Pelvic Inflammatory Disease (PID) is a common, serious reproductive disorder that is associated with significant adverse reproductive health outcomes such as ectopic pregnancy, tubal infertility, chronic pelvic pain, and significant reductions in health related quality of life for affected patients. The Technology Enhanced Community Health (TECH) Nursing Study has further demonstrated that the biological milieu associated with PID is more complicated than the Centers for Disease Control and Prevention (CDC) treatment guidance indicates, leaving women without adequate treatment for Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV). The broad-spectrum antibiotics recommended by the CDC for syndromic PID management are suboptimal because: 1) MG is often resistant to doxycycline (standard therapy) and macrolides such as Azithromycin (alternative therapy) and 2) metronidazole (effective for TV) is an optional add-on to standard PID treatment that is inconsistently prescribed at diagnosis. Further MG was not officially considered in CDC STI treatment guidelines until release until 2015, testing is only available in large research laboratories, and the paucity of data from randomized trials limits the scope of the CDC's recommendations. Finally, while there are no public health control programs in the United States for MG and TV, recurrent and persistent infection with MG and TV is associated with ongoing inflammation in the female genital tract and increased risk for secondary STI and HIV infection due to unhealthy shifts in vagina microbiota. The goals of this competitive renewal application are to leverage novel STI diagnostics (new MG macrolide resistance testing and TV testing) with our demonstrated ability to reach vulnerable youth to treat adolescents and young adult women with mild-moderate PID with precision based on their actual diagnoses rather than suboptimal syndromic management. We will add genomic analysis of vaginal specimens to assess compositional changes in the five vaginal Lactobacilli community state types associated with optimal vaginal health and measure the vaginal cytokine response to determine if TECH-precision-nursing (TECH-PN) protocols for field treatment tailored to STI results reduces the inflammatory response observed with active vaginal infections. We hypothesize that by further repackaging our previous successful TECH-N intervention protocol and translating bench science into precision healthcare, we will further reduce the risk of recurrent infection, restore vaginal health for PID- affected patients, and add new knowledge that advances public health control of STIs and has the potential to reduce the observed STI disparities after PID in urban youth.

Public Health Relevance

Pelvic Inflammatory Disease (PID) is a common, serious public health problem among adolescent and young adult (AYA) women. Our team has demonstrated that technology enhanced community health nursing (TECH-N) optimizes execution of the syndromic management protocols for PID in urban AYA, but that without integration of advances in STI diagnostics to individualize treatment protocols with greater precision, patients may have persistent changes in the vaginal microbiota that increase risk their for future STIs/HIV, recurrent PID, and complications such as ectopic pregnancy, tubal infertility, and chronic pelvic pain. The research activities in this protocol use the strength of the TECH-N design and integrate the translational potential of STI diagnostics to optimize CHN field treatment and genomic and inflammatory biomarker testing to determine the impact of precision care on vaginal health to refine clinical management for AYA with mild-moderate PID in outpatient settings.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR013507-07
Application #
9720974
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Yoon, Sung Sug
Project Start
2012-04-01
Project End
2024-03-31
Budget Start
2019-04-01
Budget End
2021-03-31
Support Year
7
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
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