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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03828994
Collaborator
National Institute of Nursing Research (NINR) (NIH)
150
Enrollment
1
Location
2
Arms
69.7
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tech-PN
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID
Actual Study Start Date :
Feb 10, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TECH-PN

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

Behavioral: Tech-PN
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
No Intervention: TECH-N

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

Outcome Measures

Primary Outcome Measures

  1. Rate of STI Trichomonas vaginalis [3 months]

    Trichomonas infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.

  2. Rate of STI Mycoplasma genitalium [3 months]

    Mycoplasma infection assessed with APTIMA vaginal swab, tested using the GEN-PROBE transcription mediated amplification (TMA) research assay.

  3. Vaginal health as assessed by proportion of high Lactobacilli community state-type 1 properties (CST) [90 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins School of Medicine Baltimore Maryland United States 21287

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Maria Trent, MD, MPH, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03828994
Other Study ID Numbers:
  • NA_00068846 Phase II
  • R01NR013507-03
First Posted:
Feb 4, 2019
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Pelvic Inflammatory Disease(PID)
Community Health Nursing
Adolescents
Text Messaging
mobile health (mhealth)
Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection

Study Results

No Results Posted as of Feb 9, 2022