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New uganda trial tackles alcohol and HIV care for men with pregnant partners

NCT ID NCT06900634

Disease control Sponsor: San Diego State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a program called Kisoboka Amaka for men living with HIV who drink heavily and have pregnant partners. The program combines counseling, financial training, and mobile savings to help men drink less and take their HIV medication consistently. Researchers will compare 15 couples receiving the program to 15 couples getting standard care, measuring alcohol use and medication adherence over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kisoboka Amaka behavioral intervention (counseling, financial literacy, mobile savings)
What this could lead to
If successful, this could point toward a practical way to help men with HIV reduce drinking and stick to their HIV medication, lowering the chance of passing HIV to their partners and babies.
What could go wrong
This is a very small pilot study (60 participants) testing feasibility, not yet proven to work. The results may not apply to other settings or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

AIDS alcohol abuse Alcohol Drinking HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol consumption HIV antiretroviral therapy (ART) adherence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Makerere University Walter Reed Program

    Kampala, Uganda

More trials for these conditions

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