Integrated Infectious Disease Capacity-Building Evaluation (IDCAP)
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ClinicalTrials.gov Identifier: NCT01190540 |
Recruitment Status
:
Completed
First Posted
: August 27, 2010
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
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Capacity Building Support for Midlevel Health Professionals Diagnostic Training | Behavioral: Training and supervision Behavioral: Training and Supervision Behavioral: Integrated Management of Infectious Disease (IMID) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Cost Effectiveness of Building Capacity of Mid-level Practitioners in Sub-Saharan Africa for the Care and Prevention of HIV, Tuberculosis, Malaria and Related Infectious Diseases |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
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Active Comparator: OSS Phase 1
Thirty-six sites will receive the On Site Support service (OSS) activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 1
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Behavioral: Training and supervision
On-Site-Support (OSS) service training will occur monthly for a period of 9 months. This training and supervision will support the proper utilization of newly learned clinical skills.
Behavioral: Integrated Management of Infectious Disease (IMID)
The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
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Active Comparator: OSS Phase 2
Thirty-six sites will receive the OSS activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 2 that will serve as a control group in phase 1 and receive OSS nine months later.
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Behavioral: Training and Supervision
On-Site-Support (OSS) service training will occur monthly for a period of 9 to 15 months. This training and supervision will support the proper utilization of newly learned clinical skills and continuous quality improvement of processes of care. For the control group, the OSS training will occur during phase 2, after a randomly assigned wait list control period.
Behavioral: Integrated Management of Infectious Disease (IMID)
The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
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- Model of Integrated Capacity Building Program [ Time Frame: monthly over 3 years ]The principal output of this evaluation will be a proven model of an integrated capacity-building package for the care and prevention of infectious disease in Africa. The package will include a single curriculum for MLP and a portfolio of on-site support services founded on Accordia Global Health Foundation's considerable experience in training clinicians in North America and Africa.
- Competence of individual clinicians [ Time Frame: 3 observations at pre/post IMID and final ]Competence of individual clinicians will be measured by scores on 12 written case scenarios or vignettes. Three blocks of 4 scenarios each covered different aspects of HIV/AIDS, tuberculosis, malaria, and other infectious diseases and included cases involving children, adults, and pregnant women. Each case scenario addressed 6 principal domains: emergency or danger signs, history and physical examination, laboratory testing, diagnosis or classification of patients' medical problems; initial treatment or referral plan, and evolution of the case over time.
- Practice of individual clinicians [ Time Frame: Baseline and Endline (9 months) ]Clinical assessments will be conducted by mobile team faculty who will observe individual clinicians during five outpatient visits with children under five years and five HIV clinic visits. Clinical practice will be assessed on history, physical examination, review of medical records (HIV clinic only), laboratory investigations ordered, diagnosis, treatment prescribed and patient education.
- Clinical performance indicators [ Time Frame: Monthly beginning 5 months before OSS ]54 clinical performance indicators used by the Ministry of Health, the Uganda Malaria Surveillance Program or recommended by international organizations will be used to measure performance in general areas: 1) HIV prevention, 2) HIV care, 3) Antiretroviral therapy, 4) TB/HIV care, 5) Case management of respiratory infections, 6) Case Management of Fever, and 7) Emergency Triage and Treatment.
- Reduce Infection, Illness, and Mortality Rates [ Time Frame: 3 years ]The population in the areas surrounding the proposed sites will benefit directly from lower infection, illness and mortality rates. The improved ability of clinic staff to deliver quality prevention and care services will increase access to cost-effective interventions delivered according to national guidelines by 9% to 25% depending on the intervention.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Facilities selected for OSS:
- The health facility had to be a HC IV or comparable facility such as a small general hospital or non-governmental organization clinic
- It had to be an active ART site or accredited ART site that is scheduled to become active by April 2009
- No past or current participation in a partnership with the U.S. Department of Defense
- Has a population of potential patients who are not prisoners
- Representation from all six administrative regions of Uganda
Exclusion Criteria:
MLP selected from the participating facilities for IMID:
Two mid-level practitioners (clinical officers, nurses, or midwives) who are actively engaged in clinical infectious-disease care will be selected for enrollment in IMID

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): NCT01190540
Uganda | |
Infectious Disease Institute, Makerere University | |
Kampala, Uganda |
Principal Investigator: | Marcia Weaver, PhD | University of Washington | |
Principal Investigator: | Sarah Naikoba, BMBCh, MPH | Infectious Disease Institute, Makarere University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marcia Weaver, Research Associate Professor, University of Washington |
ClinicalTrials.gov Identifier: | NCT01190540 History of Changes |
Other Study ID Numbers: |
42657-EG |
First Posted: | August 27, 2010 Key Record Dates |
Last Update Posted: | December 3, 2014 |
Last Verified: | December 2014 |
Keywords provided by Marcia Weaver, University of Washington:
On site support services. mid level health professionals. cost effectiveness. infectious disease. capacity building. |
Additional relevant MeSH terms:
Communicable Diseases Infection |