An interventional study of Kisoboka Amaka and Screening and Referral in HIV Antiretroviral Therapy (ART) Adherence and Alcohol Consumption, sponsored by San Diego State University. Not yet recruiting at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by San Diego State University · Not applicable, Interventional, and Treatment
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:
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:
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 60 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →San Diego State University is the lead sponsor of 149 studies on the registry; 43 are open to participants now.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
FOR MEN
FOR WOMEN
FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)
Exclusion Criteria:
FOR MEN
FOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Kisoboka Amaka
Behavioral: Screening and Referral
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.
Alcohol 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.
Time frame: 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).
Time frame: measured at baseline and 6 months follow up
Alcohol reduction (self report)
Self-reported hazardous use (AUDIT-C \>3).
Time frame: measured at baseline 3 and 6 months follow up
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Data sharing details ↗ · nda.nih.gov
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Start is estimated for Feb 2027; primary completion for Dec 2027, 10 months later.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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