Technology Based Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maria Trent, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01640379
First received: July 11, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

We are enrolling 350 young women 13-21years old diagnosed with PID in Baltimore and randomize them to receive CHN clinical support using a single post-PID face-to-face clinical evaluation and SMS communication support during the 30. We hypothesize that repackaging the recommended CDC-follow-up visit using a technology-enhanced community health nursing intervention (TECH-N) with integration of an evidence-based 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 Intervention
Pelvic Inflammatory Disease (PID)
Behavioral: Technology Enhanced Community Health Nursing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Technology Based Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • STI [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    STI testing (GC/CT/Trichomonas) tested at 90 days


Secondary Outcome Measures:
  • Adherence to Self-treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Self-reported data regarding treatment adherence to key self-management behaviors will be collected (medication adherence, temporary sexual abstinence, completion of 72 hour assessment, partner notification, & partner treatment).


Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TECH-N
Participants receive active intervention with text-messaging and community health nursing visit/support.
Behavioral: Technology Enhanced Community Health Nursing
  • Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
  • Enhanced community health nursing visit on day 3-5, includes DEBI STI/HIV prevention component (Sister to Sister Teen)
Other Names:
  • Sister to Sister Teen
  • Health CloudSMS
No Intervention: Control
Participants receive enhanced standard of care

Detailed Description:

Pelvic Inflammatory Disease (PID) remains a serious reproductive health disorder and disease rates remain unacceptably high among minority adolescent girls and young adult women. Each episode of this upper reproductive tract infection, usually caused by a sexually transmitted infection (STI), increases the risk for multiple sequelae including tubal infertility, ectopic pregnancy, and chronic pelvic pain (CPP). Previous research demonstrates that inpatient treatment for PID is expensive without incremental increases in effectiveness when compared with outpatient treatment. The investigators' work and that of others suggest that additional outpatient cost-effective PID health care supports are needed for this vulnerable population to improve short and long-term reproductive health outcomes, including recurrent sexually transmitted infection and PID.

Prior research has also demonstrated that community health nurse (CHN) interventions can increase access to appropriate resources enhance health care utilization and promote risk-reducing behavior. The investigators propose that integrating a technology component conducted by the CHN will increase appeal to adolescent females. The investigators' pilot data of a text messaging intervention for reproductive health clinical reminders has demonstrated that use of cell phones to assist urban adolescents residing in high STI prevalent communities with self-care is both highly acceptable and feasible.

The investigators hypothesize that repackaging the recommended CDC-follow-up visit using a technology-enhanced community health nursing intervention (TECH-N) with integration of an evidence-based 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). We are enrolling 350 young women 13-21years old diagnosed with PID in Baltimore and randomizing them to receive CHN clinical support using a single post-PID face-to-face clinical evaluation and SMS communication support during the 30-days following the PID diagnosis or optimized standard of care.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640379

Contacts
Contact: Steve Huettner 410-302-3103 shuettn1@jhmi.edu
Contact: Maria Trent, MD, MPH 443-287-8945 mtrent2@jhmi.edu

Locations
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Steve Huettner    410-302-3103    shuettn1@jhmi.edu   
Contact: Study Pager    410 283 9957      
Sub-Investigator: Arlene Butz, ScD, RN, CPNP         
Sub-Investigator: Jonathan M Ellen, MD         
Sub-Investigator: Kevin Frick, PhD         
Sub-Investigator: Jennifer Anders, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Maria Trent, MD, MPH Johns Hopkins School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Maria Trent, Associate Professor of Pediatrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01640379     History of Changes
Other Study ID Numbers: TECHNPID, 1R01NR013507-01
Study First Received: July 11, 2012
Last Updated: July 12, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Pelvic Inflammatory Disease (PID)
Community Health Nursing
Text Messaging
mHealth
Adolescents

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Pelvic Inflammatory Disease
Pelvic Infection
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases

ClinicalTrials.gov processed this record on July 20, 2014