Technology Enhanced Community Health Nursing (TECH-N) Study (TECH-N)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01640379|
Recruitment Status : Unknown
Verified January 2016 by Maria Trent, Johns Hopkins University.
Recruitment status was: Recruiting
First Posted : July 13, 2012
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment|
|Pelvic Inflammatory Disease (PID)||Behavioral: Technology Enhanced Community Health Nursing|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||July 2017|
Participants receive the Technology Enhanced Community Health Nursing Visit (community health nursing visits within 5 days during which Sister to Sister and clinical assessment performed and text-messaging support
Behavioral: Technology Enhanced Community Health Nursing
No Intervention: Control
Participants receive enhanced standard of care
- STI [ Time Frame: 90 Days ]STI testing (GC/CT/Trichomonas) tested at 90 days
- Adherence to Self-treatment [ Time Frame: Day 15 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640379
|Contact: Steve Huettnerfirstname.lastname@example.org|
|Contact: Maria Trent, MD, MPHemail@example.com|
|United States, Maryland|
|Johns Hopkins School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Steve Huettner 410-302-3103 firstname.lastname@example.org|
|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|
|Principal Investigator:||Maria Trent, MD, MPH||Johns Hopkins School of Medicine|