1. Recurrent PID, Subsequent STI, and Reproductive Health Outcomes: Findings from the PID Evaluation and Clinical Health (PEACH) Study Maria Trent, MD, MPH Debra Bass, MS Roberta Ness, MD, MPH Catherine Haggerty, PhD, MPH Funding: Centers for Disease Control and Prevention: K01DP001128-02; Agency for Healthcare Research and Quality Development: HS08358-05

2. Disclosures I have no relevant financial relationships with the manufacturer(s) of any commercial product(s) and/or providers (s) of commercial services discussed in this CME activity. I do not intend to discuss off-label use of products in this presentation

3. Background PID is a common reproductive health disorder Associated with significant reproductive morbidity: – Tubal infertility – Ectopic pregnancy – Chronic pelvic pain (CPP) Risk estimates of morbidity based on Scandinavian cohort of PID inpatients enrolled 1960 -1984 – Subsequent shifts in the biological organisms causing PID – Management shifted to outpatient setting Re-analysis of the impact of recurrent PID and STIs warranted

4. Objective To examine the risk of longitudinal adverse outcomes associated with recurrent STIs and PID among urban American women with mild- moderate PID To determine the potential impact of adolescence on the observed longitudinal outcomes

5. Methods Secondary data analysis PID Evaluation and Clinical Health (PEACH)Study – Women 14-38 years with mild-moderate PID – Urban Settings in United States – Randomized to inpatient/outpatient treatment – Baseline interview & gynecologic exam (endometrial biopsies, STI testing) – Visits at 5 and 30 days – Telephone interview quarterly x 84 months

6. PEACH 831 Women 14-38 years Mild-Moderate PID Randomized to Inpatient/ Outpatient Arms Main PEACH Analysis No Difference in Outcomes by group Re-Analysis based on Recurrent PID/STI Adolescent Sub-Analysis (≤19 yrs) N=209 Approach to Analysis

7. Methods Data evaluated using bivariate & multiple regression analyses Analysis approved by Johns Hopkins IRB

8. Selected Demographics Baseline Measure% (N) Race/Ethnicity Black White Hispanic Native American/Alaskan Native 74.5% (621) 16.0% (133) 6.1% (51) 3.1% (26) Insurance Status Uninsured Private Public 43.8% (364) 13.8% (115) 33.5% ( 278) Regular Access to Care65% (539) Ever Pregnant75.2% (625) Prior history of PID37.4% (311) New Sexual Partner 9.3% (78) Any Contraceptive use past 4 weeks61.0% (508)

9. 84-Month Reproductive Health Outcomes

10. Subsequent STI & Reproductive Health Outcomes: All Women Subsequent STI (N = 195) No Subsequent STI (N = 596) OR (95% CI) Adjusted OR (95% CI)* Pregnancy**124 (63.6)330 (55.4)1.4 (1.0 – 2.0)1.0 (0.7 – 1.5) Live Birth*91 (46.7)239 (40.1)1.3 (.09 – 1.8)1.0 (0.7 – 1.4) Infertility41 (21.0)104 (17.4)1.3 (0.8 – 1.9)1.4 (0.9 – 2.2) Chronic pelvic pain 105 (53.8)218 (37.7)1.9 (1.4 – 2.7)2.3 (1.6 – 3.2)

11. Outcomes by Recurrent PID Status: ALL Women Recurrent PID (N = 168) No Recurrent PID (N = 621) OR (95% CI) Adjusted OR (95% CI)* Pregnancy**95 (56.5)356 (57.3)1.0 (0.7 – 1.4)1.0 (0.6 – 1.4) Live Birth*61 (36.3)270 (43.5)0.7 (0.5 – 1.1)0.7 (0.5 – 1.0) Infertility44 (26.2)104 (16.7)1.8 (1.2 – 2.6)1.8 (1.2 – 2.8) Chronic pelvic pain 115 (68.5)213 (35.3)4.0 (2.8 – 5.7)4.2 (2.8 – 6.2)

12. Subsequent STI & Reproductive Health Outcomes: Adolescent Subsequent STI (N = 195) No Subsequent STI (N = 596) OR (95% CI) Adjusted OR (95% CI)* Pregnancy**124 (63.6)330 (55.4)1.4 (1.0 – 2.0)1.0 (0.7 – 1.5) Live Birth*91 (46.7)239 (40.1)1.3 (.09 – 1.8)1.0 (0.7 – 1.4) Infertility41 (21.0)104 (17.4)1.3 (0.8 – 1.9)1.4 (0.9 – 2.2) Chronic pelvic pain 105 (53.8)218 (37.7)1.9 (1.4 – 2.7)2.3 (1.6 – 3.2)

13. Outcomes by Recurrent PID Status: Adolescents Recurrent PID (N = 50) No Recurrent PID (N =149) OR (95% CI) Adjusted OR (95% CI)* Pregnancy**34 (68.0)108 (72.5)0.8 (0.4 – 1.6)1.1 (0.5 – 2.2) Live Birth22 (44.0)80 (53.7)0.7 (0.4 – 1.3)0.9 (0.4 – 1.7) Infertility13 (26.0)23 (15.4)1.9 (0.9 – 4.2)1.9 (0.8 – 4.4) Chronic pelvic pain 34 (68.0)44 (30.1)4.9 (2.5 – 9.8)5.0 (2.3 – 10.6)

14. Conclusions Women with recurrent PID are more likely to report infertility and CPP at 84 months Substantiates the relationship between recurrent PID and adverse – Modern microbiology – Outpatient and inpatient care approaches Highlights CPP as a major adverse outcome and recurrent lower genital tract infection (STI) as a key contributor Supports to the concept of tertiary prevention – Upper genital tract disease = smaller, well defined public health – Adolescents are also an important sub-target

15. Limitations Limited Generalizability – Demographics – Trial Participation Contraception Clinical Criteria for PID – Endometrial biopsies – Mimics clinical practice Self-Reported Longitudinal Outcomes – Supported by medical record review

16. Implications Young women with a history of PID are a clearly defined target group for public health intervention. Acute PID should prompt linkage of affected patients to tailored STI risk-reduction services to prevent the adverse outcomes associated with PID