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Completed

NCT Number: NCT04906616

An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples 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

About this study

This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.

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 who is also currently on ART for at least 6 months who has 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)

Treatment and study plan

Mlambe

Behavioral

A combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART.

Primary outcomes

  1. Enrollment Rate

    Time frame: Baseline (Time 0)

    Percentage of eligible couples enrolled in the study.

  2. Retention Rate

    Time frame: 15 months

    Percentage of enrolled and randomized participants retained at the end of the study

Secondary outcomes

  1. Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months

    Time frame: 10 months

    Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 10 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.

  2. Percentage of Couples Who Are Satisfied With the Intervention at 15 Months

    Time frame: 15 months

    Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 15 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.

  3. 10 Month Follow up Survey Completion

    Time frame: 10 months

    Percentage of couples who complete follow up surveys at 10 months

  4. 15 Month Follow up Survey Completion

    Time frame: 15 months

    Percentage of couples who complete follow up surveys at 15 months

  5. 75% Intervention Completion

    Time frame: 10 months

    Percentage of couples who attend 75% of intervention sessions

  6. 100% Intervention Completion

    Time frame: 10 months

    Percentage of couples who attend 100% of intervention sessions

Other outcomes

  1. Exploratory: Alcohol Use

    Time frame: 10 months, 15 months

    Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method

  2. Exploratory: Alcohol Use

    Time frame: 10 months, 15 months

    Non-heavy drinking determined by self-report (Alcohol Use Disorders Identification Test - Consumption [AUDIT-C], prior 3 months, negative) and phosphatidylethanol (PEth) <35 ng/mL (composite measure)

  3. Exploratory: Viral Suppression

    Time frame: 10 months, 15 months

    Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)

  4. Exploratory: ART Adherence

    Time frame: 10 months, 15 months

    Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Invest in Knowledge Initiative (IKI) - Zomba, Malawi
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Michigan
  • Washington University School of Medicine

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 28, 2021
Registry last updated
Feb 20, 2024

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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