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.
living with HIV;
AUDIT-C positive (≥4) indicating potential hazardous drinking;
>6 months since initial antiretroviral treatment (ART) initiation;
an indicator of potential suboptimal treatment as prevention (TasP) either: (i) last HIV viral load test (within 6 months) was detectable (>20) or (ii) last viral load test between 6 and 13 months ago was detectable (>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks
visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
does not speak Luganda or English;
currently receiving a majority of work payments via mobile money/digital payments;
participated in the Kisoboka pilot RCT;
Parallel
Kisoboka Amaka
BehavioralKISOBOKA 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.
Screening and Referral
BehavioralAlcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
Antiretroviral therapy adherence
ART adherence, measured by level of ARVs detected via blood sample (DBS). Complete adherence (100%) will be defined as TDF \>1250 fmol/punch, 700-1249 fmol/punch indicates 4-6 doses per week, 350-699 fmol/punch indicates 2-3 doses per week and \<350 fmol/punch indicates \<2 doses per week.
Alcohol reduction (change in PEth)
Reduction in PEth (Non-heavy use will be defined as a PEth result ≥20 ng/ml but \<200 ng/ml156. Chronic/heavy use via PEth will be defined as a PEth result ≥200 ng/ml156.\*this high threshold was selected due to high levels of heavy alcohol use among MLWH in Uganda).
Alcohol reduction (self report)
Self-reported hazardous use (AUDIT-C \>3).
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San Diego State University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Makerere University
Collaborator
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