Efficacy of a Technology-Enhanced Community Health Nursing Intervention vs Standard of Care for Female Adolescents and Young Adults With Pelvic Inflammatory Disease: A Randomized Clinical Trial

Abstract

Importance: Pelvic inflammatory disease (PID) is a common reproductive health disorder that disproportionately affects female adolescents and young adults. Despite data indicating poor adherence and adverse outcomes among those who experience subsequent Neisseria gonorrhoeae and Chlamydia trachomatis infection, few trials have been designed to address this public health need.

Objective: To examine the efficacy of a technology-enhanced community health nursing (TECH-N) intervention vs standard of care for improving PID self-management behaviors and 90-day longitudinal prevalence of N gonorrhoeae and C trachomatis infection.

Design, setting, and participants: This randomized clinical trial of the TECH-N intervention was conducted among female patients 13 to 25 years of age diagnosed with mild to moderate PID who were being discharged to outpatient treatment from September 6, 2012, to December 8, 2016, at a large academic medical center. The final analysis of data was completed in November 2018. This study compared the efficacy of the intervention with that of the standard of care using an intention-to-treat analysis.

Interventions: Enrolled participants completed an audio computer-assisted self-interview, provided specimens for N gonorrhoeae and C trachomatis testing, and were randomized to standard treatment (n = 137) or the TECH-N intervention (n = 149). Intervention participants received text-messaging support and a community health nurse visit within 5 days of diagnosis. Change in the prevalence of N gonorrhoeae and C trachomatis infection was estimated with logistic regression. The N gonorrhoeae and C trachomatis positivity rate over time was evaluated using generalized estimating equations.

Main outcomes and measures: The primary outcome was the prevalence of N gonorrhoeae and C trachomatis infection at 90-day follow-up. The secondary outcome was adherence to the Centers for Disease Control and Prevention recommendations for self-care.

Results: A total of 286 patients (mean [SD] age, 18.8 [2.5] years; 268 [93.7%] African American) participated in the study. Although the study groups were demographically similar, the intervention group had a higher baseline rate of C trachomatis infection (45 of 139 [32.4%] vs 25 of 132 [18.9%], P = .01). Although N gonorrhoeae and C trachomatis positivity was not statistically different between groups at 90-day follow-up (6 of 135 [4.4%] vs 13 of 125 [10.4%], P = .07), the differential rate of decrease was significantly higher in the intervention group (48 of 140 [34.4%] to 6 of 135 [4.4%] compared with 34 of 133 [25.6%] to 13 of 112 [10.4%], P = .02). Intervention participants were more likely to receive the Centers for Disease Control and Prevention-recommended short-term follow-up visit compared with the control group (131 of 139 [94.2%] vs 20 of 123 [16.3%], P < .001).

Conclusions and relevance: Adolescent and young adults with PID in the TECH-N intervention were more likely to experience decreases in N gonorrhoeae and C trachomatis positivity compared with the control group and to receive short-term clinical assessment. These findings suggest that the TECH-N intervention should be considered as a potential enhancement of standard of care approaches for management of female adolescents and young adults with mild to moderate PID in urban communities facing significant sexually transmitted infection disparities.

Trial registration: ClinicalTrials.gov identifier: NCT01640379.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Trent reported receiving grants and research supplies from Hologic Inc, research supplies from SpeeDx LLC, and personal fees from Church and Dwight Inc outside the submitted work. Dr Perin reported receiving grants from the National Institute of Nursing Research during the conduct of the study. Dr Gaydos reported receiving grants from Hologic outside the submitted work. Dr Anders reported receiving grants from the National Institute of Nursing Research during the conduct of the study; receiving grants from the Health Resources and Services Administration Emergency Medical Services for Children; and receiving research supplies from the Maryland Institute for Emergency Medical Services Systems outside the submitted work. Dr Rothman reported receiving personal fees from Cepheid Diagnostics outside the submitted work. Dr Butz reported receiving grants from the National Institutes of Health during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. CONSORT Flow Diagram

PID indicates pelvic inflammatory disease; TECH-N, technology enhanced community health nursing. aRecruitment hours were 8 am to 11 pm.

Figure 2.. Patients Testing Positive for Neisseria gonorrhoeae and/or Chlamydia trachomatis Over Time as Determined With Generalized Estimating Equations by Intervention Group

Error bars indicate the 95% CIs at each follow-up time point estimated with the Wald test. TECH-N indicates technology-enhanced community health nursing.