N/A N=286 Randomized Single-blind Prevention

Technology Enhanced Community Health Nursing (TECH-N) Study

Pelvic Inflammatory Disease (PID)

Bottom Line

View on ClinicalTrials.gov: NCT01640379 ↗

Enrolled (actual)

286

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Number of Participants With Positive Sexually Transmitted Infection Test (STI) — 6; 13 Participants — p=0.070

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Technology Enhanced Community Health Nursing (Behavioral)
Age: Pediatric, Adult · 13+ yrs
Sex: Female
Sponsor: Johns Hopkins University
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Positive Sexually Transmitted Infection Test (STI)	6; 13	0.070
SECONDARY Number of Participants That Adhered to Self-treatment	131; 20	<0.001 sig

Summary

The investigators are enrolling 350 young women 13-25 years old diagnosed with pelvic inflammatory disease (PID) in Baltimore and randomize them to receive community health nurse (CHN) clinical support using a single post-PID face-to-face clinical evaluation and short messaging system communication support during the 30. 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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01640379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.