Do Clinical Decision-support Reminders for Medical Providers Improve the Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya? (TBTech)
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ClinicalTrials.gov Identifier: NCT01934309 |
Recruitment Status
:
Completed
First Posted
: September 4, 2013
Last Update Posted
: August 25, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Behavioral: TB reminders | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya? |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: TB reminders
Receive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment
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Behavioral: TB reminders
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.
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No Intervention: No TB reminders
Only receive existing reminders; no TB reminders
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- Prescription of Isonazid [ Time Frame: within 3 months of initial encounter ]Provider prescribes INH within 3 months of patient's initial encounter.
- 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.
- 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.
- Isoniazid prophylactic therapy (IPT) completion [ Time Frame: 9 months after treatment initiation ]Patient completes 9-month course of IPT

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01934309
Kenya | |
AMPATH | |
Eldoret, Kenya |
Principal Investigator: | Lameck O Diero, MBChB, MMed | Moi University College of Health Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Indiana University |
ClinicalTrials.gov Identifier: | NCT01934309 History of Changes |
Other Study ID Numbers: |
AID-OAA-TO-11-00060 |
First Posted: | September 4, 2013 Key Record Dates |
Last Update Posted: | August 25, 2015 |
Last Verified: | August 2015 |
Keywords provided by Indiana University:
tuberculosis isoniazid preventative therapy clinical decision support |
HIV Kenya eHealth |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |