Region II Infertility Prevention Project

Regional Advisory Committee Meeting

Cicatelli Associates Inc., New York, NY

May31-June 1, 2006

MINUTES

Participants:

Name (*=Exec Committee) / Program/Agency / May 31 / June 1
Kathy / Gates-Ferris / CAI – Infrastructure / X / X
Karl / Labes / CAI – Infrastructure / X
Dawn / Middleton / CAI – Infrastructure / X / X
Kelly / Opdyke / CAI – Infrastructure / X / X
Tracey / Hardy / CDC/DSTDP / X / X
David / Johnson / CDC/DSTDP / X / X
Steve / Shapiro / CDC/DSTDP / X / X
Rick / Steece / NCLC / X / X
*Margaret / Springer / NJ DHSS FP / X / X
*Jo Ann / Hayduk-Kramer / NJ DHSS PHL / X / X
*Jerry / Carolina / NJ DHSS STD / X / X
Eileen / Crayne / NJ DHSS STD / X / X
*Debbie / Polacek / NJ FP League / X / X
Preeti / Pathela / NYC DOHMH STD / X / X
Meighan / Rogers / NYC DOHMH STD / X / X
*Steve / Rubin / NYC DOHMH STD / X / X
Julie / Schillinger / NYC DOHMH STD / X / X
*Gladys / Schlanger / NYC DOHMH STD / X / X
Rebecca / Sze / NYC FP – CBW CHC / X / X
*Rachel / Baum / NYC FP – MHRA / X / X
Alex / Ely / NYC FP – MHRA / X
Marquita / Wright / NYC FP – PPNYC / X
JoAnn / Fields / NYC FP – The Door / X / X
Eileen / Shields / NYS DOH FP / X / X
*Jane / Vet / NYS DOH FP / X / X
*Alison / Muse / NYS DOH STD / X / X
Gale / Burstein / NYS Erie Cty STD / X / X
Lee / Quinlan / NYS FP Provider / X / X
Robin / Lane / OPA/OFP Region II / X
Hermes / Garcia / PR DOH - CLETS / X / X
Myriam / Garcia / PR DOH ILSOCM / X / X
*Francisco / Davila / PR DOH ILSOCM / X / X
Inarvis / Bonilla / PR DOH STD / X / X
*Greduval / Duran / PR DOH STD / X / X
Ana / De Jesus / PR FP – ProFamilia / X / X
*Carmen / Rivera / PR FP – ProFamilia / X / X
Bethzaida / Diaz / PR FP – UPR TXFPP / X / X
*Ramon / Sanchez / PR FP – UPR TXFPP / X
Javier / Velazquez / PR FP – UPR TXFPP / X / X
Gowri / Nagendra / Region II PTC / X / X
Mercedes / Reyes / USVI DOH FP / X / X
*Gayann / Hall / USVI DOH STD / X / X
Taetia / Phillips-Dorsett / USVI DOH STD / X / X

Did not attend:

Name (*=Exec Committee) / Program/Agency
Lily / Blasini-Alcivar / CDC/DSTDP
Lori / De Ravello / Indian Health Service
Evelyn / Eggert / NJ DHSS OMC
Edna / Velez / NJ FP Provider
Jennifer / Howard / NJ FP Provider - PPGNNJ
Debra / Solko / NYC FP Provider - MIC
Anne / Schettine / NYS DOH OMC
*Martha / Newcomb / NYS DOH STD
*Scott / Zimmerman / NYS Erie Cty PHL
*Marc / Jerome / USVI DOH FP

DAY 1, Wednesday, May 31, 2006 [9:00am – 5:00pm]

