Clinical trial NCT01190540: Integrated Infectious Disease Capacity-Building Evaluation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capacity Building
Support for Midlevel Health Professionals
Diagnostic Training
Keywords: On site support services.
mid level health professionals.
cost effectiveness.
infectious disease.
capacity building.
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Accordia Global Health Foundation
First posted: 2010-08-27
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Model of Integrated Capacity Building Program
timeFrame: monthly over 3 years
measure: Competence of individual clinicians
timeFrame: 3 observations at pre/post IMID and final
measure: Practice of individual clinicians
timeFrame: Baseline and Endline (9 months)
measure: Clinical performance indicators
timeFrame: Monthly beginning 5 months before OSS
Secondary outcomes:
measure: Reduce Infection, Illness, and Mortality Rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Disease Institute, Makerere University
Study officials:
affiliation: University of Washington
name: Marcia Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Disease Institute, Makarere University
name: Sarah Naikoba, BMBCh, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weaver M, Krieger J, Castorina J, et. al.
citation: 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.
citation: 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.
citation: 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.