Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)

NCT03492216 | Completed Results DMC

• 1 other identifier: 17-22727
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 2

Brief 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

HIV/AIDS; Tuberculosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.

  Non-hazardous drinking is a composite outcome, measured at both 3 and 6 months. An individual must meet criteria for non-hazardous drinking (Alcohol Use Disorders Identification Test - Consumption \[AUDIT-C\], prior 3 months, negative) and phosphatidylethanol (PEth) \<35 ng/mL) at both time-points (3- and 6-months) in order to achieve the outcome.

  Both 3 months and 6 months (composite measure)

• Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH

  Isoniazid (INH) adherence percentage is defined as the number of days with \>0 pill bottle openings divided by the number of prescribed doses, times 100. Pill bottle openings are captured by the Medication Event Monitoring System (MEMS) pill cap, with no more than 1 opening per day counted. The INH adherence outcome is INH adherence percentage, dichotomized as \>90% versus \<= 90%.

  6 months

Secondary Outcomes (4)

• Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation.

  up to 9 months

• INH Concentration in Hair

  3 and 6 months

• Number of Participants With and Without HIV Viral Suppression at 12 Months

  12 months

• Number of Participants With Active Tuberculosis (TB).

  12 months

Study Arms (4)

Control

NO INTERVENTION

All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.

Escalating incentives (EtG tests)

EXPERIMENTAL

Escalating incentives for EtG negative urine test (Intervention: Incentives for negative EtG test).

Behavioral: Incentives for negative EtG test

Escalating incentives (IsoScreen tests)

EXPERIMENTAL

Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).

Behavioral: Incentives for positive IsoScreen test

Escalating incentives (EtG + IsoScreen)

EXPERIMENTAL

Escalating incentives for EtG negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).

Behavioral: Incentives for negative EtG test; Behavioral: Incentives for positive IsoScreen test

Interventions

Incentives for negative EtG test BEHAVIORAL

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.

Escalating incentives (EtG + IsoScreen); Escalating incentives (EtG tests)

Incentives for positive IsoScreen test BEHAVIORAL

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

Escalating incentives (EtG + IsoScreen); Escalating incentives (IsoScreen tests)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected adult (≥18 years) prescribed antiretroviral therapy (ART) for at least 6 months;
• Current heavy alcohol use (AUDIT-C positive for prior 3 month drinking and positive EtG urine test);
• Positive tuberculin skin test (TST) (≥5 mm induration);
• AST and ALT \<2x the upper limit of normal (ULN);
• Fluent in Runyankole or English;
• No history of active TB, TB treatment, or TB preventive therapy;
• Lives within 2-hour travel time or 60 km of the study site.

You may not qualify if:

• Prescribed nevirapine (NVP, an ART drug that is declining in usage due to high risk for hepatotoxicity);
• Plans to move out of the catchment area within 6 months;
• Prescribed anti-convulsion medications or history of recurring seizures;
• ALT or AST elevations (\>2X ULN);
• Suspected or confirmed active TB as determined by symptom screening and followed by chest X-ray and sputum testing;
• History of prior active TB treatment or prior IPT.
• Pregnant at time of screening

Sponsors & Collaborators

• University of California, San Francisco: lead
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Mbarara University of Science and Technology: collaborator

Study Sites (2)

Infectious Disease Research Collaboration (IDRC)

Mbarara, Uganda

Location

Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV

Mbarara, Uganda

Location

Related Publications (3)

• Muyindike WR, Fatch R, Lodi S, Emenyonu NI, Kekibiina A, Adong J, Beesiga B, Marson K, Thirumurthy H, McDonell MG, Kamya MR, Chamie G, Hahn JA. Alcohol use and HIV suppression after completion of financial incentives for alcohol abstinence and isoniazid adherence: a randomized controlled trial. EClinicalMedicine. 2025 Jan 8;80:103045. doi: 10.1016/j.eclinm.2024.103045. eCollection 2025 Feb.

  PMID: 39867970 DERIVED

• Chamie G, Hahn JA, Kekibiina A, Emenyonu NI, Beesiga B, Marson K, Fatch R, Lodi S, Adong J, Thirumurthy H, McDonell MG, Gandhi M, Bryant K, Havlir DV, Kamya MR, Muyindike WR. Financial incentives for reduced alcohol use and increased isoniazid adherence during tuberculosis preventive therapy among people with HIV in Uganda: an open-label, factorial randomised controlled trial. Lancet Glob Health. 2023 Dec;11(12):e1899-e1910. doi: 10.1016/S2214-109X(23)00436-9.

  PMID: 37973340 DERIVED

• Lodi S, Emenyonu NI, Marson K, Kwarisiima D, Fatch R, McDonell MG, Cheng DM, Thirumurthy H, Gandhi M, Camlin CS, Muyindike WR, Hahn JA, Chamie G. The Drinkers' Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2x2 factorial trial. Trials. 2021 May 20;22(1):355. doi: 10.1186/s13063-021-05304-7.

  PMID: 34016158 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Dr. Gabriel Chamie
• Organization: University of California, San Francisco (UCSF)

gabriel.chamie@ucsf.edu

415-476-4082

Study Officials

• Judith A Hahn, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Gabriel Chamie, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: April 10, 2018
• Study Start: April 16, 2018
• Primary Completion: February 1, 2022
• Study Completion: August 2, 2022
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2)