The Drinkers’ Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2×2 factorial trial

Trials

Debbie M. Cheng¹  Sara Lodi¹  Carol S. Camlin²  Judith A. Hahn³  Gabriel Chamie³  Kara Marson³  Nneka I. Emenyonu³  Monica Gandhi³  Robin Fatch³  Michael G. McDonell⁴  Winnie R. Muyindike⁵  Dalsone Kwarisiima⁶  Harsha Thirumurthy⁷ 

[1] Department of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, 02118, Boston, MA, USA;Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, USA;Division of HIV, Infectious Disease and Global Medicine, University of California San Francisco, San Francisco, USA;Elson S. Floyd College of Medicine, Washington State University, Spokane, USA;Global Health Collaborative, Mbarara University of Science and Technology, Mbarara, Uganda;Mbarara Regional Referral Hospital, Mbarara, Uganda;Infectious Diseases Research Collaboration, Kampala, Uganda;Perelman School of Medicine at the University of Pennsylvania, Philadelphia, USA;

关键词: Tuberculosis;    Alcohol drinking;    HIV;    Isoniazid preventive therapy;    Contingency management;    Urine ethyl glucuronide;    Isoscreen;    Adherence;    Point of care;    Incentives;    Phosphatidylethanol;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05304-7

来源: Springer

【 摘 要 】

BackgroundThe risk of tuberculosis (TB) is high among people with HIV (PWH). Heavy alcohol drinking independently increases TB risk and approximately 25% of PWH globally engage in heavy drinking. While isoniazid (INH) preventive therapy decreases TB incidence and mortality among PWH, heavy drinking during INH is associated with liver toxicity and poor adherence. Interventions are, therefore, urgently needed to decrease alcohol use and improve adherence to INH in this population in settings with high prevalence of HIV and TB like Uganda.MethodsThe Drinkers’ Intervention to Prevent TB (DIPT) study is a 2×2 factorial randomized controlled trial among HIV/TB co-infected adults (≥18 years) who engage in heavy alcohol drinking and live in Uganda. The trial will allocate 680 participants with a 1:1:1:1 individual randomization to receive 6 months of INH and one of the following interventions: (1) no incentives (control), (2) financial incentives contingent on low alcohol use, (3) financial incentives contingent on high adherence to INH, and (4) escalating financial incentives for both decreasing alcohol use and increasing adherence to INH. Incentives will be in the form of escalating lottery-based monetary rewards. Participants will attend monthly visits to refill isoniazid medications, undergo liver toxicity monitoring, and, except for controls, determine eligibility for prizes. We will estimate (a) the effect of incentives contingent on low alcohol use on reduction in heavy drinking, measured via a long-term objective and self-reported metric of alcohol use, at 3- and 6-month study visits, and (b) the effect of incentives contingent on high adherence to INH, measured as >90% pill-taking days by medication event monitoring system cap opening. We will use qualitative methods to explore the mechanisms of any influence of financial incentives on HIV virologic suppression.DiscussionThis study will provide new information on low-cost strategies to both reduce alcohol use and increase INH adherence among people with HIV and TB infection who engage in heavy drinking in low-income countries with high HIV and TB prevalence.Trial registrationClinicalTrials.gov NCT03492216. Registered on April 10, 2018

【 授权许可】

CC BY