protocolSection identificationModule nctId: NCT06367348, orgStudyIdInfo id: R01AA031445, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031445, secondaryIdInfos id: R01AA031445, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031445, briefTitle: An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: 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., conditionsModule conditions: HIV/AIDS, conditions: Alcohol Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Couples will be randomized 1:1 to intervention or control arm, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Mlambe, outcomesModule primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, secondaryOutcomes measure: Viral Suppression measured using whole blood viral load tests, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Invest in Knowledge Initiative (IKI), city: Zomba, country: Malawi, geoPoint lat: -15.38596, lon: 35.3188, hasResults: False