AEA RC T Registr y

The American Economic Association's registry for randomized controlled trials

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.

2013-10-31

2014-01-17

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.

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.

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.

The clusters were primary health care clinics.

Yes

40 clinics

400 Standardized Patient visits

10 clusters per arm, and 10 Standardized Patient visits per cluster

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.