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



Status:Recruiting
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:13 - 25
Updated:2/10/2019
Start Date:February 4, 2019
End Date:December 2023
Contact:Steven Huettner
Email:shuettn1@jhmi.edu
Phone:410-302-3103

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

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).

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.

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
We found this trial at
1
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Baltimore, Maryland 21287
Phone: 410-302-3103
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Baltimore, MD
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