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NCT Number: NCT06367348

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Alcohol Abuse Alcohol-Related Disorders Alcoholism Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Invest in Knowledge Initiative (IKI)

Zomba, Malawi

Location status: Recruiting

Location contact

James Mkandawire

CONTACT

[email protected]

CONTACT

0888370081

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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). Couples who participated in Mlambe's pilot study will also be excluded.

Treatment and study plan

Mlambe

Behavioral

A combined economic and relationship-strengthening intervention. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.

Primary outcomes

  1. Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test

    Time frame: 11 months

    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.

  2. Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test

    Time frame: 15 months

    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.

  3. Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test

    Time frame: 20 months

    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.

Secondary outcomes

  1. Viral Suppression measured using whole blood viral load tests

    Time frame: 15 months

    Viral suppression will be defined as a viral load value below the limit of detection of the test.

  2. Antiretroviral medication adherence measured using a Visual Analog Scale

    Time frame: 11 months

    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.

  3. Antiretroviral medication adherence measured using a Visual Analog Scale

    Time frame: 15 months

    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.

  4. Antiretroviral medication adherence measured using a Visual Analog Scale

    Time frame: 20 months

    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.

  5. Medical appointment adherence assessment

    Time frame: 11 months

    Appointment adherence will be defined as no missed HIV care visits in the past 3 months.

  6. Medical appointment adherence assessment

    Time frame: 15 months

    Appointment adherence will be defined as no missed HIV care visits in the past 3 months.

  7. Medical appointment adherence assessment

    Time frame: 20 months

    Appointment adherence will be defined as no missed HIV care visits in the past 3 months.

  8. Number of drinking days measured using the "Timeline follow-back" method

    Time frame: 11 months

    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.

  9. Number of drinking days measured using the "Timeline follow-back" method

    Time frame: 15 months

    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.

  10. Number of drinking days measured using the "Timeline follow-back" method

    Time frame: 20 months

    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. AUDIT-C score measured using the Alcohol Use Disorders Identification Test.

    Time frame: 11 months

    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)

  12. AUDIT-C score measured using the Alcohol Use Disorders Identification Test.

    Time frame: 15 months

    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)

  13. AUDIT-C score measured using the Alcohol Use Disorders Identification Test.

    Time frame: 20 months

    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)

  14. PEth level measured using a Phosphatidylethanol biomarker test

    Time frame: 11 months

    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. PEth level measured using a Phosphatidylethanol biomarker test

    Time frame: 15 months

    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.

  16. PEth level measured using a Phosphatidylethanol biomarker test

    Time frame: 20 months

    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.

Other outcomes

  1. Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.

    Time frame: 11 months

    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.

  2. Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.

    Time frame: 15 months

    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.

  3. Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.

    Time frame: 20 months

    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.

  4. Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.

    Time frame: 11 months

    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.

  5. Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.

    Time frame: 15 months

    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.

  6. Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.

    Time frame: 20 months

    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.

  7. Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)

    Time frame: 11 months

    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.

  8. Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)

    Time frame: 15 months

    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.

  9. Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)

    Time frame: 20 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Conroy, PhD

CONTACT

[email protected]

415-476-6021

James Mkandawire

CONTACT

[email protected]

+265 8883 70081

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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