[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544320":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":70,"studyPopulation":67,"armGroups":71,"interventions":82,"overallOfficials":88,"centralContacts":92,"locations":101,"responsibleParty":119,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":67,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":67,"enrollmentInfo":135,"targetDuration":67,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":67,"overallStatus":104,"whyStopped":67,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":46},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and\u002For the Phosphatidylethanol test","The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng\u002FmL), PEth has a value range of 0 to over 400 ng\u002FmL. Higher scores indicate unhealthy drinking.","11 months",{"measure":10,"description":11,"timeFrame":14},"15 months",{"measure":10,"description":11,"timeFrame":16},"20 months",[18,21,24,25,26,29,30,31,34,35,36,39,40,41,44,45],{"measure":19,"description":20,"timeFrame":14},"Viral Suppression measured using whole blood viral load tests","Viral suppression will be defined as a viral load value below the limit of detection of the test.",{"measure":22,"description":23,"timeFrame":12},"Antiretroviral medication adherence measured using a Visual Analog Scale","Antiretroviral medication adherence will be measured using the adapted Visual Analog Scale. Scores range from 0-100% adherence. 95% adherence or more will be considered adherent.",{"measure":22,"description":23,"timeFrame":14},{"measure":22,"description":23,"timeFrame":16},{"measure":27,"description":28,"timeFrame":12},"Medical appointment adherence assessment","Appointment adherence will be defined as no missed HIV care visits in the past 3 months.",{"measure":27,"description":28,"timeFrame":14},{"measure":27,"description":28,"timeFrame":16},{"measure":32,"description":33,"timeFrame":12},"Number of drinking days measured using the \"Timeline follow-back\" method","Number of drinking days in the past 30 days will be measured using the \"timeline follow-back\" method. Value Range from 0-30. Higher numbers indicate more drinking days.",{"measure":32,"description":33,"timeFrame":14},{"measure":32,"description":33,"timeFrame":16},{"measure":37,"description":38,"timeFrame":12},"AUDIT-C score measured using the Alcohol Use Disorders Identification Test.","The three item Alcohol Use Disorders Identification Test (Audit-C) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking (continuous variable)",{"measure":37,"description":38,"timeFrame":14},{"measure":37,"description":38,"timeFrame":16},{"measure":42,"description":43,"timeFrame":12},"PEth level measured using a Phosphatidylethanol biomarker test","The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng\u002FmL), PEth has a value range of 0 to over 400 ng\u002FmL. Higher scores indicate unhealthy drinking.",{"measure":42,"description":43,"timeFrame":14},{"measure":42,"description":43,"timeFrame":16},[47,50,51,52,55,56,57,60,61],{"measure":48,"description":49,"timeFrame":12},"Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.","The Communications Pattern Questionnaire (CPQ) assesses communication styles and patterns within relationships. Mutually constructive communication consists of three items. Scores can range from 3-15 using a 5 point Likert scale. Higher scores indicate more constructive communication.",{"measure":48,"description":49,"timeFrame":14},{"measure":48,"description":49,"timeFrame":16},{"measure":53,"description":54,"timeFrame":12},"Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.","Measure adapted from the HIV-specific Partner Support Scale. Scores can range from 9-45 using a 5 point Likert scale (9 variables). Higher scores indicate higher alcohol specific partner support.",{"measure":53,"description":54,"timeFrame":14},{"measure":53,"description":54,"timeFrame":16},{"measure":58,"description":59,"timeFrame":12},"Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)","Items adapted from the World Health Organization Domestic Violence module and the Malawi Demographic and Health Survey. Physical, sexual, and emotional IPV is captured. Three response items per variable (Never, Sometimes, Frequently). Higher scores indicate higher levels of IPV.",{"measure":58,"description":59,"timeFrame":14},{"measure":58,"description":59,"timeFrame":16},{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":67,"timePerspective":67,"maskingInfo":68},"RANDOMIZED","PARALLEL","Couples will be randomized 1:1 to intervention or control arm","SUPPORTIVE_CARE",null,{"masking":69,"maskingDescription":67,"whoMasked":67},"NONE","The inter-related issues of alcohol use, intimate partner violence (IPV), and economic insecurity threaten to derail