N/A
Completed N=680
Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
Source: ClinicalTrials.gov NCT03492216 ↗Enrolled (actual)
680
Serious AEs
3.2%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. — 57; 31; 266; 282 Participants — p=0.0025
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. |
57; 31; 266; 282 | 0.0025 sig |
| PRIMARY Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH |
244; 234; 91; 87 | 0.9435 |
| SECONDARY Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation. |
13; 10; 15; 9 | — |
| SECONDARY INH Concentration in Hair |
49.4; 49.1; 49.3; 57.1 | — |
| SECONDARY Number of Participants With and Without HIV Viral Suppression at 12 Months |
144; 147; 146; 146; 4; 8 | 0.26 |
| SECONDARY Number of Participants With Active Tuberculosis (TB). |
0; 1; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03492216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.