Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358885
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-01
Brief Title:
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
IGHID 12230 - Scaling up the Brief Alcohol Intervention to Prevent HIV Infection in Vietnam a Cluster Randomized Implementation Trial EBAI
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBAI
Brief Summary:
This study is a hybrid type 3 cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention BAI in ART clinics in Vietnam One arm will receive only facilitation for BAI implementation Facilitation is a flexible strategy that helps clinics to address common barriers such as counselor skills competing priorities and resource deficits In the other arm in addition to facilitation clinic staff irrespective of their own alcohol use will be offered the BAI themselves as experiential learning EBAI to address their own alcohol-related attitudes and behaviors Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI
Detailed Description:
In this cluster-randomized controlled hybrid type 3 implementation trial investigators will assess two approaches to the brief alcohol intervention BAI scale-up The BAI is an evidence-based intervention to address unhealthy alcohol use that comprises 2 in-person sessions and 2 booster telephone sessions Face-to-face 45-minute sessions occur 1 month apart 10-minute telephone sessions occur 2 to 3 weeks after each face-to-face session Investigators chose a hybrid type 3 design to evaluate implementation outcomes while simultaneously ensuring that effectiveness outcomes specifically viral suppression are achieved Investigators will compare facilitation FAC versus EBAIFAC in 30 ART clinics in Vietnam The FAC arm the comparison arm will use internal and external facilitators to help clinics and staff address common barriers to BAI implementation Facilitation typically works through interactive problem solving and support In the EBAIFAC arm clinic staff defined as clinic directors physicians nurses and counselors will be offered the experiential BAI EBAI regardless of their own alcohol use prior to BAI implementation and clinic staff responsible for delivering the BAI to patients will also be offered 3 additional consolidation opportunities to integrate their own experiences with their delivery of the BAI to PWH Randomization will be 11 with 15 clinics per arm Clinics will be assessed pre-training for key contextual factors related to clinic characteristics and clinic staff
Upon trial initiation persons with HIV PWH initiating or on ART will be screened for unhealthy alcohol use with the AUDIT-C Time 0 Those PWH who screen positive for unhealthy alcohol use will be offered the BAI by trained clinic counselors PWH who do not screen positive will continue to be screened with the AUDIT-C at routine ART clinic visits PWH who screen positive but refuse to participate in the trial or are excluded due to alcohol withdrawal symptoms will continue to be screened with the AUDIT-C at every routine ART clinic visit per standard clinic procedures PWH may decline AUDIT screening when it is offered Implementation and effectiveness outcomes will be evaluated to 12 or 24 months Aim 1 After the 12- month assessments mechanisms underlying successful implementation in both arms will be explored using qualitative and quantitative methods Aim 2 Investigators will explore the effect of implementing the BAI both arms and experiencing the BAI EBAIFAC arm on staff members alcohol use and attitudes toward alcohol and BAI Aim 3
Upon trial initiation persons with HIV PWH initiating or on ART will be screened for unhealthy alcohol use with the AUDIT-C Time 0 Those PWH who screen positive for unhealthy alcohol use will be offered the BAI by trained clinic counselors PWH who do not screen positive will continue to be screened with the AUDIT-C at routine ART clinic visits PWH who screen positive but refuse to participate in the trial or are excluded due to alcohol withdrawal symptoms will continue to be screened with the AUDIT-C at every routine ART clinic visit per standard clinic procedures PWH may decline AUDIT screening when it is offered Implementation and effectiveness outcomes will be evaluated to 12 or 24 months Aim 1 After the 12- month assessments mechanisms underlying successful implementation in both arms will be explored using qualitative and quantitative methods Aim 2 Investigators will explore the effect of implementing the BAI both arms and experiencing the BAI EBAIFAC arm on staff members alcohol use and attitudes toward alcohol and BAI Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA030480 | NIH | None | httpsreporternihgovquickSearchR01AA030480 |