  1. Executive Committee and Subcommittee Co-Chairs Only Pre-Meeting
  2. Introduced new members of the Executive Committee
  3. Infrastructure. Dawn Middleton takes over for Kathy Ferris as Region II IPP Director. Kathy will continue her work as VP of Special Projects for CAI, and will provide oversight to the project.
  4. New York City. Rachel Baumreplaces Irit Houvras as the family planning representative from MHRA.
  5. Puerto Rico
  6. Dr. Greduvel Durán-Guzmán, Auxiliary Director of FamilyHealth and Integrated Services at the PR DOH, takes over for Dr. Carlos Gadea as the STD representative from Puerto Rico.
  7. Dr. Francisco Dávila-Toro joins as representative of PR DOH Instituto de Laboratorios de Salud Oscar Costa-Mandry (ILSOCM) as the laboratory representative from PR.
  8. Carmen Riverajoins as a representativeof ProFamilia as a family planning representative. ProFamilia is a new Title X grantee in PR (in addition to UPR TXFPP).
  9. Discussed new meeting format
  10. General session.Members requested last November in Atlantic City that this meeting be conducted in general session, without sub-committee meetings.
  11. Regional workplan development. Dawn explained the purpose of the regional workplan development sessions was to allow members to break into smaller groups after all presentations to “prioritize the priorities” for the coming project year. The workplan, derived from or created to complement the existing 2005-2009 Strategic Plan, would focus on high priority activities to be accomplished by the region in the next 12 months.
  12. Meeting evaluation.Please complete and return meeting evaluations found in your meeting packets. Evaluation comments are an opportunity for members to provide feedback on new meeting format, and to make suggestions for future meeting formats and agenda items.
  1. Welcome, Introductions and Meeting Overview(Co-chairs, Steve Rubin and Debbie Polacek)
  2. Welcome.Steve Rubinformally welcomed the group.
  3. IPP accomplishments.Kathy Ferris provided background on the history of the IPP project and its many accomplishments. The Region II Infrastructure was established in 1994. Many members of the advisory committee, including Steve Rubin, have been part of this group since its inception.
  4. Rubin Award. Steve Rubin presented Kathy Gates-Ferriswith the Rubin Award, “in appreciation of [her] tireless regional leadership and commitment to the prevention of STDs.”
  5. Passing of the baton.Kathy welcomed Dawn as the new Region II IPP Director by symbolically passing the baton. Dawn previously served for seven years as IPP Coordinator for Region III.
  1. Centers For Disease Control and Prevention Update(Steve Shapiro, CDC National IPP Coordinator)Highlights of Presentation and Discussion are as follows (for presentation details please see power point slides):
  2. Staff changes:Steve Shapiro was appointed National IPP Coordinator in December, 2005, taking over for Dorothy Gunter. Other CDC staff changes were enumerated in Steve’s PowerPoint presentation.
  3. Funding cuts:
  4. 2.97% budget cuts were applied across all programs for the current FY2006 funding cycle. Programs should have received notice from their CDC STD Program Consultants. This cut will be reflected in the second funding allocation.
  5. Additional funding cuts can be expected in 2007.
  6. Performance measures
  7. Program evaluation and performance measures will be a continuing emphasis of CDC and HHS overall. This follows a government-wide priority to monitor program performance as articulated in the Government Performance and Results Act (GPRA).
  8. Additional performance measures are under consideration and will be rolled out over time, including some planned for FY2007.
  9. The current 12 CSPS performance measures were implemented 2 years ago. Three pertain to IPP; these relate to timeliness of treatment and screening in juvenile detention centers.
  10. The performance measures database is now online.
  11. CDC Projects and initiatives
  12. Male screening consultation. Held March 28-29, 2006 in Atlanta. Dear Colleague letter or other summary from the consultation should be available by the end of the year (2006).
  13. Partnership for Prevention (P4P). CDC developing a new contract with a two-year timeline.
  14. Generic azithromycin. 340B pricing for azithromycin expires 6/30/2006. Greenstone, a subsidiary of Pfizer is licensed to sell a generic version of Azithromycin. Pricing is about $2.00 per dose for tablets.
  15. DR. DIPSA. A guidebook for the use and application of Prevalence Monitoring data is in its final stages of development.
  1. Targeting Chlamydia Screening Resources.

Highlights of Presentation and Discussion are as follows (for presentation details please see power point slides):

  1. Proposed CDC “Measures of Effectiveness” for 2006-2007 (Kelly Opdyke). Details related to how measures could be implemented are being considered in the 2006/2007 funding cycle. CDC expects future implementation of new measures in the 2007/2008 funding cycle as part of the Infrastructure grant application process. The proposed measures are as follows:
  2. “Chlamydia screening coverage estimate for 15-19 year old sexually active women seen in Family Planning Clinics”
  3. “Proportion of Family Planning clinics adhering to regional screening criteria”
  4. Region II IPP Activities to Address Proposed “Measures of Effectiveness” (Kelly Opdyke and Preeti Pathela)
  5. Screening assessment/audit.
  6. Purpose is to estimate the proportion of females screened for chlamydia in accordance with minimally prescribed regional criteria, as stated below:
  7. Title X Family Planning Clinics:All women ≤ 24 years of age attending the clinic for an initial or annual visit will be screened for chlamydia.
  8. STD Clinics:All women ≤ 29 years of age attending the STD clinic will be screened for chlamydia.
  9. Goal for sites to complete data collection by June 30, and for projects to submit to Infrastructure by July 31.
  10. Kelly will prepare a report for review by the Executive Committee in September/October, and present summary of findings at next regional meeting in November.
  11. Region II IPP data 2005. (Kelly Opdyke).
  12. Emphasized chlamydia positivity in FP and STD by age for females.
  13. Highest positivity by age seen in females under 25. Positivity for females 15-19 years old was highest at 9.1% overall (18% in STD, 7.1% in FP sites).
  14. Overall positivity for females 30 and older was lowest at 1.7% (2.7% in STD, 1.4% in FP).
  15. Overall, 40% (92,952/229,563) of female tests reported were for females age 25 and older (38% in FP). In STD, 30% of female tests reported were for females age 30 and older.
  16. This includes all tests reported through the Prevalence Monitoring data, regardless of funding source (i.e. IPP or other).
  17. Some projects, such as NJ, are able to charge providers for tests done on older women.
  18. Implications/questions for consideration:
  19. Should regional Ct screening criteria be revised/expanded to reach additional females at risk who do not meet minimum criteria?
  20. Why are so many older women being screened?
  21. How can we reduce screening in populations with low positivity (<2%)?
  1. Gonorrhea Screening – What Do the Data Tell Us?

Highlights of Presentation and Discussion are as follows (for presentation details please see power point slides):

  1. Overview of Region II IPP Prevalence Monitoring Data (Kelly Opdyke)
  2. Overall positivity is very low, and seems to be on the decline, while testing volume has increased, especially among females.
  3. Most GC testing reported through IPP is done as part of a dual Ct/GC test.
  4. In 2005, GC positivity for females <30 years seen in STD clinics was 2.83%. GC positivity for females seen in FP clinics was <1% for all age groups, but highest (0.80%) for females < 25 years.
  5. In 2005, GC positivity for males seen in STD clinics was 4.83% (5.24% for males <30 years).
  6. In 2005, GC positivity was higher among non-Hispanic Black/African American males (5.57% positive) and females (2.06% positive) compared with other racial/ethnic groups.
  7. Decline of GC Morbidity in NYC (Preeti Pathela)
  8. GC case rates have gradually declined in NYC over the past 10 years among both males and females, paralleling a national trend.
  9. Case rates were highest for younger age groups (<25 years).
  10. GC positivity in NYC DOHMH BSTDC clinics has also declined among males in the past three years (2003-2005).Overall female positivity remained relatively flat.
  11. Possible causes for this decline:
  12. A true decline in GC
  13. Changes in screening practices
  14. Use of diagnostic tests with different sensitivities
  15. Changes in reporting practices
  16. Oral GC Screening Data (Dr. Hermes Garcia)
  17. From July 2002 to June 2004, 122 oral gonorrhea cultureswere processed with 4 GC positive (3.3%).
  18. From July 2004 to June 2005, 56 oral gonorrhea cultureswere processed with 1 GC positive (1.8%).
  19. Overall, the number of oral GC specimens taken was small relative to the number of urethral and cervical specimens. Positivity for oral specimens was also lower than other specimen types.
  20. Implications/questions for consideration:
  21. How can we better target GC screening?
  22. Is low positive predictive value (PPV) an issue where prevalence is low?
  23. Would single Ct test technology provide cost savings to programs currently using dual Ct/GC tests to screen low prevalence populations?
  1. Promote the Use of High Quality Diagnostics Tests for Chlamydia

Highlights of Presentation and Discussion are as follows (for presentation details please see power point slides):

  1. CDC Update – Laboratory Perspective (Rick Steece, CDC National Chlamydia Laboratory Consultant).
  2. Supplemental Testing – New Data/Research
  3. Zanto et al. (Region VIII). conducted a study that conducted supplemental testing on GenProbe APTIMA Combo2 test results utilizing GenProbe’s ASR’s for CT and GC (that have since been cleared as stand alone tests). She found that the vast majority of positive tests repeated when supplemental testing was applied indicating a high PPV for NAAT. Conclusion was that supplemental or repeat testing need not be routinely performed with NAAT screening (utilizing the GenProbe NAAT product), resulting in cost savings.
  4. It is important to note that the results from the Zanto study in Region VI were only for the GenProbe APTIMA Combo 2 product.
    Results and conclusions can not be applied to all NAAT products.
  5. Instead of supplemental testing of all positive test results some labs only conduct a supplemental test when the relative light units (RLU) are at a low level.
  6. NAAT non-genital(vaginal, anorectal and pharyngeal).
  7. NAATs are not currently FDA-approved for home use or non-genital specimens. A number of labs across the nation have validated NAAT on anorectal and pharyngeal specimens with good results. Laboratory validation protocols are available from the National Chlamydia Laboratory Committee.
  8. Charlotte Gaydos (Region III) out of John’s Hopkins has been conducting a pilot project that makes Chlamydia and gonorrhea testing available to women via the internet utilizing vaginal swabs. Thus far women tested through the project have had a greater than 9% positivity overall. Dr. Gaydos has plans to expand the study to males in the near future.
  9. Results from CDC/APHL 2004 National Lab Survey
  10. Results from 114 of 144 public health labs contacted.
  11. The number of labs performing NAATs for Ct and GCincreased substantially from 2000 to 2004. The majority of labs now report doing NAATs (87% for Ct, 78.7% for GC).
  12. The proportion of all Ct and GC tests done that were NAATs also increased from 2000 to 2004. Over 60% of all testing for Ct/GC was NAATs in 2004.
  13. Results of the lab survey will be available in the July 2006 issue of the Journal STD.
  14. Results from NYC 2004 Lab Survey (Preeti Pathela)
  15. 17% (23/139) reported performing NAATs for GC
  16. 19% (26/139) reported performing NAATs for Ct
  17. 10.4% of GC in males was QRNG (23.9% of anal GC infections in males)
  18. Performing gonorrhea culture is an important surveillance tool, since it can aid the BSTDC in monitoring antibiotic resistance.
  19. Recently the CDC has recommended that fluoroquinolones not be used to treat gonorrhea infections in MSM.
  20. Currently, NAAT not approved for use on anorectal or oropharyngeal specimens, howeverNYC Public Health Laboratory to validate commercial NAAT for Ct detection from anorectal specimens
  21. Implications/questions for consideration:
  22. NAATs tests are widely available through public health labs
  23. Are labs performing unnecessary and costly supplemental testing?
  1. Treatment Verification Rates for Chlamydia and Gonorrhea: Region II IPP Performance Measures Results (Kelly Opdyke)
  2. Region II GOAL: 100% of Clients will be treated within 30 days of diagnosis.
  3. Measure 1 (IPP-CS1):Among clients of IPP family planning clinics, the proportion of women with positive CT tests that are treated within 14 and 30 days of the date of specimen collection.
  4. Measure 2 (IPP-CS1):Among clients of IPP family planning clinics, the proportion of women with positive GC tests that are treated within 14 and 30 days of the date of specimen collection.
  5. Data available for Jan-Jun 2004 and Jan-Jun 2005 through PM database. (No data available for USVI).
  6. Baseline data shows a range of 38%-86% of clients treated for chlamydia within 30 days. Timeliness of treatment varied by project area, and was similar for Ct and GC except in Puerto Rico (where 100% of positive GC clients were treated within 14 days). More data is needed to assess trends.
  7. Implications/questions for consideration:
  8. What data sources are available to Projects to monitor timely treatment?
  9. What are the limitations of the data?
  10. What are the opportunities for/obstacles to providing timely treatment?
  1. Expanding Screening to “At Risk” Populations – “What About the Guys?”
  2. Overview of Region II IPP Prevalence Monitoring Data (Kelly Opdyke)
  3. No male screening criteria exist for IPP.
  4. Region II GOAL: All at risk men and women under the age of 25 will be screened at least annually.
  5. Region II Clinical Care Committee recommendation is to screen and treat all males attending STD clinics, per 2003 Protocols & Guidelines.
  6. In 2005, 32% (80,085/249,786) of all reported Ct tests were for males. 64% of these tests were reported by STD clinics.
  7. Overall male Ct positivity was 10.6% in 2005. Higher for younger males (<30 years), and males in STD clinics.
  8. CDC Male Screening Consultation(March 28-29, AtlantaGA)
  9. Introduction and Summary of Consultation(Julie Schillinger)
  10. Epidemiological questions to be considered:
  11. How effective is screening males for decreasing chlamydia in females?
  12. NOTE: Is screening males in high schools associated with decline in female chlamydia.
  13. How effective is male screening for reducing sequelae of chlamydia in females?
  14. Consensus issues:
  15. Male screening should be venue-specific, not population-based. Core sites include: STD, adult corrections, adolescent health centers, etc.
  16. Males should not be screened at the expense of females
  17. Screening must be linked to referral, partner management, and rescreening
  18. Issues lacking consensus:
  19. Age cut-off
  20. Need to establish prevalence by venue prior to screening
  21. Participant Perspective (Gail Burstein)
  22. If CDC came out with a strong statement about screening males, Professional Associations like AAP would adopt
  23. Many providers look to their professional association for guidance.
  24. Lab Perspective (Rick Steece)
  25. Urine is the specimen of choice when screening males (NAATS)
  26. Leukocyte Esterase Test (LET) is not recommended in any venue.
  27. Pooling should strongly be considered in low prevalence populations (<5%).
  28. Implications/questions for consideration:
  29. Any change in guidelines will require a training initiative.
  30. What is the role of male screening versus diagnostic testing (or presumptive treatment only, without testing, based on history or sings/symptoms)?
  31. Outcomes of screening consultation expected by end of 2006.
  1. Expanding Screening to “At Risk” Populations – Schools

