Current Studies | UNC Project-Vietnam

Brief alcohol intervention to improve pre-exposure prophylaxis (PrEP) use among men who have sex with men (MSM): A randomized controlled trial in Vietnam (B-PrEP) (2023 – present)

MSM often have unhealthy alcohol use, which influences their decision making related to PrEP use and adherence. This randomized controlled trial will evaluate PrEP persistence and related outcomes after MSM receive a brief alcohol intervention designed to reduce alcohol use. The BAI is adapted from a previous study conducted in Vietnam, known as REDART.

Scaling up the brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial (EBAI) (2023 – present)

People with HIV (PWH) who also have unhealthy alcohol use may have worse HIV-related outcomes because their drinking interferes with ART use and adherence. In this implementation science study, we are scaling up the brief alcohol intervention that was successful in REDART and will compare two implementation approaches. In one arm, 15 ART clinics will receive facilitation only—clinics will be supported with basic implementation strategies; in the other arm, 15 clinics will receive facilitation combined with an experiential training for clinic staff, in which the staff will receive the alcohol intervention before they begin providing it to PWH in their clinics.

AIDS Clinical Trials Group (ACTG) A5300B/PHOENIx: Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients (2023 – present)

Household members of individuals newly diagnosed with multidrug-resistant tuberculosis are at high risk for contracting tuberculosis. PHOENIx is a Phase III open-label multicenter trial to compare the safety and efficacy of delamanid with the standard of care, isoniazid, in preventing active TB among household contacts of adults with multidrug-resistant tuberculosis. The study is being conducted in 13 countries with a target enrollment of 2158 index cases and 3452 household contacts.

AIDS Clinical Trials Group (ACTG) A5379: B-Enhancement of HBV vaccination in persons living with HIV: Evaluation of HEPLISAV-B (2022 – present)

People living with HIV may have an impaired immune response to hepatitis B vaccines. This is a randomized controlled trial to compare the effectiveness of a new vaccine, HEPLISAV-B to the standard of care, Engerix-B, among people living HIV who have received the hepatitis B vaccine, but the vaccine did not respond well or who never received a hepatitis B vaccine. The study will compare how individuals respond to the vaccine based on type and dose of hepatitis B vaccine.

Scaling up HPTN 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam (SNaP) (2020 – present)

The systems navigation and psychosocial counseling (SNaP) intervention used in HPTN 074 helped people who inject drugs (PWID) with HIV access needed HIV care. This implementation science trial is comparing two approaches to scaling up SNaP in 42 clinics in Vietnam. In one arm, 21 clinics receive a standard implementation mapping set of strategies; in the other arm, 21 clinics receive a tailored implementation mapping approach, where clinics select approaches that they identify as helpful in their specific context.

Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. Nguyen MXB, Chu AV, Powell BJ, Tran HV, Nguyen LH, Dao ATM, Pham MD, Vo SH, Bui NH, Dowdy DW, Latkin CA, Lancaster KE, Pence BW, Sripaipan T, Hoffman I, Miller WC, Go VF. Implement Sci. 2020 Aug 8;15(1):64.