Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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)
Eligibility criteria
Qualifiers
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]
Disqualifiers
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
Trial design
Treatments tested in this trial
- Treat4All
- Standard of care (control arm)
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov