Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 30, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a program called Treat4All, which aims to help people reduce heavy drinking and improve their health outcomes related to HIV. The trial is taking place in Lilongwe, Malawi, and involves around 160 participants, including individuals at risk of HIV and those already living with HIV. The goal is to see if this program can help people who drink heavily to better manage their alcohol use and to support those at high risk of HIV or those not effectively controlling their HIV with treatment.
To be eligible for this study, participants need to be at least 18 years old, currently seeking care at the Bwaila STI clinic, and report drinking heavily. Specifically, men must have had four or more drinks a day recently, while women must have had three or more. Participants should also be willing to take an HIV test and must not be involved in other alcohol or HIV programs. Throughout the trial, participants will either receive the Treat4All intervention or usual care and will be monitored to see how these approaches affect their drinking and HIV management. This study is important because it seeks to improve health outcomes for people dealing with both heavy drinking and HIV.
Gender
ALL
Eligibility criteria
- 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.
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lilongwe, , Malawi
Lilongwe, Central Region, Malawi, Malawi
Patients applied
Trial Officials
Angela Parcesepe, PhD, MPH, MSW
Principal Investigator
University of North Carolina, Chapel Hill
Kathryn Lancaster, PhD
Principal Investigator
Wake Forest
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported