TOTAL

Transmission of Tuberculosis Among Illicit Drug Use Linkages (TOTAL) is a cross-sectional study launched in Worcester, South Africa in April, 2021. The study is led by Dr. Karen Jacobson through Boston Medical Center, in partnership with Stellenbosch University, the South African Medical Research Council, Boston University School of Public Health, and the Desmond Tutu HIV Foundation. The primary purpose of this study is to characterize the transmission dynamics of tuberculosis among people who use tik (methamphetamine) and/or Mandrax (methaqualone). TOTAL is funded by the National Institute of Allergy and Infectious Diseases (NIAID) through the R01 mechanism.

Aims

The primary aims of TOTAL are:

1.  To assess the TB exposure, risk of disease progression, and disease burden among people who use drugs (PWUD), defined as those who smoke methamphetamine and/or Mandrax, with and without HIV.

2. To estimate the proportion of active TB cases resulting from recent transmission within the network identified in Aim 1.

3. To evaluate whether PWUD who have TB disease with and without HIV have physiologic characteristics associated with more efficient TB transmission.

Methods

The target sample size for TOTAL is 750 participants. Individuals in Worcester, South Africa who use tik and/or Mandrax are eligible to participate. Participants complete two study visits, during which they complete assessments of demographic characteristics, medical history, potential TB symptoms, HIV risk, social contacts, alcohol and substance use, mental health, and household hunger. Participants also undergo HIV testing, COVID serology, PAXgene testing for RNA sequencing, urine drug testing, bioaerosol sampling, and sputum collection for culture and whole genome sequencing for tuberculosis. Participants who are diagnosed with tuberculosis complete an additional study visit.

ClinicalTrials.gov Identifier: NCT04151602
NIH RePORT Identifier: 5R01AI147316-04
Study status: Enrolling

Publications

Carney, T., Rooney, J. A., Niemand, N., Myers, B., Theron, D., Wood, R., … & Jacobson, K. R. (2022). Transmission Of Tuberculosis Among illicit drug use Linkages (TOTAL): A cross-sectional observational study protocol using respondent driven sampling. PloS one, 17(2), e0262440.