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Scaling up the brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

Award Number: R01AA030480
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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Scaling up the brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial - PROJECT SUMMARY More than 25% of people with HIV (PWH) globally report unhealthy alcohol use (UAU), which spans risky/hazardous use to alcohol use disorder (AUD). Among PWH, UAU impairs antiretroviral therapy (ART) use and reduces viral suppression. The brief alcohol intervention (BAI) helps PWH reduce alcohol use and increases their viral suppression. The BAI is ready for scale-up but buy-in by clinical staff is essential. We propose a hybrid type 3, implementation-effectiveness, cluster-randomized trial to assess the impact of clinic staff experiencing the BAI prior to delivering it to PWH. This experiential implementation strategy is compared to facilitation only for BAI implementation. We will conduct this trial in Vietnam because it offers several efficiencies while providing results that are applicable in the United States. Benefits of conducting this trial in Vietnam include a similar or higher prevalence of UAU among PWH, a streamlined governmental process for study approvals, a relatively standard clinic structure that is similar to many Federally Qualified Health Centers in the United States, and reduced costs for study implementation. We hypothesize that EBAI, added to facilitation, will increase BAI fidelity, acceptability, and penetration at the clinic level, and improve viral suppression among PWH with UAU. Our specific aims are to: 1) Compare BAI implementation using facilitation (FAC) only to experiential BAI plus facilitation (EBAI+FAC) in ART clinics in Vietnam; 2) Explore the mechanisms of successful BAI scale up in both the FAC and EBAI+FAC arms; and 3) Measure the impact of EBAI on clinic staff. ART clinics (n=30) across Vietnam will be randomized to receive FAC or EBAI+FAC. PWH in the clinics will be screened for unhealthy alcohol use with the AUDIT-C; if positive, they will be offered the BAI. The primary implementation outcomes are clinic-level BAI fidelity (primary), with secondary outcomes of acceptability, penetration, and cost. The effectiveness outcomes are viral suppression (primary) and alcohol use (secondary), measured among a cohort of PWH recruited in each clinic. Outcomes will be measured at 3 months (implementation outcomes only) and 12 months (all outcomes). In parallel with the trial, we will use mixed methods to examine the organizational and clinic staff characteristics that underly successful BAI scaleup. Given the importance of the clinic staff in the BAI implementation, we will also explore the impact of the BAI on their own alcohol-related attitudes and use and considering whether they received the BAI themselves or not. This trial will present critical information for worldwide HIV treatment as prevention efforts, providing strategies for effective scale-up of the BAI among PWH with UAU. In particular, the trial results will inform the most appropriate strategy for implementing the BAI is U.S. HIV clinics, where UAU is often recognized but infrequently treated. The use of an experiential program can be translated into continuing education for clinicians caring for PWH, ensuring that those PWH with UAU receive the treatment that they require to ensure their long-term viral suppression.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $592,038 )
2026	2026	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	001	5	8/5/2026	SUPPLEMENT FOR EXPANSION	$19,721
2026	2026	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	000	5	7/22/2026	NON-COMPETING CONTINUATION	$572,317
														Subtotal = $592,038

Issue Date FY: 2025 ( Subtotal = $588,352 )
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	000	4	8/15/2025	NON-COMPETING CONTINUATION	$568,631
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	001	4	8/22/2025	SUPPLEMENT FOR EXPANSION	$19,721
														Subtotal = $588,352

Issue Date FY: 2024 ( Subtotal = $580,635 )
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	000	3	7/3/2024	NON-COMPETING CONTINUATION	$580,635
														Subtotal = $580,635

Issue Date FY: 2023 ( Subtotal = $590,464 )
2023	2023	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	001	2	7/26/2023	NON-COMPETING CONTINUATION	$590,464
2023	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	000	1	5/24/2023	NEW	$0
														Subtotal = $590,464

Issue Date FY: 2022 ( Subtotal = $638,585 )
2022	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Alcohol Research Programs	000	1	9/15/2022	NEW	$638,585
														Subtotal = $638,585

Grand Total All Awards = $2,990,074

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Scaling up the brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

Award Number: R01AA030480

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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