Clinical trial NCT06900634: Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living with HIV with Pregnant Partners in Uganda.
Official title: Utilizing Implementation Research Methodologies to Adapt an Intervention to Reduce Alcohol Use and Improve HIV Care Outcomes Among Men Living with HIV Who Have Serodiscordant Pregnant Partners
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Alcohol Consumption
Keywords: hiv
motivational interviewing
behavioral economics
alcohol use disorder
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Makerere University
First posted: 2025-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed description: Men in Uganda who drink heavily face serious health and social challenges, including difficulty staying on HIV treatment, which increases the risk of passing HIV to their partners. Pregnant women in serodiscordant relationships, where the male partner has HIV but the woman does not, are at especially high risk of infection. Reducing alcohol use and improving HIV treatment adherence in men is critical to protecting both their partners and future children from HIV.

To address this issue, researchers previously developed Kisoboka ("It is possible"), an intervention designed to help men reduce alcohol use and engage in HIV care. The original Kisoboka program, tested among fisherfolk in Uganda, combined counseling, text message reminders, and economic strengthening-helping participants open and save money in mobile banking accounts-to improve long-term financial planning while reducing alcohol-related harm. The study found that Kisoboka successfully helped men reduce alcohol use and improve HIV care, but many participants continued drinking at risky levels, suggesting the need for additional support.

The present study adapts Kisoboka for a new population: men living with HIV who are not part of fishing communities but have pregnant partners who do not have HIV. The adapted version, called Kisoboka Amaka ("It is possible, Family!"), maintains the core elements of the original intervention while introducing new strategies tailored to this population, including couples' communication support and biofeedback on alcohol use using biomarker testing or mobile phone breathalyzers.

To ensure the program meets the needs of this new group, the study will first gather input from men living with HIV, their pregnant partners, and healthcare providers to identify necessary modifications (AIM 1). Researchers will explore whether adding biofeedback tools, such as alcohol biomarker tests or mobile phone breathalyzers, could enhance counseling by giving participants a clearer picture of their alcohol use. They will also assess whether a couples' session could improve communication and shared financial goal-setting.

Once these insights are gathered, the intervention will be refined through a collaborative process that includes community members, healthcare providers, and policymakers (AIM 2). Participants will review intervention materials in a process known as theater testing, where they can provide feedback before final adjustments are made. This step ensures that the intervention is both culturally relevant and practically feasible.

Finally, the adapted Kisoboka Amaka program will be tested in a small randomized controlled trial (AIM 3). Thirty couples will be randomly assigned to either receive the intervention or standard care. The study will assess whether Kisoboka Amaka is acceptable and feasible for both participants and providers and will gather preliminary evidence on its potential to reduce hazardous alcohol use and improve adherence to HIV treatment.

By adapting a proven intervention rather than developing a new one from scratch, this study builds on existing evidence while tailoring the program to meet the needs of a different at-risk group. If successful, Kisoboka Amaka could be scaled up to improve HIV prevention and family health across Uganda, helping protect more women and children from HIV while supporting men in reducing alcohol use and staying engaged in HIV care.

Eligibility criteria: Inclusion Criteria:

FOR MEN

1. living with HIV;
2. AUDIT-C positive (≥4) indicating potential hazardous drinking;
3. \>6 months since initial antiretroviral treatment (ART) initiation;
4. 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
5. not planning to move from the area within the next 6 months;
6. have their own mobile phone and can be reached via phone.

FOR WOMEN

1. 18+ years of age (or emancipated minor)
2. Pregnant
3. HIV negative

FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)

1. married/living together \>6 months;
2. planning to stay together \>6 months
3. lived in the area for \>3 months and
4. not planning to move within \<6 months.
5. similar responses on Couple Verification Screening (CVS) form, an instrument to determine if couples are legitimate (e.g., asking each person what they ate the last time they shared a meal with their partner).

Exclusion Criteria:

FOR MEN

1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
2. does not speak Luganda or English;
3. currently receiving a majority of work payments via mobile money/digital payments;
4. participated in the Kisoboka pilot RCT;
5. 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.

Primary outcomes:
measure: Antiretroviral therapy adherence
timeFrame: measured at baseline, 3 and 6 months follow up
measure: Alcohol reduction (change in PEth)
timeFrame: measured at baseline and 6 months follow up
Secondary outcomes:
measure: Alcohol reduction (self report)
timeFrame: measured at baseline 3 and 6 months follow up
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University Walter Reed Program
Study officials:
References: