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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Malawi
Bwaila Hospital
RECRUITING
Lilongwe
Contact Information
Primary
Angela Parcesepe, PhD
angela_parcesepe@unc.edu
919-843-9291
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-06
Participants
Target number of participants: 160
Treatments
Experimental: Treat4All
Treat4All 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
Active_comparator: Standard of care (control arm)
Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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