# Presentation: 546027

## “Gonorrhea Screening Strategies and Guideline Development for Non-Pregnant Female Patients in the California Family Planning Clinic Setting”Holly Howard, MPH1 Joan Chow1, Heidi Bauer1, Melanie Deal2, Renee Gindi2, Romni Neiman1, Gail Bolan1  1 STD Control Branch, California DHS  2 California Family Health Council

**National STD Prevention Conference****Philadelphia, PA****March 2004**

**Notes:**
Good Morning, my name is Holly Howard from the CA Dept of Health Services, STD Control Branch.
This talk will highlight findings from a study of (read title)

## 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

**Notes:**
Lack of current GC screening guidelines was the primary motivation for this study.  The most recent national guidelines for GC screening were published by the US Preventative Services TF in 1996 and the CDC in 1985. 
Further motivation was the low GC prevalence, < 1%, among women attending CA family planning clinics, and the high volume of GC screening that continues to occur at these sites.  This discrepancy between prevalence and screening volume launched concerns about a possible inefficient use of resources.
In addition, screening in a low prev pop may compromise the predictive value of diagnostic tests, leading to a low Positive Predictive Value and an increase in the proportion of false positive test results

## Research Objectives

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

**Notes:**
The objectives of the study were to determine predictors of GC within the CA family planning population that could then be used to develop targeted screening strategies that more efficiently identify Gonorrhea infections 
by limiting screening to higher risk subpopulations.

## 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

- 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

**Notes:**
To expedite results, a retrospective medical record chart review was undertaken utilizing a case-control study design.

Through collaboration with the CA Infertility Prevention Project, 5 Title X family planning clinics were recruited for study participation:
These sites: 
exhibited geographic diversity 
and served urban, rural and suburban populations

Universal GC screening was performed at 3 of the 5 clinics; the remaining two clinics screened approx 85% of their female patient population.

## 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:

- 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

**Notes:**
Study participants were limited to non-pregnant female patients who were seen at the clinics between January and December of 2001.

All gonorrhea positive patients were reviewed – these were the study cases
as well as a computer-generated random sample of GC-negative patients – these were the study controls

Abstracted patient characteristics from medical record charts included:
Demographic characteristics
Pt reported factors, such as symptoms at the time of visit, sexual history and behavioral factors, including
Sexual practices, partners in the past 12 months, if pt thought that partners may have other partners
And clinical information, such as 
clinician-documented clinical signs, test resutls, and diagnoses

## 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

- 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

**Notes:**
A number of estimates were used in the analysis of study data:
Gonorrhea prevalence was estimated by test positivy;
And weighting procedures were used to estimate the patient characteristics in the overall GC-negative population from the proportions found in the study sample

Statistical Analyses used crude and adj odds ratios to measure association of patient characteristics with GC positivity – these were determined using chi square tests and unconditional logistic regression modeling techniques

## Exclusion Criteria Applied to Screening Analysis:
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)
Patients with CT, trichomoniasis (or other STDs)

- 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)
- Patients with CT, trichomoniasis (or other STDs)

- Analytic Methods - II

**Notes:**
The goal of this study was not to attempt to limit gonorrhea testing when clinically indicated, but to devise algorithms that would better target gonorrhea screening.  
Exclusion criteria applied to the screening analysis, then, were patients considered to have been “diagnostically tested” for gonorrhea based on strong clinical indication –defined as those who either:
 Reported to their clinician contact to a partner with a confirmed or suspected STD or 
those patients who presented with a clinical syndrome associated with gonorrhea – defined further as either
Cervicitis or PID    as defined here
Additionally, excluded from the screening analysis were patients newly diagnosed with another STD, in accordance with CDC’s current recommendation for screening for STD co-infecitons.  
In this study, only those patients with either chlamydia or trichomoniasis were specifically evaluated, however, as other STDs were infrequently diagnosed in the study sample.

## Results:  Chart Review Sample

| Agency | GC+ Cases | GC Neg Controls | Total Pop | % GC Prev |
| --- | --- | --- | --- | --- |
| Agency A (2 clinics) | 30 | 90 | 3,878 | 0.8 |
| Agency B (2 clinics) | 40 | 103 | 5,652 | 0.7 |
| Agency C (1 clinic) | 68 | 92 | 3,209 | 2.1 |
| Overall Participants | 138 | 285 | 12,739 | 1.1 |

**Notes:**
The results of the chart review sample is as follows:
Over 420 client charts were reviewed from 3 agencies; 2 agencies had 2 clinics each in the study and the remaining agency had 1 clinic in the study.  The GC prevalence at these agencies ranged from 0.7-2.1%

In total, the overall sample included:
138 GC+ charts and
285 randomly selected GC negative charts.  
The study sample represents 12,739 patients either tested or screened for GC with an overall GC prevalence of 1.1%.

