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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV/AIDS; Alcohol Abuse
• Intervention / Treatment: Behavioral: Mlambe

Detailed Description

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.

To 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.

For 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Mkandawire; Phone Number: +265 8883 70081; Email: james3mkandawire@gmail.com
• Study Contact Backup: Name: Amy Conroy, PhD; Phone Number: 415-476-6021; Email: Amy.conroy@ucsf.edu

Study Locations

• Malawi
  • Zomba, Malawi
    • Invest in Knowledge Initiative (IKI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. In a married or cohabitating union
2. Have at least one partner with a positive AUDIT-C screen in prior 3 months
3. Must also currently be on ART for at least 6 months
4. Must have disclosed their HIV status to their partner

Exclusion Criteria:

1) Severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Comparison; Standard of care, e.g. regular HIV care plus brief advice on alcohol use
Experimental: Mlambe Intervention; A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or 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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	11 months
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or 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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	15 months
Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or 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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 months
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.	11 months
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.	15 months
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.	20 months
Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	11 months
Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	15 months
Medical appointment adherence assessment	Appointment adherence will be defined as no missed HIV care visits in the past 3 months.	20 months
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.	11 months
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.	15 months
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.	20 months
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)	11 months
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)	15 months
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)	20 months
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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	11 months
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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	15 months
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/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.	20 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	11 months
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.	15 months
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.	20 months
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.	11 months
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.	15 months
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.	20 months
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.	11 months
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.	15 months
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.	20 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Amy Conroy, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Conroy AA, McKenna SA, Ruark A. Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi. AIDS Behav. 2019 Jan;23(1):201-210. doi: 10.1007/s10461-018-2275-2.
• Conroy A, Leddy A, Johnson M, Ngubane T, van Rooyen H, Darbes L. 'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples. Cult Health Sex. 2017 Nov;19(11):1239-1253. doi: 10.1080/13691058.2017.1309460. Epub 2017 Apr 11.
• Conroy AA, Ruark A, McKenna SA, Tan JY, Darbes LA, Hahn JA, Mkandawire J. The Unaddressed Needs of Alcohol-Using Couples on Antiretroviral Therapy in Malawi: Formative Research on Multilevel Interventions. AIDS Behav. 2020 Jun;24(6):1599-1611. doi: 10.1007/s10461-019-02653-y.
• Darbes LA, McGrath NM, Hosegood V, Johnson MO, Fritz K, Ngubane T, van Rooyen H. Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):404-413. doi: 10.1097/QAI.0000000000001948.
• Ssewamala FM, Han CK, Neilands TB. Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda. Soc Sci Med. 2009 Jul;69(2):191-8. doi: 10.1016/j.socscimed.2009.05.019. Epub 2009 Jun 10.
• Bermudez LG, Ssewamala FM, Neilands TB, Lu L, Jennings L, Nakigozi G, Mellins CA, McKay M, Mukasa M. Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda. AIDS Behav. 2018 Nov;22(11):3763-3772. doi: 10.1007/s10461-018-2173-7.
• Conroy AA, Tebbetts S, Darbes LA, Hahn JA, Neilands TB, McKenna SA, Mulauzi N, Mkandawire J, Ssewamala FM. Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi. AIDS Behav. 2023 Jul;27(7):2255-2270. doi: 10.1007/s10461-022-03956-3. Epub 2022 Dec 15.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: R01AA031445 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The dataset will include self-reported demographic and behavioral data from surveys and laboratory data from blood specimens. Individual-participant level or IPD data will be shared. The data will be made in a de-identified format. In addition to the IPD dataset, the researcher will share the data dictionary and final protocol with amendments.

Identifiable data will be de-identified prior to repository submission. All participant-level data will be preserved and shared through deposition in the National Institute on Alcohol Abuse and Alcoholism (NIAAA) sponsored data repository, the NIAAA Data Archive (NIAAADA), a controlled access public repository. The NIAAADA is housed within the NIMH Data Archive (NDA).

• IPD Sharing Time Frame: All collection data will be shared automatically two years after the grant end date specified on the first Notice of Award. Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, even if the publication occurs before the two-year automatic share date.
• IPD Sharing Access Criteria: The data will be made available for sharing with the general research community via the NIAAA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAADA data by submitting a data access request in accordance with applicable NIAAADA policies. Data requests will be reviewed and granted by an NDA Data Access Committee. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No