NCT06668363Completed
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi
Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi: A Pilot Implementation Study
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 30 Oct 2024
- Start date
- 12 Dec 2024
- Primary completion date
- 26 May 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV
- NCT number
- NCT06668363
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 12 Dec 2024 to the primary completion date, 26 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active drug dependence that would interfere with adherence to study requirements.
Other illness
- Unable to participate in study activities due to psychological disturbance, cognitive impairment, or threatening behavior
- Acute physical or mental illness, including suicidal thoughts or behaviors
- Participating in in other HIV or alcohol programs
- 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.
Other
- Pregnant or breastfeeding
- At risk of experiencing alcohol-related withdrawal symptoms
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bwaila Hospital Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.