## Total Sample N=12,739Results:  DemographicsAge (Years)

**Notes:**
The next two of slides depict the demographic profile of the total sample of patients – including both those who were tested and those who were screened.

The overall GC-tested population was fairly evenly distributed across these four age groups, with 32% of clients tested <= to 20 years old, 25% in the 21-25 age group, 19% age 26-30, and 24% over 30.
Almost 2/3rds – or 62%, of the cases, however, were age 20 or below, 25% were age 21-25, and only about 13% of cases were older than 25 – a group that here (point to the “Overall” pie) represents almost 50% of those tested.

## Total SampleN=12,739Results:  DemographicsRace/Ethnicity

**Notes:**
When looking at those tested  by race/ethnicity, the majority of the population was either African American  at 36%, or Latina at 42%. 
However, nearly 2/3rds – or 62% of the GC positive cases were African American, 28% Latina, followed by 7% White and 3% Asian or other.

## Results:  Clinical Presentation

**(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%**

**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**

**Notes:**
Many previous analyses of gonorrhea data have not been able to segregate those patients who were screened for asymptomatic infection from those with clinical conditions that were tested for the infection.  This slide graphically depicts the process used to exclude patients from the screening analysis:
The study started with a total population of 12,739 non-preg female family planning clients, which included 138 GC positive clients and a GC prevalence of 1.1%.
The following groups of clients had clinical indications for a GC test and were thus excluded:
First were those who reported contact to an STD – this group was comprised of 414 clients which included 16 cases of GC and a GC prevalence of 3.9%.
The second group excluded were those 948 clients who had signs of cervicitis or PID, including 20 GC cases with a lower prevalence of 2.1%.  
Next removed were those infected with chlamydia – this group had the highest GC prev at 5.1%.
Lastly, those with trichomoniasis were excluded. 
Left in the analysis were 10,409 clients with no clinical indication to test for GC and therefore were considered to have been screened for the infection.  There were 63 cases of gonorrhea remaining in this group and a GC prevalence of 0.6%  

(after animation to remove other boxes...) In summation, the group of clients with clinical indication for a GC test represented 54% of the total GC positive cases in this population and only 18% of the overall population tested for gonorrhea.
The remaining group screened for GC represented 46% of GC cases and 82% of the total population.

## Screening AnalysisN = 10,409Results:  Univariate Analysis  GC Prevalence* by Patient Characteristic

*Screening Analysis**N = 10,409*Results:  Univariate Analysis  GC Prevalence* by Patient Characteristic

**Notes:**
From this point forward, results displayed will be specific to the screening analysis subgroup of 10,409 patients, after excluding those clients with clinical indications for a GC test.  

These results are the univariate analysis of GC prevalence by patient characteristic.

GC prevalence was equal to or greater than 1.0% in clients who were
 age <= 20 years, 
African Americans, 
who requested an STD check, 
who reported more than one partner in the previous 12 months, and 
Who indicated that their pts may have other partners
Each of these patient characteristics were significantly associated with GC infection with a p-value of less than .05.  
The “Other” race category appears to mimick AA prev rates, but the sample of pts in this group was small, and significance was not established.
The GC prevalence within those groups of clients with clinical factors such as vag d/c on exam, and infection with bacterial vaginosis or yeast, were less than 1%.  These factors were not significantly associated with GC infection.  

## Screening AnalysisN = 10,409Results:  Multivariate Analysis**

*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 years | 30 (58) | 57 (27) | 3.46 (1.82-6.60) | <0.001 |
| Race: African American 
(vs. all others) | 28 (54) | 71 (34) | 1.88 (0.96-3.68) | 0.065 |
| Patient requested STD check | 14 (27) | 31 (15) | 1.45 (0.66-3.21) | 0.356 |
| Vaginal discharge on exam | 16 (31) | 54 (26) | 1.29 (0.55-2.99) | 0.557 |
| BV diagnosis | 17 (33) | 56 (27) | 1.04 (0.45-2.40) | 0.928 |

- **Behavioral characteristics could not be included in the multivariate analysis due to the small sample size of these variables

**Notes:**
A multivariate model was created to include: 
All patient characteristics that displayed significant associations with GC in the univariate analysis, as well as
two clinical factors, vaginal discharge and BV infection, that have been indicated in previous studies as being associated with GC.   

In this multivariate analysis, only young age remained independently associated with GC infection after controlling for all other patient characteristics in the model.  
AA race displayed borderline significance.

The behavioral characteristics that displayed significance in the univariate analysis, such as report of multiple partners and partner having other partners, could not be included in this multivariate analysis due to their small sample sizes.

