Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06668363

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-01-30

160

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women age 18 years or older.
  • Receiving care at Bwaila STI clinic.
  • Report recent heavy drinking (≥4 drinks/day for men or ≥3 drinks/day for women in past 30 days).
  • Willing to receive an HIV test at enrollment if not previously diagnosed.
  • For PWH: not taking ART, recent suboptimal adherence, or recent unsuppressed viral load.
  • For those at risk of HIV: no recent oral PrEP use (no PrEP pills in past 7 days).
  • Plan to live in the Lilongwe area for at least 6 months.
  • Not participating in other HIV or alcohol programs.
  • Ability and willingness to provide informed consent.
  • Willingness to provide contact information for follow-up.
Not Eligible

You will not qualify if you...

  • Unable to participate due to psychological disturbance, cognitive impairment, or threatening behavior.
  • Pregnant or breastfeeding.
  • At risk of alcohol withdrawal symptoms.
  • Acute physical or mental illness, including suicidal thoughts or behaviors.
  • Currently participating in other HIV or alcohol programs.
  • Active drug dependence interfering with study adherence.
  • History of using injectable PrEP.
  • Any condition that may compromise safety or study conduct as determined by the investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Bwaila Hospital

Lilongwe, Malawi

Actively Recruiting

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Research Team

A

Angela Parcesepe, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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