# URBAN ARCH (3/5) Uganda Cohort TB preventive therapy for HIV-infected alcohol users in Uganda: an evaluation of safety tolerability and adherence

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $588,006

## Abstract

ABSTRACT
 This application proposes the Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPT-TB)
study, a continuation of the Uganda Alcohol Research Collaboration on HIV (ARCH) cohort of HIV-infected
alcohol users in Uganda. Tuberculosis (TB) is the leading cause of mortality in persons with HIV. Isoniazid
(INH) preventive therapy (IPT) decreases all-cause mortality and active TB in persons with HIV by 30-50%
above and beyond the benefits of antiretroviral therapy (ART) alone. Based on these findings, the World Health
Organization (WHO) recommends IPT for all persons with HIV in resource constrained settings, but warns
against IPT for persons with “regular and heavy alcohol use” due to concern for increased hepatotoxicity in
heavy drinkers in settings where liver enzymes are not routinely monitored. Approximately one quarter of HIV-
infected persons in sub-Saharan Africa (SSA) are heavy drinkers, but no studies have systematically assessed
the safety of TB preventive therapy in alcohol users. Thus, the ADEPT-TB study aims to determine the safety
and tolerability of TB preventive therapy for HIV-infected drinkers, and examine if the benefits in preventing TB
outweigh the risks. Adherence to TB preventive therapy impacts the level of benefit and may also impact
hepatotoxicity. Alcohol use is an established risk factor for decreased ART adherence and active TB treatment
discontinuation, but it is not known whether HIV-infected drinkers on daily ART can be adherent to TB
preventive therapy. Standard IPT is comprised of daily INH for 6-9 months; a shorter-course, such as 3 months
of INH plus rifampicin, could improve adherence.
 The ADEPT-TB study will examine the safety and tolerability of, and adherence to, 6 months of daily
INH (6H) and 3 months of daily INH plus rifampicin (3HR) in 380 HIV-infected drinkers in Uganda. We will
randomize participants to one of the two regimens (n=190 per arm). Our first aim is to evaluate the safety and
tolerability within each regimen and by level of alcohol use. Our second aim is to compare adherence by
regimen; we hypothesize that adherence will be greater in the 3HR arm compared to the 6H arm. Self-reported
measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol
use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH
exposure, INH concentration in hair. We will actively monitor for hepatotoxicity using the U.S. standard of care
for TB preventive therapy for heavy drinkers. We will use the safety, tolerability, and adherence results,
together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA,
and an established decision analytic model of TB preventive therapy to conduct our third aim: to determine
whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource
limited settings. These data will prov...

## Key facts

- **NIH application ID:** 9997764
- **Project number:** 5U01AA020776-10
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Judith Alissa Hahn
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $588,006
- **Award type:** 5
- **Project period:** 2011-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9997764

## Citation

> US National Institutes of Health, RePORTER application 9997764, URBAN ARCH (3/5) Uganda Cohort TB preventive therapy for HIV-infected alcohol users in Uganda: an evaluation of safety tolerability and adherence (5U01AA020776-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9997764. Licensed CC0.

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