Technology Based Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
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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 |
- STI [ Time Frame: 90 Days ] [ Designated as safety issue: No ]STI testing (GC/CT/Trichomonas) tested at 90 days
- 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
Other Names:
|
|
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 |
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| Contact: Steve Huettner | 410-302-3103 | shuettn1@jhmi.edu |
| Contact: Maria Trent, MD, MPH | 443-287-8945 | mtrent2@jhmi.edu |
| 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 | |
| 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 May 23, 2013