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. 2019 Apr 23;2019(4):CD004317. doi: 10.1002/14651858.CD004317.pub5

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
Participants General with N: 100 urban adolescent girls
Source: urban academic general paediatric and adolescent medicine practice
Inclusion criteria:
  • age 13 to 21 years;

  • willing to be randomized;

  • currently using DMPA;

  • had 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 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).


Comparison:
  • standard counseling and clinic appointment reminders to home telephone;

  • call from nurse case manager after missing re‐injection appointment.

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
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