Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.

Summary

Hazardous alcohol use, which is common among men in Uganda, is a primary driver of both HIV risk and intimate partner violence (IPV) in this setting. Among men living with HIV, alcohol use is associated with non-adherence to antiretroviral therapy (ART) and a detectable viral load, increasing the risk of onward HIV transmission to partners. This risk is further heightened when the partner is pregnant, due to the potential for vertical transmission. Therefore, addressing factors that interfere with optimal HIV care outcomes among men living with HIV is critical to HIV prevention in pregnant women.

The goal of this randomized controlled trial (RCT) is to pilot test an intervention that combines alcohol reduction and economic strengthening to improve ART adherence. The study will assess implementation outcomes and preliminary efficacy among men living with HIV who engage in hazardous alcohol use and their pregnant partners (n=30 couples). The main questions it aims to answer are:

1. What are the implementation outcomes (acceptability, appropriateness, feasibility, fidelity, and safety) at the individual, implementer, and organizational levels, and what bridging factors may impede success (e.g., community-academic partnership)?
2. Does the intervention reduce hazardous alcohol use and improve ART adherence among men living with HIV?

Researchers will compare the intervention group (n=15 couples) to the standard of care group (n=15 couples) to determine if the intervention leads to behavior change in alcohol use and ART adherence among men living with HIV.

Participants will:

1. Men in the intervention group will receive the Amaka intervention, designed to reduce alcohol use and improve ART adherence.
2. Complete assessments on hazardous alcohol use, ART adherence, and implementation outcomes at multiple time points (baseline, 3 and 6 months).
3. Engage with implementers to provide post-implementation feedback on feasibility and acceptability.

Conditions

• HIV Antiretroviral Therapy (ART) Adherence
• Alcohol Consumption

Interventions

BEHAVIORAL

Kisoboka Amaka

KISOBOKA AMAKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component focuses on depositing earnings into mobile savings programs. Kisoboka Amaka content will be "finalized" in aims 1 and 2. However, we expect core intervention components to remain unchanged including: 4 counseling sessions (2 individual, 2 group), 2x weekly text message reminders of goals and mobile money set up. Potential additional components include: 1 family focused couples session, self monitoring of alcohol use (via mobile breathalyzer) and PEth (an objective biomarker measure of alcohol use) boosted alcohol counseling.

BEHAVIORAL

Screening and Referral

Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Makerere University

  collaborator OTHER

• San Diego State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-02-01

Primary Completion

2027-12-01

Completion

2028-02-01

Countries

• Uganda

Study Locations