Shelley Facente, Thomas Knoble, Omar Menendez, Teri Dowling

1. Training & Quality Assurance for a Rapid Test Algorithm: Lessons from Implementation, San Francisco, CA 2007 Shelley Facente, Thomas Knoble, Omar Menendez, Teri Dowling San Francisco Department of Public Health, HIV Prevention Section Kevin Delaney Division of HIV/AIDS Prevention, NCHHSTP, Centers for Disease Control and Prevention HV Diagnostics Conference Atlanta, GA December 2007

2. A bit of background… • Rapid Testing began in San Francisco in May 2003, with a pilot at one community-based organization, Glide Health Services. • At this time, there are 17 publicly-funded agencies offering rapid HIV testing.

3. Client assumed HIV-negative = Client assumed HIV-positive Non-reactiveOraQuick ReactiveOraQuick = ReactiveStat-Pak Non-reactive Stat-Pak ReactiveUni-Gold Non-reactiveUni-Gold The Rapid Test Algorithm * All results following a reactive OraQuick are confirmed via EIA and IFA/WB in the SFDPH Microbiology Lab

4. Planning Identify necessary resources and staff Develop and pilot standard operating procedures for the study and sites Develop and conduct training for all staff Develop a quality assurance program

5. Identify necessary resources and staff • CDC funded SF and LA for this study • Included staff salaries, supplies, lab costs, and travel • San Francisco hired two full-time staff: • One to coordinate the intervention sites • One to coordinate a system for linkage to care • Three other SF staff are devoted part-time: • One to coordinate the study as a whole (.25 FTE) • One to coordinate study data (.5 FTE) • One to coordinate HIV surveillance (.1 FTE)

6. Identify necessary resources and staff Each of the five intervention sites identified: • A coordinator responsible for HIV counseling and testing at the site • Some have a separate person responsible for managing the laboratory procedures • A core group of people who would be trained as technicians to run the second and third rapid tests after a reactive OraQuick • Phlebotomist(s) to be on-site at all times testing is offered

7. Develop and pilot standard operating procedures for the study and sites • A plan for data collection was developed and forms were created or modified to ensure: • study objectives are measured • quality of study procedures are continuously monitored • A comprehensive study protocol was developed and submitted along with an application to the IRB at UCSF and CDC • All sites were required to complete site-specific protocols according to a template provided by the SFDPH

8. Develop and conduct training for all staff • After meeting with CDC, test manufacturers, and test counselors, two trainings were developed: • Technicians • 8 hour training • To date, over 25 technicians have been trained • Counselors • 3 hour training • To date, over 100 counselors have been trained

9. Counselor Training All counselors at each intervention site were required to attend a 3-hour training (many were offered) to review and practice new counseling messages

10. Develop a quality assurance program • Observation • Intervention Site Coordinator conducts weekly site visits to: • observe testing processes, • observe counseling messages being used, • review quality assurance logs (i.e. temp or control logs), and • provide technical assistance until such time that he is confident that sites are entirely self-sufficient and running with high quality • Running Controls • Competency Assessment Testing (CAT) • Model Performance Evaluation Program (MPEP) • Adjusting Data Collection

11. Develop a quality assurance program • Observation • Running Controls • Each certified tester is required to run controls for each type of test at least once per month, to keep up skills • Competency Assessment Testing (CAT) • Model Performance Evaluation Program (MPEP) • Adjusting Data Collection

12. Develop a quality assurance program • Observation • Running Controls • Competency Assessment Testing (CAT) • Every three months, each certified tester is observed and documented running both a Stat-Pak and Uni-Gold test. • If any of these testers do not pass competency, they must retest and pass or lose their certification and cannot run the tests • Model Performance Evaluation Program (MPEP) • Adjusting Data Collection

13. Develop a quality assurance program • Observation • Running Controls • Competency Assessment Testing (CAT) • Model Performance Evaluation Program (MPEP) • Each site is enrolled in CDC’s MPEP and the site laboratory manager must correctly run all six MPEP samples for the OraQuick Advance, Stat-Pak, and Uni-Gold tests twice per year • Adjusting Data Collection

14. Develop a quality assurance program • Observation • Running Controls • Competency Assessment Testing (CAT) • Model Performance Evaluation Program (MPEP) • Adjusting Data Collection • Tracking and linking each type of test run for a client • Adapting current logs (temp storage, control) to capture new tests • Modifying current databases to collect and analyze additional tests and results, including linkage information

15. Lessons Learned Staff and resources must be adequate A data collection plan must be developed and refined before implementation A slow roll-out is essential

16. Staff and resources must be adequate Our two full-time staff make this possible Each site having its own coordinator, in constant communication, is also vital Time to train all counselors and technicians should not be minimized

17. A data collection plan must be developed and refined before implementation • When you have 5 sites and over 125 counselors and technicians, being clear and consistent is key • Determine up front what data points are needed to ensure quality monitoring and meet study objectives • You can be flexible if things are not working, but adding or changing requirements all the time leads to frustration and failure

18. A slow roll-out is essential • Plan carefully, train well, and begin slowly • It takes months to develop a program that works for everybody and uses good lab practices – be prepared • Plan for a smaller pilot program and then scale upward • Communication is key • The CDC, the SFDPH, the city public health lab, and all site coordinators have been in constant communication throughout planning and implementation • Accurate results, safety, and sensitive counseling with strong linkages to needed medical care and support services are shared goals for all

19. Thank you! Teri Dowling Principal Investigator 415-554-9167 Teri.Dowling@sfdph.org Shelley Facente Study Data Coordinator 415-554-9136 Shelley.Facente@sfdph.org Thomas Knoble Intervention Site Coordinator 415-703-7279 Thomas.Knoble@sfdph.org Omar Menendez Coordinator for Linkages 415-5703-7280 Omar.Menendez@sfdph.org Kevin Delaney CDC Project Officer 404-639-6142 khd8@cdc.gov Centers for Disease Control and Prevention Division of HIV/AIDS Prevention, NCHHSTP Atlanta, GA San Francisco Department of Public Health AIDS Office, HIV Prevention Section San Francisco, CA