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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Treat4All
BehavioralAn alcohol reduction evidence-based intervention integrated with HIV status-neutral counseling
Standard of care (control arm)
BehavioralSexual risk reduction counseling
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Treat4AllExperimental treatment 2 interventions
Group B: Standard of care (control arm)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of heavy drinking days
Proportion of heavy drinking days at month 6 will defined as the proportion of days of heavy drinking (≥4 drinks a day for men and ≥3 drinks a day for women) in the past 21 days. Investigators will collect detailed information on alcohol use through the Alcohol Timeline Follow back (TLFB) to obtain the number of heavy drinking days, percent days abstinent, drinks per drinking day, and measure changes in drinking over time.
Time frame
6 months after study enrollment2
Engagement in HIV prevention or treatment
Our co-primary outcome of successful engagement in HIV prevention or treatment will be defined with parallel behaviors across HIV status: PrEP use for people at risk of HIV and viral suppression for PWH. PrEP use will be defined as self-report of \>1 pill in the past seven days at month 6. Viral suppression will be defined as an undetectable viral load (\<40 copies/mL) at month 6.
Time frame
6 months after study enrollmentSecondary outcomes
1
STI prevalence
Prevalence of biologically-confirmed STIs (chlamydia, gonorrhea, or syphilis)
Time frame
6 months after study enrollment2
ART adherence (among PWH)
Self-reported recent ART adherence
Time frame
ART adherence will be assessed among PWH 6 months after study enrollment3
HIV incidence
Prevalence of biologically confirmed HIV will be assessed among participants who tested HIV-negative at study enrollment.
Time frame
HIV incidence will be assessed 6 months after study enrollment among among participants who tested HIV-negative at study enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov