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OpenTrials
Completed

NCT Number: NCT01934309

Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya

The overall research objective is to evaluate the impact of implementing a reminder system for medical providers to improve TB case-finding and isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMPATH

Eldoret, Kenya

About this study

The purpose of this study is to evaluate the impact of implementing a clinical decision support reminder system for medical providers (i.e., nurses, clinical officers, medical officers, consultants) to improve tuberculosis case-finding and the use of isoniazid preventative therapy for adults living with HIV in western Kenya.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Clusters:

Inclusion criteria

  • active
  • uses HIV initial and return encounter paper forms
  • enters data into the AMPATH medical records system (AMRS) or sends forms to central location for data entry
  • prints or receives printed paper summary sheets with reminders
  • interprets chest x-rays
  • interprets sputum smear results
  • prescribes IPT and dispenses INH
  • completed an average of 10 initial adult HIV positive encounters per month in 2012
  • HIV Care Clinic

Exclusion criteria

-

Patients:

Inclusion criteria

  • HIV positive
  • complete an adult initial encounter at an HIV Care Clinic during the enrollment period
  • attend at least one additional appointment within 90 days after the initial encounter

Exclusion criteria

  • history of TB or IPT

Treatment and study plan

TB reminders

Behavioral

The intervention to be studied involves providing clinic-based medical care providers (e.g., nurses, clinical officers, medical officers, consultants) with patient-specific clinical reminders regarding TB that are generated from a patient's electronic medical record and based on accepted clinical algorithms for TB screening and treatment.

Primary outcomes

  1. Prescription of Isoniazid

    Time frame: within 3 months of initial encounter

    Provider prescribes INH within 3 months of patient's initial encounter.

Secondary outcomes

  1. Time to isoniazid prophylactic therapy (IPT) initiation

    Time frame: within 3 months of initial encounter

    The time in weeks from a patient's initial encounter to the week the patient picks up the initial batch of INH from the pharmacy.

Other outcomes

  1. Initiation of isoniazid prophylactic therapy (IPT)

    Time frame: within 3 months of initial encounter

    IPT will be considered "initiated" when a patient picks up the initial batch of the prescribed medications within 3 months of the initial encounter.

  2. Isoniazid prophylactic therapy (IPT) completion

    Time frame: 9 months after treatment initiation

    Patient completes 9-month course of IPT

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Academic Model Providing Access to Healthcare (AMPATH)
  • Innovative Support to Emergencies, Diseases and Disasters (InSTEDD)
  • Kijani Consulting
  • Moi University
  • Regenstrief Institute, Inc.

Registry information

Official study title

Does Providing Medical Personnel in the AMPATH Network With Patient-specific Reminders Regarding TB That Are Generated From a Patient's EMR Improve the Prevalence of IPT Initiation and Decrease the Time From Screening to Treatment?

Acronym: TBTech

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2013
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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