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.

PURPOSE: Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused 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 with PID.

METHODS: AYA women aged 13-25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing 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, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been 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 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.