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

NCT06900634 | Not Yet Recruiting

• 2 other identifiers: HS-2024-0098K01AA031208
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Antiretroviral Therapy (ART) Adherence; Alcohol Consumption

Keywords

hiv; motivational interviewing; behavioral economics; alcohol use disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  measured at baseline, 3 and 6 months follow up

• 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).

  measured at baseline and 6 months follow up

Secondary Outcomes (1)

• Alcohol reduction (self report)

  measured at baseline 3 and 6 months follow up

Study Arms (2)

Kisoboka Amaka

EXPERIMENTAL

Behavioral: Kisoboka Amaka

Screening and Referral

ACTIVE COMPARATOR

Behavioral: Screening and Referral

Interventions

Kisoboka Amaka BEHAVIORAL

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.

Kisoboka Amaka

Screening and Referral BEHAVIORAL

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

Screening and Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FOR MEN
• 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
• not planning to move from the area within the next 6 months;
• have their own mobile phone and can be reached via phone.
• FOR WOMEN
• + years of age (or emancipated minor)
• Pregnant
• HIV negative
• FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)
• married/living together \>6 months;
• planning to stay together \>6 months
• lived in the area for \>3 months and

You may not qualify if:

• FOR MEN
• 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;
• unable to read basic Luganda or English
• FOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Makerere University: collaborator

Study Sites (1)

Makerere University Walter Reed Program

Kampala, Uganda

Location

MeSH Terms

Conditions

Alcohol Drinking; Acquired Immunodeficiency Syndrome; Alcoholism

Interventions

Mass Screening; Referral and Consultation

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Central Study Contacts

Amanda P Miller, PhD, MS

CONTACT

610-203-1134; apmiller@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will not have data for sharing in the first three years of the study and will delay our first submission by updating submission dates (per the NIAAADA guidance). The research community will gain access to the uploaded data when the award ends. As required by NIAAADA, we will also create studies that contain the data used for every publication (except in instances where this data doesn't meet NIH sharing requirements, as described under #2) and include the digital object identifiers (DOI) for that study in the manuscript to aid in findability. NIAAADA will make decisions about how long to preserve the data.
• Access Criteria: Data will be findable for the research community through the NIMH Data Archive (NIAAA Data Archive specifically) which is established at the time of study funding. For all publications, an NIAAA Data Archive study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA Data Archive repository data by submitting a data access request in accordance with applicable NIAAA Data Archive repository policies. Data requests will be reviewed and granted by an NIMH/NIAAA Data Archive Data Access Committee.

Locations

UG (1)