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Completed

NCT Number: NCT01640379

Technology Enhanced Community Health Nursing (TECH-N) Study

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).

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Key information

Age range

13 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology Enhanced Community Health Nursing

Behavioral
  • 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 evidence-based STI/HIV prevention component (Sister to Sister Teen)

Other names: Sister to Sister Teen, Short Messaging System (SMS) communication (Text Messages)

Primary outcomes

  1. Number of Participants With Positive Sexually Transmitted Infection Test (STI)

    Time frame: 90 Days

    STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).

Secondary outcomes

  1. Number of Participants That Adhered to Self-treatment

    Time frame: Day 15

    Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: TECH-N

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2012
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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