Technology Enhanced Community Health Nursing (TECH-N) to Prevent Recurrent Sexually Transmitted Infections After Pelvic Inflammatory Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Number of Participants With Positive Sexually Transmitted Infection Test (STI)
Study Overview
Brief Summary
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 13 Years to 25 Years (Child, Adult)
- Sex
- 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
- •Concurrent diagnosis of Sexual Assault
- •Unable to communicate/complete study procedures
Arms & Interventions
TECH-N
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
Intervention: Technology Enhanced Community Health Nursing (Behavioral)
Control
Participants receive enhanced standard of care
Outcomes
Primary Outcomes
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
- Number of Participants That Adhered to Self-treatment(Day 15)
