“ Gonorrhea Screening Strategies and Guideline Development for Non-Pregnant Female Patients in the California Family Planning Clinic Setting ” Holly Howard, MPH 1 Joan Chow 1, Heidi Bauer 1, Melanie Deal 2, Renee Gindi 2, Romni Neiman 1, Gail Bolan 1 1 STD Control Branch, California DHS 2 California Family Health Council National STD Prevention Conference Philadelphia, PA March 2004

Background  Lack of current GC screening guidelines Most recent national GC screening guidelines:  USPSTF 1996  CDC 1985  Overall low GC prevalence, < 1%, among women attending CA family planning clinics  High volume of GC screening continues  Screening in a low GC prevalence pop may compromise predictive value of tests Low positive predictive value Increase in false positive results

Research Objectives  Determine predictors of GC within the CA family planning population  Develop targeted screening strategies that more efficiently identify GC infection

Design:  Retrospective medical record chart review  Case-control study Sites:  5 Title X family planning clinics  Geographic diversity  Urban, rural, & suburban populations  Universal GC screening Study Methods - I

Study Participants:  Non-pregnant female clients seen at clinics January-December 2001:  All GC positives (“cases”)  Random sample of GC negatives (“controls”) Data:  Patient characteristics abstracted: Study Methods - II Demographics Clinical Signs Test Results Diagnoses Symptoms Sexual History Behavioral Factors

Estimates:  Prevalence determined by test positivity  Weighting used to estimate the patient characteristics in the overall GC-negative population from the proportions in the sample Statistical Analyses:  Crude and adjusted odds ratios measured association of patient characteristics with GC positivity:  Chi square tests  Unconditional logistic regression Analytic Methods - I

Exclusion Criteria Applied to Screening Analysis: 1.Patients diagnostically tested for GC:  Contact to an STD  GC-associated clinical syndrome:  Cervicitis Endocervical discharge Cervical friability, or Cervical inflammation  Pelvic inflammatory disease (PID) Lower abdominal tenderness Adnexal/uterine tenderness, or Cervical motion tenderness (CMT) 2.Patients with CT, trichomoniasis (or other STDs) Analytic Methods - II

Results: Chart Review Sample Agency GC+ Cases GC Neg Controls Total Pop % GC Prev Agency A (2 clinics)30903, Agency B (2 clinics)401035, Agency C (1 clinic)68923, Overall Participants ,7391.1

Total Sample N=12,739 Results: Demographics Age (Years) GC Positives CasesOverall GC Tested * * Weighted

Total Sample N=12,739 Results: Demographics Race/Ethnicity * Weighted Overall GC Tested *GC Positives Cases

54% of GC Cases (75/138) Contact-to-STD n=414 (16) 3.9% CT + n=606 (31) 5.1% Cervicitis or PID n=948 (20) 2.1% NO Contact, Cervicitis, PID, CT or Trich n=10,409 (63) 0.6% Trich + n=362 (8) 2.2% NO Contact-to-STD n = 12,325 (122) 1.0% NO Contact, Cervicitis, PID or CT n = 10,771 (71) 0.7% NO Contact, Cervicitis or PID n = 11,377 (102) 0.9% Results: Clinical Presentation Total GC-Tested Clients N=12,739 (n GC + = 138) 1.1% GC+ Diagnostic Testing Key = Screening for Co-infections Screening Analysis 18% of Pop Tested 46% of GC Cases (63/138) 82% of Pop Remaining

* Weighted § P-value <.05 Screening Analysis N = 10,409 Results: Univariate Analysis GC Prevalence * by Patient Characteristic >1 ptr in 12 mos § Yes No Ptr has other ptrs § Yes No BVVag d/c (sign) Yes No Yes No Yeast Yes No Ptr requests STD check § No Yes Age § (years) <= > Race § White AA Other Latina

Screening Analysis N = 10,409 Results: Multivariate Analysis** Patient Factor Cases N = 52 n (%) Controls N = 209 n (%) Adjusted OR (95% CI)P- Value Age < 20 years30 (58)57 (27)3.46 ( ) <0.001 Race: African American (vs. all others) 28 (54)71 (34)1.88 ( ) Patient requested STD check14 (27)31 (15)1.45 ( ) Vaginal discharge on exam16 (31)54 (26)1.29 ( ) BV diagnosis17 (33)56 (27)1.04 ( ) **Behavioral characteristics could not be included in the multivariate analysis due to the small sample size of these variables

Algorithm of Selected Criteria % Cases Detected N = 63 % Pop Screened N = 10,409 % GC Prev Universal Screening Age < 20 ( “ Adolescents ” ) Adolescents OR Age AND >1 Ptr in 12 mos Adolescents OR Age AND >Ptr has/may have other ptrs Age < Screening Analysis Results: Performance of Selective Screening Algorithms

Study Limitations  Chart review: poorly documented behavioral and historical data  Study sites: convenience sample  Estimates may include duplicate clients in the # of clients tested  Weighting techniques provide approximate results only and are limited when assessing rare exposures and outcomes

Policy Implications Development of targeted GC screening guidelines:  Recommendations for targeted screening: Definite Adolescents (age < 20) Probable Clients age with risk factors (e.g., multiple partners or partner has other partners), under consideration, or All clients age  Include definitions of clinical indications for GC testing  Support screening for co-infections

Acknowledgements CADHS-STD Joan Chow, Heidi Bauer, Gail Bolan CFHC Melanie Deal, Renée Gindi Region IX IPP Charlotte Kent, Pat Blackburn CA FP Clinics The teams at Delta Health Care Stockton & Lodi clinics, San Bernardino County’s SB & Ontario clinics, and Planned Parenthood’s Eastmont clinic For further information, please contact: Holly Howard at Thank you!

