TuberculosisTBTechNCT01934309
Clinical Decision-support Reminders to Improve IPT Initiation Among HIV Positive Adults in Western Kenya
A study testing TB reminders in people with Tuberculosis, run by Indiana University at 1 site in Kenya.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- TB reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,782 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- prescribes IPT and dispenses INH
- completed an average of 10 initial adult HIV positive encounters per month in 2012
- HIV Care Clinic
- 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
Who cannot join
- Patients:
- history of TB or IPT
Trial locations and contacts
1 site in 1 country.
About this study
Official 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?
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
Read the detailed description
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.
- Conditions
- Tuberculosis
- Being tested
- TB reminders
- Keywords
- tuberculosis, isoniazid preventative therapy, clinical decision support, HIV, Kenya, eHealth
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB remindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TB reminders | Experimental | Receive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment Receives: Behavioral: TB reminders |
| No TB reminders | No intervention | Only receive existing reminders; no TB reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription of Isoniazid
Provider prescribes INH within 3 months of patient's initial encounter.
Measured: within 3 months of initial encounter
Secondary outcomes (1)
Time to isoniazid prophylactic therapy (IPT) initiation
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.
Measured: within 3 months of initial encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University, Academic Model Providing Access to Healthcare (AMPATH), Regenstrief Institute, Inc., Innovative Support to Emergencies, Diseases and Disasters (InSTEDD), Kijani Consulting
- Responsible party
- Principal investigator, Paul Biondich, Indiana University
- Investigators
- Lameck O Diero, MBChB, MMed, Principal investigator, Moi University College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934309
- Sponsor's protocol ID
- AID-OAA-TO-11-00060
- Acronym
- TBTech
- Status last verified
- Mar 2023
- First submitted
- 29 Aug 2013
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Green EP, Catalani C, Diero L, Carter EJ, Gardner A, Ndwiga C, Keny A, Owiti P, Israelski D, Biondich P. Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial. Trials. 2015 Apr 9;16:141. doi: 10.1186/s13063-015-0558-8.
PubMed 25885266
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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?
- ClinicalTrials.gov ID
- NCT01934309
- Acronym / sponsor ID
- TBTech / AID-OAA-TO-11-00060
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, isoniazid preventative therapy, clinical decision support, HIV, Kenya, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,782 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Moi University, Academic Model Providing Access to Healthcare (AMPATH), Regenstrief Institute, Inc., Innovative Support to Emergencies, Diseases and Disasters (InSTEDD), Kijani Consulting
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB reminders | Experimental | Behavioral: TB remindersReceive existing reminders plus new patient-specific reminders about TB screening, prevention, and treatment |
| No TB reminders | No intervention | –Only receive existing reminders; no TB reminders |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- history of TB or IPT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB remindersThe 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. | Behavioural | TB reminders |
Primary outcome
Prescription of Isoniazid
Time frame: within 3 months of initial encounter
Provider prescribes INH within 3 months of patient's initial encounter.
1 secondary outcome
Time to isoniazid prophylactic therapy (IPT) initiation
Time frame: within 3 months of initial encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 25885266Green EP, Catalani C, Diero L, Carter EJ, Gardner A, Ndwiga C, Keny A, Owiti P, Israelski D, Biondich P. Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial. Trials. 2015 Apr 9;16:141. doi: 10.1186/s13063-015-0558-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lameck O Diero, MBChB, MMed principal investigator
Moi University College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TB reminders in people with Tuberculosis, run by Indiana University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription of Isoniazid (time frame: within 3 months of initial encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.