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