Boyer 2005.
Methods | Cluster randomized trial: platoons were assigned to study groups. Number of platoons not specified (likely about 30, given 50 to 75 recruits in each platoon and overall sample size) Location: most likely California and South Carolina (USA) Time frame: recruitment June 1999 to June 2000 Sample size calculation (and outcome of focus): originally 477 per group to assess decreasing STI by 6%. Increased to 568 per group to address cluster effect, then increased to 1000 per group since half of participants would be stationed where STI and pregnancy screening not be possible at follow‐up. |
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Participants | General with N: 2157 women Inclusion criteria: female Marine recruits in training Exclusion criteria: no mention | |
Interventions | Study focus: preventing STI and unplanned pregnancy Theory or model: Information‐motivation‐behavioral (IMB) skills model
Duration: 12‐week intervention |
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Outcomes | Primary: unplanned pregnancy (tested); frequency of condom use; frequency of contraceptive use
Secondary: NA Follow‐up: 14 months after baseline |
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Notes | Additional data from investigator: number of events and group size for pregnancy and condom use | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table established before study start |
Allocation concealment (selection bias) | Low risk | Platoons identified prior to randomization; female Marine recruits in platoons eligible |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Platoons informed of group assignment after enrollment and baseline assessment; blinding not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) | Unclear risk | No mention |
Outcome measures | Unclear risk | Unplanned pregnancy by test; contraceptive use by self‐report |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: 38% loss for questionnaire data and 59% loss for pregnancy data (due to deployments); study groups were similar. |
Other bias | Low risk | Analysis for cluster randomized trial: robust standard errors using Huber‐White sandwich estimator in regression models. Independent variables were intervention group, sexual history, and time between assessments. |