Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (Tech-N) Pelvic Inflammatory Disease Trial

Abstract

Purpose: Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) females and can negatively impact their short and long-term reproductive health. Few randomised controlled trials (RCTs) have focussed on strategies to improve outpatient adherence, or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community health nursing (TECH-N) intervention among urban AYA females with PID. Methods: AYAs aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments to participate in this trial, approved by an International Review Board. Participants completed an audio-computerised self-interview, provided vaginal specimens, and were randomised to either standard treatment or intervention. Intervention participants received SMS messaging support for 30 days and a community health nurse interventionist performed a home visit with clinical assessment within 5 days of enrolment. All patients received a full course of medications and completed research visits at 14 days (adherence), 30 days, and 90 days with an outreach worker. Sexually transmitted infection testing was performed at the 30 and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results: In the first 48 months, 63.3% of 463 patients were eligible for the study (293), 81.2% of the eligible patients were recruited for the study (N=238). Most participants were African American (95.6%) with a mean age of 18.6 (standard deviation: 2.3). Of those individuals assigned to the TECH-N intervention, 94% completed the nursing visits. All completed visits were within the 5-day window and over 90% of patients in both arms have been retained over the 3-month follow-up period. Biological data suggests a shift in the biological milieu with the predominance of Chlamydia trachomatis , Mycoplasma genitalium , and Trichomonas vaginalis infections. Conclusions: Preliminary data from the TECH-N study demonstrated that urban, low-income, minority AYA females with PID can effectively be recruited and retained to participate in sexual and reproductive health RCTs with sufficient investment in the design and infrastructure of the study. Community-based sexual health interventions appear to be both feasible and acceptable in this population.

Keywords

• pelvic inflammatory disease (pid)
• randomised controlled trials (rcts)
• adolescents
• minority