Successful interventions to increase use of Self Obtained Vaginal Swabs (SOVs) for chlamydia/gonorrhea testing in WA State

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Successful interventions to increase use of Self Obtained Vaginal Swabs (SOVs) for chlamydia/gonorrhea testing in WA State Goldenkranz S 1, Fine D 1, Knutson C 2, Loza, R 2. Infertility Prevention Project Region X 1 Center for Health Training, Seattle WA 2 Washington State Department of Health ISSTDR 2011, Quebec CA

. Infertility Prevention Project (IPP) National program to fund chlamydia & gonorrhea screening & treatment Collaboration between US Centers for Disease Control & Office of Population Affairs Targets low-income, sexually active women Family Planning, STD, other women s health clinics Collects data for prevalence monitoring 10 Regional Infrastructures

Specimen Source Options Endocervical Urethral Urine (patient-obtained) Vaginal swab (patient- or clinician-obtained) Other sites conjunctival, rectal, pharyngeal

Self-Obtained Vaginal Swabs (SOV): Advantages Amenable to NAAT technology: highly sensitive, specific Highly acceptable to women Avoid pelvic examination Especially useful for asymptomatic screening Improves outreach to underserved population groups May allow for more representative screening group (not just people who come to clinic) Source: Vaginal Swabs Performance, Patient Preference and Applications (Webinar, Jan 2010) Jeanne Marrazzo, MD, MPH Medical Director, Seattle STD/HIV Prevention Training Center, University of Washington

Presentation Objectives Describe interventions in Washington State (WA) to increase use of Self-Obtained Vaginal Swabs (SOVs) for Chlamydia (CT) and Gonorrhea (GC) testing; Describe clinics adoption and use of SOVs; Explore trends and associations in SOV use vs. other specimen sources.

Methods 1. CDC provided 2009 Infertility Prevention Project (IPP) prevalence monitoring data N tests and specimen source, aggregated to state-level For US and each region, computed median percentage of each specimen source across states. 2. Interviewed WA IPP Coordinator and Nurse Consultant about interventions to promote SOVs.

Methods 3. WA IPP data for female patients compiled (2007-2010) Generated visit-level and aggregate clinic-level datasets Assessed SOV uptake in clinics averaging >25 female tests/year % of all female CT/GC tests collected by SOV Explored clinic and client factors associated with SOV use Developed multivariate models

Percentage (Median) 100 Results: Distribution of CT Tests by Sex and Specimen Source, NATIONAL* 75 50 25 0 Females Males Vaginal 0.6 0.1 Urine 25.7 83.7 Urethral 0.1 16.4 Cervical 71.8 0.4 2009 Infertility Prevention Project data

Percentage (median) 2009 Infertility Prevention Project data Distribution of CT Tests by Region and Specimen Source, Females* 100 2% 1% 2% 6% 75 50 25 0 I II III IV V VI VII VIII IX X Median % Vaginal 0.00 2.40 0.70 0.00 0.10 0.30 1.55 0.05 6.45 Median % Urine 40.40 28.35 24.25 12.25 25.40 4.60 20.80 24.85 80.00 39.40 Median % Cervical 58.65 71.20 72.90 74.70 68.20 89.70 78.85 71.40 16.40 47.35

Region X 2010 Female CT test distribution by state 100% 75% 76% 1% 4% 7% 37% 20% 13% 17% Clinician- Obtained Vaginal Self-Obtained Vaginal 50% 44% Urine 25% 24% 62% 70% 25% Cervix 0% AK ID OR WA *AK does not collect vaginal swab options on lab slip

2011 2010 2009 2008 2007 Intervention Timeline 1 st Q 2008 SOV data monitoring begins CSPS grant objective for 2009: make vaginal swabs specimen of choice. 2009-2010 Mailings to clinics (research articles and materials developed by regional IPP) Late 2009-2010 Follow up with slow adopters 2010 Modified CSPS grant objective to replacing urine with SOV Jan 2010 Region X vaginal swab webinar w/ Dr. Jeanne Marrazzo Dec 2010 WA State IPP webinar featured vaginal swabs 2011 Spokane and UW labs validate SOV for use outside the clinic

Results: Clinics Years in IPP N clinics % of clinics 2 years 13 10.5 3 years 17 13.7 4 years 94 75.8 Total 124 100 Analysis includes only clinics averaging >25 tests/year

% Results: % of clinics using SOV 100 75 82 80 50 54 25 0 9 2007 (n=105) 2008 (n=114) 2009 (n=121) 2010 (n=113) Chi square <.001

Mean % SOV Use Across Clinics p<.001 Year N clinics using SOV CT Tests, Mean % SOV Std. Deviation 2007 9 1.7 3.32 2008 62 4.2 4.79 2009 99 15.1 18.29 2010 90 24.6 25.08 Total 260 15.3 20.35

Median % SOV Use Across Clinics Year (n clinics using SOVs) 5.1 14.9 39.2 3.1 8.3 19.6

What factors affect whether clinics are using SOVs? Clinic size? Clinic type?

