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Implementing RTA to Identify False Positives and Immediately Refer to Care
Thomas Knoble, Omar Menendez, Teri Dowling, Shelley FacenteSan Francisco Department of Public Health, HIV Prevention Section
Kevin DelaneyDivision of HIV/AIDS Prevention, NCHHSTP Centers for Disease Control and Prevention
Study Objectives
Feasibility and Cost (Can we do it & $) Link to care, same day Identify false positives, same day
Validation (Does it work)
Impact on Linkage to Care
Protocols and Best Practices (What did we learn)
Study Structure
Standard consent
100 to 150 Positive tests at intervention sites 5 sites
100 to 150 Positive tests at control sites 10 sites
18 Months, August 1st, 2007-????
LA, additional site (200 to 300)
CBO, HomelessCBO, HomelessCBO, Gay CollectiveCBO, Gay Collective
Methadone Clinic Methadone Clinic
County JailCounty Jail
CBO, Asian CommunityCBO, Asian Community
5 Sites5 Sites
Test # 1st Test
Negative Reactive, 2nd Test
Non-reactive, 3rd Test
Negative Positive
Positive
213
San Francisco RTA
0 5 10 15 20 25 30 35 40
Minutes
#1 ORAQUICKRun TimeMin: 20 min.Max: 40 min.Read WindowBtwn. 20-40 min.
#2 STAT-PAKRun TimeMin: 15 min.Max: 20 min.Read WindowBtwn. 15-20 min.
# 3 UNI-GOLDRun TimeMin: 10 min.Max: 12 min.Read WindowBtwn. 10-12 min.
Run Time
Read Window
Run Times
Control Products 1 vs 3
Control FluidVolume in
VialUnopened Shelf Life
Opened Shelf Life
Unopened Storage Temp
Opened Storage Temp
OraQuick Advance 0.2ml 1 year 56 days2-8°C
(35-46°F)2-8°C
(35-46°F)
Clearview Stat-Pak 0.25ml 2 years 2 years2-8°C
(35-46°F)2-8°C
(35-46°F)
Uni-Gold 0.5ml 1 year 1 month2-8°C
(35.6-46.4°F)2-8°C
(35.6-46.4°F)
Xsera 1.ml 2 years 60 days2-8°C
(35-46°F)2-30◦C
Ordering and cost are varying issues as well
Numbers for 3 Months August 1st - October 31th 2007
Intervention Control# Rapid tests run 1212 1963 # Positives 22 47# Days referred to care 0 7.6 days (Mean)
5 did not get results
# False positives 8 8# Days for “resolution” 0 7 (Mean)
Note: All RTA results matched lab results 100%
“…can we get the RTA? ….”
after having 4 false positives in 1 month
Enrique Guzman
Mission Neighborhood Health Center
Control Site
Issues Encountered
Control product issues (hopefully resolved)
Phlebotomy availability (ongoing; $ in process)
Temperature range (ongoing/requires careful QA)
Agency issues have impact on participation (ongoing communication with agencies to resolve and/or support)
Stories from the field…
Thomas’ Client 8/1/07 Case study:– Middle class, 40s, gay, Latino, some metal health issues– After disclosure of preliminary positive result, client indicated
that he thought he had received a positive rapid test result in the past as well as a negative test result, but seemed confused about when he got this information. Client had trouble internalizing previous HIV information
– Counselor informed the client there was no ambiguity about the results due to RTA
– Client followed through with care appointment
RTA helps address “false hope” of “Preliminary Positive”
“…before RTA it seemed premature to introduce clients
to care staff….now it fits”
Jason KwongAsian Pacific and Islander Wellness Center
Intervention Site
Omar’s Client 8/17/07Case study; – Marginally housed, African American, 50s, Heterosexual, IDU Hx
10 years ago – Testing at wife's “request,” waiting for him – Client was in disbelief regarding reactive OraQuick. Stated
repeatedly that he had not 'cheated' and had only had sexual intercourse with wife
– Non-reactive Stat-Pak and Uni-Gold– Confirmatory testing was done, but client was able to leave with
more information in the same day– Non-reactive Stat-Pak and Uni-Gold were comforting to client
who was nervous and in a hurry to leave session, as his wife was in the waiting room
RTA identified a false positive shortly after initial reactive test
“…I trust in rapid testing again….”
Dale GluthRTA Counselor
Magnet Men’s HealthIntervention Site
Dale and Thomas’ Client 8/18/2007
Case study:– Client actively using meth., reported significant recent risk
(UAI with multiple partners)– OraQuick ‘T’ line very light, could have been missed by
reader, called reactive after Dale and Thomas looked at it– Thomas felt it “looked false positive”– “Shocked” when Stat-Pak reacted strongly and quickly,
within 2 minutes– Confirmed positive (EIA-RR, IFA positive)
RTA removes ambiguity associated with Oral fluid testing
Dale’s “Two” Clients 10/25/07
Case study– Middle class, 20s, gay, white– Partner received preliminary positive at a control site
the day before– Partner was in waiting room – Client asked Dale, “Why does my lover have to go
back to get his result?” – Dale brought partner in to explain study to both
Demand for RTA is coming……
Lessons Learned to Date
Regular on-site QA supports good communication with intervention sites and improves quality
Training is an ongoing process
Start slow and build on success
Clear written protocols are important
Recommendations
Commit resources to oversee process-Training, QA, written policies
Start with agencies that work well: competent, effective, good reputation
Benefits to clients and counselors are great, demand is coming, start moving
Call us….
Shelley FacenteShelley FacenteStudy Data Coordinator
Omar MenendezOmar MenendezCoordinator for Linkages
Teri DowlingTeri DowlingPrincipal Investigator
Thomas KnobleThomas KnobleIntervention Site Coordinator
Kevin DelaneyKevin DelaneyCDC Project Officer
Centers for Disease Control and PreventionDivision of HIV/AIDS Prevention, NCHHSTP
Atlanta, GA