Highlights of Presentation and Discussion are as follows (for presentation details please see power point slides):

  1. Puerto Rico (Inarvis Bonilla). [SEE POWERPOINT SLIDES]
  2. Formed a PR STD Prevention Planning Committee of community stakeholders. Purpose is to provide counseling, promotion and increase STD testing principally, chlamydia, gonorrhea and syphilis, targeted to high STD risk population in PR (15-19 year olds).
  3. Established collaborative agreements with Inter-University Games, University of Puerto Rico, and Department of Education
  4. Plan to begin high school screening for chlamydia and gonorrhea in September, 2006. Will provide update at November meeting.
  5. New York City(Meighan Rogers). [SEE POWERPOINT SLIDES]
  6. Funded in 2005-2006 by the New York Community Trust
  7. First observed PhiladelphiaSchool screening project to better understand process and developed protocols based on Philadelphia model.
  8. Combine STD education and referrals with screening days.
  9. Use a dual Ct/GC urine-based test was used.
  10. 5% (46/860) students tested positive(greater positivity in females as opposed to males 8% vs. 2%)
  11. Completed first series of screening days in 2005-2006, with a goal to screen 2,500 students.
  12. Planning additional screening days for 2006-2007, with a goal to screen 10,000 students.
  13. Region VI CharterSchool Screening Project (Dawn Middleton)
  14. Region VI was awarded $35,000 from GenProbe for a special project to conduct chlamydia and gonorrhea testing in Charter Schools in New Mexico, Oklahoma and Texas. Preliminary screening results in 1 school resulted in an overall 10.3% positivity.
  15. Implications/questions for consideration:
  16. Are there opportunities for Puerto Rico to learn from NYC in their efforts to implement Chlamydia screening in high school settings?
  17. Is it possible for Region II to garner funds from private industry to implement special projects much like Region VI?
  1. Concurrent Sessions
  2. Family Planning Partners Special Session: Data Collection for Proposed IPP Measures of Effectiveness
  3. During this portion of the meeting FP partners met to discuss CDC’s proposed Measures of Effectiveness which are as follows:
  4. Measure 1: Proportion of Family Planning clinics adhering to regional screening criteria.
  5. Measure 2:Chlamydia Screening Coverage Estimate for 15-19 year old sexually-active women seen in Family Planning clinics.
  6. It was noted that the region is engaging in an analysis to assess Measure 1 and will use lessons learned from this exercise to further consider mechanisms to address the measure on a routine basis.
  7. Most project areas believed that their Title X Administrative Databases could support them in the assessment of Measure 2 – this would need to be piloted at a couple of sites. It was further noted that “screening coverage” included all females who accessed services over a defined period of time – not just females who received a pelvic exam.
  8. FP partners discussed how “sexually active” should be defined and the recommendation was to assume that all clients accessing FP services were “sexually active”.
  1. STD Partners Special Session: STD-related Performance Measures
  2. During this portion of the meeting STD Representatives were given an opportunity to meet with the CDC National IPP Coordinator, Steve Shapiro and CDC Program Consultant, David Johnson, to access information and technical assistance related to all CDC Performance Measures.

Day 2, Thursday, June 1, 2006[8:15am – 3:45pm]