progress towards UNAIDS 95-95-95 targets in sub-Saharan Africa (SSA). Rates of heavy drinking are alarmingly high among people living with HIV (PLWH), and almost twice that of the general population. Heavy drinking is very common in Malawi, and has deleterious effects on antiretroviral therapy (ART) adherence and HIV clinical outcomes, but also indirectly affects health by damaging the couple relationships needed for social support, economic survival, and well-being. Most alcohol interventions treat heavy drinking as an individual-level issue; however, for people in committed relationships, research suggests an urgent need for interventions that consider alcohol use as a couple-level issue involving both partners. Novel alcohol interventions are paramount for breaking cycles of IPV and poverty, and creating stronger families to prevent HIV, and reduce HIV mortality, morbidity, and transmission. Yet, no interventions to date have jointly addressed the economic and relationship context of drinking alcohol among people living with HIV in SSA, which may have synergistic effects on heavy alcohol use when combined.\n\nTo address this gap, the investigators developed and tested Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking. Pilot results showed that Mlambe was feasible and acceptable, and showed promise of efficacy. Given this strong evidence, the investigators will evaluate the efficacy and cost-effectiveness of Mlambe with a full-scale RCT. This is the first RCT of an integrated economic and relationship-strengthening intervention to address alcohol use in HIV-affected couples.\n\nFor Aim 1, the primary hypothesis is that the odds of heavy alcohol use will be lower in Mlambe as compared to enhanced usual care (EUC). Secondarily, the investigators expect that Mlambe participants will have a higher odds of ART and appointment adherence, and viral suppression, and lower number of drinking days, AUDIT-C score, and PEth levels. For Aim 2, the investigators hypothesize that Mlambe participants will report greater improvements in relationship dynamics (e.g., better communication, less IPV) as compared to EUC participants.",[72,76],{"label":73,"type":74,"description":75,"interventionNames":67},"Control Comparison","NO_INTERVENTION","Standard of care, e.g. regular HIV care plus brief advice on alcohol use",{"label":77,"type":78,"description":79,"interventionNames":80},"Mlambe Intervention","EXPERIMENTAL","A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.",[81],"Behavioral: Mlambe",[83],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":67},"BEHAVIORAL","Mlambe","A combined economic and relationship-strengthening intervention. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.",[77],[89],{"name":90,"affiliation":5,"role":91},"Amy Conroy, PhD","PRINCIPAL_INVESTIGATOR",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":67,"email":97},"James Mkandawire","CONTACT","+265 8883 70081","james3mkandawire@gmail.com",{"name":90,"role":95,"phone":99,"phoneExt":67,"email":100},"415-476-6021","Amy.conroy@ucsf.edu",[102],{"facility":103,"status":104,"city":105,"state":67,"zip":67,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Invest in Knowledge Initiative (IKI)","RECRUITING","Zomba","Malawi","MW",{"type":109,"coordinates":110},"Point",[111,112],35.3188,-15.38596,{"lat":112,"lon":111},[115,117],{"name":94,"role":95,"phone":67,"phoneExt":67,"email":116},"james.mkandawire@investinknowledge.org",{"name":67,"role":95,"phone":118,"phoneExt":67,"email":67},"0888370081",{"type":120,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR",[122],{"name":123,"class":124},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100544320","an-economic-and-relationship-strengthening-intervention-to-reduce-alcohol-use-in-malawi-100544320",false,"NCT06367348","An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi","Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi","Inclusion Criteria:\n\n1. In a married or cohabitating union\n2. Have at least one partner with a positive AUDIT-C screen in prior 3 months\n3. Must also currently be on ART for at least 6 months\n4. Must have disclosed their HIV status to their partner\n\nExclusion Criteria:\n\n1\\) Severe intimate partner violence reported in previous 3 months and\u002For fear that safety would be at risk by participation in the study (reported at screening). Couples who participated in Mlambe's pilot study will also be excluded.",true,"ALL","18 Years",{"count":136,"type":137},500,"ESTIMATED","INTERVENTIONAL",[140],"NA","With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.",[143,144],"HIV\u002FAIDS","Alcohol Abuse","2026-05-11",{"date":147,"type":148},"2026-05-14","ACTUAL",{"date":150,"type":148},"2025-02-14",{"date":152,"type":137},"2028-05",{"name":5,"class":6},1]