Trent 2015.
Methods | Single site, parallel group, 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 paediatric and adolescent medicine practice Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention:
Comparison:
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Outcomes | Appointment adherence by 9 months (3 injection appointments) | |
Notes | Trial registration: no details Funding: Trial funded by the Thomas Wilson Sanitarium Foundation for the Children of Baltimore City, and time for manuscript development was funded in part by the National Institute of Nursing Research. Declarations of interest: no details provided |
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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 enrolment status No details provided of 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) |
Selective reporting (reporting bias) | Unclear risk | No protocol was available, however, outcomes prespecified in the manuscript were reported on. |
Other bias | Low risk | Appeared free of other sources of bias |
ACASI: audio computer‐assisted self‐interview C: counseling DPMA: depo medroxyprogesterone I+G: intervention plus generic I+T: intervention plus tailored LARCs: long‐acting reversible contraceptives OC: oral contraception P: phone calls S: standard care SC: special counseling STI: sexually transmitted infection