Actively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2026-01-30
160
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
Researchers are evaluating the short-term effectiveness and implementation of Treat4All, an alcohol reduction intervention designed to decrease heavy drinking and improve HIV-related outcomes. The study focuses on two groups: people with HIV who have a history of unsuppressed viral load or poor ART adherence and individuals at high risk for HIV who report recent heavy drinking and no recent PrEP use. About 160 participants aged 18 or older will be enrolled in this pilot randomized controlled trial comparing Treat4All to usual care. Participants in the Treat4All group will receive three weekly individual in-person sessions over three weeks, tailored to their specific issues and HIV status. These sessions include personalized feedback on alcohol use, education on alcohol's impact on STI risk, goal setting, and strategies to improve HIV prevention and treatment engagement, such as ART adherence and PrEP use. The usual care group will receive sexual risk reduction counseling that includes advice on reducing alcohol use before sex and abstaining from alcohol while on ART. All participants will receive counseling and referral to HIV care as needed. Participants will complete baseline, 3-month, and 6-month assessments including face-to-face questionnaires on alcohol use, HIV testing, health status, quality of life, and other relevant measures. Laboratory tests for HIV viral load, STI screening, and alcohol biomarkers will be conducted at baseline and 6 months. HIV-negative participants will be retested for HIV at 6 months. The study includes randomization to intervention or usual care and ongoing monitoring to assess heavy drinking days and engagement in HIV prevention or treatment six months after enrollment.
CONDITIONS
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants who are eligible provide informed consent, complete baseline questionnaires, and provide laboratory specimens including blood and urine samples.
1 visit (in-person)
Duration - Up to 12 weeks to complete 3 weekly sessions
Participants randomized to the Treat4All arm receive three individual in-person weekly counseling sessions focused on reducing alcohol use and enhancing HIV prevention and treatment.
3 weekly sessions (in-person)
Duration - Ongoing during study period
Participants randomized to the usual care arm receive sexual risk reduction counseling integrating messaging on reducing alcohol use prior to sex and abstaining from alcohol while on ART, along with all routine STI or HIV-related services.
Counseling provided during routine care visits
Duration - 6 months
Participants complete follow-up questionnaires at 3 and 6 months to assess alcohol use, HIV prevention and treatment engagement, and other health outcomes. Laboratory testing for HIV viral load, STI, and alcohol biomarkers is conducted at baseline and 6 months.
2 visits (in-person) at 3 and 6 months
Total: 1 location
1
Bwaila Hospital
Lilongwe, Malawi
Actively Recruiting
A
Angela Parcesepe, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kathryn E Lancaster, Agatha K Bula, Mitch M Matoga...
https://pubmed.ncbi.nlm.nih.gov/40371302