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 |
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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
Duration: 12 months |
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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 |
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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 |