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Integrated Infectious Disease Capacity-Building Evaluation

NCT ID: NCT01190540

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-08-31

Brief Summary

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This evaluation aim is to investigate a cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa. Classroom based training continues to be the dominant form of training, despite evidence that suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site support is the most effective way to deliver the required outputs and related outcomes is still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be studied: 1) Integrated Management of Infectious Disease (IMID) training program for individual MLP, and 2) On-site support (OSS) for team of health professionals. This study employs a mixed design with pre/post and cluster randomized trial components. Interventions are at the level of the individual participant for IMID and at the level of the site (health facility) for OSS. All participants attend a 3-week course, followed by two 1-week booster courses over a six month period. After the 3-week course, a randomized arm of half the sampled facilities also received OSS every month for 9 months and bi-monthly for 6 additional months.

Detailed Description

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There are four major components of the evaluation design as described below: 1) Site Assessment, 2) Competence and practice of individual MLP who participate in IDT, 3) Facility cost and performance indicators, and 4) Mortality survey. The site assessment guided the curriculum development and site selection. As shown in Figure 1, it occurred only once in Year 1. The effect of the IMID and OSS on competence of individual MLP will be evaluated with written case scenarios or vignettes. Data on case scenarios will be collected three times: a) before training, b) after the three-week course, and c) after the nine-month program that includes two, one-week booster courses and distance learning. To estimate the effect of IMID, aggregate changes in test score across all 3 time points for both arms will be analyzed jointly. To estimate the effect of OSS, differences in change in test score starting from after the three-week course to the end of the nine-month program will be compared across the 2 arms. The effects on practice of individual trainees will be evaluated with clinical assessments by mobile team faculty during five outpatients visits and five HIV clinic visits by individual MLP. Data on clinical assessments will be collected two times: a) before training, and b) after the nine-month program. Facility performance indicators will be collected on a monthly basis from each site. Sites will be randomly assigned to begin OSS in either Phase 1 or Phase 2 and the facility indicators of these two samples of sites will be compared. The principal investigators of IDCAP are actively considering collecting data on mortality among children under five, but a final decision has not been made. At the request of the acting chairperson of SOMREC, we are including information about this potential activity. Mortality surveys would be conducted before and after the OSS.

Conditions

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Capacity Building Support for Midlevel Health Professionals Diagnostic Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Training and supervision

Intervention Type BEHAVIORAL

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.

Integrated Management of Infectious Disease (IMID)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Training and Supervision

Intervention Type BEHAVIORAL

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.

Integrated Management of Infectious Disease (IMID)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* NA

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

Accordia Global Health Foundation

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Marcia Weaver

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcia Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Sarah Naikoba, BMBCh, MPH

Role: PRINCIPAL_INVESTIGATOR

Infectious Disease Institute, Makarere University

Locations

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Infectious Disease Institute, Makerere University

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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Weaver M, Krieger J, Castorina J, et. al.

Reference Type BACKGROUND

World Health Organization. Generalized Cost-Effeciveness Analysis: A Guide. Geneva: World Health Organization, 2003. Available online at: http://www.who.int/choice/en/ Accessed on April 14, 2008.

Reference Type BACKGROUND

The Uganda Bureau of Statistics (UBOS), Macro International Inc., and MEASURE Evaluation. 2008. Uganda Child Verbal Autopsy Study 2007. Calverton, Maryland, USA: UBOS, Macro International Inc., and MEASURE Evaluation.

Reference Type BACKGROUND

Weaver MR, Crozier I, Eleku S, Makanga G, Mpanga Sebuyira L, Nyakake J, Thompson M, Willis K. Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components. PLoS One. 2012;7(12):e51319. doi: 10.1371/journal.pone.0051319. Epub 2012 Dec 14.

Reference Type DERIVED
PMID: 23272097 (View on PubMed)

Related Links

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http://accordiafoundation.org/

Accordia Global Health Foundation

http://idi-makerere.com/

Infectious Disease Institute, University of Makerere

Other Identifiers

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42657-EG

Identifier Type: -

Identifier Source: org_study_id