# METHODS AND ANALYSIS CORE

> **NIH NIH P01** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2023 · $254,492

## Abstract

Project Summary/Abstract
Unhealthy alcohol use is a major unaddressed barrier to control of the HIV epidemic in sub-Saharan Africa and
the United States. The Zambia Alabama HIV Alcohol Comorbidities (ZAMBAMA) program aims to address this
barrier through the following overarching aims: (a) test the effectiveness of a transdiagnostic model (Common
Elements Treatment Approach [CETA]) to reduce unhealthy alcohol use and improve HIV clinical outcomes; (b)
evaluate the mechanisms through which CETA impacts HIV outcomes; (c) investigate whether the treatment
effect of CETA varies by clinical (e.g., presence of mental health comorbidities), demographic (e.g., gender) and
contextual (e.g., Zambia, Alabama) factors; and (d) examine implementation factors, including cost, related to
integrated delivery of alcohol reduction interventions to disadvantaged people with HIV and unhealthy alcohol
use at front-line HIV clinics. The Methods and Analysis Core (MAC) will support ZAMBAMA’s two clinical trials
and promote integration and synergy within the program. The specific aims of MAC are (1) implement the
scientific approach of both trials (e.g., overseeing randomization procedures, measurement tools, and data
management); (2) conduct primary and secondary outcomes analyses evaluating CETA’s effectiveness
(including moderator analyses); (3) conduct mediator/mechanisms analysis investigating the degree to which
CETA’s impact on HIV outcomes are mediated by reductions in alcohol use, substance use, and mental health
problems; (4) analyze and interpret alcohol biomarker (phosphatidylethanol) data used to confirm self-reported
alcohol abstinence data; and (5) analyze implementation and cost effectiveness data to inform the scale-up and
sustainability potential of CETA. MAC will be staffed by investigators with international and multidisciplinary
expertise in research methods, including in substance use, HIV, clinical trials, and global health. MAC will
leverage a wealth of information technology, statistical, and laboratory resources at participating institutions,
including Centre for Infectious Disease Research in Zambia, Columbia University, and the University of Alabama
at Birmingham. Harmonized patient reported outcome measures and a centralized team to oversee the
intervention (i.e., CETA core) for both trials will create unique opportunities to understand the interplay between
unhealthy alcohol use and psychiatric comorbidities, whether and how comorbidities influence alcohol treatment
outcomes, and how differences in delivery modality and contextual factors impact CETA’s effectiveness.

## Key facts

- **NIH application ID:** 10685460
- **Project number:** 5P01AA029540-03
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Samuel Bosomprah
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $254,492
- **Award type:** 5
- **Project period:** 2021-09-10 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10685460

## Citation

> US National Institutes of Health, RePORTER application 10685460, METHODS AND ANALYSIS CORE (5P01AA029540-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10685460. Licensed CC0.

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