## Screening Analysis Results:  Performance of Selective Screening Algorithms

| Algorithm of Selected Criteria | % Cases DetectedN = 63 | % Pop ScreenedN = 10,409 | % GC
Prev |
| --- | --- | --- | --- |
| Universal Screening | 100 | 100 | 0.6 |
| Age < 20 (“Adolescents”) | 60 | 31 | 1.2 |
| Adolescents OR
Age 21-25 AND >1 Ptr in 12 mos | 87 | 37 | 1.4 |
| Adolescents OR
Age 21-25 AND >Ptr has/may have other ptrs | 93 | 57 | 1.0 |
| Age < 25 | 94 | 56 | 1.0 |

*Screening Analysis** *Results:  Performance of Selective Screening Algorithms

**Notes:**
Shown here are a handful of different algorithms, or screening strategies for GC, which have been created using the results from the proceeding univariate and multivariate analyses.
These screening algorithms are compared based on the % of Gonorrhea cases that would be detected, the % of the overall population that would be screened, and the GC prevalence within the population screened.
Universal screening is provided first as a reference point – this is the GC screening strategy still used by many family planning clinics in CA.  Universal screening would, of course, capture 100% of GC cases but screens 100% of clients, and gives a GC prevalence of 0.6%, as seen in previous slides.
(Describe each algorithm)
Screening only adolescents (defined as age 20 or younger) would detect...% of GC cases and would require the screening of ....% of the pop;
Screening adolescents as well as young women age 21-25 who reported more than 1 partner in the prev 12 mos...
Screening adolescents as well as young women age 21-25 who reported that their ptrs may have had other ptrs...
Screening only on the basis of age with a cut-off at 25 or younger, similar to the current natl recs for CT screening...

## 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

**Notes:**
This study has a number of limitations;
First, the chart review, like any other, is limited to the information documented in the medical records – behavioral and historical data, in particular, were often poorly documented and this limited our power to understand the role of certain patient factors
 Second, study sites were chosen from a convenience sample of family planning sites participating in the Infertility Prevention Project and this may have an effect on the generalizability of our results
Third, estimates of gc prevalences are based in some instances on # of tests performed and not individ clients tested, therefore there may be duplicate clients in some analyses resulting in an underestimation of true prev rates
And finally, the weighting techniques used in this study can only provide approximate results and are especially limited when assessing the impact of rare exposures and outcomes.

## Policy Implications

- Development of targeted GC screening guidelines:
-  Recommendations for targeted screening:
- _Definite_
**Adolescents (age **_**<**_** 20)**
- _Probable_
**Clients age 21-25 with risk factors** **(e.g., multiple partners or partner has other partners), under consideration, ****or**
**All clients age 21-25**
-  Include definitions of clinical indications for GC testing
-  Support screening for co-infections

**Notes:**
These results have policy implications for the development of targeted GC screening guidelines.  CA Dept of Health Services and the Infertility Prevention Project of Region IX are in the process of using these and other recent data to develop targeted, cost-efficient GC screening guidelines.

The results from this study suggest that recommendations for targeted screening should definitely include adolescents age 20 and under.  Probable screening of female clients age 21-25 with risk factors such as having more than one sex partner in the past 12 or a partner who has other partners is under consideration.  

However, because of the limited behavioral data available in this study, more conservative recommendations would include all female patients age 21-25 – as noted in the previous slide, this targeted screening strategy would capture 94% of the gonorrhea infections but reduce the number of clients tested by approximately 50%.
Additionally, these screening guidelines will differentiate screening from diagnostic testing by including definitions of clinical indications for GC, and will support CDC’s recommendation for screening for STD co-infections, especially when the original STD diagnosis was either CT or trich.

It should be noted that, for those areas that are already vested in Nucleic Acid Amplified dual testing for chlamydia & gonorrhea and have been able to negotiate reduced laboratory cost for this dual testing, it might not make sense to separate out screening recommendations specific to gonorrhea.  Screening all patients age 25 and under, in line with current national recommendations for chlamydia screening, may by default also be the most applicable GC screening strategy in these situations.

## 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 _hhoward@dhs.ca.gov_

*Thank you!*

**Notes:**
Thank you.

(If time allows:  There are a number of people who were intimately involved in the day-to-day effort that went into this study, and there are those who are responsible for making this study possible, and to each of these people I am grateful.)

