Technology Enhanced Community Health Nursing (TECH-N) Study (TECH-N)
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|ClinicalTrials.gov Identifier: NCT01640379|
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : May 7, 2018
Last Update Posted : June 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Inflammatory Disease (PID)||Behavioral: Technology Enhanced Community Health Nursing||Not Applicable|
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)|
|Actual Enrollment :||286 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|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
Participants receive the Technology Enhanced Community Health Nursing Visit (CHN) 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
- 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).
- 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
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
|United States, Maryland|
|Johns Hopkins School of Medicine|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Maria Trent, MD, MPH||Johns Hopkins School of Medicine|