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 |
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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 |
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Interventions | Study focus: improve appointment adherence for contraceptive injections Theory or model: Geser’s sociological framework for understanding innovative potential of cell phone technology
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Outcomes | Primary: appointment adherence (3 contraceptive injection appointments) Follow‐up: 9 months |
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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) |