Summary of GC Screening Guidelines for Non-Pregnant Females as Delineated by Various Recommending Bodies

Univariate and multivariate analyses of patient characteristics and positive GC test results on subgroup of screened 1 patients. Univariate analysisMultivariate analysis CasesControlsCases N = 52 Controls N = 209 N = 63N = 234 Adjusted OR Characteristics n (%) OR (95% CI)P-value(Wald 95% CI)P-value Age < 20 (Adolescents)38 (60)72 (31)3.42 ( )< ( )<0.001 Age < 2559 (94)130 (56)11.80 ( )<0.001*** Race: African American (vs. all others)34 (56)76 (34)2.40 ( ) ( )0.065 Race: Latina (vs. all others)18 (30)106 (48)0.45 ( )0.010*** Patient Requests STD Check16 (25)33 (14)2.07 ( ) ( )0.356 Patient c/o Any Symptoms31 (57)119 (56)0.96 ( )0.894*** Patient c/o Irregular Bleeding3 (6)21 (10)0.53 ( )0.315*** Patient c/o Vaginal DC16 (30)64 (30)0.97 ( )0.920*** Vaginal DC on Exam17 (31)55 (25)1.35 ( ) ( )0.557 Stat Bacterial Vaginitis (BV) Diagnosis19 (33)56 (25)1.48 ( ) ( )0.928 Stat Yeast Diagnosis7 (12)27 (12)1.01 ( )0.981*** Vaginal DC on Exam/ No STAT Diagnosis of Yeast 2 15 (27)44 (20)1.47 ( )0.262*** GC + and/or CT + within Previous Year 3 44 (70)148 (64)1.31 ( )0.372*** 1 – Screened patients are defined as those who did not report contact to an STD, did not show signs of cervicitis or PID on exam, and were not diagnosed with chlamydia or trichomoniasis. 2 - Vaginal DC on exam / No STAT Diagnosis of Yeast = patient has sign of vaginal discharge on clinical exam but STAT tests performed during the visit (i.e. wet mount) did not indicate yeast. 3 – GC+ and/or CT+ within Previous Year = According to lab records located in her medical chart only, patient has a history of GC or CT within the 12 months prior to her current clinic visit. *** = not included in model

Univariate analysis Cases 1 Controls 1 Behavior Characteristicsn (%) OR (95% CI)P-value New Sex Partner in Past 2 Months4 (33)10 (16)2.65 ( )0.155 > 1 Sex Partner in Past 12 Months8 (47)14 (20)3.62 ( )0.019 Age AND > 1 Sex Partner in Past 12 Months2 (50)1 (4)22.00 ( )0.007 Patient indicated that Partner has or may have other Partner(s)7 (30)8 (9)4.54 ( )0.006 Patient indicated Monogamous Relationship8 (42)63 (79)0.20 ( )0.001 Married1 (9)28 (35)0.19 ( )0.084 Inconsistent Condom Use12 (41)30 (34)1.39 ( )0.454 Univariate analysis of behavioral patient characteristics 1 and positive GC test results on subgroup of screened 2 patients. 1 – Behavioral data available for a very limited number of patients only: New Sex Partner in Past 2 Months: Cases = 12, Controls = 63 >1 Sex Partner in Past 12 Months: Cases = 17, Controls = 71 Age AND >1 Sex Partner in Past 12 Months: Cases = 4, Controls = 23 – category limited to those patients within age only Patient indicated that Partner has or may have other Partner(s) : Cases = 23, Controls = 91 Patient indicated Monogamous Relationship: Cases = 19, Controls = 80 Married: Cases = 11, Controls = 81 Inconsistent Condom Use: Cases = 29, Controls = 89 2 – Screened patients are defined as those who did not report contact to an STD, did not show signs of cervicitis or PID on exam, and did not have a diagnosis of chlamydia or trichomoniasis.

Algorithm of Selected Criteria % Total Cases Detected N = 63 % Total Pop. Screened N = 10,409 % GC+ within Algorithm % GC+ Pop. Not Screened Universal Screening No Screening Age 1 Ptr in 12 mos Age < 20 years (“Adolescents”) Adolescents OR BV+ by STAT Exam Adolescents OR Vaginal discharge on exam Adolescents OR Age w/ >1 Ptr in 12 mos Adolescents OR Ptr has/may have other ptrs Age < 25 years Adolescents OR >1 Ptr in 12 mos Adolescents OR Age AND Ptr may have other ptrs Screening Analysis Results: Performance Selective Screening Criteria