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

NCT06668363 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-30

No results posted yet for this study

Summary

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

  • Alcohol Consumption
  • PrEP Uptake
  • Recent Heavy Drinking
  • HIV Prevention
  • HIV Treatment

Interventions

BEHAVIORAL

Treat4All

An alcohol reduction evidence-based intervention integrated with HIV status-neutral counseling

BEHAVIORAL

Standard of care (control arm)

Sexual risk reduction counseling

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Angela Parcesepe, PhD, MPH, MSW · University of North Carolina, Chapel Hill

  • Kathryn Lancaster, PhD · Wake Forest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668363 on ClinicalTrials.gov