in Kenyan antenatal care clinics. CCM includes: 1) clinic-level sensitization and integration, 2) Screening for CMD including anxiety, depression, and trauma symptoms, 3) Problem-solving type cognitive behavioral therapy delivered by lay health workers, 4) Decision Support and monitoring via an Electronic Health Registry, and 5) Psychiatrist case review and nurse-managed mental health medication.",[49],[61],"Tunawiri model",[63],{"name":64,"affiliation":5,"role":65},"Lisa Abuogi, MD, MSc","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":38,"email":71},"Lisa Abuogi, MD,MSc","CONTACT","303-724-9383","lisa.abuogi@cuanschutz.edu",[73],{"facility":74,"status":75,"city":76,"state":38,"zip":38,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Kenya Medical Research Institute","RECRUITING","Nairobi","Kenya","KE",{"type":80,"coordinates":81},"Point",[82,83],36.81667,-1.28333,{"lat":83,"lon":82},[86,89],{"name":87,"role":69,"phone":38,"phoneExt":38,"email":88},"Maricianah Onono, MBChB","monono@kemri-ucsf.org",{"name":90,"role":69,"phone":38,"phoneExt":38,"email":71},"Lisa Abuogi, MD",{"type":92,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[94,96,97],{"name":95,"class":6},"University of North Carolina, Chapel Hill",{"name":74,"class":6},{"name":98,"class":6},"University of Alabama at Birmingham","100525086","integrated-mental-health-care-for-pregnant-women-with-hiv-in-kenya-the-tunawiri-study-100525086",false,"NCT06117163","Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study","Integration of a Collaborative Care Model for Mental Health Services Into HIV Care for Pregnant and Postpartum Women in Kenya (the Tunawiri Study)","Inclusion Criteria:\n\n* pregnant woman living with HIV attending an antenatal clinic in southwestern Kenya\n* screening positive for probable common mental disorders\n* living in catchment area of study facility.\n* on\u002Finitiating ART\n* \\>15 years of age\n\nExclusion Criteria:\n\n* imminent plans of suicide\n* severe impairment due to severe mental, neurological or substance use disorders.","FEMALE","15 Years",{"count":109,"type":110},900,"ESTIMATED","INTERVENTIONAL",[40],"This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.",[115,116],"Human Immunodeficiency Virus","Mental Disorder",[118,119,120,121,122,123,124,125,126,127,128,129,130,131],"HIV transmission","Prevention of Mother to Child Transmission","Linkage to care","Retention in care","Antiretroviral therapy adherence","Infant Health","Maternal CD4\u002Fviral loads","Early infant diagnosis","Acceptability of interventions","Vertical transmission","Mental Health","The Collaborative Care Model","Problem Solving Therapy","Stigma","2026-10-05",{"date":134,"type":135},"2026-10-08","ACTUAL",{"date":137,"type":135},"2024-10-01",{"date":139,"type":110},"2028-05-31",{"name":5,"class":6},1]