Improving HIV/Tuberculosis Outcomes in Irkutsk

NCT03819374 | Completed

• 2 other identifiers: 20451R01DA044137
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis; HIV Infections; Substance Use

Outcome Measures

Primary Outcomes (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.

  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.

  At 12 months from enrollment nonadherence will be compared among those with a without ongoing substance use

Secondary Outcomes (2)

• Correlation of serum mass spectrometry to urine colorimetry for AUC of anti-tuberculosis drugs

  6 months after enrollment completed

• Correlation of serum mass spectrometry to urine colorimetry for peak concentration of anti-tuberculosis drugs

  6 months after enrollment completed

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Scientific Center for Family Health and Human Reproduction Problems, Russia: collaborator

Study Sites (1)

Irkutsk Regional Clinical Tuberculosis Hospital

Irkutsk, Russia

Location

Related Publications (2)

• Hodges J, Waldman AL, Koshkina O, Suzdalnitsky A, Schwendinger J, Vitko S, Plenskey A, Plotnikova Y, Moiseeva E, Koshcheyev M, Sebekin S, Zhdanova S, Ogarkov O, Heysell S, Dillingham R. Process evaluation for the adaptation, testing and dissemination of a mobile health platform to support people with HIV and tuberculosis in Irkutsk, Siberia. BMJ Open. 2022 Mar 29;12(3):e054867. doi: 10.1136/bmjopen-2021-054867.

  PMID: 35351714 DERIVED

• Hodges J, Zhdanova S, Koshkina O, Suzdalnitsky A, Waldman AL, Schwendinger J, Vitko S, Plenskey A, Plotnikova Y, Moiseeva E, Koshcheyev M, Sebekin S, Ogarkov O, Dillingham R, Heysell S. Implementation of a Mobile Health Strategy to Improve Linkage to and Engagement with HIV Care for People Living with HIV, Tuberculosis, and Substance Use in Irkutsk, Siberia. AIDS Patient Care STDS. 2021 Mar;35(3):84-91. doi: 10.1089/apc.2020.0233. Epub 2021 Feb 3.

  PMID: 33538649 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine and Blood

MeSH Terms

Conditions

Tuberculosis; HIV Infections; Substance-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott K Heysell

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 28, 2019
• Study Start: April 15, 2018
• Primary Completion: May 30, 2020
• Study Completion: April 30, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)