Reducing Heavy Drinking and Improving HIV Prevention and Treatment Among Adults 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
N/A
Total Duration
AI-Summary
What this Trial Is About
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 alcohols 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
Brief Title
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Research Team
A
Angela Parcesepe, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Men and women age 18 years or older
Receiving care at Bwaila STI clinic
Report recent heavy drinking (4 or more drinks per day for men, 3 or more for women in the past 30 days)
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 people with HIV)
Report no recent oral PrEP use (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 to provide informed consent
Willingness to provide contact information for follow-up
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-related withdrawal symptoms
Acute physical or mental illness, including suicidal thoughts or behaviors
Participating in other HIV or alcohol programs
Active drug dependence interfering with study adherence
History of using injectable PrEP
Any condition that would compromise safety or study conduct as judged by the investigator
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Enrollment and Baseline
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)
Behavioral Intervention
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)
Usual Care
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
Follow-up Assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
A Trauma-Informed Program to Increase HIV Prevention Medication Use Among Black Women in Baltimore
Evaluating a New Blood Test to Help Diagnose and Monitor Depression and Psychosis in Adults
Study of Tailored Hospital Interventions for Harmful Alcohol and Psychoactive Drug Use in Medical Patients in Norway
Testing a Behavioral Therapy to Improve HIV Prevention and Reduce Drug Use in Sexual Minority Adults Aged 18 to 34
Study of the MEPS Intervention for HIV and Substance Use Prevention in Recently Incarcerated Men Using Smartphones
DatAIDS Prevention Study on HIV and STI Screening and Prevention in France for Adults
Exploring Alcohol Use and Relationship Dynamics in Young Adult Couples Ages 21 to 30
Reducing Heavy Drinking and Improving HIV Prevention and Treatment Among Adults Receiving STI Care in Lilongwe, Malawi
Testing a Community-Based Long-Acting Injectable PrEP Program with Lenacapavir for HIV Prevention among Latine Gay, Bisexual Men, and Transgender Women in the South
Study of Alcohol Effects on Body Responses and Perceptions in Hot Indoor Conditions for Adults Over 19
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Testing a systematically braided alcohol reduction and HIV status neutral intervention among people receiving STI care in Malawi: study protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial.
Kathryn E Lancaster, Agatha K Bula, Mitch M Matoga...