Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi

Recruiting now · Not applicable

Conditions studied: Alcohol Consumption, PrEP Uptake, Recent Heavy Drinking, HIV Prevention, HIV Treatment

In brief

Purpose: To evaluate short-term efficacy and implementation of Treat4All, an alcohol reduction evidence-based intervention, for decreasing heavy drinking and optimizing HIV outcomes (viral suppression among People with HIV (PWH); Pre-exposure prophylaxis (PrEP) use among those at high risk of HIV) Participants: Approximately 160 participants aged 18 years or older will be enrolled into this study. Eligible participants will be recruited from two groups of individuals: Persons at risk of HIV: Individuals receiving (STI) care who report recent heavy drinking (n=80) and no recent use of PrEP. Persons with HIV: Individuals with HIV who report recent heavy drinking and either a history of unsuppressed viral load or recent suboptimal adherence to ART (n=80). Procedures (methods): Pilot two-arm randomized controlled trial (1:1; Treat4All Intervention vs Usual Care)

Key facts

Study ID

NCT06668363

Run by

University of North Carolina, Chapel Hill

People needed

160

Starts

2024-12-12

Expected to finish

2026-06-01

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bwaila Hospital — Lilongwe, Malawi (enrolling)

Full record on ClinicalTrials.gov

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