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. 2016 Mar 30;2016(3):CD012025. doi: 10.1002/14651858.CD012025.pub2

Trent 2015.

Methods Design: pilot RCT
Location: Baltimore, MD (USA)
Time frame: October 2011 to February 2012
Sample size estimation and outcome of focus: 100 minimum recruitment as practical milestone for feasibility and acceptability (pilot study); focus on injection appointment adherence
Participants General with N: 100 urban adolescent girls
Source: urban academic general pediatric and adolescent medicine practice
Inclusion criteria: age 13 to 21 years; willing to be randomized; currently using DMPA; have cellular phone with text messaging capability for personal use
Exclusion criteria: no cell phone with text messaging capability for personal use; cognitive impairment prevented use of cell phone texting
Interventions Study focus: improve appointment adherence for contraceptive injections
Theory or model: Geser’s sociological framework for understanding innovative potential of cell phone technology
  1. Intervention: standard care plus daily text appointment reminders starting 72 hours before clinical visit; monthly healthy self‐management messages (condom use, weight control, side effect management, STI testing reminder); call for missed appointment or no reply to appointment reminder (or other text message)

  2. Comparison: standard counseling and clinic appointment reminders to home phone; call from nurse case manager after missing re‐injection appointment

Outcomes Primary: appointment adherence (3 contraceptive injection appointments)
Follow‐up: 9 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Investigator communication: computer‐generated randomization sequence
Allocation concealment (selection bias) Low risk Investigator communicated randomization concealed prior to assignment. Research staff opened packet with randomization status and pertinent information for next steps.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Investigator communication: principal investigator blinded to enrollment status
Presume no blinding of participant or provider; not feasible due to type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Appointment adherence (for injections) via electronic tracking database
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: 31% did not complete cycle 3; intervention 34% (33/50); control 28% (36/50)