% SOV Use and Mean % SOV by clinic size (year 2010) 100 75 50 51.5 87.5 88.9 96.6 % of clinics using SOV 25 32.2 35.2 20.5 15.4 CT Tests, Mean % SOV* 0 25-100 (n=17) 101-200 (n=21) 201-500 (n=24) 501+ (n=28) Average Number of females tested/year (n=number of clinics) P<.05

SOV Use by Clinic Type (year 2010) FP/RH clinic N % using SOV CT Tests, Mean % SOV No 55 58.2 30.3 Yes 58 100.0 21.4 p <.001 NS

Client Results: CT/GC tests

SOV Use during client visits Year # of CT/GC tests (females) # SOV Percentage 2007 48,223 123 0.3% 2008 51,306 1290 2.6% 2009 54,055 5984 12.4% 2010 44,292 7,645 17.0% 20% 15% 10% 5% 0% % self-obtained vaginal swabs by calendar quarter 15% 8% 1% 2007 2008 2009 2010 18%

Client Visit Specimen Source Distribution by Year Clinician-collected* Urine SOV Total 2007 2008 2009 2010 % change, N N N N 2007-2010 % % % % 25,076 23,231 22,814 17,106 52.0% 45.3% 42.2% 38.6% 23,024 26,785 25,257 19,541 47.7% 52.2% 46.7% 44.1% 123 1,290 5,984 7,645 0.3% 2.5% 11.1% 17.3% 48,223 51,306 54,055 44,292 100.0% 100.0% 100.0% 100.0% *Clinician-Collected methods include endocervical and clinician-collected vaginal swabs Intervention initiated in 2008 p <.001 n=197,876-13.4% -3.6% 17.0% 0.0%

Predictors of SOV use, given availability in clinic (2010) Multivariate Logistic Regression Covariates: Age, Clinic Type, Race/Ethnicity, CT Symptoms, Pregnant (n= 36,710 visits to 90 clinics) p <.05 Characteristic % SOV AOR 95% CI Age 10-19 28.9 2.54 (2.28, 2.82) 20-24 17.0 1.70 (1.52, 1.88) 25-29 10.6 1.10 (0.97, 1.25) 30+ 9.0 REF Clinic Type FP/RH 18.3 REF STD 18.9 0.89 (0.69, 1.15) College Health 15.2 0.50 (0.41, 0.61) Adolescent school-based 61.4 5.21 (4.57, 5.92) Community Health 5.9 0.52 (0.43, 0.62) Other 9.8 0.58 (0.48, 0.7)

Predictors of SOV use, given availability in clinic (2010) Multivariate Logistic Regression Covariates: Age, Clinic Type, Race/Ethnicity, CT Symptoms, Pregnant n= 36,710 visits to 90 clinics Characteristic % SOV AOR 95% CI Race/Ethnicity White 21.2 REF Black 21.6 0.75 (0.67, 0.83) Asian 17.2 0.76 (0.68, 0.85) Hawaiian/Pacific Islander 22.2 0.87 (0.68, 1.09) American Indian 18.6 0.89 (0.71, 1.1) Hispanic 12.1 0.58 (0.53, 0.62) Symptoms No 19.9 REF Yes 10.7 0.48 (0.43, 0.52) Pregnant No 20.4 REF Yes 12.3 0.70 (0.64, 0.75)

Conclusions WA state is a leader in SOV uptake SOV use has increased substantially % of all WA state IPP tests # of clinics using SOVs volume of SOV use within clinics In clinics using SOVs, client likelihood of SOV use varies by age, clinic type, race/ethnicity, pregnancy status and CT/GC symptoms

Implications Successful implementation of a valuable innovation! multi-lateral messaging efforts Uptake particularly successful in Family Planning clinics Some clinics slower to adopt Acceptability Clients are using vaginal swabs Variations in clinic practices and client preferences need to be further studied Recommend studies to demonstrate clinic-level outcomes (e.g. clinic efficiency)

Future Directions Continue to work with clinics that have not adopted SOVs Explore reasons/barriers Data sharing via standardized annual reports Promote screening during non-routine visit types Share materials & strategies with other states Initiate off-site use of SOVs Data analyses: client & provider preferences

Acknowledgements Catherine Satterwhite, CDC Epidemiologist Jeanne Marrazzo, Seattle STD/HIV Prevention Training Center Katherine Gudgel, WA State DOH STD Field Operations Coordinator Wendy Nakatsukasa-Ono, Center for Health Training Region X IPP Regional Advisory Group and Clinical Subcommittee

Thank You! Contact Information: Sarah Goldenkranz Infertility Prevention Project Region X Data Manager Center for Health Training Seattle, WA USA 001 (206) 447-9538 sarah@jba-cht.com