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Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)

NCT03492216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2025-01-13

Study results available
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Summary

There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The goal of the study is to determine whether economic incentive interventions can promote both reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3: economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol use and for IPT adherence (rewarded independently).

Conditions

Interventions

BEHAVIORAL

Incentives for negative EtG test

Economic incentives are given to the study participant contingent on point-of-care (POC) urine ethyl glucuronide (EtG) \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.

BEHAVIORAL

Incentives for positive IsoScreen test

Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.

Sponsors & Collaborators

Principal Investigators

  • Judith A Hahn, PhD · University of California, San Francisco

  • Gabriel Chamie, MD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2022-02-01
Completion
2022-08-02

Countries

  • Uganda

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492216 on ClinicalTrials.gov