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Improving HIV/Tuberculosis Outcomes in Irkutsk

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ClinicalTrials.gov Identifier: NCT03819374
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Scientific Center for Family Health and Human Reproduction Problems, Russia
Information provided by (Responsible Party):
Scott Heysell, MD, University of Virginia

Brief Summary:
The investigators propose to examine the prospective influence of substance use patterns on HIV/tuberculosis adherence, pharmacokinetics and disease progression while developing novel methods for early detection and correction of these mechanisms of treatment failure in Irkutsk. At the University of Virginia, the investigators have considerable research experience with vulnerable HIV populations and have adapted mobile phone methods for data collection of adherence, substance use, and study retention. The investigators have also begun development of colorimetric methods for pharmacokinetic monitoring that utilizes urine which may be suitable as a non-invasive sample for the unique environmental factors affecting HIV patients in Irkutsk, namely geographic remoteness and concurrent substance use

Condition or disease
Tuberculosis HIV Infections Substance Use

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving HIV/Tuberculosis Outcomes in Irkutsk
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Nonadherence as measured by clinic attendance, pharmacy refill and daily adherence response to the mHealth app will be more frequent in participants with ongoing substance use. [ Time Frame: At 12 months from enrollment nonadherence will be compared among those with a without ongoing substance use ]
    Participants will be assessed for measurements of adherence by clinic attendance, pharmacy refill at each study visit. Antiretroviral and anti-tuberculosis medication adherence is also questioned daily through the mHealth application. Additionally, a trans-renal DNA assay be measured at baseline and subsequent study visits to detect the presence of M. tuberculosis fragments in the urine.


Secondary Outcome Measures :
  1. Correlation of serum mass spectrometry to urine colorimetry for AUC of anti-tuberculosis drugs [ Time Frame: 6 months after enrollment completed ]
    Urine colorimetry will be compared to conventional serum mass spectrometry for kinetics of anti-tuberculosis drugs (rifampin and levofloxacin pending the participants' drug regimen), to generate ROC at baseline for total area under the concentration curve (AUC). Urine will then be collected via limited sampling strategy at 2 and 6 months after enrollment to determine correlation with the baseline urine sample.

  2. Correlation of serum mass spectrometry to urine colorimetry for peak concentration of anti-tuberculosis drugs [ Time Frame: 6 months after enrollment completed ]
    Urine colorimetry will be compared to conventional serum mass spectrometry for kinetics of anti-tuberculosis drugs (rifampin and levofloxacin pending the participants' drug regimen), to generate ROC at baseline for peak concentration (Cmax). Urine will then be collected via limited sampling strategy at 2 and 6 months after enrollment to determine correlation with the baseline urine sample.


Biospecimen Retention:   Samples With DNA
Urine and Blood


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected adults initiating anti-TB and antiretroviral therapy over the course of 1 year at Irkutsk Regional TB Hospital with a history of substance use will undergo prospective adherence and substance use data collection facilitated by a population-adapted smart phone application, to assess the impact of this technology on medication adherence.
Criteria

Inclusion Criteria:

  • Adults 18-64 years of age
  • HIV infected (confirmed by medical chart review)
  • Initiating TB treatment (with anti-TB medicine)
  • Initiating HIV treatment (with antiretroviral medicine)
  • History of any substance use (confirmed by medical chart review)
  • Primary residence in Irkutsk City, Russian Federation

Exclusion Criteria:

  • Unable or unwilling to operate a smartphone
  • Pregnant at time of enrollment per lab results (urine or serum) from Medical Record
  • Prisoners Cognitively unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819374


Contacts
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Contact: Scott K Heysell, MD 434-243-9064 skh8r@virginia.edu
Contact: Jennifer A White, BSN 434-982-3649 jaw9r@virginia.edu

Locations
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Russian Federation
Irkutsk Regional Clinical Tuberculosis Hospital Recruiting
Irkutsk, Russian Federation
Contact: Oleg Ogarkov, PhD       obogarkov@gmail.com   
Sponsors and Collaborators
University of Virginia
National Institute on Drug Abuse (NIDA)
Scientific Center for Family Health and Human Reproduction Problems, Russia
Investigators
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Principal Investigator: Scott K Heysell University of Virginia
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Responsible Party: Scott Heysell, MD, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT03819374    
Other Study ID Numbers: 20451
R01DA044137 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections