Hybrid trial for alcohol reduction among people with TB and HIV in India
Research Grant Start Date:
11/01/2023
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Research Summary
This is 2-arm hybrid type 1 RCT implementation RCT. Arm I will receive the HATHI Intervention (Counseling on Alcohol Problems), a four-session combined Cognitive Behavioral Therapy/Motivational Enhancement Therapy alcohol reduction intervention. And Arm II will receive usual care (provider advice, referral to treatment as needed). Aim 1: To examine the effectiveness of HATHI intervention (Cognitive Behavioral Therapy/Motivational Enhancement Therapy--CBT/MET based) integrated into tuberculoisis (TB) and HIV/TB care compared to usual care on alcohol reduction. Aim 2: To examine the effectiveness of the HATHI intervention (CBT/MET based) integrated into TB and HIV/TB care compared to usual care on TB and HIV treatment outcomes. Aim 3: Guided by the RE-AIM implementation framework, and using mixed methods, to 3a) evaluate patient, provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIV/TB settings, and 3b) measure incremental costs from health system and societal perspectives, and to estimate their incremental cost-effectiveness, compared to treatment as usual. The primary implementation outcome domains for aim 3 include: 3a) intervention Reach, Effectiveness, Adoption (Feasibility, Acceptability, Appropriateness), Implementation (Fidelity), and Maintenance (Sustainability); and 3b) costs defined as estimated incremental cost per incremental Disability Adjusted Life Years (DALY) averted.