Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID II

NCT03828994 | Active Not Recruiting DMC

• 2 other identifiers: NA_00068846-2R01NR013507-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Inflammatory Disease

Keywords

Pelvic Inflammatory Disease(PID); Community Health Nursing; Adolescents; Text Messaging; mobile health (mhealth)

Outcome Measures

Primary Outcomes (3)

• Rate of STI Trichomonas vaginalis

  Trichomonas infection assessed with Aptima vaginal swab, tested using the Gen-Probe transcription mediated amplification (TMA) research assay.

  3 months

• Rate of STI Mycoplasma genitalium

  Mycoplasma infection assessed with Aptima vaginal swab, tested using the Gen-Probe transcription mediated amplification (TMA) research assay.

  3 months

• Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST)

  Vaginal microbiota will be identified with a 16S ribosomal RNA (16S rRNA) amplicon sequencing analysis. The proportion of rRNA assigned to the bacterial genera Lactobacillus will be measured for each sample. CST (I, II, II, IV) will be assigned based on taxa identified.

  90 days

Study Arms (2)

TECH-PN

EXPERIMENTAL

Participants receive community health nurse visits, text-messaging support, additional testing and field based visits with a nurse practitioner.

Behavioral: Tech-PN

TECH-N

NO INTERVENTION

Participants receive enhanced standard of care with community health nurse visits and text-messaging support.

Interventions

Tech-PN BEHAVIORAL

* text messaging(daily medication reminders and tri-weekly messages following the 14-day treatment period) * enhanced community health nurse visits on day 3-5, 14 and 30 * field based treatment visits * clinical assistance with notification, testing and treatment

TECH-PN

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (12)

• 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.

  PMID: 29756068 BACKGROUND

• 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.

  PMID: 27617108 BACKGROUND

• 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.

  PMID: 27507807 BACKGROUND

• 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.

  PMID: 28280783 BACKGROUND

• 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.

  PMID: 30221216 BACKGROUND

• 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.

  PMID: 26825087 BACKGROUND

• 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.

  PMID: 25524398 BACKGROUND

• 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.

  PMID: 30149363 BACKGROUND

• 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.

  PMID: 30113305 BACKGROUND

• 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.

  PMID: 30294592 RESULT

• Perin J, Anders J, Barfield A, Gaydos C, Rothman R, Matson PA, Huettner S, Toppins J, Trent M. Undermining the Translational Potential of Clinical Research With Adolescents and Young Adults: Differential Enrollment in Randomized Clinical Trials During COVID-19. Sex Transm Dis. 2024 Oct 1;51(10):681-685. doi: 10.1097/OLQ.0000000000001994. Epub 2024 May 1.

  PMID: 38691409 DERIVED

• 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.

  PMID: 34396402 DERIVED

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maria Trent, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: February 10, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)