Hybrid trial for Alcohol reduction among people with TB and HIV in India (HATHI)

NIH RePORTER · NIH · R01 · $114,088 · view on reporter.nih.gov ↗

Abstract

In 2021, there were 2.4 million persons living with HIV (PWH) in India and 63,000 new HIV infections. Among PWH in India, 65% are on antiretroviral therapy (ART) and 55% are virally suppressed. Unhealthy alcohol use, encompassing heavy/hazardous use, binge drinking and alcohol use disorders (AUD), is on the rise in India and is a barrier to HIV treatment as prevention (HIV TASP) success. Furthermore, PWH’s unhealthy alcohol use is associated with HIV transmission, decreased use of and adherence to ART, lower viral suppression, decreased engagement and retention in care, more rapid disease progression, and mortality. Given the increased risk for adverse HIV outcomes, unhealthy alcohol use is an important but neglected modifiable risk factor for morbidity and mortality among PWH. In a hybrid effectiveness-implementation study, R01AA027972 “Hybrid trial for alcohol reduction among people with TB and HIV in India (HATHI)”, we are funded to test a behavioral alcohol reduction intervention that incorporates cognitive behavioral (CBT) and motivational enhancement therapy (MET) among persons with tuberculosis (TB) and TB/HIV co-infection in Pune, India. We have culturally adapted an evidence-based intervention and initiated recruitment in September 2022 at BJGMC and Dr. D.Y Patil Medical College. We are recruiting people from both TB and HIV clinics. In our first ten months of alcohol screening in HIV clinics with the AUDIT, 437 PWH met criteria for unhealthy alcohol use who were not TB co-infected. Given that unhealthy alcohol use contributes to poor outcomes among PWH and is a major barrier to global initiatives to end the HIV pandemic, excluding individuals with HIV only is a missed opportunity to see if this evidence-based intervention can also improve outcomes among PWH only. In this administrative supplement to HATHI, we propose to extend our inclusion criteria to PWH without TB. We will recruit 150 PWH and unhealthy alcohol use from our two Pune HIV ART clinics. and randomize them to our CBT/MET-based HATHI intervention or standard of care. The intervention consists of four counseling sessions followed by three boosters, integrated into HIV care. Effectiveness outcomes measured at 3, 6 and 12 months include 1) self-reported alcohol use and phosphatidyl ethanol, an alcohol biomarker, and 2) HIV clinical outcomes (HIV RNA suppression and ART adherence). Using the RE-AIM implementation framework, we will use mixed methods to assess barriers and facilitators to alcohol treatment integration in HIV clinical settings and the incremental costs of this intervention strategy. This supplement provides an opportunity to examine whether our adapted intervention will effectively reduce unhealthy alcohol use among PWH in India. We have trained counselors in the intervention delivery, developed systems for fidelity monitoring, and developed our database and procedures. Leveraging resources and infrastructure of HATHI through this supplement will increase efficie...

Key facts

NIH application ID
10976745
Project number
3R01AA027974-04S1
Recipient
JOHNS HOPKINS UNIVERSITY
Principal Investigator
GEETANJALI CHANDER
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$114,088
Award type
3
Project period
2020-09-05 → 2025-05-31