Skip to main content
. 2016 Mar 30;2016(3):CD012025. doi: 10.1002/14651858.CD012025.pub2

Kirby 2010.

Methods Design: RCT
Location: San Francisco, CA (USA)
Time frame: July 2005 to August 2007
 Sample size calculation and outcome of focus: 80% power to detect 10‐percentage‐point difference between groups in the proportion of women who used hormonal contraception for 6 months or longer, needed 600 women; with expected follow‐up 75%, planned to enroll 800
Participants General with N: 805 young women, 14 to 18 years old
 Source: reproductive health clinic for adolescents and young adults
 Inclusion criteria: not pregnant or trying to become pregnant; had sex in the last 3 months; no consistent hormonal contraception for 3 months and no IUD or contraceptive implant
 Exclusion criteria: no information
Interventions Study focus: improve contraceptive use; reduce unintended pregnancy and STI
Theory or model: motivational interviewing; Health Belief Model
  1. Intervention: intense phone follow‐up after initial visit; 9 calls planned (1 per month for 6 months then every 2 months for 6 months); addressed effective use of contraceptives and superiority of hormonal methods over condoms for preventing pregnancy

  2. Comparison: usual care (no phone follow‐up)


Duration: 12 months
Outcomes Primary: hormonal contraceptive use at last sex, condom use at last sex, self‐reported pregnancy; completed online at youth center or phone survey
 Secondary: no information
 Additional data from investigator (2010): pregnancy rates by group (self report and clinic charts); effect sizes and P values for outcomes without detail in report
Follow‐up: 6, 12, 18 months after baseline
Notes Analysis: multiple linear and logistic regression repeated measures; adjusted for differences between groups
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number generator; participants stratified by age
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Research team blind to group composition until after analysis of primary hypothesis.
Presume no blinding of participants or providers; not feasible due to type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Outcome assessor unaware of group assignment, except for final follow‐up, which included questions about intervention
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up: 6 months 22%, 12 months 26%, 18 months 25%; reportedly did not differ by group
 No N per group for assessments