Clinical trial NCT03828994: Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID II
Official title: Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Inflammatory Disease
Keywords: Pelvic Inflammatory Disease(PID)
Community Health Nursing
Adolescents
Text Messaging
mobile health (mhealth)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-02-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are enrolling 150 young women 13-25 years old diagnosed with pelvic inflammatory disease (PID) in Baltimore to receive community health nurse (CHN) clinical support visits and short messaging system communication support for 30 days. The investigators' intervention group(TECH-PN) will receive additional testing and treatment in the field. The investigators hypothesize that repackaging the recommended Centers for Disease Control and Prevention (CDC) follow-up visit using a technology-enhanced community health nursing intervention (TECH-N) with integration of an evidence-based sexually transmitted infection (STI) prevention curriculum will reduce rates of short-term repeat infection by improving adherence to PID treatment and reducing unprotected intercourse and be more cost-effective compared with outpatient standard of care (and hospitalization).

Detailed description: 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 study are to leverage novel STI diagnostics (new MG macrolide resistance testing and TV testing) with the investigators' demonstrated ability to reach vulnerable youth to treat adolescents and young adult women with mild-moderate PID with precision based on the actual diagnoses rather than suboptimal syndromic management. The investigators will add genomic analysis of vaginal specimens to assess compositional changes in the five vaginal Lactobacilli community state types associated with optimal vaginal health 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. The investigators hypothesize that by further repackaging the investigators' previous successful TECH-N intervention protocol and translating bench science into precision healthcare, the investigators will further reduce the risk of recurrent infection, potentially 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.

Eligibility criteria: Inclusion Criteria:

* Mild-moderate PID
* Outpatient treatment disposition
* Permanently reside in the Baltimore Metropolitan area
* Willing to sign informed consent \& be randomized

Exclusion Criteria:

* Pregnant
* Concurrent diagnosis of Sexual Assault
* Unable to communicate/complete study procedures

Primary outcomes:
measure: Rate of STI Trichomonas vaginalis
timeFrame: 3 months
measure: Rate of STI Mycoplasma genitalium
timeFrame: 3 months
measure: Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maria Trent, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anders J, Hill A, Chung SE, Butz A, Rothman R, Gaydos C, Perin J, Trent M. Patient Satisfaction and Treatment Adherence for Urban Adolescents and Young Adults with Pelvic Inflammatory Disease. Trauma Emerg Care. 2018 Jan;3(1):10.15761/TEC.1000152. doi: 10.15761/TEC.1000152. Epub 2017 Aug 25.
citation: Trent M, Chung SE, Gaydos C, Frick KD, Anders J, Huettner S, Rothman R, Butz A. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial. Eur Med J Reprod Health. 2016 Aug;2(1):41-51.
citation: Butz AM, Gaydos C, Chung SE, Johnson BH, Huettner S, Trent M. Care-Seeking Behavior After Notification Among Young Women With Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease. Clin Pediatr (Phila). 2016 Oct;55(12):1107-12. doi: 10.1177/0009922816662863. Epub 2016 Aug 8.
citation: Munoz Buchanan CR, Chung SE, Butz A, Perin J, Gaydos C, Trent M. Perceived Social Support, Parental Notification, and Parental Engagement after Pelvic Inflammatory Disease among Urban Adolescent and Young Adults. Pediatr Neonatal Nurs. 2016;4(1):12-16. doi: 10.17140/pnnoj-4-124. Epub 2016 Nov 17.
citation: Tabacco L, Chung SE, Perin J, Huettner S, Butz A, Trent M. Relationship Status and Sexual Behaviors in Post-Pelvic Inflammatory Disease (PID) Affected Urban Young Women: A Sub-Study of a Randomized Controlled Trial. Int Arch Nurs Health Care. 2018;4(1):088. doi: 10.23937/2469-5823/1510088. Epub 2018 Jan 10.
citation: Haggerty CL, Totten PA, Tang G, Astete SG, Ferris MJ, Norori J, Bass DC, Martin DH, Taylor BD, Ness RB. Identification of novel microbes associated with pelvic inflammatory disease and infertility. Sex Transm Infect. 2016 Sep;92(6):441-6. doi: 10.1136/sextrans-2015-052285. Epub 2016 Jan 29.
citation: Mitchell CM, Haick A, Nkwopara E, Garcia R, Rendi M, Agnew K, Fredricks DN, Eschenbach D. Colonization of the upper genital tract by vaginal bacterial species in nonpregnant women. Am J Obstet Gynecol. 2015 May;212(5):611.e1-9. doi: 10.1016/j.ajog.2014.11.043. Epub 2014 Dec 16.
citation: Molenaar MC, Singer M, Ouburg S. The two-sided role of the vaginal microbiome in Chlamydia trachomatis and Mycoplasma genitalium pathogenesis. J Reprod Immunol. 2018 Nov;130:11-17. doi: 10.1016/j.jri.2018.08.006. Epub 2018 Aug 22.
citation: Wang Y, Zhang Y, Zhang Q, Chen H, Feng Y. Characterization of pelvic and cervical microbiotas from patients with pelvic inflammatory disease. J Med Microbiol. 2018 Oct;67(10):1519-1526. doi: 10.1099/jmm.0.000821. Epub 2018 Aug 16.
citation: Zheng X, O'Connell CM, Zhong W, Poston TB, Wiesenfeld HC, Hillier SL, Trent M, Gaydos C, Tseng G, Taylor BD, Darville T. Gene Expression Signatures Can Aid Diagnosis of Sexually Transmitted Infection-Induced Endometritis in Women. Front Cell Infect Microbiol. 2018 Sep 20;8:307. doi: 10.3389/fcimb.2018.00307. eCollection 2018.
citation: Trent M, Perin J, Rowell J, Shah M, Anders J, Matson P, Brotman RM, Ravel J, Sharps P, Rothman R, Yusuf HE, Gaydos CA. Using Innovation to Address Adolescent and Young Adult Health Disparities in Pelvic Inflammatory Disease: Design of the Technology Enhanced Community Health Precision Nursing (TECH-PN) Trial. J Infect Dis. 2021 Aug 16;224(12 Suppl 2):S145-S151. doi: 10.1093/infdis/jiab157.