The Effect of Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa A Cluster Randomized, Controlled Trial October 2015 Acknowledgments I-TECH would like to express its gratitude to the University of Washington following individuals: Marcia Weaver, Principal Investigator King Holmes, Sean Galagan, Jennifer Gilvydis, South Africa National Department of Health Gabrielle O’Malley, Harnik Gulati, Linda Campbell, Ms. Eva Marumo, Ms. Lufuno Malala, Ms. Thuthukile Elizabeth M. Frick, Anya Nartker, and Liz Scott. Mabuella, and Ms. Thato Chidarikire at the South Africa National Department of Health STI I-TECH South Africa sub-directorate Erushka Pillay, Suzanne Jed, Evasen Naidoo, Julia DeKadt, Gladys Makati Mema, Shumani Makatu, North West Department of Health Fulufhelo Malamatsho, Sipho Mazibuko, Mary-Jane Provincial DOH, Bojanala District DOH- Dr. J.M. Ratlagang, Lebogang Isidoro, Jessica Grignon, and Tumbo, Moretele (Ms. Mangezi), Madibeng (Ms. Albert Bakor. Leseto) and Rustenburg (Mr. Tlhowe)DOH Sub- Districts and the Clinic Managers from Bosplaas, Funding Maubane, Leseding, Lefathleng, Makapanstad, The developers of REDCap were supported by grant Lebotloane, Sediane, Tladistad, Kutlwanong, UL1 RR025014 from National Center for Research Ngobi, Mmakaunyane, Ga-Motla, Rekopantswe, Resources of the US Department of Health and Mphoyabatho, Mogogelo, Classic, Gateway, Human Services, National Institutes of Health. This Boitekong, Sunrise, Karlienpark, Kana, Thekwane, information/content and conclusions are those of the Mfidikwe, Anna Legoale, Hartebeesfontein, author(s) and should not be construed as the official Monakato, Luka, Chaneng, Phatsima, Mothutlung, position or policy of, nor should any endorsements Broederstroom, Rabokala, Madidi, Jericho, Fafung, be inferred by HRSA, HHS or the U.S. Government. Maboloka, Lethlabile, Segwaelane, Bapong and Wonderkop Clinics, and all of the nurses who willingly participated. Howard University Tamara Owens for developing the actor cases and providing training for the actors. Morgeez Casting Agency And their talented actors who served as standardized patients. Page 2 The Effect of Three Methods of Delivering Clinic-Based STI Training on STI Syndromic Management in South Africa: A Cluster Randomized, Controlled Trial Contents Acknowledgments ...........................................................................................................................................2 Funding ...........................................................................................................................................................2 Abstract ............................................................................................................................................................4 Introduction ..............................................................................................................................................4 Methods ....................................................................................................................................................4 Results .......................................................................................................................................................4 Discussion .................................................................................................................................................4 Conclusion ................................................................................................................................................4 I. Introduction .................................................................................................................................................5 II. Methods ......................................................................................................................................................6 Trial Design ...............................................................................................................................................6 Participants ................................................................................................................................................6 Training .....................................................................................................................................................6 Table 1: Overview of STI Curriculum and Learning Objectives ................................................................7 Outcomes ..................................................................................................................................................8 Sample size calculation ..............................................................................................................................8 Randomization ..........................................................................................................................................8 Blinding.....................................................................................................................................................9 Data management ......................................................................................................................................9 Statistical analysis ......................................................................................................................................9 Human subjects review ........................................................................................................................... 10 III. Results ..................................................................................................................................................... 11 Participant Flow ...................................................................................................................................... 11 Figure 1: CONSORT Flow Diagram ......................................................................................................... 12 Table 2: Comparison of Clinicians Consented, Pretests Completed and Post Tests .................................. 13 Figure 2: Tests completed as percentage of clinicians consented by facility operating hours ................. 13 Stakeholder Engagement & Recruitment ................................................................................................. 14 Description of Sample and Baseline Outcomes ........................................................................................ 14 Wait Time ................................................................................................................................................ 14 Table 3: Characteristics of Sample ........................................................................................................... 15 SP Results ................................................................................................................................................. 15 STI Knowledge Results ............................................................................................................................ 16 Table 4: Bivariate Comparison of STI Care by Training Delivery Method: All Sub-Districts ................... 17 Table 5: Comparison of STI Care Pre and Post Training by Sub-District.................................................. 18 Table 6: The Effect of STI Training on STI Care as Measured by Unannounced Standardized Patient Visits ............................................................................................................................................ 19 Table 7: Effect of STI Training on Case-Based Test Results....................................................................... 20 IV. Discussion ................................................................................................................................................ 21 Limitations .............................................................................................................................................. 21 Generalizability ....................................................................................................................................... 22 V. Recommendations .................................................................................................................................... 23 VI. Conclusion ............................................................................................................................................... 24 Appendix A: Female Vaginal Discharge Syndrome Case Standard Script ................................................... 25 Appendix B: Male Uretheritis Syndrome Case ............................................................................................. 30 Appendix C: Data Collection Tools ............................................................................................................... 35 References...................................................................................................................................................... 38 The Effect of Three Methods of Delivering Clinic-Based STI Training on Page 3 STI Syndromic Management in South Africa: A Cluster Randomized, Controlled Trial Abstract Introduction classroom arm, 17% increase (RRR=1.17, 95% The South African National Department of Health CI=0.59, 2.28) with paper-based distance learning, (NDOH) updated the national guidelines for and a 13% decrease (RRR=0.87, 95% CI=0.40,