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Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa
Last registered on March 25, 2015

Pre-Trial

Trial Information
General Information
Title
Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa
RCT ID
AEARCTR-0000668
Initial registration date
March 25, 2015
Last updated
March 25, 2015 6:46 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
University of Washington
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2013-10-01
End date
2014-02-13
Secondary IDs
Abstract
Introduction. The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STI). An STI training was delivered at primary health care (PHC) clinics, and a cluster randomized trial compared controls to participants with three different delivery methods: 1) lecture, 2) computer, 3) paper-based.

Methods. Ten PHC clinics were randomly assigned to control and 10 to each delivery method arm. Clinicians participated in on-site training on two modules per week for three weeks. Each clinic was visited by three or four unannounced Standardized Patient (SPs) actors pre and post training. Male SPs reported symptoms of male urethritis syndrome and females SPs reported symptoms of vaginal discharge syndrome. Quality of care was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms, and partner notification.

Results. An average of 31% of clinicians from each PHC attended the beginning of each module. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95%CI=0.67,1.84). Across delivery arms, there was a 26% increase (RRR=1.26, 95%CI=0.77, 2.06) associated with lecture, 17% increase (RRR=1.17, 95%CI=0.59,2.28) with paper-based, and 13% decrease (RRR=0.87, 95%CI=0.40,1.90) with computer arm relative to the control.

Conclusion. STI management improved for lecture and paper-based delivery methods despite low training attendance. Increases were not statistically significant.
External Link(s)
Registration Citation
Citation
Weaver, Marcia. 2015. "Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa." AEA RCT Registry. March 25. https://doi.org/10.1257/rct.668-1.0.
Former Citation
Weaver, Marcia. 2015. "Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa." AEA RCT Registry. March 25. https://www.socialscienceregistry.org/trials/668/history/3850.
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Experimental Details
Interventions
Intervention(s)
The six modules of the Sexually Transmitted Infection (STI) training program were: 1) STI Introduction and Patient History, 2) STI Physical Exam and Counseling, 3) Male Urethritis Syndrome, 4) Vaginal discharge syndrome, 5) Genital Ulcer Syndrome, and 6) Lower Abdominal Pain. Each module was designed to be completed in one hour. Computer-based modules are available at http://edgh.uw.edu/series/sexually-transmitted-infections and on compact disc. All training materials are in English, which is one of eleven official languages of South Africa.

Training frequency and time allocated was the same for all delivery methods: two modules per week for three weeks. Tests were given before and after the allocated time. All participants received a printed version of the national STI guidelines. For the lecture arm, a trainer taught two modules and gave participants handouts for those modules. For the computer arm, computers and assistance with navigation were provided. For the paper-based arm, participants were provided two modules, which they could keep.
Intervention Start Date
2013-10-31
Intervention End Date
2014-01-17
Primary Outcomes
Primary Outcomes (end points)
Effectiveness of delivery methods were compared using unannounced standardized patient (SP) encounters. SPs are widely used in medical and nursing education in the United States and unannounced SPs are considered the gold standard for measuring quality of care. Unannounced SPs have been used to measure outcomes of interventions for syndromic management of Sexually Transmitted Infection (STIs) in pharmacies and clinics.

We measured whether or not clinicians completed five STI management tasks during an unannounced SP encounter and the primary outcome was total number completed. Professional actors who were fluent in Setswana attended a three-day SP training and one-day pilot in September 2013. Actors were trained on a standard script for vaginal discharge syndrome for women and male urethritis syndrome for men. All scripts were adapted to the actor’s age, and other personal characteristics. To prevent potential bias due to acting quality, the SPs encounters were balanced meaning that each SP visited a similar number of clinics in each arm during each time period.

After the encounters, SPs provided information about five STI tasks: correct medication, HIV test, provide condoms, partner notification slip, and genital exam. To avoid ingesting or removing drugs from the clinic, SPs disclosed at the end of the encounter. The clinicians recorded the drug name, dose, mode of administration, frequency, and duration on a Medication Slip, and all five elements had to be correct.

STI knowledge was a secondary outcome measured by tests with five, case-based, multiple choice questions per module. Module 4 was the exception, with one question withdrawn. Case-based questions began with a description of a case that the participants might encounter, and then poses questions about managing that case.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
To compare the effectiveness of the three training delivery methods, 40 primary health care (PHCs) clinics in North West Province were randomly assigned to four parallel arms (1:1:1:1 balance): 1) delayed implementation arm that served as a control during the trial, 2) lecture, 3) computer, and 4) paper-based training delivery methods. Trainees were randomized by clinic, because the training was delivered at clinics.
Experimental Design Details
Randomization Method
Forty PHC clinics were randomized to four parallel arms (1:1:1:1 balance): Arm 1 was control, Arm 2 was lecture, Arm 3 was computer, and Arm 4 was paper-based. Sites were randomized in strata to control for two characteristics of PHC clinics: subdistrict, and and operating hours, meaning 24-hour services vs. fewer hours. The randomization was conducted using a random number generator in Stata version 11 (Statacorp, 2009 College Station, TX). It was conducted on September 30, 2013, before the pre-training SP visits and knowledge tests.
Randomization Unit
The clusters were primary health care clinics.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
40 clinics
Sample size: planned number of observations
400 Standardized Patient visits
Sample size (or number of clusters) by treatment arms
10 clusters per arm, and 10 Standardized Patient visits per cluster
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Power calculations were based on a sample size of 10 PHC clinics per arm and 10 SP visits per clinic across all time periods. We calculated the power of a test for post-training differences across arms in the percentage of SPs with correct medications assuming 35% for the control arm, 75% for lecture, and 60% for the other two delivery methods. Under three different assumptions about the random effects for facilities and for SPs, and 0.05 level of significance, the estimated power to detect a 15% difference between the lecture and other delivery arms was at least 0.8.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
South African Human Sciences Review Council
IRB Approval Date
2013-01-14
IRB Approval Number
REC 1/22/08/12
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
January 17, 2014, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
February 13, 2014, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
40
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
274
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers