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Can cutting back on drinking help stop HIV? malawi study aims to find out.

NCT ID NCT06668363

Prevention Sponsor: University of North Carolina, Chapel Hill 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 2 times

Summary

This study tests a program called Treat4All that helps people who drink heavily and are at risk for HIV or already have HIV. About 160 adults from an STI clinic in Lilongwe, Malawi, will either get the program or usual care. The goal is to see if the program reduces heavy drinking and increases use of HIV prevention pills (PrEP) or viral suppression.

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

130 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

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: * Men and women age 18 years or older. * Receiving care at Bwaila STI clinic. * Report recent heavy drinking (greater than or equal to 4 drinks a day in the past 30 days for men and greater than or equal to 3 drinks a day in the past 30 days for women * Willing to receive an HIV test at study enrollment, if not previously diagnosed Report not taking ART, recent suboptimal adherence to ART, or recent history of unsuppressed HIV viral load \[for PWH\] or no recent oral PrEP use (self-reported taking no PrEP pills in past 7 days) \[for those at risk of HIV\] * Plan to reside in the Lilongwe area for at least 6 months. * Not participating in other HIV or alcohol programs * Ability and willingness of participant to provide informed consent. * Willingness to provide contact/locator information to be contacted for follow up study activities. Exclusion Criteria: * Unable to participate in study activities due to psychological disturbance, cognitive impairment, or threatening behavior * Pregnant or breastfeeding * At risk of experiencing alcohol-related withdrawal symptoms * Acute physical or mental illness, including suicidal thoughts or behaviors * Participating in in other HIV or alcohol programs * Active drug dependence that would interfere with adherence to study requirements. * History of using injectible PrEP * Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff or would prevent proper conduct of the study.

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking HIV infectious disease sexually transmitted disease

As listed by the trial registrant

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

Alcohol consumption HIV prevention HIV treatment Prep uptake Recent heavy drinking

Contacts and locations

Locations

  • Bwaila Hospital

    Lilongwe, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.