HIVCDSSNCT01634802
Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings
A study testing EMR Only and EMR+CDSS in people with HIV, run by Kenya Medical Research Institute at 1 site in Kenya.
Trial summary
The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- HIV
- What is being tested?
- EMR Only and EMR+CDSS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,460 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2012to Dec 2013
- 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 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All HIV patients enrolled in participating clinics
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
KEMRI/CDC Clinical Research Center
Kisumu, Nyanza
Patrick Langat, BSc, +254 722 750 072, Plangat@kemricdc.org
Daniel Kwaro, MD
About this study
Official title: Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings
The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.
Read the detailed description
We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.
- Conditions
- HIV
- Being tested
- EMR Only, EMR+CDSS
- Keywords
- Clinical Decision Support Systems, Electronic Medical Record, Resource constrained countries, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR OnlyOther
Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.
EMR+CDSSOther
Also called Clinical Decision Support Systems, Electronic Medical Records
Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.
| Study group | Role | What they receive |
|---|---|---|
| EMR Only | No intervention | Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system. Receives: Other: EMR Only |
| EMR+CDSS | Experimental | Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making. Receives: Other: EMR+CDSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.
Measured: 12 months
Secondary outcomes (1)
Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenya Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Oluoch, Centers for Disease Control and Prevention
- Investigators
- Tom Oluoch, MSc, Principal investigator, Centers for Disease Control and PreventionDaniel Kwaro, MD, Principal investigator, KEMRI-CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634802
- Sponsor's protocol ID
- 2073
- Acronym
- CDSS
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Oluoch T, Cornet R, Muthusi J, Katana A, Kimanga D, Kwaro D, Okeyo N, Abu-Hanna A, de Keizer N. A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial. BMC Med Inform Decis Mak. 2021 Dec 20;21(1):357. doi: 10.1186/s12911-021-01718-0.
PubMed 34930228Oluoch T, Katana A, Kwaro D, Santas X, Langat P, Mwalili S, Muthusi K, Okeyo N, Ojwang JK, Cornet R, Abu-Hanna A, de Keizer N. Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e76-84. doi: 10.1016/S2352-3018(15)00242-8. Epub 2015 Dec 17.
PubMed 26847229
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings
- ClinicalTrials.gov ID
- NCT01634802
- Acronym / sponsor ID
- CDSS / 2073
- Conditions
- HIV
- Keywords
- Clinical Decision Support Systems, Electronic Medical Record, Resource constrained countries, HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,460 participants (estimated)
- Lead sponsor
- Kenya Medical Research InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Jul 2012 (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 purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.
Detailed description
We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR Only | No intervention | Other: EMR OnlyClinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system. |
| EMR+CDSS | Experimental | Other: EMR+CDSSClinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All HIV patients enrolled in participating clinics
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EMR OnlyClinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system. | Other | EMR Only |
| EMR+CDSSAlso: Clinical Decision Support Systems, Electronic Medical RecordsClinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making. | Other | EMR+CDSS |
Primary outcome
The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.
Time frame: 12 months
1 secondary outcome
Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Derived from this study: PubMed 34930228Oluoch T, Cornet R, Muthusi J, Katana A, Kimanga D, Kwaro D, Okeyo N, Abu-Hanna A, de Keizer N. A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial. BMC Med Inform Decis Mak. 2021 Dec 20;21(1):357. doi: 10.1186/s12911-021-01718-0.
- Derived from this study: PubMed 26847229Oluoch T, Katana A, Kwaro D, Santas X, Langat P, Mwalili S, Muthusi K, Okeyo N, Ojwang JK, Cornet R, Abu-Hanna A, de Keizer N. Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e76-84. doi: 10.1016/S2352-3018(15)00242-8. Epub 2015 Dec 17.
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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.
Tom Oluoch, MSc principal investigator
Centers for Disease Control and Prevention
Daniel Kwaro, MD principal investigator
KEMRI-CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR Only and EMR+CDSS in people with HIV, run by Kenya Medical Research Institute 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 Jul 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Kwaro, MD (+254 700 858 288, Dkwaro@kemricdc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines. (time frame: 12 months). 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 NCT01634802, which also lists 2 linked publications.
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 6 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.