Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Treat4All
2 other identifiers
interventional
160
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
December 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedJanuary 30, 2026
January 1, 2026
1.5 years
October 30, 2024
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 months after study enrollment
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.
6 months after study enrollment
Secondary Outcomes (3)
STI prevalence
6 months after study enrollment
ART adherence (among PWH)
ART adherence will be assessed among PWH 6 months after study enrollment
HIV incidence
HIV incidence will be assessed 6 months after study enrollment among among participants who tested HIV-negative at study enrollment
Study Arms (2)
Treat4All
EXPERIMENTALTreat4All will be based on Fleming's Project TrEAT, culturally adapted to the Malawi context, and enhanced to include content on HIV prevention and treatment activities (PrEP use for those at risk for HIV; ART adherence and viral suppression for PWH). The sessions will provide personalized feedback on alcohol use; a description of adverse effects of alcohol and its role in STI acquisition; a review of reasons to cut down or quit; risky situations, and how to handle them; and optional goal setting. Alcohol-related content of sessions will include reviewing drinking patterns, harmful effects of drinking, and alcohol use behavior change strategies. HIV prevention and treatment content of session will include strategies for increasing HIV care engagement, including ART initiation and adherence and PrEP use for those at risk for HIV. Each session will use cognitive problem solving, skills building, and goal setting to facilitate knowledge, motivation, and behavior to reduce heavy drinking
Standard of care (control arm)
ACTIVE COMPARATORParticipants in the control arm will receive usual care (UC). This includes sexual risk reduction counseling that integrates messaging on reducing alcohol use prior to sex and the recommendation to abstain from alcohol while on ART. Participants in this arm will continue to receive all STI or HIV-related services.
Interventions
An alcohol reduction evidence-based intervention integrated with HIV status-neutral counseling
Sexual risk reduction counseling
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bwaila Hospital
Lilongwe, Malawi
Related Publications (1)
Lancaster KE, Bula AK, Matoga MM, Hosseinipour MC, Hoffman IF, Grullon JA, Umar E, Msolola J, Magidson JF, Bonumwezi JL, Hahn JA, Parcesepe AM. 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. Front Public Health. 2025 Apr 30;13:1572288. doi: 10.3389/fpubh.2025.1572288. eCollection 2025.
PMID: 40371302DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Parcesepe, PhD, MPH, MSW
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Kathryn Lancaster, PhD
Wake Forest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Data analysts will be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
October 31, 2024
Study Start
December 12, 2024
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/ sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.