Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID II
Primary Purpose
Pelvic Inflammatory Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tech-PN
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Inflammatory Disease focused on measuring Pelvic Inflammatory Disease(PID), Community Health Nursing, Adolescents, Text Messaging, mobile health (mhealth)
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
Sites / Locations
- Johns Hopkins School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TECH-PN
TECH-N
Arm Description
Participants receive community health nurse visits, text-messaging support, additional testing and field based visits with a nurse practitioner.
Participants receive enhanced standard of care with community health nurse visits and text-messaging support.
Outcomes
Primary Outcome Measures
Rate of STI Trichomonas vaginalis
Trichomonas infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.
Rate of STI Mycoplasma genitalium
Mycoplasma infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.
Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST)
Vaginal microbiota will be identified with a 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03828994
First Posted
February 1, 2019
Last Updated
February 13, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03828994
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Pelvic Inflammatory Disease(PID), Community Health Nursing, Adolescents, Text Messaging, mobile health (mhealth)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TECH-PN
Arm Type
Experimental
Arm Description
Participants receive community health nurse visits, text-messaging support, additional testing and field based visits with a nurse practitioner.
Arm Title
TECH-N
Arm Type
No Intervention
Arm Description
Participants receive enhanced standard of care with community health nurse visits and text-messaging support.
Intervention Type
Behavioral
Intervention Name(s)
Tech-PN
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of STI Trichomonas vaginalis
Description
Trichomonas infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.
Time Frame
3 months
Title
Rate of STI Mycoplasma genitalium
Description
Mycoplasma infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.
Time Frame
3 months
Title
Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST)
Description
Vaginal microbiota will be identified with a 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.
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Huettner
Phone
410-302-3103
Email
shuettn1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Trent, MD, MPH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Trent, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Huettner
Phone
410-302-3103
First Name & Middle Initial & Last Name & Degree
Study Pager
Phone
410-283-0796
First Name & Middle Initial & Last Name & Degree
Jennifer Anders, MD
First Name & Middle Initial & Last Name & Degree
Charlotte A Gaydos, DrPH
First Name & Middle Initial & Last Name & Degree
Arlene Butz, ScD, MSN
First Name & Middle Initial & Last Name & Degree
Maunank Shah, MD, PhD
First Name & Middle Initial & Last Name & Degree
Richard Rothman, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rebecca Brotman, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Jacques Ravel, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29756068
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.
Results Reference
background
PubMed Identifier
27617108
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.
Results Reference
background
PubMed Identifier
27507807
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.
Results Reference
background
PubMed Identifier
28280783
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.
Results Reference
background
PubMed Identifier
30221216
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.
Results Reference
background
PubMed Identifier
26825087
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.
Results Reference
background
PubMed Identifier
25524398
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.
Results Reference
background
PubMed Identifier
30149363
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.
Results Reference
background
PubMed Identifier
30113305
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.
Results Reference
background
PubMed Identifier
30294592
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.
Results Reference
result
PubMed Identifier
34396402
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.
Results Reference
derived
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Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID II
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