[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633329":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":60,"centralContacts":64,"locations":73,"responsibleParty":95,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":34,"enrollmentInfo":111,"targetDuration":34,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":126,"whyStopped":34,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Yale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants diagnosed","Number of participants screened and diagnosed with anxiety and\u002For depression.","up to 18 months",[14,17,21,25,28,31],{"measure":15,"description":16,"timeFrame":12},"Number of participants linked to care","Number of participants linked to care for mental health, alcohol use disorder, HIV and\u002For hypertension.",{"measure":18,"description":19,"timeFrame":20},"Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)","3-item alcohol screening tool (abbreviated version of the 10-question AUDIT) that identifies hazardous drinking or active alcohol use disorders. It is scored 0-12. Higher scores indicate a higher likelihood of harmful alcohol consumption.","Baseline and 6, 12, 18 months",{"measure":22,"description":23,"timeFrame":24},"Mean systolic blood pressure","Mean systolic blood pressure in mmHg","Baseline and 6, 12 months",{"measure":26,"description":27,"timeFrame":24},"Mean diastolic blood pressure","Mean diastolic blood pressure in mmHg",{"measure":29,"description":30,"timeFrame":24},"Number of participants with HIV viral load suppression","HIV viral load suppression defined as having \\\u003C200 copies\u002FmL of HIV RNA in the blood",{"measure":32,"description":33,"timeFrame":24},"Self-reported medication adherence","Assessed as mean days adherent in the last 7 days",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Adult participants from 3 clinic sites from the Kampala district that are living with HIV and\u002F hypertension that are currently receiving care at the participating clinic sites. . (A subset of these participants with hypertension will be enrolled into a longitudinal cohort.)","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","All staff will be trained in mental health screening prior to the trial launch, and all clinics will be equipped with health education materials to raise awareness of mental health, self-care and available resources in the clinic and community",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"SAMU intervention","EXPERIMENTAL","Participants will receive the SAMU digital mental health screening intervention and SMS reminders to complete a SAMU session over the duration of trial consistent with their level of need.",[49],"Device: Syndemic-Adapted Medly Uganda (SAMU)",{"label":51,"type":52,"description":53,"interventionNames":34},"Control","NO_INTERVENTION","Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"DEVICE","Syndemic-Adapted Medly Uganda (SAMU)","Participants will receive an SMS reminding them to enter a SAMU screening session at a regular basis, based on their initial screening scores. Subsequent screeners will trigger a tailored message based on the participants' inputs.",[45],[61],{"name":62,"affiliation":5,"role":63},"Jeremy Schwartz, MD","PRINCIPAL_INVESTIGATOR",[65,69],{"name":62,"role":66,"phone":67,"phoneExt":34,"email":68},"CONTACT","203-530-7261","jeremy.schwartz@yale.edu",{"name":70,"role":66,"phone":71,"phoneExt":34,"email":72},"Sarah Christie, PhD, MPH","475-439-4660","sarah.christie@yale.edu",[74,85,90],{"facility":75,"status":34,"city":76,"state":34,"zip":34,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":34},"Kawaala Hospital","Kampala","Uganda","UG",{"type":80,"coordinates":81},"Point",[82,83],32.58219,0.31628,{"lat":83,"lon":82},{"facility":86,"status":34,"city":76,"state":34,"zip":34,"country":77,"countryCode":78,"cosmosGeoPoint":87,"geoPoint":89,"contacts":34},"Naguru Hospital",{"type":80,"coordinates":88},[82,83],{"lat":83,"lon":82},{"facility":91,"status":34,"city":76,"state":34,"zip":34,"country":77,"countryCode":78,"cosmosGeoPoint":92,"geoPoint":94,"contacts":34},"Nsambya Hospital",{"type":80,"coordinates":93},[82,83],{"lat":83,"lon":82},{"type":96,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[98],{"name":99,"class":100},"National Institute of Mental Health (NIMH)","NIH","100633329","trial-phase-syndemic-adapted-medly-uganda-100633329",false,"NCT07525271","Trial Phase: Syndemic Adapted Medly Uganda","An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)","SAMU","Inclusion Criteria:\n\n* Patient at a participating HIV clinic site\n* Currently living in Uganda with no intention of moving abroad in next 2 years\n* Access to a mobile phone\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.\n\nExclusion Criteria:\n\n* No access to a mobile phone\n* Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW\n\nHealthcare Workers\u002FCaregivers Criteria:\n\n* Age \\>=18 years\n* Healthcare worker at participating site or caregiver for study participant at site\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant","ALL","18 Years",{"count":112,"type":113},1500,"ESTIMATED","INTERVENTIONAL",[116],"NA","The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.",[119],"Mental Health",[121,122,123,124,125],"Depression","Anxiety","HIV","Alcohol Use Disorder","hypertension","NOT_YET_RECRUITING","2026-08-18",{"date":129,"type":130},"2026-08-19","ACTUAL",{"date":132,"type":113},"2026-09",{"date":134,"type":113},"2028-06",{"name":5,"class":6},3]