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HIV Antiretroviral Therapy (ART) AdherenceKisoboka AmakaNCT06900634

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

A study testing Kisoboka Amaka and Screening and Referral in people with HIV Antiretroviral Therapy (ART) Adherence and Alcohol Consumption, run by San Diego State University at 1 site in Uganda.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kisoboka Amaka and Screening and Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUganda
Study dates
1 Feb 2027to 1 Feb 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • have their own mobile phone and can be reached via phone.
  • FOR WOMEN
  • 18+ 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
  • not planning to move within <6 months.
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda P Miller, PhD, MS contact

610-203-1134

apmiller@sdsu.edu

Uganda1 site
  • Makerere University Walter Reed Program

    Kampala

    Fred Magala, Program Director, +256312330400, muwrp@muwrp.org

Other trials in Uganda

About this study

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

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:

Read more
  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.
Read the 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.

Being tested
Kisoboka Amaka, Screening and Referral
Keywords
hiv, motivational interviewing, behavioral economics, alcohol use disorder
Medical subject headings
Alcohol Drinking, Acquired Immunodeficiency Syndrome, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kisoboka AmakaBehavioural

    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.

  • Screening and ReferralBehavioural

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

Study groups in NCT06900634
Study groupRoleWhat they receive
Kisoboka AmakaExperimentalNot described
Receives: Behavioral: Kisoboka Amaka
Screening and ReferralActive comparatorNot described
Receives: Behavioral: Screening and Referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: measured at baseline, 3 and 6 months follow up

  2. 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: measured at baseline and 6 months follow up

Secondary outcomes (1)
  1. Alcohol reduction (self report)

    Self-reported hazardous use (AUDIT-C >3).

    Measured: measured at baseline 3 and 6 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900634
Sponsor's protocol ID
HS-2024-0098
Other IDs
K01AA031208
Acronym
Kisoboka Amaka
Status last verified
Jun 2026
First submitted
21 Mar 2025
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from Aims 1 and 2 will be used to develop, theater test, and pilot an intervention and will not generate generalizable knowledge; thus, they are not subject to the NIH Data Sharing Policy. However, data from the Aim 3 pilot study-including raw questionnaire and biological specimen data-will be shared via the NIAAADA repository. All data will be de-identified, with global unique identifiers assigned through the NIMH NDA. Identifiable information will be stored separately and securely for future contact but will not be shared. Survey datasets will be preserved and made available upon request. Audio files and verbatim transcripts from Aim 3 qualitative work will not be shared due to the high risk of participant identification given the purposive sampling and limited geographic area. Instead, we will share codes derived from the qualitative transcripts with NIAAADA.

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