Reducing alcohol use and improving HIV prevention in Malawi

Enhancing HIV Prevention and Reducing Alcohol Use Among People Receiving STI Care in Lilongwe, Malawi: A Pilot Implementation Study

This study is testing a new program in Malawi to see if helping people reduce their drinking can also improve their HIV prevention and treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 1 site (Lilongwe)
• Trial ID: NCT06668363 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Treat4All, an intervention designed to reduce heavy drinking and enhance HIV outcomes among individuals receiving STI care in Lilongwe, Malawi. Approximately 160 participants, including those at risk of HIV and individuals living with HIV, will be enrolled and randomly assigned to either the Treat4All intervention or usual care. The intervention consists of personalized sessions addressing alcohol use and its impact on HIV prevention and treatment, with a focus on increasing PrEP uptake and ART adherence. Sessions will be tailored to individual needs and will include cognitive problem-solving strategies to facilitate behavior change.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 and older who are receiving care at the Bwaila STI clinic and report recent heavy drinking.

Not a fit: Patients who do not report heavy drinking or are not at risk for HIV may not receive benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce alcohol consumption and improve HIV prevention and treatment outcomes for participants.

How similar studies have performed: Other studies have shown success with similar interventions aimed at reducing alcohol use and improving health outcomes, suggesting a promising approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Lilongwe

• Bwaila Hospital — Lilongwe, Malawi (RECRUITING)

Study contacts

• Principal investigator: Angela Parcesepe, PhD, MPH, MSW — University of North Carolina, Chapel Hill
• Study coordinator: Angela Parcesepe, PhD

Conditions: Alcohol Consumption, PrEP Uptake, Recent Heavy Drinking, HIV Prevention, HIV Treatment, PrEP, HIV, Alcohol reduction