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

**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 screened1 patients.   

|   | Univariate analysis |  |  |  | Multivariate analysis |  |
| --- | --- | --- | --- | --- | --- | --- |
|   | Cases | Controls |  |  | Cases N = 52  Controls N = 209 |  |
|   | N = 63 | N = 234 |  |   | Adjusted OR |   |
| Characteristics | n (%) | n (%) | OR (95% CI) | P-value | (Wald 95% CI) | P-value |
| Age < 20 (Adolescents) | 38 (60) | 72 (31) | 3.42 (1.92-6.08) | <0.001 | 3.46 (1.82-6.60) | <0.001 |
| Age < 25 | 59 (94) | 130 (56) | 11.80 (4.15-33.55) | <0.001 | *** | *** |
| Race:  African American (vs. all others) | 34 (56) | 76 (34) | 2.40 (1.35-4.28) | 0.003 | 1.88 (0.96-3.68) | 0.065 |
| Race:  Latina (vs. all others) | 18 (30) | 106 (48) | 0.45 (0.25-0.84) | 0.010 | *** | *** |
| Patient Requests STD Check | 16 (25) | 33 (14) | 2.07 (1.05-4.08) | 0.032 | 1.45 (0.66-3.21) | 0.356 |
| Patient c/o Any Symptoms | 31 (57) | 119 (56) | 0.96 (0.52-1762) | 0.894 | *** | *** |
| Patient c/o Irregular Bleeding | 3 (6) | 21 (10) | 0.53 (0.15-1.86) | 0.315 | *** | *** |
| Patient c/o Vaginal DC | 16 (30) | 64 (30) | 0.97 (0.50-1.86) | 0.920 | *** | *** |
| Vaginal DC on Exam | 17 (31) | 55 (25) | 1.35 (0.71-2.58) | 0.363 | 1.29 (0.55-2.99) | 0.557 |
| Stat Bacterial Vaginitis (BV) Diagnosis | 19 (33) | 56 (25) | 1.48 (0.79-2.78) | 0.218 | 1.04 (0.45-2.40) | 0.928 |
| Stat Yeast Diagnosis | 7 (12) | 27 (12) | 1.01 (0.42-2.46) | 0.981 | *** | *** |
| Vaginal DC on Exam/
     No STAT Diagnosis of Yeast2 | 15 (27) | 44 (20) | 1.47 (0.75-2.90) | 0.262 | *** | *** |
| GC+ and/or CT+ within Previous Year3 | 44 (70) | 148 (64) | 1.31 (0.72-2.40) | 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 of behavioral patient characteristics1 and positive GC test results on subgroup of screened2 patients.

|  | Univariate analysis |  |  |  |
| --- | --- | --- | --- | --- |
|  | Cases1 | Controls1 |  |  |
| Behavior Characteristics | n (%) | n (%) | OR (95% CI) | P-value |
| New Sex Partner in Past 2 Months | 4 (33) | 10 (16) | 2.65 (0.67-10.51) | 0.155 |
| > 1 Sex Partner in Past 12 Months | 8 (47) | 14 (20) | 3.62 (1.18-11.06) | 0.019 |
| Age 21-25 AND > 1 Sex Partner in Past 12 Months | 2 (50) | 1 (4) | 22.00 (1.33-362.92) | 0.007 |
| Patient indicated that Partner has or may have other Partner(s) | 7 (30) | 8 (9) | 4.54 (1.44-14.29) | 0.006 |
| Patient indicated Monogamous Relationship | 8 (42) | 63 (79) | 0.20 (0.07-0.56) | 0.001 |
| Married | 1 (9) | 28 (35) | 0.19 (0.2-1.53) | 0.084 |
| Inconsistent Condom Use | 12 (41) | 30 (34) | 1.39 (0.59-3.28) | 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 21-25 AND >1 Sex Partner in Past 12 Months:  Cases = 4, Controls = 23 – category limited to those patients within age 21-25 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.

## Screening Analysis Results:  Performance Selective Screening Criteria

| Algorithm of Selected Criteria | % Total Cases DetectedN = 63 | % TotalPop. ScreenedN = 10,409 | % GC+
within Algorithm | % GC+ 
Pop. 
Not Screened |
| --- | --- | --- | --- | --- |
| Universal Screening | 100 | 100 | 0.6 | 0.0 |
| No Screening | 0 | 0 | 0.0 | 0.6 |
| Age < 25 AND >1 Ptr in 12 mos | 47 | 13 | 2.2 | 0.4 |
| Age < 20 years (“Adolescents”) | 60 | 31 | 1.2 | 0.4 |
| Adolescents OR 
BV+ by STAT Exam | 77 | 49 | 1.0 | 0.3 |
| Adolescents OR 
Vaginal discharge on exam | 79 | 49 | 1.0 | 0.3 |
| Adolescents OR 
Age 21-25 w/ >1 Ptr in 12 mos | 87 | 37 | 1.4 | 0.1 |
| Adolescents OR 
Ptr has/may have other ptrs | 93 | 57 | 1.0 | 0.1 |
| Age < 25 years | 94 | 56 | 1.0 | 0.1 |
| Adolescents OR 
>1 Ptr in 12 mos | 95 | 65 | 1.1 | 0.1 |
| Adolescents OR 
Age 21-25 AND Ptr may have other ptrs | 95 | 74 | 1.2 | 0.2 |

***Screening Analysis****** *****Results:  Performance Selective Screening Criteria**